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Invitations: Speech (1) [5 of 11] [1991]
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Invitations: Speech (1) [5 of 11] [1991]
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Originally Processed With FOIA(s): foia Number: 2005-0336-F 2005-0336-F FOIA MARKER This is not a textual record. This is used as an administrative marker by the George Bush Presidential Library Staff. Record Group/Collection: George H.W. Bush Presidential Records Collection/Office of Origin: Science and Technology Policy, Office of (OSTP) Series: Bromley, D. Allan, Files Subseries: Correspondence Files OA/ID Number: 62016 Folder ID Number: 62016-005 Folder Title: Invitations: Speech (1) [5 of 11] [1991] Stack: Row: Section: Shelf: Position: 0 0 0 0 "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121252 SPEECH: YES NO FROM: GRAY, Paul E.: MIT DATE OF EVENT: 05/31/91 LOCATION OF EVENT: MIT, CAMBRIDGE, MASSACHUSETTS TIME OF EVENT: 04:30PM SUBJECT: INVITATION TO GIVE THE CLOSING LECTURE AT A TWO-DAY SYMPOSIUM HONORING VANNEVAR BUSH. RSVP: 05/13/91 CONTACT PERSON: PROF. HARVEY SAPOLSKY CONTACT NUMBER: INVITATION ACCEPTED? NO COPIES TO: REMARKS: Marian nice write one say will since I be think aut of DAB country knows She Make Gray Basya DATE OF LETTER: 04/23/91 DATE RECEIVED: 04/29/91 FILE: P. INVITATION - Speech 9121252 MASSACHUSETTS RECEIVED 91 APR 29 P12 11 INSTITUTE OF OFFICE OF THE CHAIRMAN OF THE CORPORATION CAMBRIDGE, MASSACHUSETTS 02139 ROOM 5-205, 77 MASSACHUSETTS AVENUE TELEPHONE 617-253-4665 OFFICE THE DIRECTOR April 23, 1991 Dr. Allan Bromley Special Assistant for Science and Technology to the President The White House Washington, DC 20506 Dear Allan: I would like to invite you to give the closing lecture at a two-day symposium honoring Vannevar Bush that MIT is holding May 30-31, 1991. The symposium which is part of the inaugural series for MIT's new president, Charles Vest, has as its theme "Remembering the Past and Shaping the Future of American Science Policy." The session you would give is scheduled for Friday, May 31, 1991, at 4:30 p.m. and will be open to the MIT community. It would be followed by a private reception and dinner if that is convenient for you. Vannevar Bush did so much to establish the policies that have guided the development of American science and technology over the last 50 years. Inevitably though these policies will change. We are hoping that you will describe some of the changes the administration prefers. Attached is a program outline for the symposium. Professor Harvey Sapolsky is coordinating the event. He will call your office in a few days to determine whether or not you can participate. Sincerely yours, Sharl Paul E. Gray PEG:fg Enclosure President Charles M. Vest Inauguration Series THE VANNEVAR BUSH CENTENNIAL SYMPOSIUM Remembering the Past and Shaping the Future of American Science Policy Sponsored by The MIT Defense and Arms Control Studies Program Massachusetts Institute of Technology Cambridge, Massachusetts May 30-31, 1991 VANNEVAR BUSH SYMPOSIUM As one of the activities marking the inauguration of Charles Vest as President of the Massachusetts Institute of Technology, the MIT Defense and Arms Control Studies Program is arranging a symposium on May 30-31, 1991, to commemorate the science policy contributions of Vannevar Bush. the symposium is entitled "Remembering the Past and Shaping the Future of American Science Policy" and is intended to describe the system of government- science relations that Bush helped establish and to chart the significant changes that system is currently undergoing. The official leader of American science and engineering during the Second World War, Bush helped formulate the policies that have guided engineering education, the federal government's support of basic research, and the generation and utilization of technical knowledge for America's military and industry since then. In all of these fields, Bush sought to shape the future. The Bush Centennial Year, slightly elongated, provides opportunity to reflect on his initiatives and to consider what needs to be done today if the policy challenges of the future are to be met. Bush had a life of considerable achievement. He invented or helped invent several precursors to modern computers, a justifying typewriter, a phototypesetting machine, submarine detection 1 devices, and anti-aircraft fire control mechanisms. As director of the Office of Scientific Research and Development during the Second World War, he supervised the atomic bomb project, the development of radar, and hundreds of other contributions of science and engineering to victory. Bush helped found the firm that evolved into the Raytheon Corporation and served on several corporate boards, including Merck and Company, where he became Chairman, and AT&T. At M.I.T. he was Professor of Electrical Engineering, the first Dean of Engineering, Vice President, Chairman and Honorary Chairman of the Corporation. His contribution to government in addition to his wartime service included chairmanship of the National Advisory Committee on Aeronautics and offering recommendations that led to the establishment of the National Science Foundation. 2 VANNEVAR BUSH SYMPOSIUM May 30-31, 1991 Program May 30 Introduction 9 a.m. Charles M. Vest Welcome MIT President Howard Johnson Bush and MIT MIT David Hamburg Science Policy from President, Bush to Bush and Carnegie Corporation Beyond Session I: The Civilian Role in Military R & D Jack Ruina Chair MIT Harold Sorenson Vice President, MITRE Michael Dennis National Air and Space Museum Alex Roland Duke University Rod Nichols Carnegie Commission Lunch MIT Faculty Club * Dennis J. Picard Chairman and Chief Executive Officer, Raytheon Walter Rosenblith MIT 3 May 30 2-4 p.m. Session II: National Policy for Basic Research Carl Kaysen Chair MIT Daniel J. Kevles California Institute of Technology David Robinson Carnegie Commission Harvey M. Sapolsky MIT Bruce Smith Brookings Institution Dinner MIT Museum Mitch Kapor "As We May Think" Formerly, Lotus Charles M. Vest MIT President Jay Keyser MIT 4 May 31 10 a.m. - Noon Session III: Private and International Sponsorship of R & D Michael Dertouzos Chair MIT Michael Schrage LA Times/Washington Post Robert Reich Kennedy School Suzanne Berger MIT Eugene Skolnikoff MIT Lunch MIT Faculty Club * P. Roy Vagelos Chief Executive Officer, Merck Lester Thurow, Host Dean, MIT School of Management May 31 2-4 p.m. Session IV: Designing Engineering Education for the Future Joel Moses Chair Dean, MIT School of Engineering Gordon Brown retired Dean, MIT Paul Penfield MIT Granger Morgan Carnegie Mellon Kent Bowen MIT 5 "CORRESPONDENCE TRACKING" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121216 FROM: MARCHESE, Jim: UNIVERSITY OF WISCONSIN-EAU CLAIRE 715/832-0301 TO: DR. BROMLEY July DATE OF CORRESPONDENCE: 04/17/91 Eau Claire, Wisc. SUBJECT: REQUEST FOR A KEYNOTE SPEAKER WITH A THEME OF SCIENCE, TECHNOLOGY AND EDUCATION TO EXCITE YOUNG PEOPLE TO PURSUE SCIENCE AS A CAREER. ASSIGNED TO: D. Allan Bromley ACTION REQUIRED: SENDER'S DUE DATE: OSTP DUE DATE: 05/07/91 DATE COMPLETED: 6/3/91 COPIES TO: Thomas Ratchford The WHITE HOUSE TRACKING #: CONTACT PERSON: REMARKS: 5/9/91 - Regutted to mr. marchase mn Marian Say that he will be too busy to do any additional tranding this summer. Sturs Tom cannot do. DATE RECEIVED: 04/23/91 FILE: P-INVITATION-SPEECH 9121216 UNIVERSITY OF WISCONSIN-EAU CLAIRE Education Outreach (715) 836-5843 EAU CLAIRE, WI 54702-4004 UVVEC RECEIVED SCIENCE SUMMER INSTITUTE 91 APR 23 All: 43 JULY 8-19, 1991 OFFICE OF THE DIRECTOR April 17, 1991 Dr. Allen Bromley The White House Washington, D.C. 20500 Dear Dr. Bromley: I am Jim Marchese, coordinator of guest speakers for the University of Wisconsin-Eau Claire Summer Science Institute for High Potential Students (note enclosed brochure). Our main goal is to excite young people to pursue science as a career. My need is for a dynamic keynote speaker with a theme of science, technology, and education. If you or any of your colleagues have any time to speak with these kids for about 45 minutes between July 8 to July 19, please contact me at your earliest convenience. Yours truly, Jim Marchese Jim Marchese 1220 Webster Ave. Eau Claire, WI 54701 715-832-0301 TWELFTH ANNUAL SCIENCE SUMMER INSTITUTE FOR HIGH-POTENTIAL STUDENTS JULY 8-19, 1991 UNIVERSITY OF WISCONSIN-EAU CLAIRE SPONSORED BY THE UNIVERSITY OF WISCONSIN-EAU CLAIRE EDUCATION OUTREACH AND UW-EXTENSION + + + t + + + + + + + + D escriptions of the Science Summer Institute Courses ACTION ASTRONOMY ELECTRONICS The course will focus on three components: classroom study of Build a robot and other electronic projects and study operating sky motion, planets, stars, moons, nebulae, galaxies, etc., in- principles and theory related to the devices to be built. "Hands cluding laboratory work and planetarium use; telescope-building on" lab study of basic electric, electronic and digital circuits will where students will assemble their own 6-inch, reflecting complement construction of various breadboard projects in- telescope at a cost of only $185 for the components (about 1/4 cluding a seven-segment LED readout. An electronic multitester the cost of commercial units with comparable quality); sky ob- will be assembled as well as the robot. The student will have the serving sessions to learn telescope use and become familiar with robot, multitester and an electronic lab kit involving 30 different sky objects, constellations, star charts, etc. In total, the course experimental circuits to take home. Special equipment fee is provides a comprehensive introduction to an exciting field of $120.00. science. Telescope fee is $185.00. DATE PARTIAL ADVANCED DIGITAL JANGLES ELECTRONICS This is a follow-up course to "Action Electronics," physics or other basic electronics courses. The students will construct basic logic gates, shift registers, digital counters, multiplexers, A to D converters, and interface TTL logic to discrete devices. Each stu- dent will also build a digital logic probe, a programmable microprocessor, and a digital clock to take home. Special equip- ment fee is $165.00. AVIATION SCIENCE "Aviator" enthusiasts are invited to experience the science-related challenges of general aviation pilots. Ground School topics in- clude aerodynamics of flights, radio navigation, instrumentation, cross-country flight planning, instrument landing systems, private pilot license written exam practices, and meteorology for pilots. Also included are airplane ownership information, using personal computers for simulated flight, and careers in aviation. A short flight and field trip are offered at the Eau Claire County Airport fixed base operator. MEDICAL BIOLOGY PHYSICS This course provides an introduction to the anatomy and Students will be introduced to electronics and optics, especially physiology of the human body through "hands on" activities, lasers. Laboratory projects will be featured. Topics include rela- experiments and group problem-solving in the laboratory. Com- tionships of voltage, current and resistance, energy forms, parisons between healthy and diseased states for a number of amplifiers and integrated circuits, meters and oscilloscopes, selected body systems will be emphasized. Some of these might lenses, mirrors, lasers and laser projects. (Students should bring include: eating disorders, Lyme disease, heart disease, AIDS, a calculator.) osteoporosis and skeletal trauma and the process of aging. Field trips and visits by experts in these areas will be included. STUDENT APPLICATION PROCEDURES QUALIFICATIONS Complete both sides of the application form and send it with a deposit of $50 ($25 non-refundable) directly to 12-16 years of age; minimum education, completion of Education Outreach Office. Receipt date of application sixth grade by June 1991 except for prerequisites for cer- form establishes consideration priority. tain courses. Ask two persons who know the applicant to write letters recommended by two persons (e.g., science or sixth grade of recommendation using the student qualification list. teacher and a coordinator for gifted/talented, counselor Have the letters sent directly to: Education Outreach Office, or other appropriate person) indicating that the student: Brewer 55, UW-Eau Claire, Eau Claire, WI 54702-4004; (715) 836-5843. (1) scores at the 90th percentile or above in math and science on standardized tests Applications will be considered on a first-come, first-served basis (2) can handle abstract concepts well and work 2 or more upon receipt of the application form. Teachers or coordinators years above grade level in the topic selected for study should be asked to write their letters as soon as possible and (3) can function successfully in a group for instruction and should be provided with addressed stamped envelopes. It is the dorm living (if student is not living at home) student's responsibility to be sure the letters are sent. (4) can maintain high motivation and interest in topic selected Applications will be reviewed by a committee of UW-Eau Claire for study. faculty when the application form and two letters of recommen- dation are on file. Applicants will be notified of acceptance desire to study academic science and/or computers is the promptly. main reason for the student attending the Institute. Applications are accepted starting January 15, 1991; the applica- tion deadline is April 1, 1991. Most classes are held in Phillips Science Hall on lower campus. Housing is in Towers Hall on upper campus. APPLICATION FORM SCIENCE SUMMER INSTITUTE - 1991 Name: Sex: M F Birthdate: Soc. Sec. # Address: City, State & Zip Phone Numbers: Home ( ) Office: Father ( ) Mother ( ) Name(s) of Parent(s): First Second Grade In Course Name: Choice Choice School (90-91) School Attended: Name Address City State Zip Make $50 deposit check ($25 non-refundable) payable to UW-Eau Claire and return this application and check to: Education Outreach Office, Brewer 55, UW-Eau Claire, Eau Claire, WI 54702-4004; phone (715) 836-5843. Application Deadline: April 1, 1991 Office Please complete other side of form before mailing. Use Only OVER FEES Costs for the two-week Institute are: $230.00 Room (double occupancy) and 3 meals daily, supervision, recreational activities, sports DORM LIFE AND $250.00 Instruction, field trips, resource persons, instruc- SCHEDULES tional materials, and an Institute T-shirt. (Day students pay only this fee.) Students in the Science Institute may choose to commute or live in dormitories at UW-Eau Claire and eat in adjoining dining areas. $480.00 Total Costs (Telescope parts for the Astronomy The living fee includes 12 nights lodging and three meals daily; course and equipment fees for the Electronics that is, the nights of July 7-18 and meals from dinner on July 7 courses are extra.) through lunch on July 19. Eau Claire area students may live in the dorms or live at home and attend on a day basis. A deposit of $50 ($25 non-refundable) is due with registration. Payments may then be made at a schedule of your choice. The Students will be supervised by an adult resident coordinator and total fees are due no later than May 31, 1991. resident college student counselors at meals, during sports and other activities and events and in the evenings. A typical week- Financial Aid: Some partial tuition grants are available through day schedule follows: the Association for High-Potential Children, Inc. Tuition grants are based on need. To be considered, please request a form from the Education Outreach office. Deadline for tuition grant applica- Breakfast 8:00 a.m. tions is April 1, 1991, and notification of grant distribution will Class 9:00 a.m.-Noon be within two weeks. Should we be unable to award you the re- Lunch Noon-1:00 p.m. quested assistance, and you choose not to attend the Institute, Class 1:00-3:00 p.m. your $50 deposit will be refunded. Recreation/Study 3:00-5:00 p.m. Dinner 5:00-6:00 p.m. Cancellations and Refunds: UW-Eau Claire reserves the right to Study/Recreation/Free 6:00-10:00 p.m. cancel any program due to insufficient enrollment. In this event, registrants will be notified and offered full refund or the oppor- Activities, which are arranged between 3 and 5 p.m. and after tunity to enroll in an alternative class. In all other cases, a dinner for students who live in the dorms, will include sports, registrant who chooses to cancel will be charged a handling fee excursions, and cultural events such as plays and concerts. of $25.00 for cancellations prior to April 1 and $50.00 for cancella- Facilities for swimming, bowling and exercise will be available tions between April 1 and June 21. These amounts will be sub- in addition to outdoor activities. Students will have study time tracted from any refunds requested by registrants who cancel. set aside for the after-class work related to their classes. They will After June 21, refunds will be granted only for medical reasons also have access to University libraries and computers. and must be accompanied by a doctor's signed statement of explanation. A special event will be planned for the weekend of July 13-14. There will also be picnics, competitions and other group activities. Those students who find it difficult to return home on Friday afternoon may choose to remain in the dormitory Friday night for an additional fee. Arrangements must be made before the start of the Institute. Contact the Education Outreach Office for more details. TRANSPORTATION Students must provide their own transportation to and from the Institute. There will be pick-up and delivery available to the Eau Claire bus station and the Eau Claire County airport. Please provide the information requested below about the persons who are recommending the student for the Science Summer Institute. Previous Student: Year Class No new letters needed. Science Teacher/ Classroom Teacher: Name Title Address City State & Zip Phones: School ( ) Home ( ) Coordinator/Counselor: Name Title Address City State & Zip Phone: School ( ) Home ( ) AMB EXPERIMENTAL CHEMISTRY PSYCHOLOGY This course allows students to investigate some of the basic con- This course has two aims: 1) to help students learn to apply the cepts of chemistry and its applications in our environment and scientific method to the analysis of human behavior; and 2) to our lifestyles. Students will spend most of their time in the teach students to think critically about what we do and do not laboratory doing and learning from experiments. Subjects include know about human behavior. A strong emphasis on "hands on" basic atomic structure, chemical properties and reactions, laboratory experiences teaches the scientific method. Structured methods of analysis, energy in reactions and practical applica- thinking exercises, discussion, and debate foster critical think- tions in the chemistry of foods, medicinal products and plastics. ing about major topics such as learning, motivation, perception, personality, thinking, and social group behavior. VETERINARY MEDICINE The course is designed as an introduction to veterinary medicine and includes a combination of laboratory and discussion. Topics include reproduction and the genital-urinary system, hematology, parasitology, radiology, anaesthesiology and surgery. Students will have "hands on" experiences working in the veterinary laboratory and observing in surgery. Field trips will be a special part of the learning experience. Class will meet on the campus and at the Eau Claire Animal Hospital or other local animal hospitals. (Prerequisites: completion of eighth grade and a basic biology/life science course in junior/senior high school.) SUPERCOMPUTER APPLICATIONS-TECHNOLOGY ADVANCED LOGO- IN THE SCIENCES COMPUTERS BEYOND Here is a special opportunity to work directly with a supercom- THE TURTLE puter. An overview of the Cray X-MP supercomputer will be shared through pictures, slides, and examination of the internal Much like chess, the Logo programming language takes only structure of this powerful machine. Questions about how it works minutes to learn, but a lifetime to master. This class will include and what makes it a supercomputer will be explored. Then na- some comparisons of procedural and non-procedural languages tional networking with Lawrence Livermore National Laboratory, and compiled and interpretive languages. Students will use the California, will be explained and experienced. Students will then Logo language to learn advanced programming techniques such work on PC's to improve skills in problem-solving and creativi- as divide-and-conquer problem solving, modular programming, ty and, utilizing networking with the Cray X-MP, experience how recursion and data structures. Challenges to use these techniques technology can enhance their solutions. Applications will be in will be in areas of "Visual Modeling," artificial intelligence, and the subject areas of graphics and ray tracing, global warming, graphic simulation. (Prerequisites: Formal programming ex- and particle physics. Students will experience being a "scientist" perience in any language with some knowledge of a procedural and learn how technology helps science. language. Student must be familiar with procedures, functions, parameters, and return values.) EXPERIMENTAL GEOLOGY Through hands-on activities, model constructions and field trips, this course introduces methods for studying geological materials and processes. Students will explore the world of rocks, minerals and fossils and learn about earthquakes, planets, plate movements, evolution and earth processes. Projects include use of maps and compass, chemical and physical tests of minerals, identification of rocks and minerals, field trips to local outcrops, collection and extraction of fossil specimens, mapping planetary terrains, and studying an actual earthquake record. Participating students will also examine problems related to natural hazards, origins and limitations of our geological resources and impact of human activities on earth's environment. G eneral Information About the Institute T he twelfth annual Science Summer Institute for to gain new knowledge and to make lasting friendships with 12- to 16-year-olds is designed to provide opportunities others who have similar interests and aspirations. In addition, for high-potential students to explore a science or students have opportunities to use the facilities of a university science-related topic intensively for a two-week period. campus and to interact with outstanding instructors from the Also, students will have opportunities to interact with specialists University of Wisconsin-Eau Claire, area school faculties and the in several fields of science, mathematics and computers. community. The 1991 Science Summer Institute will offer a choice of 12 Classes for the Institute will be held on the UW-Eau Claire cam- courses-astronomy, aviation science, medical biology, action pus. Resident students will live in the University dormitories electronics, advanced digital electronics, chemistry, physics, under appropriate supervision. After-class activities will include veterinary medicine, experimental psychology, experimental sports, cultural events and trips. Both residential and day students geology, advanced logo and supercomputer applications. Each are welcome. course will include 50 hours of instruction and each participant will select one course for study. Class limit is 18 participants. Students can apply for the Institute by completing the applica- tion form in this brochure and arranging for two letters of recom- Objectives for each course include opportunities for students to mendation. Letters are requested to help ensure a successful ex- learn about the knowledge base in their area of study, to learn perience for each student. Parents, teachers and counselors are the methodology of carrying out scientific investigation in the encouraged to call the Education Outreach Office if they have laboratory and field, to work with instruments and techniques questions. and to apply the knowledge. Course descriptions, living and instruction costs, student This Institute, in its twelfth year, has become a model for pro- qualifications and application procedures are presented elsewhere grams in Wisconsin and other areas. It offers students unusual in this brochure. In 1990, 209 students from 10 states attended and inspiring opportunities to develop their academic potential, the Institute. You are invited to apply in 1991! Direct inquiries to: Education Outreach Office, Brewer 55, UW-Eau Claire, Eau Claire, WI 54702-4004 Telephone (715) 836-5843 Science Summer Institute Non-Profit Org. Education Outreach U.S. Postage Brewer Hall 55 PAID University of Wisconsin-Eau Claire Eau Claire, WI 54702-4004 Permit No. 219 Eau Claire, WI TWELFTH ANNUAL SCIENCE SUMMER INSTITUTE FOR HIGH-POTENTIAL STUDENTS July 8-19, 1991 "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121360 SPEECH: YES NO FROM: NASH, Martin, Forrest Anthony, Frank Kung and Bruce Mackler: ASSOCIATION OF BIOTECHNOLOGY DATE OF EVENT: 05/14/91 LOCATION OF EVENT: WASHINGTON, D.C. TIME OF EVENT: 01:15PM SUBJECT: INVITATION TO BE THE KEYNOTE LUNCHEON SPEAKER AT THEIR ANNUAL MEETING. RSVP: 05/08/91 CONTACT PERSON: DR. BRUCE MACKLER CONTACT NUMBER: 202/861-1539 INVITATION ACCEPTED? YES NO COPIES TO: LIFE SCIENCES REMARKS: Reqrests conveyed to Bruce Mackler by KenYalc. Shic Ism (05/09/91) DATE OF LETTER: 04/23/91 DATE RECEIVED: 05/08/91 FILE: P. INVITATION-SPEECH 9121360 RECEIVED Association of Biotechnology Companies 91 MAY 8 Alo 54 President: MARTIN NASH Regentech, Inc. President-Elect: 'OFFICE OF THE THOMAS WIGGANS April 23, 1991 DIRECTOR Serono Laboratories, Inc. Vice President: FRANK F.C. KUNG, Ph.D. Genelabs, Inc. Secretary: DOUGLAS A. DOERFLER The Honorable D. Allan Bromley Life Technologies, Inc. Assistant to the President for Treasurer: EDWARD A. BARTKO, C.P.A. Science and Technology Coopers & Lybrand Executive Office of the President Past Presidents: GRAHAM STRACHAN Washington, D.C. 20500 Allelix Biopharmaceuticals, Inc. (Canada) ROBERT J. JUDGE Charles River Biotechnical Services, Inc. Dear Dr. Bromley: SAMUEL H. RONEL, Ph.D. Interferon Sciences, Inc. Executive Director: Thank you for your strong and ongoing support of the U.S. PAMELA J. BRIDGEN, Ph.D., M.B.A. biotechnology industry. We appreciate the significant role you and your staff General Counsel: BRUCE F. MACKLER, Ph.D., J.D. play in the oversight and administrative policy towards our industry. Directors: Science, particularly NIH and NSF funded research are critical to the FORREST H. ANTHONY, M.D., Ph.D. Quality Biotech, Inc. continual innovation and growth of biotechnology. MARK D. DIBNER, Ph.D. North Carolina Biotechnology Center For this reason, we would like to invite you, on behalf of the RICHARD K. KOEHN, Ph.D. Center for Biotechnology Association of Biotechnology Companies, to be a keynote luncheon speaker State University of New York at our annual meeting which will be held in Washington, D.C., May 13-16, GEORGE W. MASTERS Hemosol, Inc. (Canada) 1991. Your address is tentatively scheduled for 1:15 p.m. on Tuesday, May RUSSELL C. MCLAUCHLAN 14th, but we would, of course, be willing to work with you to accommodate Immunomedics, Inc. MARVIN L MILLER your schedule. Lederle Laboratories Division American Cyanamid Company SUSAN MICHAL SMITH By way of background, ABC is a not-for-profit trade association with Medimorphics, Inc. over 250 members consisting of: biotechnology and pharmaceutical companies; academic and state biotechnology centers; not-for-profit and government-affiliated entities; and, other organizations interested in biotechnology. ABC was founded to represent the unique and diverse interests, both business and scientific, of small biotechnology companies. In addition to the areas mentioned above, other areas of interest to ABC are Federal research support for biotechnology, small business issues, Federal regulation of biotechnology, research and development tax credits, and the European Community 1992. We have attached a brochure on ABC for your information. 1666 Connecticut Avenue, NW, Suite 330 Washington, DC 20009-1039 USA (202) 234-3330 Telefax (202) 234-3565 Page two Dr. Bromley April 23, 1991 Based upon registration at previous meetings, attendance at the Annual Meeting is expected to number about 600. Registration is open to all in the biotechnology industry and will include ABC members, officials and staff of Federal agencies, the press (including the trade press), and members of other scientific associations. If we can be of any assistance or answer any questions, please feel free to contact Dr. Bruce F. Mackler at 202-861-1539. We hope that your schedule will permit you to join us. Thank you for your consideration of this matter and we look forward to hearing from you. Sincerely, Marth Nash ,Hemthony Martin Nash Forrest H. Anthony, M.D., Ph.D. President, ABC and President-Elect, ABC and President President Regentech, Inc. Quality Biotech Inc. Justing Bruce 7 Macblex Frank F. C. Kung, Ph.D. Bruce F. Mackler, Ph.D., Esq. Vice President, ABC and General Counsel, ABC and President & CEO Partner Genelabs, Inc. Baker & Hostetler "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121233 SPEECH: YES NO FROM: Verrick French DATE OF EVENT: 05/15/91 LOCATION OF EVENT: HOTEL WASHINGTON TIME OF EVENT: 06:00PM SUBJECT: Speak to the Board of Directors and membership ofthe International Electronics Manufacturers and Consumers of America RSVP: 05/01/91 CONTACT PERSON: Verrick French CONTACT NUMBER: 202 783-7276 INVITATION ACCEPTED? YES NO COPIES TO: REMARKS: Marian Shin 5/15/91 - Regutted to Tracy Gilman! DATE OF LETTER: 04/23/91 DATE RECEIVED: mn FILE: P. Invitation - Speech 9121233 International Electronics Manufacturers and Consumers of America, Inc. Suite 1260, The Willard, 1455 Pennsylvania Ave., N.W., Washington, D.C. 20004 Telephone Facsimile (202) 783-7276 (202) 783-4345 Keith H. Smith Executive Director April 23, 1991 Honorable D. Allan Bromley Assistant to the President for Science and Technology Room 360 Old Executive Office Building Seventeenth Street and Pennsylvania Avenue, N.W. Washington, D.C. 20506 Dear Dr. Bromley: I am writing to invite you to speak briefly and informally during DIRE "OFFICE the 91 APR 25 rescheduled annual meeting of the Board of Directors and membership of the International Electronics Manufacturers and Consumers of America RECEIVED (IEMCA), at any time between 6:00 and 8:00 p.m. on Wednesday, May. 15, 1991, or 8:30 a.m. and 1:30 p.m. on Thursday, May 16, 1991, at the Hotel Washington, 15th Street and Pennsylvania Avenue, N.W., here in town. IEMCA is an American trade association composed of the United States manufacturing subsidiaries of 18 major overseas electronics companies, including, for example, Fujitsu America, Hitachi America, the Matsushita Electric Corporation of America, Mitsubishi Electronics America, and the Sony Corporation of America, plus the National Office Machine Dealers Association, and the J.C. Penney Company. During the past decade, all of IEMCA's manufacturing members have established substantial and rapidly expanding plants in the United States which produce virtually every kind of commercial and consumer electronics product. Collectively their American investment exceeds an estimated $35 billion, their annual United States sales exceed $30 billion, and their current American employment is over 175,000 people. In addition, the organization includes a dozen well-known Washington law firms and consulting firms retained by IEMCA's members. IEMCA's members are committed to freer international trade, in general, and committed, in particular, to an improved trading relationship between the United States, Japan, and Europe. Their specific concerns include, for example, the Section 301 process, the structural impediments initiative, foreign investment in the United States, intellectual property law and regulation, antidumping law and regulation, international tax policy, re-extension of "fast-track" authority, the GATT Uruguay Round, and the proposed North American Free Trade Agreement. A3819 MDTTOO onl 6011901 to aiemwano bits 2101 abinosta T 100. W.W. jove SNAH 517. X 30 - 'II 3 11 DATE A.C.B 03 HILHOWH International Electronics Manufacturers and Consumers of America, Inc. The Honorable D. Allan Bromley April 23, 1991 Page Two I will be happy to provide you with additional information about IEMCA, its officers and members, and the event on May 16. Sincerely, Verrick Vick O. French President, French & Company, and Consultant to IEMCA FOUR UND SDU 25% COTTON FIDER "CORRESPONDENCE TRACKING" TYPE: INFORMATION DOCUMENT NUMBER: 9121234 FROM: SCHRIESHEIM, A. TO: DR. BROMLEY DATE OF CORRESPONDENCE: 04/22/91 SUBJECT: A THANK YOU FOR ACCEPTING TO SPEAK ON JUNE 20 AT THE DIRECTOR'S COLLOQUIUM AT ARGONNE NATIONAL LABORATORY ASSIGNED TO: D. Allan Bromley ACTION REQUIRED: SENDER'S DUE DATE: OSTP DUE DATE: DATE COMPLETED: COPIES TO: WHITE HOUSE TRACKING #: CONTACT PERSON: REMARKS: DATE RECEIVED: FILE:P INVITE-SPEECH FOLLOW-UP 9/2/234 ARGONNE NATIONAL LABORATORY TELEPHONE 312/972-3872 9700 SOUTH CASS AVENUE, ARGONNE, ILLINOIS 60439 FAX 312/972-3679 April 22, 1991 Dr. D. Allan Bromley Assistant to the President for Science and Technology Executive Office of the President Washington, DC 20506 Dear Allan, I'm delighted that you will be able to visit Argonne on June 20th to speak at the Director's Colloquium. It will be a wonderful opportunity for our staff and a particular personal pleasure for me. Dr. Valentin, who chairs the Colloquium committee, has been in contact with your office and will coordinate the details of your visit. I'm also looking forward to joining you on the upcoming visit to BRECER the and will be talking with you then. CE THE Soviet OR R 25 Union A10 RECEIVED Regards, RAV/AS:sam A. Schriesheim, Tel Director U.S. DEPARTMENT OF ENERGY THE UNIVERSITY OF CHICAGO "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121153 SPEECH: YES NO FROM: WILLIAMS, Susan: BRACY WILLIAMS & COMPANY DATE OF EVENT: 05/01/91 LOCATION OF EVENT: 1625 M STREET N.W., WASHINGTON TIME OF EVENT: 10:00AM SUBJECT: INVITATION TO BE THE FEATURED SPEAKER AT THE WESTERN FUELS ASSOCIATION'S ANNUAL BOARD OF DIRECTORS MEETING ON THE SUBJECT OF GLOBAL WARMING. RSVP: 04/22/91 CONTACT PERSON: CONTACT NUMBER: INVITATION ACCEPTED? NO COPIES TO: Thomas Ratchford Nancy Maynard REMARKS: 4/30/91 Regretted! mr DATE OF LETTER: 04/17/91 DATE RECEIVED: 04/17/91 FILE: P. INVITATION-SPEECH TRANSMITTED FROM 2026 94805 i 04.17.91 15:54 P.02 * 9121153 Bracy Williams & Company Government & Public Affairs Consultants RECEIVED April 17, 1991 91 APR 17 P5: P 07 OFFICE OF THE Dr. Allan D. Bromley DIRECTOR Assistant to the President for Science and Technology old Executive Office Building 17th St. and Pennsylvania Ave., N.W. Washington, D.C. 20506 Dear Dr. Bromley: I am writing on behalf of the Western Fuels Association to invite you to be the featured speaker at its annual Board of Directors meeting to be held in Washington on Wednesday, May 1, 1991. The Western Fuels Association is a national fuel supply cooperative operating on a not-for-profit basis and providing fuel supply services to consumer-owned utilities in the Rocky Mountain West, the Great Plains, and the Southwest. As both a coal producer and consumer, the Western Fuels Association has been deeply involved with the issue of global climate change. The Association has worked with members of the scientific community in an attempt to promote more balanced, broad- based and objective research on the issue. To that end, the Association is extending this invitation for you to speak to its Board on the subject of global warming. The meeting will be held at 10 a.m., Wednesday, May 1, 1991, at the Western Fuels Association offices at 1625 M Street N.W., in Washington. I understand that there are many demands for your time but we at the Western Fuels Association are hopeful that you can attend and give us your views of this increasingly important subject. Sincerely, Susan Williams 1000 Connecticut Ave., N.W. Suite 304 Washington, D.C. 20036 (202) 659-4805 FAX (202) 331-3247 TRANSMITTED FROM 2026 94805 i 04.17.91 15:54 P.01 * Bracy Williams & Company Government & Public Affairs Consultants TELECOPY COVER SHEET 2 pages, including this page TO: Allen Bromley Susan Williams FR: If you do not receive all pages, or if you have further questions, please call: (202) 659-4805. 1000 Connecticut Ave., N.W. Suite 304 Washington, D.C. 20036 (202) 659-4805 FAX (202) 331-3247 "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121126 SPEECH: YES NO FROM: TRULL, Frankie L.: NABR DATE OF EVENT: 05/20/91 LOCATION OF EVENT: CAPITAL HILTON HOTEL, 16TH & K STREETS, N.W. TIME OF EVENT: 09:00AM SUBJECT: INVITATION TO OPEN THE NATIONAL ASSOCIATION FOR BIOMEDICAL RESEARCH'S 1991 ANNUAL CONFERENCE. RSVP: 04/30/91 CONTACT PERSON: CONTACT NUMBER: INVITATION ACCEPTED? YES NO COPIES TO: Dr. Henderson REMARKS: Morion write them that DAB cannot doit but "I with D.A. Hend erscn's office to inguire about his understand that you tan been in intoct availability. I tope he can meet with Shre you." DATE OF LETTER: 03/29/91 DATE RECEIVED: 04/16/91 FILE: P. INVITATION-SPEECH 9/2/126 NABR NATIONAL ASSOCIATION FOR BIOMEDICAL RESEARCH RECEIVED March 29, 1991 91 APR 16 A10: 18 D. Allan Bromley, Ph. D. OFFICE OF THE Special Assistant to the President and DIRECTOR Director, Office of Science and Technology Policy Old Executive Office Building 17th Street and Pennsylvania Avenue, N.W. Washington, D. C. 20506 Dear Dr. Bromley: Please accept the National Association for Biomedical Research's invitation to open its 1991 annual conference on Monday, May 20 at 9:00 a.m. in the Capital Hilton Hotel, 16th and K Streets, N.W., Washington, D.C. The conference will be attended by representatives of Association member institutions which include 350 universities, medical and veterinary schools, academic and professional societies, and voluntary health organizations as well as pharmaceutical and other research intensive companies. The purpose of the conference is to discuss current legislative and regulatory activities affecting the use of laboratory animals in research, testing and education. Attendees will spend the second day of the conference visiting their Members of Congress. They would very much appreciate hearing your views on communicating with elected officials, federal agencies and the public concerning the process and needs of science. We do hope your crowded schedule will allow you meet and briefly address the NABR membership. I know that they would welcome the opportunity to hear your remarks, and also to thank you in person for your activities on behalf of science. My office will be in touch with yours to learn whether you will be able to attend. Thank you very much for considering our invitation; we hope to see you in May. Sincerely, Orankei L. Grull Frankie L. Trull President 818 Connecticut Avenue, N.W. Suite 303 Washington, D.C. 20006 (202) 857-0540 FAX (202) 659-1902 THE WHITE HOUSE WASHINGTON May 13, 1991 Dear Ms. Trull: Thank you for your letter of March 29, 1991, inviting me to open the NABR annual conference on May 20, 1991. I apologize for the much belated response. Unfortunately, due to scheduling difficulties, I will not be able to accept you kind invitation, as much as I would like to have done so. I understand that you have been in contact with Dr. D. A. Henderson's office to inquire about his availability. I hope he can meet with you. I appreciate your thinking of me and would like to offer my best wishes for a successful conference. Sincerely yours, Dorran Rromley D. Allan Bromley The Assistant to the President for Science and Technology Ms. Frankie L. Trull President National Association for Biomedical Research 818 Connecticut Avenue, N.W., Suite 303 Washington, D.C. 20006 "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121111 SPEECH: YES NO FROM: LAWSON, Richard L.: NATIONAL COAL ASSOCIATION DATE OF EVENT: 06/21/91 LOCATION OF EVENT: GREENBRIER HOTEL, WHITE SULPHUR SPRINGS, WV TIME OF EVENT: SUBJECT: REQUEST TO PARTICIPATE IN A MORNING BUSINESS SESSION TITLED, "ENERGY NEEDS & CLIMATE CHANGE POLICY OPTIONS FOR THE 90'S" OF THE NCA'A 74th ANNIVERSARY CONVENTION. RSVP: 04/29/91 CONTACT PERSON: DAN GERKIN CONTACT NUMBER: 202/463-2659 INVITATION ACCEPTED? NO COPIES TO: Thomas Ratchford Nancy Maynard Dr. Wong REMARKS: 4/16/91 Regutted to Shuly mr DATE OF LETTER: 04/11/91 DATE RECEIVED: 04/15/91 FILE: P. INVITATION-SPEECH 9121111 NATIONAL COAL COAL ASSOCIATION RICHARD L. LAWSON President (202) 463-2647 April 11, 1991 OFFICE DIRECTOR OF THE 15 A9: 38 CEIVED Mr. Allan Bromley Assistant to the President for Science and Technology Office of Science and Technology Policy Old Executive Office Building 17th Street & Pennsylvania Ave., N.W. Washington, D.C. 20506 Dear Mr. Bromley: The National Coal Association (NCA) is planning its 74th anniversary convention June 20-23, 1991, at the Greenbrier Hotel, White Sulphur Springs, WV. With the theme Coal: Freedom's Foundation, our program objective is to examine key energy and environmental policy issues, as well as the important link between coal and electricity. It is my pleasure to invite you to participate in a morning business session on June 21 titled, Energy Needs and Climate Change-Policy Options for the '90s. Our members would be most interested in your perspectives regarding the Administration's position on global climate change issues, congressional climate change initiatives, a status of the Intergovernmental Panel on Climate Change activities and its potential impact on U.S. energy policy development. Your prepared remarks should last approximately 20 minutes. As you know, NCA is the national trade organization for coal and represents the entire spectrum of the industry's producers--small, medium and large--as well as numerous major equipment manufacturers and suppliers, transporters, utilities and others interested in coal. Last year, NCA members produced approximately 65 percent of the nation's coal tonnage. I hope your schedule will allow you to join us and enjoy the magnificent facilities at the Greenbrier. If you have any questions or need additional information, please call me or Dan Gerkin (202) 463-2659. I hope to hear from you soon. Richard Sincerely, L.Lawron Richard L. Lawson 1130 Seventeenth Street, N.W. Washington, D.C. 20036-4677 (202) 463-2625 FAX: (202) 463-6152 "CORRESPONDENCE TRACKING" TYPE: INFORMATION DOCUMENT NUMBER: 9121115 FROM: VAN DOMELEN, John F.: WENTWORTH INSTITUTE OF TECHNOLOGY TO: DR. BROMLEY DATE OF CORRESPONDENCE: 04/09/91 SUBJECT: APPRECIATION FOR DR. BROMLEY'S PARTICIPATION IN THE ACADEMIC SYMPOSIUM. ASSIGNED TO: ACTION REQUIRED: SENDER'S DUE DATE: OSTP DUE DATE: DATE COMPLETED: COPIES TO: D. Allan Bromley WHITE HOUSE TRACKING #: CONTACT PERSON: REMARKS: DATE RECEIVED: 04/15/91 FILE: INVITATION SPEECH FOLLOWUP 9/2/115 RECEIVED Wentworth Office of the President 91 / APR 15 All: 16 Institute of Technology OFFICE OF THE DIRECTOR April 9, 1991 Dr. D. Allan Bromley Assistant to the President The White House Washington, D.C. 20506 Dear Dr. Bromley: I want to express my deep appreciation for your participation in our Academic Symposium - a highlight of the inaugural events. Your remarks were timely, warmly received and continue to spark lively and thoughtful discussion on campus. It is indeed a pleasure to welcome you to the Wentworth family. I will take advantage of your offer and will stay in touch. You deserve news about your alma mater and the progress it makes towards its goal of developing a new curriculum for the teaching of technology. Warm regards, John John F. Van Domelen President JVD/rs Mac#R16 XC: File Chrono A Associate and Bachelor Degree Programs. 550 Huntington Avenue, Boston, Massachusetts 02115 617-442-9010 "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121084 SPEECH: YES NO FROM: DAVIS, Irwin L.: UNIVERSITY HILL CORPORATION DATE OF EVENT: LOCATION OF EVENT: SYRACUSE, NEW YORK TIME OF EVENT: SUBJECT: REQUEST TO SPEAK AT THEIR ANNUAL MEETING (to be scheduled at your convenience in June). RSVP: 04/26/91 CONTACT PERSON: DAVID MANKIEWICZ CONTACT NUMBER: 315/475-7244 INVITATION ACCEPTED? (AA NO COPIES TO: Dr. Phillips REMARKS: DATE OF LETTER: 04/08/91 DATE RECEIVED: 04/12/91 FILE: P- INVITATION-SPEECH THE WHITE HOUSE WASHINGTON April 18, 1991 Dear Mr. Davis: Thank you for your letter of April 8, 1991, inviting me to speak at your Annual Meeting scheduled to be held in Syracuse in June. However, the number of requests I have received for the month of June is overwhelming, so as much as I would like to join you, I must regretfully decline. I appreciate your thinking of me and wish you a successful meeting. Sincerely yours, Donan D. Allan Bromley The Assistant to the President for Science and Technology Mr. Irwin L. Davis President University Hill Corporation 736 Irving Avenue Crouse Unit, East Wing, Room 252 Syracuse, New York 13210 9121084 University Hill James W. Maher, Chairman RECEIVED Corporation Irwin L. Davis, President David A. Mankiewicz, Executive Vice President 91 APR 12 A 9 : 48 OFFICE OF THE DIRECTOR April 8, 1991 Dr. Allan Bromley, President's Science Advisor Old Executive Office Building Room 358 Washington, D.C. 20500 Dear Dr. Bromley: The University Hill Corporation is a private, not for profit organization which seeks to encourage the growth and development of the University Hill area in Syracuse. The Corporation was created in 1963 and has among its members the major educational and medical institutions, businesses, religious organizations and others who are concerned with the future of University Hill. Our major institutional members include Syracuse University, the SUNY Health Science Center at Syracuse, the SUNY College of Environmental Science and Forestry, the Veterans Administration Medical Center and Crouse Irving Memorial Hospital. On behalf of the membership of the University Hill Corporation, I am asking you to speak at our Annual Meeting which would be scheduled at your convenience in June. Given the location of the major research institutions of the community within our area, our membership is extremely interested in the subjects of technology development and technology transfer, and using the scientific expertise of the institutions to stimulate economic development. We are now undertaking a cooperative effort with Cornell University, Syracuse University, and the business leadership of the Central New York area represented by the Metropolitan Development Association to create the "supercomputing corridor" between Cornell and Syracuse. This program seeks to take advantage of Cornell's supercomputing center (funded by NSF) and the parallel processing expertise at Syracuse (funded by DAPPA) 736 Irving Avenue - Crouse Unit - East Wing - Room 252 Syracuse, NY 13210 Tel: (315) 475-7244 to make Central New York one of the centers of the next generation of computer development. I would appreciate it if you could let us know if you could attend our meeting as our guest. We will have approximately 200 guests including the public and private leadership of Central New York, and the luncheon will be held at Syracuse University. If you or your staff have any questions, please feel free to contact David Mankiewicz or me at (315) 475-7244. Thank you for your consideration. Sincerely, Irwin L. Davis President CC: Hon. James Walsh Hon. Alfonse D'Amato H. Douglas Barclay "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121197 SPEECH: YES NO FROM: STENBAEK, Marianne: MCGILL DATE OF EVENT: 01/22/92 LOCATION OF EVENT: MONTREAL TIME OF EVENT: SUBJECT: INVITATION TO BE THE KEYNOTE SPEAKER AT THE OPENING PLENARY SESSION OF THE POLARTECH '92 CONFERENCE. RSVP: 05/06/91 CONTACT PERSON: CONTACT NUMBER: INVITATION ACCEPTED? YES NO COPIES TO: Dr. Phillips Thomas Ratchford REMARKS: DATE OF LETTER: 04/11/91 DATE RECEIVED: 04/22/91 FILE: P- INVITATION-SPEECH 9/2/197 McGill RECEIVED Centre for Northern Studies and Research McGill University 805 Sherbrooke Street West 2: 25 Tel.: (514) 398-6052 Burnside Hall Montreal Quebec, Canada Fax: (514) 398-8364 Room 720 H3A 2K6 Telex: 05 268510 OFFICE OF THE April 11, 1991 DIRECTOR Mr. D. Allan Bromley Science Advisor to the President and Director of the Office of S&T Policy Room 358 - Old Executive Office Bldg. White House Complex 17th & Pennsylvania NW Washington, DC 20506 Dear Mr. Bromley, On behalf of the executive organizing committee I want to take this opportunity to officially invite you to be a keynote speaker at the opening plenary session of the Polartech '92 conference. This very prestigious and multi-faceted event will take place in Montreal, January 22-25, 1992. Polartech '92 will involve some 400 to 500 participants from all the circumpolar countries as well as other countries interested in the development of polar technologies. There will be scholars, professionals, civil servants, entrepreneurs from these regions. The general theme of Polartech '92 is the development and commercial utilization of technologies in polar regions. The sub- themes are: a. Application of Polar Technology b. Offshore and Onshore Hydrocarbon Technology C. Hydropower and Mining Technology d. Polar Environment and Technology e. Small Businesses and Technology. f. Polar Telecommunications It will also be a multi-faceted event because it follows immediately upon the Fifth Winter Cities Biennale, staged by the City of Montreal and includes a Mayor's conference forum, a competition of ideas, an exhibition, as well as a "Business Rendez-Vous" organised by the Chamber of Commerce and business people, all of these events will be combined with a comprehensive cultural and social program. The whole focus of this week in Montreal will be 'northern regions'. 2 POLARTECH'92 Mr. D. Allan Bromley April 11, 1991 Page Two We are inviting all the ministers of science and technology/ industry from the circumpolar countries. It is our expectation to make the first day a very high-powered and high profile introduction and discussion of the circumpolar countries' expertise and future deve- lopment of polar technologies. As one of our keynote speakers, we would ask of you to speak about development and application of polar technology in your country. We hope that our invitation will interest you and that you will find time in your busy schedule to make room to make this international event a truly successful one. We look forward to hearing from you. Sincerely Yours, Marianne Stenbaek, Ph.D. Director Centre for Northern Studies and Research encl. THE WHITE HOUSE WASHINGTON June 4, 1991 Dear Dr. Stenbaek: Thank you for your letter of April 11, 1991, inviting me to be a keynote speaker at the opening session of the Polartech '92 conference scheduled for January 22-25, 1992. I would very much like to attend the conference and would tentatively accept your invitation. However, because that particular time is during our budget season, I cannot make a firm commitment this far in advance. Please write to me later this fall, and by that time I should be able to give you a definite answer. Thank you for thinking of me. I look forward to hearing from you later this year. Sincerely yours, D. Allan Bromley The Assistant to the President for Science and Technology Dr. Marianne Stenbaek Director Centre for Northern Studies and Research McGill University Burnside Hall - Room 720 805 Sherbrooke Street West Montreal, Quebec, Canada H3A 2K6 5e BIENNALE 5ᵗʰ INTERNATIONAL INTERNATIONALE WINTER CITIES DES VILLES D'HIVER BIENNIAL MONTRÉAL 1992 MONTRÉAL 1992 l'hiver Le 350e anniversaire de fondation de Montréal et la 5e N ous sommes des citadins nordiques. L'hiver et Biennale internationale des villes d'hiver me donnent le la neige nous rassemblent et nous font partager une Living Vivre in en harmony privilège de vous inviter à une rencontre internationale façon de vivre, de travailler, de nous distraire. d'envergure qui se déroulera dans notre métropole du De l'environnement à l'aménagement urbain à 17 au 21 janvier 1992. toutes les formes de loisirs, les diverses activités de Montréal connaît un hiver froid et enneigé. Nous la 5e Biennale internationale des villes d'hiver nous avons su l'apprivoiser en mettant au point différentes permettront des échanges nombreux et variés sur technologies et même, en faire une source de plaisir. notre mode de vie et sur notre condition de citoyens A | occasion de la 5e Biennale internationale des du froid. villes d'hiver qui se déroulera sous le thème prometteur de A titre de Montréalais et de président du club de "Vivre en harmonie avec l'hiver", nous pourrons mettre en hockey Le Canadien de Montréal, c'est avec honneur commun nos expériences et voir ensemble comment faire que j'ai accepté la présidence du comité organisateur de l'hiver l'un de nos meilleurs atouts dans le de cet événement et c'est avec beaucoup développement de nos communautés. d'enthousiasme que Montréal vous attend. Vous serez, je l'espère, au rendez-vous. La population de Montréal vous accueillera avec l'hospitalité proverbiale qu'elle sait réserver à ses amis. A bientôt à Montréal, The 350th Anniversary of the founding of Montréal and We are urban dwellers of the north. Winter and the 5th International Winter Cities Biennial have afforded snow bring us together, and as a result, we share a me the privilege of inviting you to a gathering of way of living, of working, of playing. international scope which will take place in our City from From the environment to urban development, January 17 to 21, 1992. to the many forms that leisure and recreation can take, Winter in Montréal is cold and snowy. But we have the various activities of the Vth International Winter managed to master winter by perfecting a variety of Cities Biennial will allow us to share, in a variety of technologies, and have even turned winter into a source different ways, both our lifestyle and our condition of of pleasure. citizens of colder climates. The 5th International Winter Cities Biennial, which As a Montrealer and President of the Montréal will unfold around the general theme of "Living in Harmony Le Canadien hockey club, / was honoured to accept with Winter", will be an opportunity to share our the chairmanship of the organizing committee for this experiences and look at how we can make winter a major event and let me tell you that Montréal eagerly awaits. asset in the development of our communities. / hope you'll be there. The people of Montréal will greet you with the proverbial hospitality that it reserves for MON friends. See you soon in Montréal, Jan Sac Jelany 17-21 17-21 janvier January Jean Doré Ronald Corey 1992 1992 Le maire / Mayor Président / President La 5e Biennale The 5th Winter Vivre en harmonie avec l'hiver Living in harmony with winter des Villes d'hiver Cities Biennial Un événement de prestige A Prestige Event Six volets uniques! A Unique Six-Part Program! Pour marquer de facon prestigieuse le To launch the celebration of the 350th début des célébrations de son 350e Anniversary of its founding in a fitting anniversaire de fondation, Montréal vous manner, Montréal is inviting you to the 5th convie, du 17 au 21 janvier 1992, à la 5e International Winter Cities Biennial, to be Biennale internationale des Villes d hiver. held from January 17 to 21, 1992. Après Sapporo, Shenyang, Edmonton After Sapporo, Shenyang, Edmonton et Tromso, la Ville de Montréal a obtenu le and Tromso, it is now the City of Montréal's privilège d organiser cette manifestation privilege to organize this event, the only one unique en son genre dans l'hémisphère of its kind in the northern hemisphere. nord. In the heart of winter, Montréal will En plein coeur de l'hiver, Montréal become the setting for a major multifaceted deviendra le théâtre d un événement event where the realities of winter will take d envergure a multiples facettes ou les center stage for five (5) days, during a réalités hivernales feront I objet pendant conference of mayors from northern cities, cinq (5) jours une conférence des maires a forum of experts, an exhibition, an des villes nordiques, d'un forum, d une international competition seeking innovative exposition, di un concours international ideas, and a program of cultural and sports d idées et un programme activités activities. culturelles et sportives. Don't miss this historic rendez-vous in II ne faut pas rater ce rendez-vous Montreal, winter city par excellence. historique a Montréal, ville d'hiver par excellence. Montréal Québec Canada CÉLÉBRATIONS MONTREAL Bell SNC AirCanada 1642-1992 Transporteur officiel Officiel Carrier La 5e Biennale The 5th Winter des Villes d'hiver Cities Biennial Un événement de prestige A Prestige Event Six volets uniques! A Unique Six-Part Program! Photo: Sylvain Mageau La conférence des maires The Mayors Conference L'exposition The Exhibition La rencontre La conférence réunira au-delà de cinquante The conference will bring together over fifty Vivre l'hiver en ville L'exposition "Vivre l'hiver en ville" The "Winter in the City" exhibition will (50) maires des villes de toutes tailles des décideurs (50) mayors of cities of every size from Asia, favorisera le développement et les encourage development and trade d'Asie, d'Europe et d'Amérique qui Europe and North America who, together, Winter in the City échanges entre les industries d'hiver between winter industries, and enhance relèvent ensemble un défi: créer un A meeting of will take up the challenge of creating an ainsi que la mise en valeur du potentiel the potential for tourism of the cities that environnement urbain adapté aux réalités urban environment that is adapted to the touristique des villes présentes. are represented. decision-makers et aux plaisirs de l'hiver. pleasures and realities of winter. Les villes d'hiver des pays The winter cities of participating Cette rencontre leur permettra The conference will allow them to participants et les industries des secteurs countries and industries in the housing, d'échanger leurs expériences et de talk about their experiences and share a de l'habitation, du transport, du vêtement, transportation, clothing, energy, partager un héritage commun, la gestion common heritage, that of managing winter, de l'énergie, de l'environnement, des environment, leisure and tourism sectors de l'hiver dans un contexte d'échanges in a context of frank discussion and loisirs et du tourisme présenteront leurs will showcase their products, their know- directs et de contacts personnels. personal contact. produits, leur savoir-faire et leurs attraits. how and their attractions. Le design de cette exposition The design of the exhibition will Le Forum The Forum s'inspirera d'une trame urbaine d'un reflect the urban makeup of a busy city Pour une meilleure L'activité du forum est centrée sur The focus of the Forum will be on quadrilatère très achalandé de Montréal. block in Montréal. qualité de vie l'amélioration de la qualité de vie à improving quality of life through a variety Le concours international d'idées travers les thèmes de l'environnement, of themes, including the environment, The International Competition Towards a better de l'aménagement urbain et de la santé urban development, and health and "A la recherche Afin de promouvoir une meilleure qualité In an effort to promote advances in the par l'activité physique en plein air. fitness through outdoor activities. de l'excellence" de vie en hiver, la 5e Biennale organise quality of life in winter, the 5th Biennial is quality of life Depuis plusieurs décennies les For decades now, scientific un concours d'idées novatrices dans les organizing a competition seeking innovative progrès de la science et les nouvelles progress and new technologies have "In Search secteurs de l'environnement, de l'activité ideas in the following categories: the technologies ont transformé l'art de vivre continued to transform the art of living in physique et de l'aménagement urbain. environment, outdoor fitness activities and dans les régions froides. L'hiver n'est cold climates. Winter no longer puts a of Excellence" Si vous oeuvrez dans ces secteurs urban planning. plus un frein à l'activité des citadins. dent in the lives of urban dwellers. et que vous résidez, travaillez ou étudiez If you are engaged in any of these La présence de conférenciers de The workshops and panel dans une ville nordique, vous pouvez fields and reside, work or study in a renommée internationale et l'organisation discussions will be enriched by keynote participer à ce concours régi par un jury northern city, you are eligible to participate de visites techniques s'ajouteront aux speakers of international repute and by international de sept personnes. Ce in this competition which will be judged by discussions et échanges en ateliers. technical tours. concours offre des prix totalisant a panel of seven internationally known 86 000$ (CAN) dont un grand prix de individuals. Competition prizes will total 000$ (CAN). $86,000 (CDN), including a grand prize of Toutes les personnes intéressées $20,000 (CDN). peuvent obtenir plus d'informations à For more information, please fill out l'aide de la carte réponse de ce dépliant. and return the attached reply card. oto: Louis Michel Major 5th INTERNATIONAL 5ᵉ BIENNALE WINTER CITIES INTERNATIONALE BIENNIAL DES VILLES D'HIVER MONTRÉAL 1992 MONTRÉAL 1992 Activités populaires Community Activities Last Name: Nom: La Fête des neiges A la fin du 19e siècle, Montréal a organisé In the late 19th Century, Montréal First Name: Prénom: le premier festival d'hiver en Amérique. organized the first winter festival in North La Fête des Neiges L'événement a eu tellement de succès America. The event was such a success Organization: Organisme: que plusieurs autres villes ont imité that many other cities followed suit and Montréal et ont tenu des événements held similar festivals. Mailing Address: Adresse postale: similaires. Today, La Fête des neiges is a La Fête des neiges d'aujourd'hui, modern celebration of winter that une célébration moderne de l'hiver, annually attracts over 550,000 Country: attire plus de 550 000 participants et Pays: participants and visitors over a ten (10)- visiteurs pendant dix (10) jours à chaque day period. Postal Code: Code postal: année. Telephone: Les Internationaux du commerce Business worldwide Téléphone: Rendez-vous Dans le cadre de la 5e Biennale, les deux As part of the 5th Biennial, Montréal's Fax: Télécopieur: à Montréal principales associations de gens d'affaires two principal business associations, La de Montréal, La Chambre de commerce du Chambre de Commerce du Montréal Please send me more information on the A Montréal Montréal métropolitain et le Bureau de métropolitain and the Montréal Board of Veuillez me faire de plus amples informations following items: sur: commerce de Montréal, tiendront du 17 au Trade, will be holding the first edition of Rendez-vous 21 janvier 1992, la première édition des Les Internationaux du Commerce de The Forum Le forum Internationaux du commerce de Montréal. Montréal, from January 17 to 21, 1992. The Exhibition L'exposition Les Internationaux du commerce de Les Internationaux du Commerce The Competition Le concours Montréal favoriseront les jumelages de Montréal will encourage business Les Internationaux du Commerce Les Internationaux du commerce d'entreprises afin d'établir des liens twinnings, in order to establish lasting d'affaires durables entre les gens d'affaires commercial ties between Montréal's des villes participantes et ceux de Montréal. Business Community and participating Date: Date: cities. Signature: Signature: 5th INTERNATIONAL 5e BIENNALE INTERNATIONALE WINTER CITIES BIENNIAL DES VILLES D'HIVER MONTRÉAL 1992 MONTRÉAL 1992 770, rue Sherbrooke Ouest 770, rue Sherbrooke Ouest 11 ième étage 11 ième étage Montréal (Québec) CANADA Montréal (Québec) CANADA IWCC International H3A 1G1 H3A 1G1 Winter Cities Commitee Téléphone: (514) 872-0571 Téléphone: (514) 872-0571 Télécopieur: (514) 872-9222 Télécopieur: (514) 872-9222 NICC NORTHERN INTERCITY CONFERENCE COMMITEE Conference announcement and call for papers McGill CENTRE FOR NORTHERN STUDIES AND RESEARCH McGILL UNIVERSITY MONTREAL, CANADA POLARTECH'92 INTERNATIONAL CONFERENCE ON DEVELOPMENT AND COMMERCIAL UTILIZATION OF TECHNOLOGIES IN POLAR REGIONS 22-25 JANUARY 1992 POLARTECH The international POLARTECH Conferences were established by industrial organizations and governmental institutions from nordic countries. The first POLARTECH conferences were held in Helsinki, Finland in 1986, in Trondheim, Norway in 1988, and in Copenhagen, Denmark in 1990. The POLARTECH '92 conference will be held in Montreal, Canada, in January 1992. OBJECTIVE The objective of the POLARTECH conferences is to create an international forum for exchanging information and discussing experiences and ideas for technology to be applied in Arctic and Antarctic regions or for use under other extreme conditions. The POLARTECH Conference focuses on the development and commercial application of polar technology with emphasis on onshore and offshore hydrocarbon technology, hydropower, and mining technology in polar regions. Logistics, interaction with local communities, and protection of the sensitive polar environment are highlighted. The POLARTECH '92 Organising Committee hereby invites papers for presentation under the following headings: THEME A Application of Polar Technology Infrastructure and urbanisation Logistics Transport and shipping Communication and navigation Ice management Man-technology interaction Community-project interaction Application of technology in other challenging environments (deserts, space, deep water, etc.) THEME B Offshore and Onshore Hydrocarbon Technology Exploration and planning Engineering and construction Operation and maintenance Facilities, abandonment and environmental restoration THEME C Hydropower and Mining Technology Exploration and Planning Construction and Production THEME D Polar Environment and Technology Arctic and Antarctic experiences Environmental impact studies Regulation, control and evaluation Impact of technology on humans and society THEME E Small Businesses and Technology Please return this form to: POLARTECH '92 Dr. Marianne Stenbaek Centre for Northern Studies and Research McGill University Burnside Hall 720 Tel.: (514) 398-6052 805 Sherbrooke Street West Fax: (514) 398-8364 Montreal, Canada H3A 2K6 Tlx: 05-268510 Surname First name Organization Postal Address Country Telephone Telefax Telex Please send me further information I plan to participate in the Conference and wish to receive further information I intend to present a paper related to: Theme A Theme B Theme C Theme D Theme E April 30, 1991 Due date for abstracts. September 30, 1991 Due date for papers I plan to attend both the Vth International Winter Cities Biennial and the POLARTECH '92 Conference and take advantage of their combined pre-registration fees rebate I would like information on participating in a trade show. Signature Date POLARTECH '92 follows the Vth International Winter Cities WINTER CITIES Biennial which will be held MONTREAL 1992 January 17-21, 1992 in Montreal. Avis de conférence et appel de communications McGill CENTRE D'ÉTUDES ET DE RECHERCHES NORDIQUES DE L'UNIVERSITÉ McGILL MONTRÉAL, CANADA POLARTECH '92 CONFÉRENCE INTERNATIONALE SUR LE DÉVELOPPEMENT ET L'UTILISATION COMMERCIALE DES TECHNOLOGIES DANS LES RÉGIONS POLAIRES 22-25 JANVIER 1992 POLARTECH Les conférences internationales POLARTECH sont une initiative des industriels et des institutions gouvernementales des pays nordiques. Les conférences POLARTECH se sont tenues précédemment à Helsinki en Finlande en 1986, à Trondheim en Norvège en 1988 et à Copenhague, au Danemark en 1990. La conférence POLARTECH '92 aura lieu à Montréal, au Canada en janvier 1992. OBJECTIF L'objectif des conférences POLARTECH est de créer un forum international d'échanges, d'information et de discussions sur les technologies à appliquer en régions arctiques et antarctiques ou à utiliser dans des conditions climatiques extrêmes. La Conférence POLARTECH porte sur le développement et les applications commerciales et technologiques polaires, notamment sur les techniques d'exploitation des hydrocarbones offshore et sur terre ferme, sur l'énergie hydraulique et la technologie minière dans les régions polaires. La logistique, l'interaction avec les collectivités locales et la protection de l'environnement polaire sont également à l'ordre du jour. Le comité organisateur de POLARTECH '92 vous invite à venir présenter des communications sur les thèmes suivants: THÈME A Application de la technologie polaire infrastructure et urbanisation logistique transport et expédition communication et navigation gestion des glaces interaction homme-technologie interaction communauté-projet application technologique dans d'autres environnements (déserts, espace, eaux profondes, etc.) THÈME B Technologie des hydrocarbones offshore et sur terre ferme exploration et planification génie et construction exploitation et maintenance installations, cession et restauration de l'environnement THÈME C Énergie hydraulique et technologie minière exploration et planification construction et production THÈME D Environnement polaire et technologie expériences dans l'Arctique et l'Antarctique études d'impact environnemental réglementation, contrôle et évaluation impact de la technologie sur les êtres humains et la société THÈME E Petites entreprises et technologie Veuillez renvoyer ce formulaire à l'adresse suivante: POLARTECH Dr. Marianne Stenback Centre d'études et de Recherches Nordiques Université McGill Pavillon Burnside 720 Téléphone (514) 398-6052 805, rue Sherbrooke Ouest Télécopieur: (514) 398-8364 Montréal, Canada H3A 2K6 Télex: 05-268510 Nom Prénom Organisme Adresse postale Pays Téléphone Télécopieur Télex Veuillez me faire parvenir de plus amples renseignements Je pense participer à la conférence et souhaite obtenir de plus renseignements J'ai l'intention de présenter une communication: thème A thème B thème C thème D thème E 30 avril, 1991 faire parvenir le résumé de votre communication. 30 septembre, 1991 faire parvenir le texte de votre communication. J'ai l'intention de participer à la fois à la biennale des VILLES D'HIVER et à la Conférence POLARTECH '92 et de bénéficier d'un rabais sur les frais d'inscription. Je serais intéressé(e) à participer à une exposition. Veuillez me faire parvenir de plus amples renseignements. Date Signature POLARTECH '92 fait suite à la Ve Biennale internationale des VILLES D'HIVER VILLES D'HIVER qui aura lieu MONTRÉAL 1992 du 17 au 21 janvier 1992 à Montréal "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121390 SPEECH: YES NO FROM: CAREY, Ann E,: NATIONAL RESOURCE SOCIETY DATE OF EVENT: 05/16/91 LOCATION OF EVENT: ARLINGTON, VA TIME OF EVENT: 08:30AM SUBJECT: INVITATION TO SPEECH AT THE OPENING SESSION OF THE 11TH ANNUAL SCIENCE DAY. RSVP: 04/19/91 CONTACT PERSON: CONTACT NUMBER: INVITATION ACCEPTED? YES NO COPIES TO: REMARKS: DATE OF LETTER: 04/10/91 DATE RECEIVED: 04/10/91 FILE: P. INVITATION-SPEECH Sponsor: Natural Resource Societies Subject: Current environmental and natural resource issues 4/16 Audience: 300-400 natural resource scientists and administrators Date: May 16-Th Location: Arlington, Va. Contact: Ann Carey, USDA Conflicts: Your calendar says you will be in the Soviet Union, YES NO 4/19/91 Regietted to am Carry mn 9121390 NATURAL RESOURCE SOCIETIES SCIENCE DAY PRESENTED BY THE WASHINGTON AREA CHAPTERS THE WILDLIFE SOCIETY AMERICAN FISHERIES SOCIETY SOCIETY OF AMERICAN FORESTERS THE SOCIETY FOR RANGE MANAGEMENT SOIL CONSERVATION SOCIETY OF AMERICA April 10, 1991 Dr. D. Allen Bromley Assistant to the President for Science and Technology Executive Office of the President Fax: 202-395-3261 AF Dear Dr. Bromley: This is to invite you to speak at the opening session of the 11th annual SCIENCE DAY '91 on May 16, 1991, in Washington, D.C. SCIENCE DAY is an annual event at which 300 to 400 natural resource scientists and administrators from government and the private sector address current environmental and natural resource issues. It is jointly sponsored by the Washington, D.C. chapters of the American SOCIETY Fisheries Society, Wildlife Society, Society of American OF Foresters, Society for Range Management, and Soil and Water AMERICAN Conservation Society. FORESTERS 1900 The theme for this year's event, to be held at the Key Bridge Marriott Hotel in Arlington, VA, is "NATURAL RESOURCES: Human Pressures, Changing Values". It will deal with the pressures of human populations on natural resources, and the different values that society places on natural resources as we approach the 21st century. The topic of the morning's first plenary session is "The Role of Science in Setting Public Policies for Natural Resources", and that is the general topic we would like you to address. You would have 30 minutes for your presentation; the keynote address is scheduled from 8:30 - 9:00 a.m., in a plenary session scheduled for 8:30 - 10:00 a.m. If you have any questions about this request, please contact me at 245-5008 (Fax 202-447-7690). I hope that you can join us on May 16, and I look forward to your reply. Sincerely, E Carey ANN E. CAREY SOILD CONSERVATION Special Assistant to the Chief SOCIETY OF AMERICA for Science and Technology USDA Soil Conservation Service and Program Chair SCIENCE DAY '91 002/002 202 447 7690 16:24 16/01/19 FACSIMILE TRANSMITTAL SHEET DATE 4/10/91 U.S. DEPARTMENT OF AGRICULTURE SOIL CONSERVATION SERVICE P.O. Box 2890 Washington, D.C. 20013-2890 Number of Pages: Transmittal Sheet + / TO: Wr. D. allen Bromley Executive Office of the President Telephone No. FACS Machine Telephone No. 202-395-3261 FROM: ann E. Carey Special assist to the Chief, SCS Telephone No. 202-245-5008 COMMENTS: Transmission completed by: Date 001/002 202 447 7690 16:24 16/01/19 "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121125 SPEECH: YES NO FROM: MILLER, Michael S.: PERFORMANCE MATERIALS DATE OF EVENT: 10/14/91 LOCATION OF EVENT: WASHINGTON, D.C. TIME OF EVENT: SUBJECT: REQUEST TO SPEAK DURING THE BUSINESS CONFERENCE FOR EXECUTIVES IN THE ADVANCED MATERIALS INDUSTRY HELD BY MCGRAW-HILL'S PERFORMANCE MATERIALS PUBLICATION AND KLINE & COMPANY. RSVP: 04/30/91 CONTACT PERSON: MICHAEL MILLER CONTACT NUMBER: 202/822-4681 INVITATION ACCEPTED? NO COPIES TO: Perry Lindstrom Dr. Phillips Thomas Welch REMARKS: DATE OF LETTER: 04/04/91 DATE RECEIVED: 04/16/91 FILE: P- INVITATION-SPEECH 9/21/25 Performance Materials RECEIVED Information Services Company 1156 15th Street, NW Suite 600 Washington, DC 20005 91 APR 16 A10: 48 Telephone 202/822-4600 FAX 202/293-7482 OFFICE OF THE April 4, 1991 DIRECTOR D. Allan Bromley Chairman National Critical Materials Council 730 Jackson Place Washington, D.C. 20506 Dear Dr. Bromley, McGraw-Hill's Performance Materials publication and the consulting firm Kline & Company, which concentrates on advanced materials, will hold a two-day business conference in Washington November 14-15, 1991 for executives in the advanced materials industry. We would very much appreciate it if you would consider speaking during either of the two days. The event's theme is "Advanced Composites-Beyond Aerospace in the 1990s" and the audience will be 50 to 100 of the top decision-makers in the advanced materials industry-from presidents of companies to directors of business development. No other event in the near future will bring together so many of this country's key leaders from the advanced materials industry. Your topic would be fully up to you, though I would suggest it concern the Administration's doctrine for advanced materials and how the industry could play a role. Other possible areas could include the Critical Technologies Institute or critical technologies research in general. I have worked with Perry Lindstrom and attended various PCAST meetings during the past year and have appreciated your elevation of advanced materials to the top of the Administration's technology agenda. Performance Materials is the leading publication for business news on advanced materials and is read in more than 20 countries. Kline & Company is based in Fairfield, N.J., with offices in Brussels, Melbourne, Tokyo and Toronto, and is the top U.S. consulting firm on advanced materials. Please consider this event and the captive audience of advanced materials leaders you would be addressing. My direct line is 202-822-4681. Sincerely, Michael S. Miller Editor Aerospace and Defense Group Newsletters Aerospace Daily Regional Aviation Weekly Airports The Weekly of Business Aviation Aviation Daily 9/21/25 Performance Materials RECEIVED Information Services Company 1156 18th Street, NW Suite 600 Washington, DC 20005 STAPR 16 A10 48 Telephone 202/822-4600 FAX 202/293-7482 OFFICE OF HE April 4, 1991 DIRECTOR D. Allan Bromley Chairman National Critical Materials Council 730 Jackson Place Washington, D.C. 20506 Dear Dr. Bromley, McGraw-Hill's Performance Materials publication and the consulting firm Kline & Company, which concentrates on advanced materials, will hold a two-day business conference in Washington November 14-15, 1991 for executives in the advanced materials industry. We would very much appreciate it if you would consider speaking during either of the two days. The event's theme is "Advanced Composites-Beyond Aerospace in the 1990s" and the audience will be 50 to 100 of the top decision-makers in the advanced materials industry-from presidents of companies to directors of business development. No other event in the near future will bring together so many of this country's key leaders from the advanced materials industry. Your topic would be fully up to you, though I would suggest it concern the Administration's doctrine for advanced materials and how the industry could play a role. Other possible areas could include the Critical Technologies Institute or critical technologies research in general. I have worked with Perry Lindstrom and attended various PCAST meetings during the past year and have appreciated your elevation of advanced materials to the top of the Administration's technology agenda. Performance Materials is the leading publication for business news on advanced materials and is read in more than 20 countries. Kline & Company is based in Fairfield, N.J., with offices in Brussels, Melbourne, Tokyo and Toronto, and is the top U.S. consulting firm on advanced materials. Please consider this event and the captive audience of advanced materials leaders you would be addressing. My direct line is 202-822-4681. Sincerely, Michael S. Miller Editor Aerospace and Defense Group Newsletters Aerospace Daily Regional Aviation Weekly Airports The Weekly of Business Aviation Aviation Daily THE WHITE HOUSE WASHINGTON June 4, 1991 Dear Mr. Miller: Thank you for your letter of April 4, 1991, inviting me to address your business conference scheduled to be held November 14-15, 1991 in Washington, D.C. I apologize for the much belated response. As much as I would like to join you and your colleagues, I must regretfully decline. I will be chairing a two-day meeting that has been on my calendar for some time on those dates. I appreciate your thinking of me and send my best wishes for a successful conference. Sincerely yours, JAnan D. Allan Bromley Romley. The Assistant to the President for Science and Technology Mr. Michael E. Miller Editor McGraw-Hill Performance Materials 1156 15th Street, Northwest Suite 600 Washington, D.C. 20005 "CORRESPONDENCE TRACKING" TYPE: INFORMATION DOCUMENT NUMBER: 9121579 FROM: STURGES, Claudia J.: AAAS TO: Dr. D. Allan Bromley DATE OF CORRESPONDENCE: 05/30/91 SUBJECT: THE SPEECH TO THE AAAS ENVIRONMENTAL SCIENCE & ENGINEERING FELLOWS; REQUEST TO DISCUSS OSTP'S ROLE IN FORMULATING ENVIRONMENTAL POLICY, HOW IT INTERACTS WITH AGENCIES & CEQ, AND ENVIRONMENTAL PRIORITIES. DIRECTORATE STAFF ASSIGNED: ASSIGNED: ACTION STAFF REQUIRED: ACTION: SENDER'S DUE DATE: OSTP DUE DATE: DATE COMPLETED: DATE COMPLETED/DEPT: COPIES TO: D. Allan Bromley Steve Olson ENVIRONMENT WHITE HOUSE TRACKING #: CONTACT PERSON: REMARKS: DATE RECEIVED: 05/31/91 FILE: P INVITATION-SPEECH 9121579 American Association for the Advancement of RECEIVED Science Directorate for Science and Policy Programs 1333 H Street, NW, Washington, DC 20005 91 MAY 31 P : 54 (202) 326-6600 FAX (202) 371-9526 'OFFICE OF THE DIRECTOR May 30, 1991 Dr. D. Allan Bromley Assistant to the President for Science and Technology White House Office of Science and Technology Policy Old Executive Office Building Room 358 Washington, DC 20500 Dear Dr. Bromley: On behalf of the 1991 AAAS Environmental Science and Engineering Fellows, I want to thank you for agreeing to speak to them as part of their orientation program. Your remarks are scheduled Tuesday, June 4, from 11 - 12 a.m., in Room 180 of the Old Executive Office Building. In that hour I would ask you to discuss the role OSTP plays in formulating environmental policy, how the Office interacts with the agencies and CEQ, and perhaps some discussion of your environmental priorities. If you would talk for about 20 - 30 minutes, that would allow time for questions at the conclusion. Enclosed is a list of the 1991 Fellows and a copy of the orientation schedule. I look forward to seeing you next week. Sincerely, Clandeng Sturge Claudia J. Sturges Manager AAAS Environmental Science and Engineering Fellowship Program CJS/hs Enclosures American Association for the Advancement of Science Directorate for Science and Policy Programs 1333 H Street, NW, Washington, DC 20005 (202) 326-6600 FAX (202) 371-9526 1991 AAAS/EPA ENVIRONMENTAL SCIENCE AND ENGINEERING FELLOWS Name, Discipline/Institution, Current Affiliation Dr. Mary A. Bober Physiology/Oklahoma State University University of California, Santa Barbara Dr. Vera Brankovan Biological Structure, Engineering, Technology/Seattle City University Bristol-Myers Squibb Pharm. Research Institute Dr. Mark A. Brown Environmental Agricultural Chemistry/Unversity of California, Berkeley Hazardous Materials Laboratory Dr. Charles A. Cole Environmental Science/Rutgers University Penn State University Dr. Robert G. Croy Toxicology/Massachusetts Institute of Technology Cambridge Environmental Inc. Dr. Marvin Fleischman Chemical Engineering/Unversity of Cincinnati Unversity of Louisville Dr. Hilary I. Inyang Civil Engineering/Iowa State University University of Wisconsin, Dept. of Civil Engineering 1 Name, Discipline/Institution, Current Affiliation Mr. Keith A. Matthews Law/Georgetown University Dewey Ballantine Dr. Eric A. Pani Geosciences/Texas Tech University Northeast Louisiana University Ms. Christine A. Paszkiet Materials Science and Engineering/Cornell University Cornell University 5/7/91 2 American Association for the Advancement of Science Directorate for Science and Policy Programs 1333 H Street, NW, Washington, DC 20005 (202) 326-6600 FAX (202) 371-9526 ORIENTATION SCHEDULE 1991 AAAS EPA Environmental Science and Engineering Fellows Monday, June 3 AAAS 1333 H Street, NW 10th Floor Board Room 9:00 a.m. Continental Breakfast 9:30 a.m. Welcoming Remarks: Richard S. Nicholson Executive Officer, AAAS 9:45 a.m. Albert H. Teich Director AAAS Directorate for Science and Policy Programs 10:00 a.m. Roger Cortesi Director EPA Office of Exploratory Research 10:15 a.m. Claudia J. Sturges Manager, AAAS/EPA Environmental Science and Engineering Fellowship Program 10:30 a.m. Break 10:45 a.m. Introductions Monday, June 3 continued AAAS 10th Floor Board Room 12:00 Noon Luncheon William G. Wells, Jr. Consultant, Office of Science & Technology Policy Executive Office of the President "Perspectives on Washington" 1:30 p.m. Leave for Environmental Protection Agency Take Orange or Blue Metro Line to L'Enfant Plaza Station, take 7th & D/DOT Exit, walk to 4th St.,SW. Environmental Protection Agency 401 M Street, SW Meet Mary McCarthy-O'Reilly at Waterside Mall West Tower (main entrance) 2:15 p.m. Get visitor passes 2:30 p.m. Get EPA Badges, Room 3307 Court Yard 3:00 p.m. Meet with Mentors Gangplank Restaurant Rear Deck 600 Water Street, SW 5:00 p.m. 7:00 p.m. Reception Invitees include Selection Committee Members, EPA Staff, other friends of the fellowship program and the 1990-91 AAAS Congressional, Diplomacy, and Arms Control Science and Engineering Fellows, and the summer 1991 AAAS Mass Media Fellows. Tuesday, June 4 Old Executive Office Building 17th & Pennsylvania Avenue, NW Pennsylvania Avenue Entrance - be there at 8:30 am, to allow time for Security Clearance Room 180 Environmental Policy in the Executive Branch 9:00 a.m. Erich Bretthauer Assistant Administrator for Research and Development U.S. Environmental Protection Agency 10:00 a.m. Michael R. Deland Chairman White House Council on Environmental Quality 11:00 a.m. D. Allan Bromley Assistant to the President for Science & Technology White House Office of Science and Technology Policy 700 Water Street Restaurant 700 Water Street, SW The Red Room 12:30 Luncheon Deanna Richards Senior Program Officer National Academy of Engineering "Looking Back: Some Advice from an Ex-Fellow" Environmental Protection Agency Room 103, North East Mall 401 M Street, SW Overview of EPA 2:00 p.m. Mary McCarthy - O'Reilly Program Manager EPA Office of Research Program Management 2:30 p.m. Pollution Prevention: Gerald Kotas Director, Pollution Prevention Division Office of Pollution Prevention Tuesday, June 4 continued Environmental Protection Agency 3:00 p.m. Nonregulatory Programs: Eileen B. Claussen (invited) Director, Office of Atmospheric and Indoor Air Programs 3:30 p.m. Regulatory Programs: Joseph Cotruvo Director, Health and Environmental Review Division, Office of Toxic Substances Wednesday, June 5 Congressional Research Service The James Madison Building, LM 423 1st Street and Independence Avenue, SE Science and Policy Division Conference Room Legislative Branch and the Environment 9:00 a.m. Science and Policy Research Division Staff 10:30 a.m. Break 10:45 a.m. Environment and Natural Resources Division Staff Congressional Research Service Montpelier Room 6th Floor Madison Building 12:00 Noon Luncheon with Congressional Research Service Staff AAAS 10th Floor Board Room 2:30 p.m. Stephen D. Nelson Director, AAAS Program on Science, Technology and Government "How the Budget Drives the Process" Thursday, June 6 Office of Technology Assessment 600 Pennsylvania Avenue, SE Conference Room D Overview of ota Activities 9:00 a.m. - 12:00 Noon Howard Levenson Project Director, Oceans and Environment Program "Welcome" Robert Niblock Program Manager, Oceans and Environment Program "Introduction to OTA" Robin Roy Senior Analyst, Energy and Materials Program "Energy Efficiency in the Federal Government" Daryl Chubin Senior Analyst, Science, Education and Transportation Program "Federally-funded Research; Decisions for a Decade" Emilia Govan Senior Analyst, Oceans and Environment Program "Complex Cleanup: The Environmental Legacy of Nuclear Weapons Production" Hunan Dynasty 215 Pennsylvania Avenue, SE 12:30 p.m. Luncheon with OTA Staff Office of Technology Assessment 600 Pennsylvania Avenue, SE Conference Room D Public Interest Groups and Environmental Policy 2:30 - 4:00 p.m. Moderator: Robert Rycroft George Washington University Program on Science and Technology and Public Policy Howard Geller Executive Director American Council for an Energy Efficient Economy Thursday, June 6 continued Office of Technology Assessment 600 Pennsylvania Avenue, SE Conference Room D Kevin Fay Executive Director Alliance for Responsible CFC Policy Daniel Becker Lobbyist Sierra Club Henry Cole Science and Policy Director Clean Water Action Fund Friday, June 7 AAAS 1st Floor Conference Room 10:00 a.m. Law, the Courts and the Environment Jonathan Turley Associate Professor of Law National Law Center George Washington University Old Ebbitt Grill 675 15th Street, NW Near 15th and G Streets 12:15 p.m. Luncheon The National Science Foundation and Environmental Issues W. Franklin Harris Executive Officer, Biological, Behavioral, and Social Sciences, NSF Friday, June 7 continued National Academy of Sciences National Research Council 2101 C Street, NW Room 180 2:00 p.m. Briefing by National Research Council Staff James J. Reisa Director Board of Environmental Studies and Toxicology Richard Thomas Program Director Toxicology and Risk Management THE AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE Invites applications for the Summer 1991 AAAS Environmental Science and Engineering Fellowships PROGRAM: Fellows will spend ten weeks (June 3 and energy. A brief description of EPA's priorities for through August 9) working as special research con- 1991 is enclosed. sultants with the Office of Research and Development (ORD) of the U.S. Environmental Protection Agency CRITERIA: Prospective Fellows must be postdoc- (EPA) in Washington, DC. Fellows will undertake a toral to mid-career professionals, show exceptional detailed, future-oriented research project of mutual competence in a relevant professional area. have a interest to the Fellow and one of EPA's research or broad professional background, and have a strong program offices and prepare a report at the completion interest and some experience in applying scientific or of the summer's work. The program includes a week- other professional knowledge toward the identification long orientation to EPA and relevant congressional and assessment of future environmental problems. and executive branch operations, as well as a weekly Fellows are expected to be critical thinkers, articulate, seminar program on environmental issues and science, adaptable, and able to work with a variety of people technology and public policy. from different professional backgrounds. Persons may apply from any physical, biological, or behavioral PURPOSE: The purpose of the fellowship program is science field, any field of engineering, or any other to assist ORD in identifying and assessing the signifi- relevant professional field. Applicants must be resi- cance of long-range environmental problems and dents of the U.S. opportunities. Broad areas of research interest within EPA include: environmental risk assessment; biologi- AWARDS: In cooperation with EPA. AAAS will cal pesticides; acid deposition; mobile source air select ten Environmental Science and Engineering pollution; oxidants; gases and particles; global cli- Fellows for the summer of 1991. The stipend is $850 mate; stratospheric ozone depletion; municipal waste per week plus nominal relocation and travel expenses. water and spills; drinking water; hazardous waste; The deadline for receipt of applications is March 1, chemical testing and assessment: pesticides; radiation; 1991. Further information about the program and detailed application information are available from: Environmental Science and Engineering Fellows Program American Association for the Advancement of Science 1333 H Street, NW, Washington, DC 20005 202/326-6600 Minorities and persons with disabilities are especially encouraged to apply. The continuation of this program, now in its eleventh year, is contingent upon the availability of funds. "CORRESPONDENCE TRACKING" TYPE: INFORMATION DOCUMENT NUMBER: 9121714 ORIGINATOR: 02 STATUS C DIRECTORATE STATUS FROM: SPENCER, Jean E.: UNIVERSITY OF MARYLAND SYSTEM TO: DR. D.A. BROMLEY DATE OF CORRESPONDENCE: 06/07/91 SUBJECT: INFORMATION REGARDING YOUR PARTICIPATION IN THE INAUGURATION OF CHANCELLOR LANGENBERG. DIRECTORATE STAFF ASSIGNED: ASSIGNED: ACTION STAFF REQUIRED: ACTION: SENDER'S DUE DATE: OSTP DUE DATE: STAFF DUE DATE DATE COMPLETED: DATE COMPLETED/DEPT: COPIES TO: D. Allan Bromley Steve Olson WHITE HOUSE TRACKING #: CONTACT PERSON: PHONE: EXT: REMARKS: OSTP RECEIVED: 06/11/91 FILE: P INVITATION SPEECH FOLLOW-UP DEPT RECEIVED: 9121714 UNIVERSITY OF MARYLAND SYSTEM OFFICE OF THE DEPUTY CHANCELLOR OF UNIVERSITY MARYLANDO 3300 Metzerott Road SASTEM 11 P5: 25 (301) 853-3701 Adelphi, Maryland 20783 THE FAX (301) 853-4761 1807 June 7, 1991 OFFICE OF The DIRECTOR The Honorable D. Allan Bromley Assistant to the President for Science and Technology Old Executive Office Building 17th and Pennsylvania Avenues, N.W. Washington, D.C. 20506 Dear Dr. Bromley: I am pleased that you will participate in the inauguration of Chancellor Langenberg on June 26, 1991. This letter includes information for members of the academic procession. The inauguration will begin at 2:30 p.m.; members of the procession are asked to arrive at 1:45 p.m. for robing. Please enter by the rear entrance of the Lyric, 1404 Maryland Avenue, Baltimore, Maryland. An attendant will meet you at the door. All members of the procession will wear academic robes, hoods, and caps, as appropriate. Please bring academic attire with you, unless your order was placed through the System Administration Office. Attire ordered by the System Administration for members of the Board of Regents and elected officials will be hanging in the outer room in the robing area. Marshals will assist in robing. Signs will indicate robing areas for platform guests and for other members of the procession. Lockers and restrooms are located in both robing areas. There will be security in the robing area throughout the ceremony and reception. You may park in University of Baltimore lots 7A and 7B on Bolton Street. A map of the University is enclosed with this letter. Also enclosed are 1) a copy of the program, 2) a copy of the order of procession, 3) a seating chart indicating the seating of platform guests, and 4) guidelines for speakers. Marshals will assist in guiding the procession and in seating members of the procession. There will be reserved seating for members of the procession who are not seated on the platform. I appreciate your helping to make the inauguration a memorable ceremony. If you have questions about the program, please call me or Dr. Sheila Tolliver at 301 853-3701. Sincerely yours Jean Spence Jean E. Spencer Chair, Inauguration Committee No Dr. Robert E. Stevenson - 1925 American Type Culture Collection 12301 Parklawn Drive Rockville, MD 20852-1776 No Mr. Allan W. Ostar, President - 1961 American Association of State College and Universities Suite 700 One Dupont Circle Washington, D.C. 20036 No Dr. Jim Harrison - 1975 Association of Urban Universities 1225 Connecticut Avenue, NW, Suite 306 Washington, DC 20036 Representatives of NASULGC, AASCU, AAU Institutions Yes Chancellor John J. Quinn - 1794 University of Tennessee at Knoxville Knoxville, Tennessee 37996 Yes Dr. Donald A. MacPhee - 1826 President State University of New York College at Fredonia Fredonia, NY 14063 Yes Dr. William W. Chmurny - 1866 Chancellor University of Wisconsin - Platteville 1 University Plaza Platteville, WI 53818-3099 Yes Dr. Robert J. Dillman - 1867 President Fairmont State College Locust Avenue Fairmont, WV 26554 Yes Dr. Gordon H. Lamb - 1869 President Northeastern Illinois University 5500 N. Saint Louis Avenue Chicago, IL 60625-4699 2 Dr. Paul LeClerc - 1870 Yes President City University of New York Hunter College 695 Park Avenue New York, NY 10021 President Walter Washington - 1871 Yes Alcorn State University Lorman, Mississippi 39096-9998 President James D. McComas - 1872 Yes Virginia Polytechnic Institute and State University Blacksburg, Virginia 24061 Dr. Robert N. Aebersold - 1889 Yes President Slippery Rock University of Pennsylvania Slippery Rock, PA 16057-9989 Dr. Thomas E. Everhart - 1891 Yes President California Institute of Technology 1201 East California Boulevard Pasadena, CA 91125 Dr. Hazo W. Carter, Jr. - 1891 Yes President West Virginia State College Institute, WV 25112 Dr. Robert A. Corrigan - 1899 Yes President San Francisco State University 1600 Holloway Avenue San Francisco, CA 94132 Dr. G. Warren Smith -1925 Yes President Southeastern Louisiana University 100 West Dakota Hammond, LA 70402 Representatives of Other Regional Schools Dr. Martin Meyerson- 1740 Yes President Emeritus University of Pennsylvania 2016 Spruce Street Philadelphia, Pennsylvania 19103 3 Rev. William J. Bryon - 1887 Yes President Catholic University of America 620 Michigan Avenue, NE Washington, DC 20064 Representatives of Other Maryland Institutions Dr. Charles H. Trout - 1782 Yes President Washington College Chestertown, MD 21620 Rev. Joseph A. Sellinger, S.J. - 1852 Yes President Loyola College 4051 North Charles Street Baltimore, MD 21210-2699 Dr. Robert H. Chambers - 1867 Yes President Western Maryland College Westminster, MD 21157 Dr. Rhoda M. Dorsey - 1885 Yes President Goucher College 1021 Dulaney Valley Road Towson, MD 21204 Dr. G. William Troxler - 1932 Yes President Capitol College 11301 Springfield Road Laurel, MD 20708 Dr. Robert E. Parilla - 1946 Yes President Montgomery College Central Administration 900 Hungerford Drive Rockville, Maryland 20850 Dr. James D. Tschechtelin - 1947 Yes President New Community College off Baltimore 2901 Liberty Heights Avenue Baltimore, MD 21215 4 Yes Dr. Lee J. Betts - 1957 President Frederick Community College 7923 Opposumtown Pike Frederick, Maryland 21701 Dr. Thomas E. Florestano - 1961 Yes President Anne Arundel Community College 101 College Parkway Arnold, Maryland 21012 Dr. Dwight A. Burrill - 1966 Yes President Howard Community College Little Patuxent Parkway Columbia, Maryland 21044 Dr. Charles W. Simmons - 1972 Yes President Sojourner-Douglass College 500 North Caroline Street Baltimore, MD 21205 Mr. Robert M. Duggan - 1980 Yes President Traditional Acupuncture Institute, Inc. American City Building, Suite 100 Columbia, MD 21044 REPRESENTATIVES OF UMS INSTITUTIONS UMAB 1807 Yes Dr. Errol Reese President Dr. Warren Morganstein No Dean No Dr. Michael Kelly Dean Dr. Richard Richards No Dean No Dr. Barbara Heller Dean 5 No Dr. David Knapp Dean No Dr. Howard Altstein Dean No Dr. Steven Max Dean No Dr. James P. Flynn Dean No Dr. Preston Shelton Faculty Senate No Ms. Cathleen Snelling Student Government No Dr. Morton Rapoport UMMS UMCP 1856 Yes Dr. William Kirwan President No Dr. Kathryn Costello Vice President No Dr. Robert Dorfman Vice President No Dr. Charles Sturtz Vice President No Dr. William Thomas, Jr. Vice President No Dr. Bruce Fretz Campus Senate No Ms. Vicki Gruber Student Government BSU 1865 Yes Yes Dr. James Lyons President 6 Dr. Ida Brandon No Vice President No Dr. Zola Boone Vice President Mr. E.R. Golden No Vice President Dr. O.E. Jack No Faculty Senate Mr. Darren Swain No Student Government TSU 1866 Dr. Hoke Smith Yes President Dr. Robert Caret No Vice President Mr. Dan McCarthy No Vice President Dr. Donald McCulloh No Vice President Ms. Dorothy Siegel No Vice President Dr. Neil Gallagher No Faculty Senate Mr. David Cameron No Student Government UMES 1886 Dr. William Hytche Yes President Dr. Edward Ellis No Vice President Dr. Herman Franklin No Vice President Mr. Ronnie Holden No 7 Vice President No Dr. Jean Moore Vice President No Dr. Carolyn Brooks Faculty Senate Mr. Karl White No Student Government FSU 1898 Yes Dr. Harold Delaney Acting President Dr. Kenneth Stewart No Vice President No Mr. Richard Metz Vice President Dr. Alice Manicur No Vice President Mr. Mark Atchison No Vice President Dr. Karen Holbrook No Faculty Senate No Mr. Todd Hancock Student Government CSC 1900 Yes Dr. Calvin Burnett President Dr. Carlton Molette No Vice President Mr. Gregory Davis No Vice President Mr. Charles Wright No Vice President Dr. Clayton McNeill No Vice President 8 Ms. Myra Chichester No Faculty Senate Mr. Kunle Fagbenle No Student Government SSU 1925 Dr. Thomas Bellavance Yes President Dr. K. Nelson Butler No Vice President Mr. Joseph Gilbert No Vice President Dr. Frederick Kundell No Faculty Senate Miss Lynn Maguire No Student Government UB 1925 Dr. H. Mebane Turner Yes Yes President Dr. Catherine Gira No Vice President Dr. Daniel Costello No Vice President Dr. Wayne Markert No Dean No Ms. Rebecca Korzec Faculty Senate No Ms. Kate Kppel Student Government Mr. Craig Frechette No Student Government 9 UMUC 1947 Yes Dr. Benjamin Massey President No Dr. David Montgomery Vice President No Mrs. Vida Bandis Vice President No Dr. Julian Jones Vice President No Dr. Julie Porosky Vice President No Ms. Adelaide Lagnese Faculty Senate No Mr. Larry Reynolds Student Government UMBC 1966 Yes Dr. Michael Hooker President Dr. Freeman Hrabowski No Executive Vice President No Dr. Arthur O. Pittenger Vice President Mrs. Constance Beims No Vice President No Mr. Mark Behm Vice President No Dr. Susan Kitchen Vice President No Dr. Robert Rasera Faculty Senate No Mr. David Smith Student Government 10 MARYLAND INSTITUTE FOR AGRICULTURE AND NATURAL RESOURCES 1888/1914 Dr. Raymond J. Miller Yes President Dr. Robert Kennedy No Director, AES Dr. Craig Oliver No Director, CES Mr. Kenneth Stafford No Dr. J. Lee Majeski No Faculty Senate CEES 1973 Dr. Donald Boesch Yes President Dr. Wayne Bell No Vice President Mr. Steven Wilson No Vice President Dr. Robert E. Ulanowicz No Faculty Senate Ms. Joan McKearnan No Student MBI 1984 Dr. Rita Colwell Yes President Dr. Tom Poulos No Director, CARB Dr. Fred Singleton No Director, COMB Dr. Edmund Tramont No Director, MBC Dr. Antonio Moreira No Director, CBM 11 Dr. William Weigand No Director, CBM Dr. Chris D'Elia No Director, Sea Grant Dr. Darrell Hueth No Director, CPIB Dr. Theodor Diener No Director, CAB Other Platform Guests Dr. John S. Toll Yes Chancellor Emeritus Dr. Shaila Aery Yes Secretary, Maryland Commission for Higher Education 12 SYSTEM REPRESENTATIVES Dr. Jean Spencer Yes Deputy Chancellor Mr. John Martin Yes Acting Vice Chancellor Mr. Donald Myers Yes Vice Chancellor BOARD OF REGENTS MEMBERS Dr. Albert Whiting Yes Secretary Mrs. Ilona Hogan Yes Treasurer Ms. Constance Unseld Yes Assistant Secretary Mrs. Margaret Alton Yes The Hon. Mary Arabian Yes Mr. Richard Berndt Yes Mr. Benjamin Brown Yes Mr. Earle Palmer Brown Yes Mr. Wayne A. Cawley, Jr. Yes Mr. Charles W. Cole, Jr. Yes Mrs. Ann Hull Yes Mr. Harry Lord Yes Ms. Joann M. McCartney Yes Mr. Franklin P. Perdue Yes Dr. Louis Kaplan Yes Yes UM Regent Emeritus Mr. Roger Blunt Yes Yes Vice Chairman 13 Yes Yes Mr. George McGowan Chairman OTHER PLATFORM GUESTS The Hon. William D. Schaefer Yes Yes Governor Yes The Hon. Lucille Maurer State Treasurer The Hon. Louis Goldstein Yes Comptroller of the Treasury Yes The Hon. J. Joseph Curran Attorney General Yes Dr. Patricia Langenberg Yes Yes Dr. D. Allan Bromley Asst. to the President for Science and Technology and Director, Office of Science and Technology Policy Dr. William Richardson - 1876 Yes Yes President Johns Hopkins University Baltimore, Md. Yes Yes Dr. Robert Atwell President, American Council on Education Yes Yes Mr. Quentin Lawson Vice Chairman, Md. Higher Education Commission Yes Yes Mr. David Lasher Chairman, Systemwide Student Council Yes Yes Dr. Amos White Chairman, Systemwide Faculty Council Yes Yes Dr. Donald Langenberg Chancellor 14 white Imarshal Reese Duggan Kiswan I hasher Thousan Anwell Lord / Nam Icole simmuns Betts PLATFORM SEATING ARRANGEMENT AS OF JUNE 7, 1991 Iparilla the varial leurran /Goldskin Imaurer lungeld I Nogan Impers Imartin l Aery 1Toll Trout Buron Colwell Ismik Incorrigan carter Schaeler Imaguan Boeseh /Blunt 1211:00 1 Nooker Kaplan \Turner /hons \sparks Bunnett belaney litytche hamb \smith GUIDELINES FOR GREETERS INAUGURATION OF CHANCELLOR DONALD N. LANGENBERG JUNE 26, 1991 We are delighted you will be bringing greetings at the Inauguration of Chancellor Donald N. Langenberg on June 26. For your convenience, we offer the following guidelines to enable you to plan your remarks: 1. Please take your seat on the stage in the front row as you process to the platform (the red velvet chairs are reserved for your use). 2. You will be summoned to the podium and introduced by H. Mebane Turner, president of the University of Baltimore, when it is your turn to offer remarks. 3. Please be brief. You should prepare approximately two minutes of spoken text. 4. Please don't cite everyone seated on the stage. It will be sufficient to open your greetings by acknowledging Governor Schaefer, Chancellor Langenberg, and "honored guests." 5. Please be upbeat. 6. Please personalize the content of your remarks. 7. Please feel free to express your expectations of the University of Maryland System under the leadership of Chancellor Langenberg. For your information, the entire ceremony will be videotaped. Please forward a copy of your prepared remarks to us in advance of the ceremony to be bound for presentation to Chancellor Langenberg. We hope you find these guidelines helpful. If you have questions, comments, or concerns, please call: Dr. Jean E. Spencer Deputy Chancellor The University of Maryland System 3300 Metzerott Rd. Adelphi, MD 20783 (301)853-3701 6/11 Please close out - DAB has been there + bach! "CORRESPONDENCE TRACKING" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121659 ORIGINATOR: 02 STATUS I DIRECTORATE STATUS FROM: OLLERHEAD, R.W.: UNIVERSITY OF GUELPH TO: DR. D.A. BROMLEY DATE OF CORRESPONDENCE: 05/29/91 SUBJECT: RE: DR. BROMLEY'S VISIT TO THE UNIVERSITY. REQUEST TO GIVE A 15/20 MINUTE OVERVIEW OF MAJOR ISSUES TO THE PHYSICS FACULTY MEMBERS. DIRECTORATE STAFF ASSIGNED: D. Allan Bromley ASSIGNED: ACTION STAFF REQUIRED: AS NECESSARY ACTION: SENDER'S DUE DATE: OSTP DUE DATE: STAFF DUE DATE DATE COMPLETED: DATE COMPLETED/DEPT: COPIES TO: Steve Olson WHITE HOUSE TRACKING #: CONTACT PERSON: PHONE: EXT: REMARKS: OSTP RECEIVED: 06/07/91 FILE: P INVITATION-SPEECH FOLLOW UP DEPT RECEIVED: 9121659 UNIVERSITY GUELPH RECEIVED May 29, 1991 COLLEGE OF PHYSICAL AND ENGINEERING SCIENCE 7 43 Department of Physics Office of the Chair Dr. D. Allan Bromley OFFICE OF THE Executive Office of the President DIRECTOR Office of Science and Technology Policy Old Executive Office Building Washington, DC 20506 U.S.A. Dear Dr. Bromley: Thank you for your telephone call regarding your visit to Guelph. I am sorry I missed you. As I understand it, you will be met at Toronto airport by a private limousine service ("Red Car") at the ground transportation booth, which will bring you to the College Inn, adjacent to the University of Guelph campus. If you would call me at the number given below when you are settled, I will meet you at the College Inn and bring you to the university. Our physics faculty members would welcome the opportunity to hear your views on science policy, in the U.S.A. certainly, and also your perceptions as far as Canada is concerned. Perhaps you could give a fifteen or twenty minute overview of major issues, and we could have an open and informal discussion. We would plan to invite our graduate students, who clearly have a vested interest in these matters! Topics of interest would include "big science" versus "little science", industrial support (or lack of it) for science, the best strategies for granting agencies in times of limited budgets (e.g. a little bit for everyone, or major funding for a few "stars"), the future of SSC and/or the kaon factory, etc. This will be followed by a reception from 5:30 to 6:30. Plans for dinner have been altered since I wrote to you previously. It turns out that the annual dinner for the University Senate and the Board of Governors is being held that night, and many of the people I would like you to meet will be there. The President has kindly extended an invitation to you to join us at the dinner. The Dean of our college (Iain Campbell) and the Vice- President Academic (Jack R. MacDonald) are both accelerator physicists, and former members of the Physics Department, and would be pleased to have the opportunity to chat with you. You will be seeing John Kuehner and Peter Egelstaff the next day at luncheon, following Convocation. I trust these plans are satisfactory. I look forward to seeing you next week. Yours sincerely, Robin R.W. Ollerhead, Chair, RWO/bem Department of Physics. GUELPH ONTARIO CANADA N1G 2W1 (519) 824-4120 EXT 3771 FAX (519) 836-9967 [email protected] "INVITATION FOR DR. BROMLEY" TYPE: INVITATION-SPEECH DOCUMENT NUMBER: 9121513 SPEECH: YES NO FROM: MAGAZINE, Alan H.: HIMA DATE OF EVENT: 06/04/91 LOCATION OF EVENT: MADISON HOTEL, WASHINGTON, D.C. TIME OF EVENT: 07:30PM SUBJECT: INVITATION TO ADDRESS THE HIMA BOARD OF DIRECTORS AT THEIR BOARD DINNER. RSVP: 05/28/91 CONTACT PERSON: CONTACT NUMBER: INVITATION ACCEPTED? YES NO COPIES TO: LIFE SCIENCES Regulted to REMARKS: 5/30/91 - m arilyn! mn DATE OF LETTER: 05/22/91 DATE RECEIVED: 05/28/91 FILE: P INVITATION-SPEECH 9/2/513 HIMA RECEIVED HEALTH INDUSTRY MANUFACTURERS ASSOCIATION 91 MAY 28 A9: 23 ALAN H. MAGAZINE PRESIDENT OFFICE DIRECTOR May 22, 1991 D. Allen Bromley Assistant to the President Science and Technology The White House 1600 Pennsylvania Avenue, N.W. Washington, DC 20500 Dear Dr. Bromley: You may recall that shortly after you were sworn in you accepted my invitation to address the Council on Competitiveness Board of Directors at a luncheon meeting. I have since become President of the Health Industry Manufacturers Association, an organization of approximately 300 companies that manufacture 95 percent of this country's medical devices, diagnostics and health information systems. It is a pleasure to extend an invitation to you to address the HIMA Board of Directors and guests at our upcoming Board Dinner at 7:30 p.m., June 4 at the Madison Hotel here in Washington. I am enclosing our recently released report, Competitiveness of the U.S. Health Care Technology Industry for your information. I very much hope that you will be able to join us on the evening of June 4. If you have any questions, please don't hesitate to let me know. I look forward to hearing from you. Best regards, Alla Alan H. Magazine AHM:rll Enclosure World Leaders in Health Care Innovation 1030 15TH STREET, N.W.. SUITE 1100 WASHINGTON, D.C. 20005-1598 (202) 452-8240 FAX (202) 289-1978 HIMA HEALTH INDUSTRY MANUFACTURERS ASSOCIATION COMPETITIVENESS OF THE U.S. HEALTH CARE TECHNOLOGY INDUSTRY Contribution to the U.S. Economy and Trade World Leaders in Health Care Innovation COMPETITIVENESS OF THE U.S. HEALTH CARE TECHNOLOGY INDUSTRY Contribution to the U.S. Economy and Trade Project Director: Ed Rozynski Vice President, International Matt Gallivan Director, International © 1991 Health Industry Manufacturers Association Report # 91-2 HIMA No portion of this publication may be reprinted or reproduced without the express written permission of the Health Industry Manufacturers Association Copyright ©1991 by the Health Industry Manufacturers Association. All rights reserved. TABLE OF CONTENTS LIST OF FIGURES i PREFACE ii ACKNOWLEDGMENTS iv EXECUTIVE SUMMARY 1 INTRODUCTION 6 A History of Growth and Innovation 6 Important Terms 7 Looking to the Future 8 I. PRODUCTION, CONSUMPTION AND EMPLOYMENT 10 A Major Contributor to U.S. Manufacturing Growth 11 Employment in the Health Care Technology Industry 11 II. INTERNATIONAL TRADE 13 Bilateral Trade Flows 14 Composition of Medical Products Trade Flows 16 Export Intensity and Import Penetration Ratios 17 III. INNOVATION 19 Research and Development Spending 19 FDA Medical Device Approvals 20 Medical Products Patents 20 IV. PROSPECTS 22 Growth Projections 22 Negative Scenario 23 Positive Scenario 27 V. CONCLUSION 29 VI. APPENDICES 30 Appendix A: Notes on Data 30 Appendix B: SIC Codes 31 Appendix C: Tables 35 VII. NOTES 56 HIMA ACKNOWLEDGMENTS This report was prepared by Ed Rozynski, HIMA Vice President for International, and Matthew Gallivan, Director for International. The report was made possible by the cooperation of many other members of HIMA's staff, including Marie Briones and Beverly Pettigrew, as well as U.S. Depart- ment of Commerce officials, includ- ing Alan Dunn and Michael Fuchs. This report was edited by Leslie Albin and Adam Kernan-Schloss, of Kernan-Schloss Associates, and designed by Carter/Cosgrove & Company. iv HIMA LIST OF FIGURES 1. U.S. Health Care Technology Industry Production, 1990 1 2. U.S. Health Care Technology Industry Fact Sheet, 1990-1995 3 3. U.S. Health Care Technology Industry Trade Surplus, 1985-1990 6 4. U.S. Production of Medical Devices and Diagnostic Products, 1987-1990 10 5. U.S. Production and Consumption of Health Care Technology Products, 1980-1990 11 6. Employment in the Health Care Technology Industry, 1987-1990 11 7. U.S. Exports and Imports of Health Care Technology Products, 1984-1990 13 8. U.S. Medical Products Exports, 1987-1990 13 9. U.S. Medical Products Imports, 1987-1990 14 10. Major Purchasers of U.S. Medical Products Exports, 1980 and 1990 15 11. Major Suppliers of U.S. Medical Products Imports, 1980 and 1990 15 12. Export Intensity Ratios for Selected U.S. Industries, 1977-1990 18 13. Import Penetration Ratios for Selected U.S. Industries, 1977-1990 18 14. R&D as a Percentage of Sales in 1988 and 1989 19 15. Ownership of U.S. Medical Device Patents, 1980-1990 21 16. Growth Rate Projections for Selected U.S. Industries, 1991 22 17. U.S. Health Care Technology Industry Growth, 1990-1995 23 18. U.S. Production of Health Care Technology Products, 1985-1995 23 19. Projected Trade Surplus for Medical Products Under Current Environment, 1985-1995 24 20. Potential Negative Developments 24 21. Relative Competitiveness of U.S. Industry 27 HIMA PREFACE Health care technology can be The U.S. health care technology the very nature of their business to awe-inspiring - the balloon catheter industry has flourished during the global trends and to the fast pace of used to repair the fragile heart of an trend of global competition that has change - are alert to challenges unborn baby as the infant rests in her stymied so many other American ahead that, if not well met, could mother's womb. industries. In fact, over the past two weaken the U.S. health care technol- It can be high tech - the artificial decades, while import displacement ogy industry's vitality to the detri- lungs that help the 70-year-old has devastated communities that had ment of each and every American. librarian to breathe. relied for years on the local mill or These challenges are arising both It can be small and simple - - the factory, this industry has proven by on the domestic U.S. scene and suture that helps patch the Little example that American industry can abroad. But, fortunately, there is Leaguer's leg. compete - and win - in global much U.S. industry and policymakers And it can be preventive and markets. can and must - do to safeguard practical - the immunization for the During the past five years, for the nation's wealth and health in both infant or the mammography screen- example, the exports of this industry arenas. ing that saves the life of the infant's have increased at a double-digit rate. For instance, there can be no 41-year-old mother. In 1990, the industry rang up an doubt that the global marketplace the The manufacturers of medical estimated $6.5 billion in exports and industry will confront in the 1990s devices and diagnostic products who a $3.2 billion trade surplus, while at will be even more competitive than make up America's $31.2 billion the same time providing high-value that of the 1980s. The unification of health care technology industry jobs for more and more Americans the European Community (EC) in produce a vast array of life-saving - nearly a quarter of a million, in 1992 will help forge larger and and life-enhancing equipment and fact. stronger firms in that 12-nation supplies. These include surgical and This deeply ingrained export market. Already dominant German medical instruments, electromedical mentality, which other industries are firms should continue to prosper in apparatus, diagnostic imaging just now trying to develop, is one of this environment. The liberation of equipment, in vitro diagnostic two factors that more than any other the East Bloc and the trade liberaliza- products and much more. They also explain why the medical products tion of Mexico and other Latin make health information systems - industry has succeeded while others American countries will spawn new computer hardware and software have failed. business and investment opportuni- designed to process everything from The second factor is a tradition of ties that will help local and foreign patient records to lab and blood bank technological innovation and rapid, companies compete against U.S. data - an increasingly important but careful, product commercializa- companies in world markets. The segment of the health care technology tion. The health care technology newly industrialized nations of the industry. industry invests an average of some 6 Pacific Rim will be larger and The products of this industry are percent of sales in research and tougher competitors in the more not only world-class in terms of development - - twice the average of advanced technology industries, quality and technological sophistica- all other American manufacturers. including health care technology. tion, but also world-class in terms of Given these two strengths and the And Japan will continue to improve the contributions they make to the industry's history of success, it would its technological and manufacturing quality of human life. The more than be easy to become complacent, to prowess while extending its global 300 companies that belong to the expect the stream of life-sustaining reach. With trade playing an Health Industry Manufacturers innovations and the large trade increasingly important role in the Association (HIMA) account for over surpluses to continue of their own prosperity of both the U.S. health 90 percent of the health care technol- accord. The fact is, however, that the care technology industry and our ogy sales in the United States. industry's leaders - - sensitized by nation as a whole, it is vitally ii HIMA important that American product approval process will take. If policymaking on behalf of policymakers persevere in their they cannot plan realistically for government - coupled with contin- efforts to establish and maintain a these factors, they cannot survive. If ued enterprise and innovation on level playing field. they cannot survive, the nation will behalf of industry — can guarantee On the regulatory front, proposed lose their entrepreneurial skills, their Americans the rising standard of changes in U.S. and EC regulations technical innovation and their living and the rising standard of stand in startling contrast to trends in economic contributions for all time. health to which they are entitled. other parts of the world. As the To understand how and why the economies of Eastern Europe and the changing national and international Soviet Union struggle toward more environment affects this industry and open markets and a freer private all those who depend on it, it is sector, the U.S. and EC governments helpful to review major trends and are contemplating policies that could the worldwide market position of produce more regulation and make U.S. medical products manufacturers. innovation more difficult, especially This report provides just such a during the next several years. The review. A second volume of this uncertainty that is being created by report, which analyzes world markets the new U.S. and EC medical device and opportunities in greater depth, legislation will take its toll until the should be available in late 1991. new legislation is implemented and HIMA plans to update and reissue tested in the marketplace. At that both volumes periodically. time, it is possible that industry will This first volume attempts to put benefit from the new U.S. and EC the contribution that the health care regulatory schemes and from any technology industry makes to resulting harmonization of regulation. America's economy and international Although it is important that we all trade performance in perspective. It continue to work to ensure that health is designed to be used by both care technology is safe, effective policymakers and executives as they and provided at reasonable cost, it is address the complex business, also important that regulatory and regulatory and trade issues facing the cost-control measures not handicap, industry. These issues are not only even temporarily, the innovativeness complex, they are vital - to the that is a major strength of the industry itself, of course, but also to industry and its key to international the U.S. economy and to individual competitiveness. Americans. Contrary to common belief, We have seen strong industries medical products manufacturers are falter before. We know how the not all huge corporations. Two-thirds impact ripples through the nation's of HIMA's members are small economy for years to come and how businesses with annual revenues of it affects the lives of everyone who $20 million or less. These compa- works in an industry, supplies an nies, in particular, need a regulatory industry or depends on an industry environment in which the product for goods and services. The contribu- approval process is timely, predict- tion the U.S. health care technology able, consistent and not unduly industry makes to America's balance burdensome. They need to know in sheet does not have to wane. How- advance what types of studies must ever, cooperation between govern- be done, what types of applications ment and industry and within need to be filed and how long the government itself is vital. Wise iii HIMA EXECUTIVE SUMMARY Like virtually every other industry to the field who have less than $20 Of the six industry sectors in America, the health care technol- million in annual revenues. They identified by the U.S. Department of ogy industry has encountered the thrive by being highly entrepreneur- Commerce as the fastest growing in trend toward global markets and ial, excelling at taking an innovation 1991, three are health care technol- increased international competition. from the lab and speeding it to ogy industry sectors — surgical and Unlike virtually every other industry market. Together, these companies, medical instruments (forecast to grow in America, however, the health care old and new, large and small, create a 9 percent), surgical appliances and technology industry has maintained stream of ever-improving products supplies (8 percent) and diagnostic and increased its positive trade that lengthen the lives of Americans substances (7 percent). balance throughout the last decade, and people around the world - and Consumption of health care despite the nation's recent overall make those lives more productive and technology products within the trade deficits. The keys to the pleasant. United States is growing, too, industry's high degree of interna- The future of this industry is far totalling $26.3 billion in 1989, up 7 tional competitiveness are its abilities from certain, however. This report percent from the 1988 figure. Recent to innovate, to commercialize its provides a snapshot of where the estimates indicate that consumption innovations rapidly and to penetrate health care technology industry reached $28.0 billion in 1990. In all, foreign markets. stands today and how various factors both production and consumption The manufacturers of medical could shape the industry tomorrow. have grown nearly 200 percent devices and diagnostic products who during the 1980-1990 period. comprise the health care technology PRODUCTION, CONSUMPTION This growth has contributed to industry are a diverse group. Some AND EMPLOYMENT strong industry employment figures. date back to the pioneering days of Since 1980, employment in the modern medicine in the 19th century. In 1989, the U.S. health care medical products industry has grown Over the decades, some have evolved technology industry produced a total by more than 38 percent. In the past into multinational corporations with a of $28.7 billion in equipment and two years alone, the health care variety of product lines and annual products, up 10 percent over the year technology industry has increased the sales in the billions of dollars. Many before. For 1990, the figure is number of jobs it provides by an other firms, however, are newcomers estimated to have climbed another 9 annual rate of 4 percent. During percent to $31.2 billion (Figure 1). 1990, some 248,300 were employed in the industry. Figure 1 U.S. HEALTH CARE TECHNOLOGY INDUSTRY PRODUCTION INTERNATIONAL TRADE 1990 The health care technology Medical devices $27.8 billion industry is one of America's foremost Surgical and medical instruments $ 9.5 billion exporters. It is, in fact, one of the few U.S. industries that did not run a Surgical appliances and supplies 10.1 billion trade deficit during the 1980s, even Dental equipment and supplies 1.3 billion when the U.S. dollar was very strong. X-ray apparatus and tubes 1.9 billion Today, the industry continues to generate a trade surplus averaging $1 Electromedical equipment 5.0 billion billion or more. Not only does this Diagnostic products 3.4 billion strong international performance help the industry's bottom line, it also 1990 TOTAL U.S. PRODUCTION $31.2 billion helps the nation's balance of trade. In 1989, the industry racked up a $2.3 1 HIMA billion surplus. In 1990, the the American market: the most health care technology products were industry's trade surplus reached an innovative and effective manufactur- Japanese (accounting for about 10 estimated $3.2 billion as exports ers, regardless of home country, can percent) and German (about 9 grew by more than 18 percent to $6.5 readily capture a chunk of what is the percent). billion. world's largest market for health care Meanwhile, 48 percent of all U.S. This success has been achieved technology products - - the United patents granted in 1990 went to despite tough global competition. States. foreign residents. In other words, Germany has a particularly strong U.S. health care technology compa- and broad-based health care technol- INNOVATION nies dominate patent activity in their ogy industry. Japan is also extremely field far more than do U.S. compa- competitive in several product areas The U.S. health care technology nies as a whole. such as electromedical imaging industry's international success stems equipment. These two countries alone in no small part from its commitment PROSPECTS account for nearly half of U.S. to innovation. In both 1988 and medical products imports. In 1990, 1989, the industry invested 6.2 Conservative Health Industry Germany bought an estimated $691 percent of sales in research and Manufacturers Association (HIMA) million worth of U.S. medical development. The average for U.S. forecasts predict that U.S. health care products. Nevertheless, although the industry as a whole was 3.4 percent. technology production will grow 7.4 U.S. achieved a worldwide trade The medical products industry even percent each year between 1990 and surplus in medical products that year, out-invested other industries recog- 1995 (see Figure 2). American it ran a $127 million medical prod- nized for innovation - aerospace consumption is forecast to grow 5.1 ucts deficit with Germany. In (4.1 percent of sales invested in percent annually during that period, medical products trade with Japan, R&D), chemicals (3.8 percent), and while U.S. exports and the U.S. trade the U.S. trade surplus with that electrical and electronics (5.4 surplus are expected to grow at country grew to $115 million in percent). annual rates of 15.5 percent and 24.3 1990, after going into surplus in 1989 This major investment in innova- percent, respectively. for the first time in many years. In tion brought nearly 5,000 new health As conservative as these forecasts all, two-thirds of the medical devices care technology products to market in are, however, it remains possible that exported from the United States in fiscal 1990. Most of these products various policy-related decisions could 1990 were consumed by the Euro- were reviewed under the Food and be made in the United States and pean Community, Japan and Canada. Drug Administration's (FDA's) abroad that could significantly curtail The Pacific Rim nations and Mexico premarket notification, or 510(k), the industry's annual growth. are also important rapidly growing process. The total review time for markets for U.S. exports. In addition the 4,748 products approved this way Negative Scenario to exporting to these countries, many averaged 98 days. (By comparison, Domestically, for instance, the U.S. medical products companies the 47 products approved through the FDA upon which the industry have made overseas investments in FDA's premarket approval [PMA] must depend so heavily for efficient local production to better serve these procedure averaged 415 days.) regulation could be hampered by markets. Another measure of the industry's continued chronic under-funding and Industry import/export figures innovativeness and international by recent legislation, such as the Safe bear witness to the increasing competitiveness is patent activity. Medical Devices Act of 1990, which internationalization of the health care During the period 1980-1990, the adds a number of new requirements technology market. Both the U.S. number of medical device patents to the FDA's review process. It will export intensity level and the import granted annually by the U.S. Patent take months and, in some instances, penetration ratio have risen gradually and Trademark Office more than years before many of the new since 1975. In other words, America doubled, reaching 4,180 in 1990. requirements are implemented by the is both exporting more and importing Only 32 percent of the U.S. medical government and understood by an more of these products. Today, being device patents granted in 1990 were industry that creates new products an American manufacturer carries no foreign owned. The most frequent very rapidly. Even before the guarantee of holding a given share of foreign owners of U.S. patents for enactment of the new legislation, the 2 HIMA Figure 2 Medicare cost-control measures. U.S. HEALTH CARE TECHNOLOGY INDUSTRY FACT SHEET 1990-1995 Medicare coverage policies involve a large portion of the U.S. health care 1990 Subtotals 1990 1995 Projected delivery system and directly affect Production $31.2 billion $43.9 billion the environment for technological - Medical devices $27.8 billion - Diagnostic products 3.4 billion innovation. Over the past decade, Market size (consumption) $28.0 billion some Medicare coverage and $35.5 billion - Medical devices $25.3 billion payment regulations have been - Diagnostic products 2.8 billion implemented that constrained the U.S. exports 6.5 billion $13.1 billion introduction and diffusion of new U.S. imports 3.3 billion 4.7 billion U.S. trade surplus 3.2 billion 8.4 billion technologies. Furthermore, a recent - with the EC $1,017 million study found that coverage decisions - with Japan 115 million - with Canada 841 million for new technologies took an average - with Germany -127 million of nearly 2.4 years to complete, thus - with Mexico 43 million 174 million delaying the availability of critical - with the U.K. technologies. U.S. Industry employment 248,300 Another initiative that could harm Industry R&D expenditures 6.2% as a percentage of sales this industry is the regulations being Annual U.S. Industry growth (1990 & drafted to implement the Clinical projected annual growth through 1995) Laboratory Improvement Amend- - Market size up 6.4% up 5.1% - Production up 8.8% up 7.4% ments of 1988. These regulations - Exports up 18.4% up 15.5% could change laboratory testing in - Imports up 5.3% up 6.9% ways that add up to multimillion- - Trade surplus up 35.8% up 24.3% - Employment up 2.8% dollar losses to the diagnostics sector Device approvals and favorable decisions of the health care technology PMAs: 47 down 16% industry. Also, a number of environ- PMA supplements: 700 up 35% 510(k)s: 4,748 down 2% mental and worker safety regulations PMA review time (days) up 19% are under consideration at both the 510(k) review time (days) up 20% state and federal level that could significantly affect certain segments Sources: U.S. Department of Commerce unpublished data; FDA data for fiscal year 1990; Business Week, *R&D Scoreboard 1990"; and HIMA projections based on historical trends. of the health care technology industry. The revised Clean Air Act, for example, will pose a number of number of PMAs approved and user fees, seen by some as a solution challenges to the industry and is 510(k)s cleared by the FDA had to the FDA's funding problems, must expected to result in increased costs. already fallen in FY 1990, while be paid with each new product Internationally, how much access average review and approval time approval application, the small, U.S. manufacturers have to key increased. entrepreneurial companies in the markets such as Japan and the 12- If regulatory delays, uncertainty industry will be crippled. In addition, nation European Community (EC) and a number of burdensome user fees could create a host of and how foreign governments decide requirements sparked by the new conflict-of-interest questions because to treat their own health care technol- legislation further inhibit the U.S. companies would, in effect, be ogy industries at home will also have medical products industry from paying money to the FDA to approve a significant impact. The EC's plans bringing its innovations to market, it their new products. to completely overhaul and harmo- will not be able to continue to invest What's more, changes in Medicare nize its approval process by 1992 will so vigorously in R&D. Nor will the coverage and payment regulations create uncertainty and possible chaos industry be able to improve already could reduce the amount of money for manufacturers trying to access the developed technologies by incorpo- available to be plowed back into the European market. In Japan, the rating information learned from their development of new technologies and government is in the process of manufacture and use. Furthermore, if products, as could certain proposed revising its health care requirements 3 HIMA and reimbursement system in an Administration could help ensure that medical products companies, both effort to control the cost of serving its FDA-approved products are covered large and small, to R&D and to rapidly aging population. for Medicare reimbursement pur- exporting sets the industry apart from Can U.S. companies adapt as poses. A more efficient system of many others. Its future rests on the quickly and freely as local companies preparing export certificates also ability of these companies to continue to the major changes taking place in could help the industry strengthen its their commitment to developing and the foreign regulatory environment? performance in overseas markets by marketing innovative products at A recent U.S. Department of reducing the delays that U.S. suppli- home and abroad. Furthermore, the Commerce study warns that trends ers face in marketing their products industry must strive to meet this emerging overseas in product in many countries. challenge in the face of increasingly introduction and government support Internationally, the possible strong foreign competition and to industry are making foreign harmonization of regulatory require- increasingly tight government companies more vital global competi- ments that the unification of the reimbursement and regulatory tors than ever before. Given the European Community could bring to controls. increasingly favorable climate some that 12-nation market, the restructur- HIMA recognizes that the health foreign health care technology ing of Japan's distribution system and care technology industry itself is companies are enjoying at home, improvements in international trade responsible for continuing to meet its U.S. companies may begin to lag - rules in the General Agreement on global competitors with the same especially if they do not have the Tariffs and Trade (GATT) could all vision, energy and innovativeness as same open access to their competi- bolster the U.S. health care technol- it has in the past. The industry is also tors' home markets as their competi- ogy industry's export performance. responsible for alerting U.S. tors have to the vast U.S. market. Finally, efforts to enhance policymakers to the priorities and All told, the U.S. industry's future America's overall international pitfalls in the regulatory and legisla- success is much more fragile than its competitiveness, such as the reduc- tive spheres that could boost or strong historical performance tion of the U.S. budget deficit, would impair the industry's ability to buoy suggests. increase growth prospects for U.S. the nation's trade balance and - just industries in general, including the as important - to safeguard the Positive Scenario health care technology industry. health and well-being of every There are, of course, circum- American. stances that could fuel the U.S. health CONCLUSION American legislators and regula- care technology industry's growth tors will decide how well funded and beyond what HIMA's conservative In recent years, the U.S. health efficient the FDA is in coming years, forecasts predict. Domestically, care technology industry has per- how well attuned to new technologies Congress could end the FDA's formed extremely well in both Medicare is, how reasonable labora- chronic under-funding, giving it the domestic and international markets. tory testing regulations are and how resources to attract well-qualified Not only has the industry helped aggressive U.S. negotiations with scientists to develop guidance on shore up America's balance of trade trading partners are. regulatory requirements and to serve by running a large surplus in an era Greater coordination within U.S. as medical reviewers. Furthermore, of widespread deficits, it has also government circles will be needed to the FDA could implement the new created a wealth of innovative life- shape and balance often competing Safe Medical Devices Act of 1990 in saving and life-enhancing products national priorities - the need for a manner that minimizes the potential and provided jobs to nearly a quarter U.S. competitiveness versus the need negative impact and uncertainty of a million workers. In coming for adequate regulatory controls, for caused by any major new legislation years, the industry is expected to instance. The dismal trade perfor- of this type. But some degree of remain a major contributor to U.S. mance of other U.S. industries uncertainty and disruption cannot be manufacturing growth and U.S. trade throughout the 1980s should serve as avoided. performance, with a projected trade a reminder that the competitiveness Better coordination between the surplus of $8.4 billion in 1995. of this industry is as fragile as some FDA and the Health Care Financing The commitment of America's of the patients it serves. Moreover, 4 HIMA it underscores the importance of policy coordination both within the government and between the govern- ment and the private sector. By working together, the U.S. government and the U.S. health care technology industry can continue to meet these challenges and to fulfill these important national priorities. 5 HIMA INTRODUCTION The trend toward global markets 3).¹ The industry provided jobs to the United States grew from approxi- and increased international competi- nearly 250,000 and put nearly 5,000 mately 200 to 6,000. tion is a phenomenon that is affecting new medical devices on the market to Just as the development of health virtually every U.S. industry. The help Americans live longer and care technology encouraged the health care technology industry is no healthier lives. establishment of medical services and exception. But the industry's facilities that could use the new consistently strong growth and A HISTORY OF GROWTH technologies to save lives, the positive trade balance over the last AND INNOVATION proliferation of those services and several decades, including the recent facilities also encouraged the period of high U.S. trade deficits, The beginnings of the modern expansion of the fledgling health care have made it an exceptionally bright health care technology industry can technology industry. Other develop- spot on America's economic balance be traced back to the 1880s, when the ments in that era reinforced this sheet. Thanks to the U.S. health care use of anesthetics and antisepsis for trend. The shift in physician training technology industry's ability to surgical purposes was pioneered. in the early 1900s to a stronger innovate and to commercialize its These developments vastly changed emphasis on the biological and innovations rapidly, its competitive- the role hospitals played from that of chemical sciences, for instance, ness in world markets has been caretaking to that of intervening in prepared doctors to better understand, ensured, despite increased competi- patients' health. The development of develop and use technological tion from overseas suppliers in recent x-ray technology at the turn of the advances. The creation of Blue years. century added even greater impetus Cross insurance in 1927 helped make In 1990, U.S. production of for establishing well-capitalized those advances available to more medical devices and diagnostic hospitals that could acquire such Americans. products reached $31.2 billion, while equipment and provide the lab-testing The inclusion of medical insur- the U.S. trade surplus in medical and other facilities needed for ance as a standard part of employee products rose to an estimated $3.2 surgical procedures. Between 1880 benefits during the World War II era billion, its highest level ever (Figure and 1920, the number of hospitals in and the creation of Medicare/ Medicaid in 1965 went even further Figure 3 in making health care technology U.S. HEALTH CARE TECHNOLOGY INDUSTRY TRADE SURPLUS widely available in this country and 1985-1990 provided hospitals with a stable 4 financial base on which to operate. In addition, the National Institutes of Health's large-scale funding of 3 biomedical research after World War II made the development of more $ billions effective surgical techniques and 2 technological advances possible. Together, these trends and develop- ments have contributed greatly to the 1 dramatic advances in health care that Americans - and people all around 0 the world - have enjoyed in recent 1985 1986 1987 1988 1989 1990* decades. * Estimate. A number of today's major health Source: U.S. Department of Commerce unpublished data. care technology companies date back to those pioneering days of medicine 6 HIMA IMPORTANT TERMS In this report, the health care health information system segment mentioned above — products that technology industry is also referred figures are included in the medical are used outside the patient's to as the medical products industry device totals and not shown as a body. This category is the larger and the medical devices and separate industry segment. of the two, and most manufactur- diagnostic products industry. The This has been done because the ers of these products are repre- industry is described as having two U.S. Department of Commerce sented by HIMA. major segments: recently began including partial data Some in vitro diagnostic Medical devices — By far the on health information systems in its products such as HIV assays or largest industry segment, medical device Standard Industrial blood bank reagents are regulated medical devices range from Classification (SIC) grouping for by the FDA as in vitro biologicals. tongue depressors to surgical electromedical equipment. This is a As such, they are subject to instruments, from implantable step forward — in the past, neither regulatory oversight that differs devices to magnetic resonance government nor private data sources slightly from the above mentioned imaging (MRI) systems. tended to classify computer hardware groups. Makers of such products Diagnostic products A rapidly and software by their end use. The are also represented by HIMA. growing industry segment, contribution health information In vivo reagents, on the other diagnostics are products that systems manufacturers made to the hand, are injected into or ingested allow patients to be tested for a health care technology industry's by the patient. Examples include variety of conditions. Examples production, consumption and trade the various radiological substances include immunoassay kits, totals, therefore, was invisible in that are administered to a patient allergy measuring products and industry statistics. Although that to make x-ray or CAT scan images drug-abuse tests. As is contribution is now being at least more revealing. These products explained below, there is an partially recorded, adequate statistics are used inside the patient's body. important distinction to be made are not yet available for this report to The makers of these products are between the two basic types of discuss the health information system represented by pharmaceutical diagnostic products: in vitro and segment with the same comprehen- industry groups, not by HIMA. biological products, and in vivo siveness as the medical devices and When it comes to compiling diagnostic reagents. diagnostics product industry statistics on diagnostic products, segments. however, the distinction between A Third Segment in vitro and in vivo products is The Health Industry Manufac- Diagnostic Products rarely made — both are grouped turers Association (HIMA) also As mentioned above, the diagnos- together. Fortunately, for the recognizes a third important tic products segment is divided into purposes of this report, inclusion of industry segment, health informa- two basic categories: (1) in vitro and in vivo reagent products in the tion systems — the computer biological diagnostic products and (2) figures does not significantly distort hardware and software that do a in vivo reagents. In vitro products use health care technology industry number of health care-related chemical or biological reagents to test totals. tasks such as processing patient specimens (blood, urine, etc.) drawn For more detailed information records, financial information, or from a patient. Examples include the on the data in this report, see lab and blood bank data. For the immunoassay kits, allergy measuring Appendix A. purposes of this report, however, products and drug-abuse tests 7 HIMA in the 1880s. Many of these compa- delivers an electric shock to the heart benefits to a number of industries, nies began by producing what are to restore normal heartbeats - has including telecommunications and today simple products, such as greatly reduced the risk of death due computers. bandages, alkaloids and relatively to a fibrillating (or racing) heart. By broadening U.S. research and crude medical instruments. Over the Artificial limbs and joints such as hip manufacturing in emerging technol- decades, they evolved into multi- implants have improved the lives and ogy areas, medical products clearly national corporations with diverse productivity of countless people by contribute to the stream of develop- product lines and annual sales in the increasing mobility and, often, by ments that fuel other American high- billions of dollars. relieving pain. New instruments and tech industries. Many of these The commitment to innovation techniques are also greatly reducing industries, along with the health care that is the hallmark of today's health the risks and recovery times for a technology industry, will play key care technology industry was present number of surgical procedures. For roles in America's future prosperity. from the start. A turn-of-the-century example, the laparoscopic technique, ice-box manufacturer that began by in which surgeons make small LOOKING TO THE FUTURE exploring refrigeration technology, incisions through which they insert for instance, developed a niche in the cameras and surgical tools, is The health care technology health care field and, though still a currently being expanded to a number industry is expected to experience relatively small company, is today of applications - from the removal strong growth as the U.S. economy one of the world's premier suppliers of gallbladders to intestinal and chest enters the 1990s. Both increased of blood bank refrigeration equip- surgery. Other devices such as consumption of medical products and ment and hospital coolers. surgical lasers are being used to stronger foreign demand are expected In contrast, however, many other remove infected body tissue, includ- to contribute to this growth. health care technology companies are ing cancerous growths. Such The consumption of health care newcomers to the field. In fact, one procedures, and the medical devices technology products in the United distinguishing characteristic of the used to carry them out, offer not only States is expected to grow for several industry is the large role that newer, health advantages but also significant reasons. One factor is the aging of smaller companies - those with less financial benefits. the U.S. population. The proportion than $20 million in annual revenues It should also be noted that, of the population 65 years old and - play. Some of these companies although these innovations improve older, for example, is projected to are highly entrepreneurial and excel the quality of life in the United States rise from 9.8 percent in 1970 to 13.0 at taking a technological innovation and abroad, they also contribute to percent by the year 2000.2 The from the lab, developing it into a U.S. economic competitiveness by increased availability of various marketable product and making it incorporating and otherwise broaden- treatments on an outpatient basis, as available to patients. ing America's use of advanced well as shortened recovery periods This corporate mix of old and technologies and materials. The associated with many new treatments, new, large and small, has produced a defibrillator was made possible only encourages individuals to take vast number of innovative products in through advances in sensor technol- advantage of these services and recent decades that save lives and ogy and electronic engineering. products. In addition, the increase in greatly improve the quality of life. Artificial limbs and implants increas- the incidence of infectious diseases For example, in fewer than 20 years, ingly rely on advanced materials to such as AIDS will also stimulate diagnostic imaging equipment has improve their effectiveness. In the demand for certain medical products. progressed from x-ray to CAT scan area of x-ray imaging, many believe Stronger foreign demand will also to MRI. One of the benefits of this that a major part of the next leap play a major role in this industry's progression has been the dramatic forward will come from high- growth prospects. U.S. medical increase in the survival rate of head- definition imaging, which will store products manufacturers maintain a trauma victims. A decade ago, one in and display images electronically and worldwide reputation as suppliers of 10 survived; today, the survival rate result in vastly sharper pictures. It is high-quality, very competitive approaches 9 in 10. expected that the work done on products. Overseas sales are ex- Another notable innovation, the digital imaging technology for pected to increase not only in the implantable defibrillator - which medical purposes will spin off fast-growing developed country 8 HIMA markets of Canada, Japan and the all segments of the industry. In European Community (EC), but also addition, numerous efforts underway in less traditional developing country to contain health care costs are markets. The high-growth Pacific creating another form of regulatory Rim economies, in particular, have complications and uncertainty for the strong sales potential for American industry. medical products firms. The U.S. health care technology Trade in medical products is also industry achieved its highest trade expected to grow strongly as a result surplus ever in 1990. Clearly, this of companies' continued efforts to industry represents one of the respond to global competitive competitive industries the United pressures. Medical technology States will have to rely upon as it companies, given the heavy invest- grows out of its trade deficits. ment they must make in technology However, as is discussed extensively and R&D, must work to achieve in a later section, the industry's economies of scale, lower their costs growth prospects and its future and leverage their technology contribution to U.S. trade perfor- investments beyond the U.S. market. mance could be greatly diminished In addition to their commitment to by changes in the regulatory and innovation, another distinguishing international environment. characteristic of health care technol- ogy companies, both large and small, is their commitment to exporting. Although the United States is the largest market in the world for medical products, many companies in this industry operate with the stated objective of doing at least 50 percent of their business outside the United States. In a recent survey of 222 of its smaller company members, HIMA found that more than 77 percent were active in exporting their products. One of these companies recently won the Presidential "E Award" for excellence in exporting from the U.S. Department of Commerce. This company, a maker of monitors and respiratory care products based in California, exports well over 50 percent of its products. A third distinguishing characteris- tic of health care technology compa- nies is the degree of regulation they face. In fact, the health care technol- ogy industry is one of the most highly regulated manufacturing industries in America, with regulations at the state and federal level affecting virtually 9 HIMA I. PRODUCTION, CONSUMPTION AND EMPLOYMENT The U.S. health care technology of nearly 9 percent, with medical enced average annual growth of industry comprises manufacturers of device production experiencing approximately 11 percent. Growth in medical devices and diagnostic average annual growth of 8.9 percent these product areas has been fueled products. In 1990, the United States and diagnostic products 8.2 percent primarily by health concerns over the produced an estimated total of $31.2 (Table 1). spread of AIDS and other infectious billion in medical devices and The size of the U.S. market for diseases. Shipments of electro- diagnostic products (Figure 4). Of health care technology products, in medical equipment experienced a this total, medical device production terms of consumption, amounted to similarly strong annual growth rate of amounted to $27.8 billion in 1990, $28.0 billion in 1990, approximately 9.2 percent during this period, as while production of diagnostic 6.3 percent higher than 1989 levels.³ purchases of MRI equipment and products reached $3.4 billion (see Over the three-year period 1988- ultrasound devices have remained at Table 1 in Appendix C). 1990, U.S. consumption of medical high levels. Table 2 contains a The $31.2 billion in U.S. produc- products grew annually by an average breakdown of medical device tion of health care technology of approximately 7 percent, with production by SIC code.4 products represents a 9 percent medical device consumption growing Most important, as Table 1 increase over 1989 levels. This by an average 6.6 percent and indicates, the increase in medical increase helped to supply the U.S. diagnostic products averaging annual device and diagnostics production in market, which expanded by 6 growth of 7.0 percent. recent years has, to a large degree, percent, and the export market, which The two medical device product been driven by export growth. U.S. grew by 18 percent in 1990. During categories with the strongest growth production in the past three years has the three-year period, 1988-1990, in production during the period 1988- risen at an average annual rate of medical device and diagnostics 1990 were surgical appliances and almost 9 percent, while consumption production in the United States supplies, and surgical and medical has risen less than 7 percent annually. experienced average annual growth instruments, both of which experi- At the same time, U.S. exports averaged annual growth of more than 21 percent. Figure 4 U.S. PRODUCTION OF MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS Table 1 also provides a longer 1987-1990 term perspective on U.S. production 40 and consumption of medical devices and diagnostic products. Since 1975, the U.S. health care technology 30 industry has grown from a $5 billion industry to one of over $31 billion. $ billions During the same period, the U.S. 20 market has grown from under $5 billion to more than $28 billion. In the past 10 years alone, both produc- 10 tion and consumption of health care technology products in the United 0 States have increased nearly 200 1987 1988 1989 1990* percent (Figure 5). * Estimate. Source: U.S. Department of Commerce unpublished data. 10 HIMA A MAJOR CONTRIBUTOR Figure 5 U.S. PRODUCTION AND CONSUMPTION OF HEALTH CARE TO U.S. MANUFACTURING TECHNOLOGY PRODUCTS, 1980-1990 GROWTH 40 Production The U.S. Department of Com- Consumption merce has forecast that the health 30 care technology industry will be a major source of U.S. manufacturing growth over the near term. In fact, the health care technology and other $ billions 20 high-tech industries are expected to dominate U.S. manufacturing growth 10 over the next few years. Table 3 lists the 10 industries - identified by the U.S. Department of 0 Commerce on a four-digit SIC code 1980 1985 1990* basis - that are expected to experi- * Estimate. ence the strongest growth in 1991 (in Source: U.S. Department of Commerce unpublished data. terms of industry shipments, on a constant dollar basis). Medical devices and diagnostic products account for three of the six industry Figure 6 sectors identified as the highest- EMPLOYMENT IN THE HEALTH CARE TECHNOLOGY INDUSTRY 1987-1990 growth industries. Surgical and medical instruments, 300 and surgical appliances and supplies rank near the top of the list of fastest 250 growing U.S. industries, with projected growth rates of 8.6 percent Employees in thousands 200 and 7.6 percent, respectively, for 150 1991. Shipments by firms producing diagnostic substances are expected to 100 grow by 6.9 percent in 1991. Over- all, the U.S. Department of Com- 50 merce estimates that shipments by companies producing medical 0 devices will grow 7.3 percent in 1987 1988 1989 1990* 1991, in constant dollar terms * Estimate. (Table 4). Source: U.S. Department of Commerce unpublished data and HIMA estimates. EMPLOYMENT IN THE HEALTH CARE TECHNOLOGY health care technology industry markets, and as new entrants in the INDUSTRY employment has averaged annual industry have commercialized new growth of approximately 4.3 percent, technologies. The growth in U.S. production and reaching 248,300 in 1990 (Figure 6 The major portion of employment consumption of health care technol- and Table 5). This employment in the health care technology industry ogy products over the past decade has growth has occurred as existing can be attributed to medical device contributed to strong employment companies have expanded their production. Employment in the growth in the industry - more than activities to respond to increased medical device area totalled 231, 100 38 percent. Over the past three years, demand in both the U.S. and overseas in 1990, up approximately 3 percent 11 HIMA from 1989 levels. Over the period 1980-1990, employment in the medical device area has grown by more than 37 percent. The major portion of medical device employ- ment growth over this 10-year period can be attributed to surgical and medical instruments, and surgical appliances and supplies. Employment in the diagnostic products sector, which reached 17,200 in 1990, has shown even more impressive growth over the past 10 years. During the period 1980-1990, employment in the diagnostic products area grew by more than 68 percent. Over the past three years, employment in this sector has experienced average annual growth of 3.8 percent (Table 5). 12 HIMA II. INTERNATIONAL TRADE The strong growth in the U.S. remained flat in 1988 and 1989 and 1980s, with the overall effect that trade surplus in medical products in are estimated to have increased only imports climbed from $650 million in recent years makes the health care marginally in 1990 (Figure 9). 1980 to $3.3 billion in 1990. This technology industry one of the few Medical products imports, strong growth can be attributed to a U.S. industries to consistently however, did rise strongly in the early number of factors. The United States generate a trade surplus averaging $1 billion or more.⁵ The trade surplus Figure 7 for the medical products industry U.S. EXPORTS AND IMPORTS OF HEALTH CARE TECHNOLOGY PRODUCTS 1984-1990 over the past 10 years has ranged from a high of $2.3 billion in 1989 to 7 a low of $890 million in 1986 (Figure Exports 6 7). Preliminary information from the Imports U.S. Department of Commerce Surplus 5 indicates that the export-driven growth in the medical products trade surplus continued in 1990, with the $ billions 4 surplus reaching an estimated $3.2 3 billion (Table 6). The major factor contributing to 2 the consistent surplus is the strength of U.S. medical products exports 1 (Figure 8). Annual medical products 1984 1985 1986 1987 1988 1989 1990* exports increased from $1.9 billion in * Estimate. 1980 to $6.5 billion in 1990, an Source: U.S. Department of Commerce unpublished data. increase of more than 242 percent (Table 6). In the past three years, exports of health care technology products have experienced an Figure 8 average annual growth of more than U.S. MEDICAL PRODUCTS EXPORTS 21 percent. The significant growth in 1987-1990 exports, cushioned by recent slower 7 growth in imports, has reversed the 6 five-year deterioration of the trade surplus that occurred during the mid- 5 1980s. The recent slowdown in medical 4 products imports is due, in part, to the $ billions 3 weakening of the U.S. dollar in relation to the currencies of the 2 countries that host major suppliers of medical products (i.e., Germany and 1 Japan). It also reflects the overall 0 competitiveness of the U.S. industry 1987 1988 1989 1990* across the range of medical devices * Estimate. and diagnostic products. U.S. Source: U.S. Department of Commerce unpublished data. imports of medical products 13 HIMA Figure 9 growth in U.S. exports to that market U.S. MEDICAL PRODUCTS IMPORTS and modest market liberalization by 1987-1990 the Japanese government, some of 4 which occurred at the behest of the U.S. government. In 1988, these efforts, in combination with increased 3 competitiveness as result of the lower value of the dollar, began to pay off $ billions in terms of the industry's trade 2 performance. In 1990, the U.S. trade surplus with Japan in medical 1 products reached an estimated $115 million. U.S. trade with its North Ameri- 0 can neighbors also increased signifi- 1987 1988 1989 1990* cantly in recent years. U.S. medical * Estimate. device and diagnostics exports to Source: U.S. Department of Commerce unpublished data. Canada are estimated to have grown over 60 percent in 1990, to $934 million, contributing to a medical is the largest market for medical significant medical products deficit products trade surplus with that products, and U.S. demand has is Germany. As can be seen from country of $841 million (Table 8). grown substantially. Compared to Table 7, that deficit expanded during With regard to Mexico, both exports other major countries, the U.S. the period 1980-1990, despite the fact and imports have nearly doubled in market provides for relatively rapid that U.S. exports to Germany also the last three years, reaching $297 acceptance of new medical technol- increased significantly during the million and $254 million, respec- ogy. The relative strength of the U.S. period. After peaking at $265 million tively, in 1990. Medical products economy and limited growth oppor- in 1987, the U.S. trade deficit for trade with Mexico is now nearly as tunities in high-debt developing medical products with Germany has large as U.S. medical products trade countries also contributed to strong decreased to $127 million in 1990 with France and the United Kingdom. competition in the U.S. market. This (Table 8). Similarly, the bilateral Trade with Mexico is expected to rise in imports — - as well as exports trade balance with the European grow in future years with the negotia- - is also further evidence of the Community (EC), which had been a tion of a Free Trade Agreement, increasing globalization of the health surplus of only $225 million in 1987, which will further enhance economic care technology industry. has grown to a surplus of $1.017 ties between the United States and billion in 1990. Mexico. BILATERAL TRADE FLOWS At the beginning of the decade, the United States had a bilateral trade Major Purchasers of U.S. During much of the 1980s, the surplus in medical products of $92 Exports U.S. health care technology industry million with Japan, the second largest Table 9 provides a comparison of experienced chronic trade deficits bilateral trade surplus that year in fact the major purchasing countries of with Germany and Japan. However, (Table 7). However, by the mid- U.S. medical products in 1980 and the big rise in the U.S. medical 1980s the United States had devel- 1990. The percentages attributable to products trade surplus in the last oped a medical products trade deficit purchasing countries have remained three years has reversed the with Japan that peaked at $95 million surprisingly stable during the decade. industry's trade deficit with Japan, in 1987. The U.S. industry's inability The 10 largest purchasers of U.S. and substantially reduced the trade to keep up with exports from Japan health care technology products in deficit with Germany. during the period 1980-1987 oc- 1980 continued to be the 10 largest The only nation with which the curred despite the industry's in- purchasers in 1990, although for United States currently runs a creased sales efforts in Japan, strong some the rankings have changed. 14 HIMA Canada (15 percent), Japan (14 (Figure 11 and Table 10). Imports million, respectively, which together percent) and Germany (11 percent) from Japan as a percent of total U.S. accounted for nearly half of total U.S. remain the three largest single- imports increased from 18 percent to imports of medical products. country markets for U.S. medical 24 percent during the period 1980- Imports from Mexico rose so products exports and purchased the 1990. In contrast, the German share dramatically during the period 1980- lion's share of U.S. exports in 1990. of U.S. medical products imports fell 1990 that Mexico is now the third As illustrated in Figure 10, the EC, from 35 percent to 25 percent. In largest supplier to the U.S. market. Japan and Canada account for two- 1990, imports from Germany and Imports from Mexico rose from $11 thirds of total U.S. medical products Japan totalled $818 million and $794 million in 1980 to $254 million 1990. exports. The EC itself took 39 percent of the United States' medical Figure 10 products exports in 1990. It should MAJOR PURCHASERS OF U.S. MEDICAL PRODUCTS EXPORTS 1980 AND 1990 also be noted that the EC and Japan accounted for an even greater 1980 1990 percentage of U.S. exports in 1990 Total exports: $1.9 billion Total exports: $6.5 billion than they did in 1980, reflecting the importance of these markets to U.S. Canada Canada medical products manufacturers. (13.8%) (14.5%) U.S. exports to Asian markets other than Japan (e.g., South Korea EC EC (37.6%) (39.0%) and Taiwan) have grown strongly in Other Other (27.7%) (23.1%) recent years as a result of increased demand for medical equipment in these expanding economies. These Japan Japan (12.5%) Other Asia (14.1%) markets now account for 9.3 percent and Australia Other Asia of U.S. medical products exports. (8.4%) and Australia Mexico's share of U.S. medical Note: 1980 figures exclude diagnostic products. (9.3%) products exports increased from 3.2 Source: U.S. Department of Commerce unpublished data. percent in 1980 to 4.6 percent in 1990. It is likely that increased exports to Mexico can, in part, be attributed to import liberalization in Figure 11 that country and some alleviation of MAJOR SUPPLIERS OF U.S. MEDICAL PRODUCTS IMPORTS the country's debt situation. How- 1980 AND 1990 ever, these numbers, rather than 1980 1990 reflecting only an increase in the Total imports: $0.7 billion Total imports: $3.3 billion Mexican market for medical prod- Canada Canada ucts, may also reflect the fact that (5.0%) (2.8%) U.S. companies are increasingly Other locating there for production and Other (16.0%) (21.3%) assembly purposes. This results in EC (45.9%) increased exports to Mexico of EC partially assembled products, which (58.3%) Japan (18.3%) are then finished and re-exported to Japan the U.S. market. (24.2%) Other Asia and Australia Major Suppliers of U.S. Imports Other Asia (2.4%) and Australia In contrast to export patterns, the Note: 1980 figures exclude diagnostic products. (5.8%) data reveal that import patterns have Source: U.S. Department of Commerce unpublished data. changed substantially since 1980 15 HIMA Again, however, it is not clear to Surgical appliances and supplies accounted for by electromedical what extent these figures reflect also contributed strongly to recent equipment stood at approximately 28 actual sales to end users or border growth in the medical products trade percent in 1990, down from approxi- transactions between producers and surplus, as exports have grown by mately 35 percent in 1987 and 1988 assemblers. more than 25 percent during the (Table 12). period 1988-1990, and imports have MRI equipment, along with x-ray COMPOSITION OF MEDICAL remained stagnant (Table 11). This equipment, makes up the diagnostic PRODUCTS TRADE FLOWS category includes implantable imaging product area. As Table 11 medical devices, a product area in shows, the U.S. trade deficit in x-ray Table 11 provides a breakdown of which U.S. suppliers are particularly and irradiation equipment decreased health care technology products trade competitive and have a large world to $312 million in 1990, as U.S. flows by major product groups. market share. For example, U.S. exports of x-ray equipment rose and Surgical and medical instruments suppliers hold over 90 percent of the imports remained static. have been the major contributor to Japanese market in heart valves and The competition has become the surge in the U.S. medical prod- artificial joints. Intra-ocular lenses is particularly fierce in the x-ray ucts trade surplus in recent years. another implantable product area in technology area as suppliers in Japan, Exports of these products have grown which the U.S. suppliers are strong. Germany, the Netherlands and the by an average annual rate of more However, although U.S. suppliers are United Kingdom have grown from than 35 percent in the past three competitive in the implantable being predominantly "national years, reaching an estimated $1.9 products area, they are by no means suppliers" to global players. In billion in 1990. At the same time, dominant and face tough competition addition, with the U.S. market for U.S. imports of surgical and medical from European suppliers, particularly x-ray equipment being primarily a instruments have remained relatively from German suppliers. With the replacement market with relatively flat. As can be seen in Table 12, with growth in exports of these products, slow growth prospects, U.S. suppliers the surge in exports of these instru- surgical appliances and supplies now must increasingly fight for market ments, this category now accounts for account for 17 percent of total health share elsewhere, such as in Japan and nearly 29 percent of total U.S. care technology products exports, the EC. exports of health care technology compared with 11 percent of exports Diagnostic products in recent products. in 1980. years have become a key product The major factor contributing to Electromedical equipment has group contributing to the U.S. trade the growth in exports of surgical and continued to be a strong contributor surplus in medical products. In 1990, medical instruments is probably the to the U.S. medical device trade the trade surplus in diagnostic spread of AIDS and other infectious surplus in recent years, despite the products reached $649 million. diseases. Exports of medical fact that exports of these products Relative to their foreign competitors, equipment used for infectious control have not grown as rapidly as other U.S. diagnostics manufacturers are purposes (e.g., syringes, needles and medical product categories (Table very competitive in terms of market various transfusion equipment) have 11). The U.S. trade surplus in sales. While a number of foreign grown significantly in recent years. electromedical equipment reached an competitors have developed strong In addition, U.S. suppliers are estimated $811 million in 1990. Key positions in certain product niches, particularly competitive (i.e., have a products in this category — in which U.S. diagnostics suppliers have large percentage of world market U.S. suppliers have strong market captured the largest percentage of share) in the more technologically share - are pacemakers and mag- world sales, followed closely by advanced medical instruments such netic resonance imaging (MRI) European manufacturers and more as microsurgical equipment. Al- equipment. Pacemakers represent distantly by Japanese suppliers. With though U.S. suppliers are also strong another example of implantable the populations aging in the key in the hand-held instrument area, they devices where the major foreign markets of the EC and Japan, as well face tough competition from suppli- competition for U.S. suppliers comes as in the United States, it is likely that ers in Europe and Japan in this from Germany. The percentage of U.S. production and exports of product area. total medical products exports diagnostic products will remain strong over the medium term. 16 HIMA With regard to the composition intensity, with 30 percent of industry apparatus and equipment bought of U.S. imports (Table 13), shipments devoted to exports in in America and nearly 24 percent electromedical equipment and x-ray 1990. Given their heavy dependence of electromedical equipment apparatus together accounted for on export markets, as well as the consumption. nearly 57 percent of total U.S. strong competition suppliers of these On the whole, Table 14 provides medical products imports in 1990, products face worldwide, the further evidence of the increasing compared with approximately 50 electromedical and x-ray industry importance of internationalization in percent in 1980. The percentage of sectors are especially sensitive to the health care technology industry. imports accounted for by surgical and foreign exchange rate fluctuations Both the export intensity level and medical instruments, and surgical and other external factors influencing the import penetration ratio for the appliances and supplies has dropped trade.⁷ industry have exhibited a gradual rise since 1980, to 23 percent and 12 Dental equipment and surgical and since 1975. percent, respectively, in 1990. medical instruments also have The industry's consistently relatively strong export intensities. favorable trade intensity, especially EXPORT INTENSITY AND In 1990, exports as a percentage of relative to other U.S. industries, is IMPORT PENETRATION RATIOS shipments stood at approximately 27 indicative of its strength in the face of percent for dental equipment, while growing international competition. As a result of the health care the percentage for surgical and Figures 12 and 13 compare the technology industry's historical medical instruments grew to over 19 import and export intensities of the commitment to exporting, as well as percent. Diagnostic products also U.S. medical products industry with the competitive dividends of invest- have a relatively strong export. those of several other U.S. industries. ment in research and development, intensity, with nearly 23 percent of The other industries shown are a the industry has had a strong and product shipments going to foreign sample of some of America's highest relatively consistent export intensity markets in 1990. and lowest exporting and importing ratio since 1975.6 On the import side, foreign industries. Although gradually increasing, products accounted for less than 12 The export intensity of the health exports as a percentage of production percent of total U.S. consumption of care technology industry now stands have tended to range between 15 and health care technology products in at approximately 21 percent, which is 20 percent during the period 1975- 1990 (Table 14). Similar to this significantly higher than the rela- 1990 (Table 14). In 1990, the U.S. industry's export intensity ratio, the tively low export intensities experi- health care technology industry import penetration ratio has steadily enced by the U.S. footwear and drug exported approximately 21 percent of increased over the past 15 years from industries. The U.S. pulp mill its production, the highest level ever. the 7 percent level experienced in industry has a very strong export The export intensity of the industry 1975. intensity of more than 40 percent; had stood at 18 percent in 1980, Import penetration ratios vary however, it should be noted that that dropped slightly during the mid- widely across the categories of health industry's import intensity also 1980s, and has increased in recent care technology products. Import exceeds 40 percent. Although the years as the export performance of a penetration in the surgical and export intensity for the medical number of product categories has medical instruments, and surgical products industry is lower than that improved. appliances and supplies categories for the computer industry, both of Electromedical equipment is stood at 9 percent and 4 percent, these high-tech industries have clearly the most export-intensive of respectively, in 1990. However, in experienced a similar increase in the the medical products categories. the x-ray apparatus and electro- percentage of their production that is Exports accounted for approximately medical equipment sectors - the shipped to foreign markets. 36 percent of U.S. shipments of sectors that account for the major On the import penetration side, electromedical equipment in 1990, portion of medical device imports - imports as a percentage of new down from 42 percent in 1988. the penetration levels are much supply for the health care technology X-ray apparatus and irradiation higher. In 1990, imports accounted industry remain relatively low in equipment also has a high export for more than 40 percent of x-ray relation to such import-intensive HIMA 17 Figure 12 industries as consumer electronics EXPORT INTENSITY RATIOS FOR SELECTED U.S. INDUSTRIES 1977-1990 and footwear. This is despite the fact that the U.S. market, as for so many 50 industries, represents the world's largest medical device market and is 40 the one that foreign suppliers target with their products. 30 Percent 20 10 0 '77 '78 '79 '80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90 Drugs Computer equipment Pulp mills Footwear, except rubber Medical products Consumer electronics Note: Export intensity ratio = export/shipments. Source: U.S. Department of Commerce, U.S. Industrial Outlook 1988 and 1990. Figure 13 IMPORT PENETRATION RATIOS FOR SELECTED U.S. INDUSTRIES 1977-1990 70 60 50 Percent 40 30 20 10 0 '77 '78 '79 '80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90 Drugs Automobiles Pulp mills Footwear, except rubber Medical products Consumer electronics Note: Import ratio = import/(shipments + imports). Source: U.S. Department of Commerce, U.S. Industrial Outlook 1988 and 1990. 18 HIMA III. INNOVATION The rapid introduction of new magnetic resonance imaging (MRI) American consumers demand high- products and the refinement of instead of exploratory surgery. And quality, innovative health care existing products are hallmarks of the when surgery is still necessary, products, and the FDA's 510(k) U.S. health care technology industry. technological innovations such as process, under which the majority of Innovation and new product introduc- angioplasty devices (small hollow products are reviewed before going tion, in fact, are the key to the catheters) and the microsurgical tools on the market, allows for relatively industry's international competitive- used in laproscopy provide for less rapid product introduction. ness. Firms that can successfully invasive procedures. By reducing The industry's innovativeness can develop new products and satisfy risks and recovery times, these health be measured in a number of ways. consumer demand remain competi- care technologies can reduce costs One measure is the percentage of tive in both the domestic and world over the long term. sales that health care technology health care technology markets. Where medical technology does companies invest in research and Innovation is also a key factor in lead to increased costs, it is often development. Another is the number financial performance, a very because these advances allow doctors of new medical products approved by important business consideration. to do more for more people. When the FDA for use in the United States. According to one Wall Street analyst, used effectively, medical technology Patents are also a useful indicator of the health care technology companies helps keep people alive, get them the industry's innovativeness. whose stocks perform the best are back to work sooner and improve those that have made new product their quality of life. RESEARCH AND development a part of their opera- More than most industries, the DEVELOPMENT SPENDING tions strategy. health care technology industry has But technology and innovation been receptive to technological Better health care is based on have little intrinsic value until they innovation. This is related in no constant change, constant invention. are used to benefit people. The true small part to the fact that the U.S. To retain their international competi- benefits of health care technology are market is, in general, receptive to tiveness in the coming decade and found in the lives saved and the advancing health care technology. into the 21st century, U.S. health care improved quality of lives lived by people around the world; the eco- Figure 14 nomic considerations of competitive- R&D AS A PERCENTAGE OF SALES IN 1989 ness and stock performance pale in comparison. 7 All too often, technological 6 innovation is blamed for increased health care costs. However, this 5 assumption does not accurately 4 reflect the relationship between health care technology and costs. Percent 3 Newer technologies can actually 2 reduce the costs associated with health care by allowing for care in 1 lower-cost settings and by replacing 0 more invasive procedures. Thanks to All Medical Aerospace Chemicals Electrical technological innovations, doctors industries products and electronics can use sophisticated diagnostic equipment such as positron emission Source: "Innovation 1990, R&D Scoreboard," Business Week tomography (PET scans) and 19 HIMA technology manufacturers must be process, a manufacturer must file a United States work to ensure that able to continue to market new and premarket notification with FDA medical products entering the market more effective products. before placing into commercial are safe and effective, it is also The U.S. health care technology distribution a medical device that is important that the regulatory ap- industry has demonstrated its substantially equivalent to devices proval process not handicap commitment to innovation by already on the market. These industry's ability to develop innova- investing heavily in research and procedures suffice, in the overwhelm- tions and new products and to make development. In both 1988 and ing majority of cases, to ensure that them available to patients. In the 1989, the industry spent 6.2 percent products entering the marketplace majority of cases, the 510(k) process of sales on R&D, compared to an can be used by patients with minimal provides both the FDA and the health average for all U.S. industry of 3.4 risk. care technology industry with percent in those years (Table 15). As can be seen in Table 17, in FY effective regulatory procedures that Figure 14 shows the health care 1990 the FDA decided in 4,748 cases do not constrain the application of technology industry's R&D expendi- - out of a total of 5,831 510(k) relatively recent innovations and new tures relative to other innovative U.S. submissions received - that devices technologies. The 510(k) process is industries such as the electrical and being marketed for the first time were well-suited for an engineering-based electronics industry, which spent 5.4 substantially equivalent to devices industry that relies on incremental percent of sales on R&D in 1989. already on the market. The total product improvements in most cases. Table 16 shows the magnitude of review time averaged 98 days for U.S. health care-related R&D. The these cases. The 4,748 cases that MEDICAL PRODUCTS American public and private sectors were cleared under the 510(k) PATENTS spent an estimated $141.8 billion on process in FY 1990 represent about a research and development in all areas 2 percent drop from the number of The rapid rate of innovation in the in 1989. Of that total, health care cases cleared in FY 1989 under these health care technology industry R&D accounted for an estimated procedures. makes many medical devices $20.8 billion, or 14.7 percent.⁹ In the case of products that are technologically obsolete within a few During the period 1985-1989, U.S. breakthrough devices, manufacturers short years or months. For this health-related R&D grew at an are required to submit a PMA reason, patent protection is typically average annual rate of 11.4 percent. application for FDA review and less important in the medical prod- approval. PMAs must provide ucts area than in related fields such as FDA MEDICAL DEVICE assurance that the device is safe and pharmaceuticals. However, patent APPROVALS effective for its intended use and that protection in many instances can help it will be manufactured in accordance medical products manufacturers In fiscal year 1990, the FDA with good manufacturing practices protect important rights and, by cleared 4,795 new medical devices (GMPs). During FY 1990, a total of encouraging the disclosure of for sale in the United States. The 79 original PMAs were submitted. information concerning new tech- overwhelming majority of these The 47 approved represent a 16 nologies, stimulate further innova- clearances were processed under the percent drop from the number of tions in a number of high-tech FDA's premarket notification, or PMAs approved in FY 1989 (Table medical product areas. 510(k), process. Forty-seven of these 18). The total average review time A recent HIMA study estimated approvals were granted under the on these cases was 415 days - that approximately 4 percent of the FDA's premarket approval (PMA) considerably longer than for the total number of patents approved by procedures. 510(k) cases. However, the law the U.S. Patent and Trademark Office The FDA's 510(k) process is stipulates that PMAs should be in 1990 were granted to medical uniquely suited for technology that is approved within six months (i.e., 180 products.¹⁰ Of the approximately improved through incremental days). PMA supplements, which 4,180 medical products patents refinement and allows the FDA to represent modifications to existing granted that year, 32 percent were scrutinize a product to a degree PMAs, rose from 510 to 700, or 35 foreign owned (Table 19). Figure 15 commensurate with its sophistication percent, in FY 1990. shows the increasing number of U.S. and complexity. Under the 510(k) Although it is important that the medical patents granted on an annual 20 HIMA Figure 15 OWNERSHIP OF U.S. MEDICAL DEVICE PATENTS 1980-1990 3000 Total foreign Total U.S. 2500 2000 Number of patents 1500 1000 500 0 1980 1985 1990 Source: U.S. Department of Commerce, Patent & Trademark Office, 1991. basis. The 4,180 total medical device of medical device patents include the patents granted in 1990 represent United Kingdom, France and Canada. more than a 100 percent increase Although the number of medical over the number granted in 1980. device patents going to foreign During this same 10-year period, the residents has been increasing, patent ownership share of U.S. medical data still reflect the U.S. health care device patents granted to foreign technology industry's strong interna- entities grew from 27 percent to 32 tional competitiveness. While 32 percent. Japanese entities generally percent of the medical products receive the largest foreign share of patents granted in 1990 did go to U.S. medical products patents foreign residents, 48 percent of all granted to foreign owners, accounting patents for inventions granted in 1990 for approximately 10 percent of the went to foreign residents. In other U.S. medical products patents words, U.S. health care technology granted in 1990. German concerns companies are far more dominant in also receive a substantial number of terms of patent activity than are U.S. U.S. medical device patents. Other companies as a whole.¹¹ countries with a significant number 21 HIMA IV. PROSPECTS The focus of the paper to this for the year. Figure 16 provides projections for 1990 were reduced by point has been to review the growth comparable projections for selected 10 percent and projections for the and development of the health care U.S. high-growth industries. The period 1991-1995 were reduced by technology industry. The data clearly health care technology industry is 20 percent in anticipation of a identify and establish the industry's expected to grow significantly faster sluggish U.S. economy over the next positive, substantial and unique than some of the fastest growing U.S. several years (Figure 17 and Table contribution to the U.S. economy and industries and much faster than the 20). Figure 18 provides a year-by- to the quality of American life and U.S. economy in general. year picture of the industry's size for health. In coming years, the industry Since the mid-1980s, production the period 1985-1995 based on has the potential to continue to be a in the health care technology industry historical data and current industry major source of economic growth and has grown an average of 9 percent projections. technological advances. If that annually. Based on U.S. Department Despite the conservative projec- potential is to be realized, however, of Commerce historical data and tions, export growth is still forecast to policymakers - both American and 1990 projections, HIMA estimates be a major contributor to the contin- foreign — must refrain from disrupt- that U.S. production and consump- ued growth in U.S. production, as it ing the regulatory environment in tion will maintain exceptionally has been in the past. Both U.S. which the industry operates. strong growth for the next five years. government and industry sources HIMA also estimates that the expect U.S. medical products exports GROWTH PROJECTIONS industry's trade surplus will expand to continue to grow at a double-digit 39 percent in 1990 and will record pace over the next five years. At the U.S. Department of Commerce average annual growth of 24 percent HIMA-forecasted annual growth estimates rank the health care for the years 1990-1995. rates of approximately 19.0 percent technology industry as the fastest HIMA's projections represent a for 1990 and 15.5 percent for 1990- growing U.S. industry in 1991, with conservative estimate of the 1995, U.S. exports would reach $13.1 an expected growth rate of 7.3 industry's future prospects, given billion in 1995. Imports, however, percent (on a constant dollar basis) recent historical trends. Specifically, are expected to grow much more modestly over the next several years, with annual growth forecast to be Figure 16 GROWTH RATE PROJECTIONS FOR SELECTED U.S. INDUSTRIES about 7.6 percent in 1990 and 6.9 1991 percent in 1990-1995, which would place U.S. imports of medical devices All U.S. industries at $4.7 billion in 1995. Based on these projections, the Medical equipment U.S. trade surplus in medical products would reach $8.4 billion in Aerospace 1995 (Figure 19). Under HIMA's Computers conservative projections, the size of the U.S. market for health care Industrial machinery technology products, in terms of consumption, would be $35.5 billion Machine tools in 1995, reflecting average annual growth of 5 percent during 1990- Rubber/plastics products 1995. 0 1 2 3 4 5 6 7 8 It is important to note that these projections assume no major changes Source: U.S. Department of Commerce, U.S. Industrial Outlook, 1991. in the regulatory or competitive 22 HIMA Figure 17 about 2 percent (Figure 18). The U.S. HEALTH CARE TECHNOLOGY INDUSTRY GROWTH 1990-1995 competitive edge the U.S. health care technology industry currently holds in world markets could substantially Amounts Annual growth (in $ billions) (in percentages) deteriorate and, ultimately, the health and wealth of the nation could suffer. Category 1990 1995 1990 1990-1995 These potentially negative factors can U.S. production 31.0 43.9 8.1 7.4 be divided into two categories - Exports 6.5 13.1 19.0 15.5 domestic and international Imports 3.3 4.7 7.6 6.9 (Figure 20). U.S. trade surplus 3.2 8.4 39.1 24.3 U.S. market size (consumption) 27.8 35.5 5.7 5.1 Domestic Factors How the FDA implements the Source: HIMA projections. Safe Medical Devices Act of 1990 could have a tremendous impact on the strength of the U.S. health care technology industry's future perfor- mance. All of the innovations that Figure 18 U.S. PRODUCTION OF HEALTH CARE TECHNOLOGY PRODUCTS flow from the industry must pass 1985-1995 through the FDA's approval process 45 before they can benefit American patients. If that approval process is 40 slowed or disrupted, the flow of 35 innovations will also be slowed and 30 disrupted. $ billions 25 The most apparent losers in that instance would be the Americans 20 Projected growth under who would have lived longer or had 15 current regulatory and better lives if they had had access to international environment 10 Projected growth under the latest technology. At the same 5 negative regulatory and time, the health care technology international environment industry itself would be weakened 0 '85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 because it could not bring its prod- ucts to market. Thus, sources of revenue would be cut off as would Source: U.S. Department of Commerce and industry sources. opportunities to continue developing the stalled technologies. Meanwhile, companies in nations without environment in which the industry hands of policymakers. Ironically, regulatory bottlenecks would be able operates. There are, however, a the policy options that could have the to forge ahead with their innovation number of potential changes facing most negative effects on the industry processes in their home markets and the industry that could substantially from a competitiveness standpoint make themselves increasingly alter the industry's future are those designed to improve the competitive in the global market, performance. current system for medical products while American companies lag. An from a regulatory standpoint. The efficient FDA, therefore, is a vital NEGATIVE SCENARIO impact of these options could be ingredient in preserving the U.S. great, however, reducing the industry's international preeminence. Nearly all of the factors that could industry's 1990-1995 growth Three policy areas are particularly dim the U.S. health care technology potential from the currently projected important here: protecting the FDA's industry's growth prospects are in the annual rate of 7.4 percent to only review procedures, providing 23 HIMA Figure 19 to the FDA's review procedures that PROJECTED TRADE SURPLUS FOR MEDICAL PRODUCTS UNDER CURRENT are likely to complicate further the ENVIRONMENT, 1985-1995 510(k) process upon which the U.S. 14 health care technology industry must Exports so heavily depend to get improved 12 Imports Surplus products to market. Requirements 10 contained in the new legislation include changes in premarket review $ billions 8 requirements, including the prepara- tion of a summary of safety and 6 effectiveness data for most products 4 and the certification that a search of adverse incidents for certain products 2 has been conducted. Additional requirements include tracking certain 0 '85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 high-risk devices, reporting removals and corrective actions taken by Source: 1990-1995 figures are HIMA projections based on historical data from the U.S. Department of Commerce. manufacturers, postmarket surveil- lance and reporting by health care providers of certain incidents involving devices. The new law also Figure 20 adds design validation of quality POTENTIAL NEGATIVE DEVELOPMENTS systems to the FDA's good manufac- turing practices (GMPs) require- ments, which will increase the U.S. Legislative and Regulatory Factors regulatory burden on the industry, but Adding requirements to the FDA's review process may also facilitate agreement A lack of resources at FDA between the United States and the EC Imposition of user fees on a common GMP standard. The Reductions in reimbursement levels/coverage legislation also provides the FDA Cost-control measures discouraging innovation with the authority to assess civil Ill-conceived clinical laboratory regulations penalties, to issue emergency recalls and to suspend PMAs temporarily. Foreign Regulatory Factors Although it is unclear how these Imposition of price controls on most medical products in Japan new requirements initially will affect Regulatory gridlock and chaos as a result of EC 1992 the efficiency of the FDA's review Cost-control measures discouraging innovation processes, the legislation is expected Source: HIMA. to create some degree of regulatory uncertainty in the marketplace. The uncertainty is likely to remain until sufficient resources to the FDA and legislation and its implementation. As the new requirements have been avoiding the imposition of user fees. discussed in the previous chapter, the implemented by the government and The new requirements to the number of PMAs approved and understood by an industry that FDA's review process called for by 510(k)s favorably reviewed had innovates very rapidly. Lacking any recent legislation, including the Safe already fallen in FY 1990, while at additional resources for the FDA, the Medical Devices Act of 1990, could the same time the average number of legislation is also likely to increase significantly impair the competitive- days required for reviews and the FDA's paperwork load, further ness of the U.S. health care technol- approvals had increased. slowing down product review times. ogy industry, if only because of the The Safe Medical Devices Act of The second important policy area, uncertainty caused by the new 1990 adds a number of requirements FDA resources, has long been a 24 HIMA problem for the agency and the scheme contained in the President's only hope for restoring limited industry. In fiscal 1989, for example, FY 1991 budget proposal. The hearing to a significant number of the FDA's Device Center had only President's budget proposal called for profoundly hard-of-hearing people. 3.2 percent more staff-years at its companies to pay some $157 million In addition, because of the Medicare disposal than it did in 1980, even in FDA user fees in FY 1991 even restriction, one manufacturer of the though the device submissions it though they already contribute device has discontinued production. must handle had grown by more than millions of dollars each year to the The Medicare coverage decision 155 percent during that period. In an support of the federal government in process is another area of concern. era of high federal budget deficits, the form of corporate income taxes. The process for determining whether such problems may only grow worse. What's more, only a portion of the a new product should be paid for, and Continued, chronic under-funding revenues from user fees would at what level of reimbursement, has will prevent the agency from attract- actually go toward FDA program become increasingly difficult as ing and retaining enough qualified improvements. Beyond that, industry government health agencies have reviewers and scientists to handle the funding of FDA activities raises a intensified their efforts to evaluate flow of applications for FDA product host of conflict-of-interest questions new technology before paying for its approvals. and undermines the concept of public use. Stalling the movement of innova- funding for federal activities that A recent study found that Medi- tions from the labs to the marketplace benefit the public at large. care coverage decisions for new is just as detrimental for the industry In addition to policy consider- products took an average of nearly and the Americans in need of the new ations related to the FDA, the U.S. 2.4 years to complete. For one products whether it occurs because health care technology industry's product, the review and approval the FDA review process is made growth prospects could be harmed by time took 5.5 years. 13 In the case of more burdensome or because the changes in other federal regulations, magnetic resonance imaging (MRI), FDA lacks the resources to do its job such as those pertaining to the the coverage decision process took efficiently. Under-funding the FDA Medicare program, to laboratory 3.5 years. Delays in the decision can also lead to inconsistent compli- testing requirements and to environ- process are particularly common ance enforcement, which further mental safety issues. for implantables and other high- discourages the industry from making The Medicare payment program is technology products. While the new, more effective products an issue that is likely to be of increas- evaluations take place, many prod- available while encouraging poor- ing importance in coming years. ucts that could save lives or other- quality products that, ultimately, will Medicare coverage policies involve a wise improve patient care are denied harm the reputation of better-quality large portion of the U.S. health care to patients. products. Lack of resources can also delivery system and directly affect Future changes, such as the limit the FDA's ability to inspect the environment for technological recently passed Medicare physician imported products and manufacturing innovation. Over the past decade, payment reform legislation, pose facilities overseas, which in turn can Medicare coverage and payment similar challenges to the health care result in delays or inadequate regulations were implemented that technology industry. If reimburse- inspection of foreign products. constrained the introduction and ment levels are reduced significantly, The third important policy area, diffusion of some new technologies. the amount of money available to be user fees, is sometimes suggested as A case that exemplifies the effects plowed back into the development of the panacea for the FDA's funding of these regulations is the cochlear new technologies and products will problems. Such fees, however, have implant, a device designed to aid also be reduced. The same effect the effect of taxing innovation and patients with hearing disabilities. A could be caused by instituting certain represent a special hardship for the recent study found that Medicare Medicare cost-control measures that small, entrepreneurial companies that payment for the cochlear implant preclude the use of leading-edge are an especially vital part of the remains well below its cost, with the technology. By discouraging health care technology industry. The result that hospitals restrict the avail- innovation, certain cost-control cost of a single premarket approval ability of the implant to Medicare measures may, in fact, actually serve for a new device would be an beneficiaries.¹² This is despite the to keep costs up, because develop- estimated $90,000 under the user fee fact that cochlear implants remain the ments that might reduce the cost of 25 HIMA patient treatment will simply never International Factors tion bodies is not allowed to rely on occur. According to one expert Because the U.S. health care information from U.S. test and panel, technology will save more technology industry is such a strong inspection facilities, then U.S. than $200 million in Medicare exporter, negative changes in the manufacturers could face long delays hospital costs this fiscal year alone.¹⁴ international context in which the and de facto discrimination in In terms of the laboratory testing industry operates could have a major entering the EC 1992 market. issue, the regulations being drafted to impact on the industry's performance In Japan, the government is also in implement the Clinical Laboratory in coming years. Such changes the process of revising its health care Improvement Amendments of 1988 include developments in the interna- requirements and reimbursement may severely impact the health care tional regulatory environment and in system in order to control the cost of technology industry by substantially the overall competitiveness of foreign serving its rapidly aging population. reducing the diagnostic testing done suppliers. As part of these efforts, the Japanese in physicians' offices and in facilities The European Community (EC) recently proposed establishing price other than traditional laboratories. and Japan represent major markets controls in the three areas of The changes in laboratory testing that for health care technology products. implantables in which U.S. industry could result from these regulations In 1990, the EC market for medical is most competitive and dominates may add up to a multimillion-dollar devices and diagnostic products the Japanese market. Thus far, the loss to the diagnostics sector of the amounted to $18.1 billion, while the Japanese government has agreed to industry - while at the same time Japanese market stood at $10.5 consult with the U.S. government and increasing the costs of testing and billion. U.S. medical products industry regarding this issue, but the making testing services less acces- companies, given their overseas possibility remains that some form of sible in rural and inner-city areas. investments in local production as price controls may be implemented A number of environmental and well as their trade interests in these and, in fact, may be imposed across a worker safety regulations are markets, could be significantly broad range of medical products in currently under consideration at both affected by negative developments in Japan. the state and federal level that will either the regulatory environments of As the chapter on international significantly affect certain segments these countries or the degree of trade showed, the U.S. health care of the health care technology access they have to these markets. technology industry excels at industry. These regulations cover The EC is currently developing exporting its products around the issues ranging from industrial legislation for the regulation of world. However, significant changes emissions to disposal of medical medical devices in the unified in the level and quality of foreign wastes to increased penalties for European marketplace. The EC's competition could also have a great workplace safety and health viola- plans to completely overhaul and effect on the future performance of tions. Under the recently revised harmonize its approval process by the industry in the United States. Clean Air Act, the Environmental 1992 will create uncertainty and European and Japanese health care Protection Agency is expected to possible chaos for manufacturers technology companies are extremely propose new federal emission trying to access the European market. competitive on a global basis. standards for a number of chemicals It is not yet clear what level of Japanese companies are particularly used in the health care technology regulation the industry will face there competitive in the areas of x-ray and industry, including ethylene oxide. after 1992. Nor is it clear whether imaging equipment. With the next The revised Act is expected to U.S. companies will have nondis- step forward in x-ray technology increase the costs of doing business criminatory access to the EC market- likely to come from high-definition in the health care technology industry place. The U.S. industry could be imaging, the Japanese are expected to and, together with the other regula- seriously disadvantaged if European remain strong in this area. With tory and legislative factors discussed testing and certification procedures regard to European companies, above, could have a significant do not provide the flexibility for tests German suppliers are particularly impact on the future performance of and inspections to be carried out by competitive across the broad range of the industry. non-European bodies or outside the medical products, including imaging EC's geographical boundaries. If the equipment. Figure 21 illustrates the limited number of European certifica- relative competitiveness of U.S. 26 HIMA Figure 21 play. If, as foreign governments RELATIVE COMPETITIVENESS OF U.S. INDUSTRY strengthen and nurture their health care technology companies, the Supplies, instruments United States makes it more difficult Implantables and equipment for American companies to innovate and market their products, U.S. industry's global competitiveness may erode quickly. In fact, HIMA calculates that if In vitro Electromedical unfavorable U.S. and foreign diagnostics (imaging) equipment regulatory measures are enacted or if U.S. product groups that are U.S. product groups that are foreign competitors grow in strength, very competitive and in which very competitive and in which the industry's current annual growth foreign products are currently foreign products are also less competitive extremely competitive projections of 7.4 percent could be reduced to a much weaker 2 percent Note: "Relative competitiveness" is based on market sales rather than on techno- or so. In addition, other non- logical superiority. regulatory factors such as procure- Source: HIMA. ment practices can adversely affect future growth prospects. Many of the negative factors that could so industry across the range of health medical device market - like the debilitate an industry with such care technology products. ("Relative U.S. market — has grown rapidly in promise are in the hands of American competitiveness" is based on market recent years. Although U.S. medical policymakers, however. Wise sales rather than on technological device exports to Japan have been decisionmaking at home and wise superiority.) rising significantly, there are indica- foreign trade policies can help offset One factor that could affect the tions that the actual U.S. share of the whatever competitive advantages level of competition that the U.S. Japanese market has remained foreign governments try to bestow health care technology industry faces constant. upon health care companies based in from overseas is the support that Similarly, Germany - like the their countries. Therefore, the fate of foreign governments provide their United States - has a sizable global the U.S. health care technology own industries. A recent U.S. trade surplus in health care technol- industry, the people it employs and Department of Commerce study ogy trade. In fact, Germany is the the people it benefits with life-saving warns that trends emerging overseas only country to run a trade surplus in and life-enhancing products is to no in product introduction and govern- medical products with both the small degree a matter for America's ment support to industry are making United States and Japan. The global leaders to decide. foreign companies more vital strength of the German industry and competitors than ever before.¹⁵ America's chronic medical products POSITIVE SCENARIO Given the increasingly favorable trade deficit with Germany point to climate some foreign health care the danger inherent in allowing the There are, of course, circum- technology companies are enjoying U.S. health care technology industry stances that could fuel the U.S. health in their home countries, the U.S. to falter. Although the U.S. health care technology industry's growth industry may begin to lag behind care technology industry stacks up beyond what HIMA's conservative both Japanese and EC companies in incredibly well when compared to forecasts predict. These circum- certain advanced medical technology other U.S. industrial sectors, its stances are, generally speaking, the areas, particularly imaging equipment continued competitiveness hinges on mirror image of those outlined in the and diagnostics, the report found. not yielding any advantage to its negative scenario above and include The U.S. industry's future success, aggressive and able foreign counter- potential changes in the U.S. regula- therefore, is much more fragile than parts. Here, then, the domestic U.S. tory and legislative environment and its strong historical performance policy considerations outlined at the in the international marketplace. suggests. For example, the Japanese beginning of this chapter come into To avoid complicating its current 27 HIMA review procedures, the FDA could restructuring of Japan's distribution implement the new Safe Medical system (and associated regulatory Devices Act of 1990 in a manner that mechanisms) that reduces the many minimizes the potential negative inefficiencies that contribute to impact and uncertainty caused by any higher prices there. major new legislation of this type. The U.S. health care technology But some degree of uncertainty and industry could also benefit from anxiety cannot be avoided. HIMA improvements in international trade will work with the FDA to lessen this rules in the General Agreements on concern. Furthermore, Congress Tariffs and Trade (GATT) as a result could end the chronic under-funding of the Uruguay Round of negotia- of the agency, providing the FDA tions. These negotiations may lead to with the resources to attract well- significantly reduced tariff and non- qualified scientists to develop tariff barriers in the major medical guidance on regulatory requirements products markets. In addition, and to serve as medical reviewers. economic growth in non-traditional Other domestic factors that markets such as Asia and Eastern would aid the U.S. health care Europe, as well as a U.S.-Mexico technology industry's growth include Free Trade Agreement, could lead to increased coordination between the expanded trade opportunities for U.S. FDA and the Health Care Financing companies. Administration to ensure FDA- International harmonization of approved products are covered for regulatory requirements, a long-term Medicare reimbursement purposes. goal of the U.S. health care technol- A more efficient system of preparing ogy industry, would bring significant export certificates could also aid the benefits to the quality of health care industry by reducing the delays that in the United States and to the U.S. U.S. suppliers face in marketing their industry. Harmonization of require- products overseas. ments (such as those for quality A number of international factors assurance) with those of other could also fuel the U.S. health care countries would enable manufactur- technology industry's growth. The ers to meet major requirements for all unification of the EC in 1992 could markets and help eliminate many of lead to the harmonization of regula- the trade barriers U.S. companies tory requirements in the 12-nation face overseas. Finally, efforts to market and contribute to increased enhance overall U.S. competitive- sales prospects there for U.S. ness, such as reduction of the U.S. companies - if the level of regula- budget deficit and continued focus on tion in the EC 1992 market is not regulatory reform, are positive factors unduly burdensome and if U.S. that would contribute to increased suppliers get equal access to the growth prospects for U.S. industries market. U.S. companies' concern in general. over access to the European market In sum, if some of the above will be greatly reduced if European positive changes were implemented certification bodies have the ability to by policymakers, in the U.S. or subcontract outside the EC for abroad, the U.S. industry could easily product testing and quality assurance continue the near double-digit growth inspections. In the Japanese market, that it experienced during the 1980s. U.S. companies could benefit from a 28 HIMA V. CONCLUSION In recent years, the U.S. health impair the industry's ability to buoy competitiveness.¹⁶ With regard to the care technology industry has per- the nation's trade balance and - just health care technology industry, it is formed extremely well during a as importantly — to safeguard the important that there be cooperation turbulent period for the United States health and well-being of every between industry and government, as in international trade. The consis- American. well as within government itself, to tency of the industry's performance Some of the factors that will achieve a more coordinated approach has been built on a tradition of determine the industry's fate are also in dealing with health care issues product excellence, technological in the hands of U.S. policymakers. affecting the industry's competitive- innovation and rapid, but careful, American legislators and regulators ness. This includes more consistent product commercialization. Recent will determine how efficient the FDA regulatory and reimbursement dramatic increases in export perfor- is in coming years, how well attuned climates and a continued focus on mance and the overall trade surplus to new technologies Medicare is, how opening global markets. of the industry are the dividends of reasonable laboratory testing regula- By working together, the U.S the industry's investment in research tions are and how aggressive U.S. government and the U.S. health care and development. In coming years, negotiations with trading partners are technology industry can continue to the industry is expected to remain a in matters such as assuring U.S. meet these challenges and to fulfill major contributor to U.S. manufac- access to the post-EC 1992 market- these important national priorities. turing growth and trade performance, place. with a projected trade surplus of $8.4 Greater coordination within U.S. billion in 1995. government circles will be needed to The commitment of America's shape and balance often competing health care technology companies, national priorities — the need for both large and small, to R&D and to U.S. competitiveness versus the need exporting sets the industry apart from for adequate regulatory controls, for many others. Its future rests on the instance. The poor trade perfor- ability of these companies to continue mance of other U.S. industries their commitment to developing and throughout the 1980s should serve as marketing innovative products at a reminder that this industry's home and abroad. Moreover, the competitiveness is as fragile as the industry must strive to meet this patients it serves. Moreover, it serves challenge in the face of stronger and to underscore the importance of stronger foreign competition and policy coordination both within the tighter and tighter government government and between the govern- reimbursement and regulatory ment and the private sector. controls. In his recent book, George Lodge HIMA recognizes that the health points out that coordination of care technology industry itself is government policies - both those responsible for continuing to meet its that promote and those that constrain global competitors with the same industry is a critical factor for vision, energy and innovativeness as achieving competitive success in the it has in the past. The industry is also high-tech industries of tomorrow. responsible for alerting U.S. To this end, industry needs to work policymakers to the priorities and with policymakers in all areas of pitfalls in the regulatory and legisla- the government to promote aware- tive spheres that could boost or ness of the importance of industrial 29 HIMA VI. APPENDICES APPENDIX A NOTES ON DATA 1. The data utilized in this study, with the exception of 3. In addition, HIMA has utilized, where available, data U.S. patent data, are based on the U.S. government's collected on diagnostic substances under SIC category Standard Industrial Classification (SIC) codes. 2835. This category was also created as a result of recent changes in the SIC system. 2. The Department of Commerce defines the medical device industry using a total of five SIC codes: 4. It should also be noted that due to the recent changes in the SIC system, as well as U.S. adoption of the Harmo- Surgical and Medical Instruments (SIC 3841) nized Tariff System (HS) in 1989, trade data for periods Surgical Appliances and Supplies (SIC 3842) prior to 1989 are not directly comparable to data for Dental Equipment and Supplies (SIC 3843) 1989-1990. However, the data are reflective of overall X-Ray Apparatus and Tubes (SIC 3844) trends and are useful for comparison purposes. Electromedical and Electrotherapeutic Apparatus (SIC 3845) 5. The U.S. Patent and Trademark Office does not provide a specific category that encompasses all medical Appendix B lists the products that are included in these devices. For its analysis of U.S. patents granted to SIC medical device categories. Prior to 1987 changes medical devices, HIMA evaluated those categories that in the SIC system, x-ray apparatus and electromedical should be considered medical devices. equipment were grouped under the same four-digit SIC category. 30 APPENDIX B U.S. DEPARTMENT OF COMMERCE SIC CLASSIFICATIONS SIC Code 3841: Surgical & Medical Instruments Anesthesia apparatus Muscle exercise apparatus, ophthalmic Biopsy instruments and equipment Needle holders, surgical Blood pressure apparatus Needles, suture Blood transfusion equipment Operating tables Bone drills Ophthalmic instruments and apparatus Bone plates and screws Ophthalmometers and ophthalmoscopes Bone rongeurs Optometers Bronchoscopes, except electromedical Optoscopes, except electromedical Cannulae Oxygen tents Catheters Pelvimeters Clamps, surgical Physiotherapy equipment, electrical Corneal microscopes Probes, surgical Cystoscopes, except electromedical Retinoscopes, except electromedical Diagnostic apparatus, physicians' Retractors Eye examining instruments and apparatus Rifles for propelling hypodermics into animals Fixation appliances, internal Saws, surgical Forceps, surgical Skin grafting equipment Gastroscopes, except electromedical Slit lamps (ophthalmic goods) Hemodialysis apparatus Speculums Holders, surgical needle Sphygmomanometers Hypodermic needles and syringes Stethoscopes and stethographs IV transfusion apparatus Suction therapy apparatus Inhalation therapy equipment Surgical instruments and apparatus, except electromedical Inhalators, surgical and medical Surgical knife blades and handles Instruments and apparatus, except electromedical: Surgical stapling devices medical, surgical, ophthalmic and veterinary Tonometers, medical Instruments, microsurgical: except electromedical Trocars Knives, surgical Ultrasonic medical cleaning equipment Metabolism apparatus Veterinarians' instruments and apparatus 31 SIC Code 3842: Orthopedic, Prosthetic and Surgical Appliances and Supplies Abdominal supporters, braces and trusses Intrauterine devices Absorbent cotton, sterilized Iron lungs Adhesive tape and plasters, medicated or nonmedicated Life preservers, except cork and inflatable Applicators, cotton tipped Ligatures, medical Atomizers, medical Limbs, artificial Autoclaves, hospital and surgical Linemen's safety belts Bandages and dressings, surgical and orthopedic Models, anatomical Bandages: plastics, muslin, plaster of paris Noise protectors, personal Belts: sanitary, surgical and corrective Orthopedic devices and materials Braces, elastic Pads, incontinent and bed Braces, orthopedic Personal safety appliances and equipment Bullet proof vests Plugs, ear and nose Canes, orthopedic Prosthetic appliances and supplies Cervical collars Radiation shielding aprons, gloves and sheeting Clothing, fire resistant and protective Respirators Colostomy appliances Respiratory protection equipment, personal Com remover and bunion pads Restraints, patient Corsets, surgical Safety appliances and equipment, personal Cosmetic restorations Safety gloves, all materials Cotton, absorbent: sterilized Socks, stump Cotton, including cotton balls Space suits Crutches and walkers Splints, pneumatic and wood Drapes, surgical: cotton Sponges, surgical Dressings, surgical Sterilizers, hospital and surgical Ear stoppers Stockinette, original Elastic hosiery, orthopedic Stretchers Extension shoes, orthopedic Suits, firefighting: asbestos First aid, snake bite and burn kits Supports: abdominal, ankle, arch and kneecap Foot appliances, orthopedic Surgical appliances and supplies except medical Fracture appliances, surgical instruments Gas masks Suspensories Gauze, surgical: not made in weaving mills Sutures Grafts, artificial: for surgery-made of braided or mesh Swabs, sanitary cotton artificial fibers Tongue depressors Gynecological supplies and appliances Traction apparatus Hearing aids Trusses: orthopedic and surgical Helmets, space Welders' hoods Hosiery, support Wheel chairs Hydrotherapy equipment Whirlpool baths, hydrotherapy equipment Implants, surgical Infant incubators 32 SIC Code 3843: Dental Equipment and Supplies Abrasive points, wheels and disks: dental Forceps, dental Autoclaves, dental Furnaces, laboratory dental Broaches, dental Glue, dental Burs, dental Gold, dental Cabinets, dental Hand pieces and parts, dental Cement, dental Ultrasonic dental equipment Chairs, dentists' Dental laboratory equipment Compounds, dental Dental metal Cutting instruments, dental Impression material, dental Dental alloys for amalgams Investment material, dental Dental engines Orthodontic appliances Dental equipment and supplies Plaster, dental Dental hand instruments, including forceps Pliers, dental Denture materials Sterilizers, dental Drills, dental Teeth, artificial not made in dental laboratories Enamels, dentists' Tools, dentists' Wax, dental SIC Code 3844: X-Ray Apparatus and Tubes and Related Irradiation Apparatus Beta-ray irradiation equipment Radium equipment Fluoroscopes Therapeutic x-ray apparatus and tubes: medical, industrial Fluoroscopic x-ray apparatus and tubes and research Gamma-ray irradiation equipment X-ray apparatus and tubes: medical, industrial, research Irradiation equipment and control Lamps, x-ray X-ray generators Nuclear irradiation equipment Radiographic x-ray apparatus and tubes: medical, industrial, research 33 SIC Code 3845: Electromedical and Electrotherapeutic Apparatus Arc lamp units, electrotherapeutic: Laser systems and equipment, medical except infrared and ultraviolet Lithotripters Audiological equipment, electromedical Magnetic resonance imaging device (diagnostic), nuclear Automated blood and body fluid analyzers, Otoscopes, electromedical except laboratory Pacemakers Bronchoscopes, electromedical Patient monitoring equipment: intensive care/coronary Cardiographs unit Colonscopes, electromedical Phonocardiographs Computerized axial tomography (CT/CAT scanner) Positron emission tomography apparatus Respiratory analysis equipment, electromedical Cystoscopes, electromedical Retinoscopes, electromedical Defibrillators Surgical support systems: heart-lung machines, except Dialyzers, electromedical iron lungs and blood flow systems Diathermy apparatus, electromedical Transcutaneous electrical nerve stimulators (TENS) Electrocardiographs Ultrasonic medical equipment, except cleaning Electroencephalographs Ultrasonic scanning devices, medical Electromedical apparatus Electromyographs Endoscopic equipment, electromedical: e.g., bronchoscopes, cyctoscopes and colonoscopes Gastroscopes, electromedical SIC Code 2835: In Vitro and In Vivo Diagnostic Substances Angionrographic diagnostic agents* Enzyme and isoenzyme diagnostic reagents Barium diagnostic agents* Hematology diagnostic reagents Blood derivative diagnostic reagents In vitro diagnostics Clinical chemistry reagents (including toxicology) In vivo diagnostics* Clinical chemistry standards and controls In vivo radioactive reagents* (including toxicology) Iodinated diagnostic agents Coagulation diagnostic reagents Metabolite diagnostic reagents Cold kits for labeling with technetium* Microbiology, virology and serology diagnostic products Contrast media diagnostic products* Pregnancy test kits (e.g., iodine and barium) Radioactive diagnostic substances Cytology and histology diagnostic products Technetium products* Diagnostic agents, biological Viral test diagnostic reagents Electrolyte diagnostic reagents *These represent in vivo diagnostic products, the manufacturers of which are represented by pharmaceutical groups. 34 APPENDIX C TABLES 1. U.S. Market for Health Care Technology Products, 1975-1990 36 2. U.S. Production of Health Care Technology Products, 1987-1990 37 3. 10 Fastest-Growing Four-Digit (SIC) Industries in the U.S., 1991 38 4. Growth Rate Projections for Selected Industry Groups, 1990-1991 39 5. Employment in the Health Care Technology Industry, 1975-1990 40 6. U.S. Trade Balance for Health Care Technology Products, 1975-1990 41 7. Health Care Technology Products Trade Balance with the U.S. by Country, 1980 and 1990 42 8. Trade Balance with the U.S. by Country, 1987-1990 43 9. U.S. Medical Products Exports by Selected Countries, 1980 and 1990 44 10. U.S. Medical Products Imports by Selected Countries, 1980 and 1990 45 11. Health Care Technology Products Trade Balance by Major Product Groups, 1980-1990 46 12. Composition of U.S. Medical Products Exports, 1980-1990 47 13. Composition of U.S. Medical Products Imports, 1980-1990 48 14. Export Intensity and Import Penetration Ratios, 1975-1990 49 15. R&D as a Percentage of Sales in Medical Products and Other Industries, 1988 and 1989 50 16. U.S. Health R&D Compared to Total U.S. R&D, 1978-1989 51 17. FDA Premarket Notifications, 510(k)s, FY 1985-FY 1990 52 18. FDA Original Premarket Approval (PMA) Applications, FY 1985-FY 1990 53 19. Ownership of U.S. Medical Device Patents, 1980-1990 54 20. Projected Industry Performance, 1989-1995 55 35 Table 1 U.S. MARKET FOR HEALTH CARE TECHNOLOGY PRODUCTS 1975-1990 ($ billions) Average Annual Growth 1988-1990 1975 1980 1985 1986 1987 1988 1989 1990* (percent) Medical Devices Production 4.6 9.7 17.5 18.0 21.5 23.2 25.6 27.8 8.9 Exports 0.7 1.7 2.4 2.8 3.2 4.0 4.8 5.7 21.6 Imports 0.3 0.6 1.7 2.2 2.6 3.0 3.0 3.2 7.5 Consumption 4.2 8.7 16.8 17.5 20.9 22.2 23.8 25.3 6.6 Diagnostic Products Production 0.3 0.9 1.7 2.0 2.7 2.9 3.1 3.4 8.2 Exports - 0.2 0.3 0.4 0.5 0.6 0.7 0.8 18.4 Imports - - - - - - 0.1 0.1 60.3 Consumption 0.3 0.6 1.4 1.7 2.2 2.3 2.6 2.8 7.0 TOTAL PRODUCTION 4.9 10.5 19.2 20.1 24.2 26.1 28.7 31.2 8.9 TOTAL CONSUMPTION 4.5 9.3 18.3 19.2 23.1 24.5 26.3 28.0 6.6 * Estimate. Source: U.S. Department of Commerce unpublished data. 36 Table 2 U.S. PRODUCTION OF HEALTH CARE TECHNOLOGY PRODUCTS 1987-1990 Average Production ($ billions) Annual Growth 1988-1990 1987 1988 1989 1990* (percent) Medical device production 21.50 23.25 25.55 27.79 8.9 Surgical and medical instruments 7.23 7.98 8.70 9.53 10.8 Surgical appliances and supplies 7.98 8.52 9.29 10.09 11.1 Dental equipment and supplies 1.22 1.22 1.26 1.34 5.4 X-ray apparatus and tubes 1.56 1.52 1.71 1.86 4.7 Electromedical equipment 3.51 4.00 4.59 4.96 9.2 Diagnostic products 2.68 2.88 3.13 3.40 8.2 TOTAL PRODUCTION 24.18 26.13 28.68 31.19 8.9 * Estimate. Source: U.S. Department of Commerce unpublished data. 37 Table 3 10 FASTEST GROWING FOUR-DIGIT (SIC) INDUSTRIES IN THE U.S. 1991 (based on constant dollar shipments) SIC Percent Code Industry Change 3111 Leather tanning and finishing 9.4 3674 Semiconductors and related devices 8.9 3841 Surgical and medical instruments 8.6 3842 Surgical appliances and supplies 7.6 2833 Medicinals and botanicals 7.1 2835 Diagnostic substances 6.9 2015 Poultry slaughtering and processing 6.8 2836 Biological products except diagnostics 6.2 3721 Aircraft 6.0 3843 Dental equipment and supplies 5.9 Source: U.S. Industrial Outlook, 1991. 38 Table 4 GROWTH RATE PROJECTIONS FOR SELECTED INDUSTRY GROUPS 1990-1991 (based on constant dollar shipments) Industry Group 1990 1991 Medical devices* 9.1 7.3 Aircraft and parts 17.9 4.6 Steel mill products -1.0 -4.8 Chemicals 1.6 1.0 Rubber and plastic products 1.0 0.8 Industrial machinery 2.5 1.9 Machine tools 5.3 5.0 Computers 4.4 5.6 Electronic components 1.8 6.2 Motor vehicles -2.6 -1.4 Construction materials -0.8 -3.2 Paper and allied products 1.6 2.2 Telephone and communication equipment 1.9 1.9 All industries 1.4 1.1 * Medical devices component of larger category labelled "scientific and medical equipment." Source: U.S. Industrial Outlook, 1991. 39 Table 5 EMPLOYMENT IN THE HEALTH CARE TECHNOLOGY INDUSTRY 1975-1990 Employment (000) 1975 1980 1985 1987 1988 1989 1990 Medical devices 126.8 168.6 198.4 203.8 213.7 225.0 231.1 Surgical and medical instruments 40.1 51.3 61.4 73.1 76.0 82.1 85.0 Surgical appliances and supplies 54.3 61.8 76.3 78.5 81.2 84.9 87.2 Dental equipment and supplies 14.6 16.7 14.4 14.3 15.0 15.2 15.3 X-ray apparatus and electromedical 17.8 38.8 46.3 - - - - X-ray apparatus and tubes - - - 8.7 10.2 11.2 12.0 Electromedical equipment - - - 29.2 31.3 31.5 31.6 Diagnostic substances 5.6 10.2 13.7 15.4 15.7 16.6 17.2 TOTAL EMPLOYMENT 132.4 178.8 212.1 219.2 229.4 241.6 248.3 Percent Change Average Annual Growth 1980-1990 1988-1990 Medical and dental equipment 37.1 4.3 Surgical and medical instruments 65.7 5.2 Surgical appliances and supplies 41.1 5.1 Dental equipment and supplies -9.2 2.3 X-ray apparatus and electromedical 12.4 - X-ray apparatus and tubes - 11.4 Electromedical equipment - 2.7 Diagnostic substances 68.6 3.8 TOTAL: MEDICAL EQUIPMENT AND DIAGNOSTICS 38.9 4.3 Note: Prior to recent changes in the SIC system, x-ray apparatus and electromedical equipment were grouped together under the same classification (SIC 3693). These products are now broken out separately under SIC 3844 for x-ray apparatus and SIC 3845 for electromedical equipment. The 1987 changes in the SIC also resulted in a new SIC category for diagnostic substances, SIC 2835. Employment data on diagnostic products are HIMA estimates. Sources: U.S. Department of Commerce unpublished data and HIMA estimates. 40 Table 6 U.S. TRADE BALANCE FOR HEALTH CARE TECHNOLOGY PRODUCTS 1975-1990 ($ billions) 1975 1980 1985 1986 1987 1988 1989 1990* Medical devices Exports 0.71 1.66 2.42 2.76 3.17 4.05 4.79 5.69 Imports 0.30 0.64 1.74 2.21 2.56 3.00 3.01 3.20 Trade balance 0.41 1.03 0.68 0.55 0.61 1.05 1.78 2.53 Diagnostic products Exports 0.04 0.22 0.29 0.37 0.47 0.61 0.67 0.77 Imports - 0.01 0.03 0.03 0.03 0.05 0.11 0.12 Trade balance 0.04 0.21 0.26 0.34 0.44 0.56 0.57 0.65 TOTAL EXPORTS 0.75 1.88 2.71 3.13 3.64 4.65 5.46 6.46 TOTAL IMPORTS 0.30 0.65 1.77 2.24 2.59 3.04 3.12 3.28 TOTAL TRADE BALANCE 0.45 1.24 0.93 0.89 1.05 1.61 2.34 3.18 * Estimate. Source: U.S. Department of Commerce unpublished data. 41 Table 7 HEALTH CARE TECHNOLOGY PRODUCTS TRADE BALANCE WITH THE U.S. BY COUNTRY 1980 and 1990 ($ millions) 1980 1990 Exports Imports Balance Exports Imports Balance Canada 229 32 197 Canada 934 93 841 Japan 208 117 92 Italy 355 51 304 Netherlands 104 32 72 France 409 166 243 France 85 24 61 Netherlands 376 141 235 Italy 60 8 53 Belg. & Lux. 203 10 193 U.K. 87 38 49 Australia 199 8 191 Belg. & Lux. 57 8 48 U.K. 388 214 174 Australia 52 6 46 Japan 909 794 115 Mexico 54 11 42 S. Korea 106 16 90 Brazil 26 5 21 Brazil 81 3 78 Taiwan 21 2 19 Taiwan 98 39 59 S. Korea 20 1 19 Switzerland 131 74 57 Switzerland 43 29 14 Mexico 297 254 43 China 6 - 6 Ireland 75 66 9 Ireland 16 11 5 China 37 28 9 Sweden 25 25 0 Sweden 94 111 -17 West Germany 164 225 -61 West Germany 691 818 -127 Note: Figures for 1980 exclude diagnostic products, whereas 1990 figures are estimates based on preliminary data. Source: U.S. Department of Commerce unpublished data. 42 Table 8 TRADE BALANCE WITH THE U.S. BY COUNTRY 1987-1990 ($ millions) 1987 1988 1989 1990 Exports Imports Balance Exports Imports Balance Exports Imports Balance Exports Imports Balance Canada 483 86 397 530 108 422 573 87 486 934 93 841 Japan 532 627 -95 680 716 -36 842 735 107 909 794 115 EC 1,529 1,304 225 1,956 1,457 499 2,326 1,485 841 2,522 1,505 1,017 Belg. & Lux. 141 12 129 147 12 135 181 9 172 200 138 62 France 221 123 98 309 150 159 356 144 212 409 166 243 Germany 429 692 -265 527 765 -238 642 835 -194 691 818 -127 Ireland 47 53 -6 73 57 16 69 59 10 75 66 9 Italy 155 39 116 225 44 181 268 43 225 355 51 304 Netherlands 200 125 75 253 154 99 315 139 176 376 141 235 U.K. 243 179 64 294 203 91 331 196 135 388 214 174 43 Western Europe (EC & EFTA) 1,714 1,496 218 2,223 1,683 540 2,642 1,703 939 2,879 1,748 1,131 Mexico 139 129 10 189 178 11 228 214 14 297 254 43 Australia 132 13 119 161 20 141 193 13 180 199 8 191 Sweden 51 83 -32 87 91 -4 96 90 6 94 111 -17 Switzerland 74 69 5 93 82 11 119 72 47 131 74 57 Taiwan 46 34 12 71 41 30 77 43 34 98 39 59 S. Korea 51 10 41 78 20 58 96 18 78 106 16 90 Brazil 23 4 19 34 4 30 91 3 88 81 3 78 China 31 4 27 41 15 26 39 28 11 37 28 9 WORLD 3,639 2,591 1,048 4,650 3,042 1,609 5,456 3,115 2,341 6,459 3,279 3,179 Source: U.S. Department of Commerce unpublished data. Table 9 U.S. MEDICAL PRODUCTS EXPORTS BY SELECTED COUNTRIES 1980 and 1990 ($ millions) 1980 As Percent 1990 As Percent U.S. Exports of Total U.S. Exports of Total 1. Canada 229 13.8 1. Canada 934 14.5 2. Japan 208 12.5 2. Japan 909 14.1 3. West Germany 164 9.8 3. West Germany 691 10.7 4. Netherlands 104 6.3 4. France 409 6.3 5. U.K. 87 5.3 5. U.K. 388 6.0 6. France 85 5.1 6. Netherlands 376 5.8 7. Italy 60 3.6 7. Italy 355 5.5 8. Belg. & Lux. 57 3.4 8. Mexico 297 4.6 9. Mexico 54 3.2 9. Belg. & Lux. 203 3.1 10. Australia 52 3.1 10. Australia 199 3.1 11. Switzerland 43 2.6 11. Switzerland 131 2.0 12. Brazil 26 1.6 12. S. Korea 106 1.6 13. Sweden 25 1.5 13. Taiwan 98 1.5 14. Taiwan 21 1.3 14. Sweden 94 1.5 15. S. Korea 20 1.2 15. Brazil 81 1.3 16. Ireland 16 0.9 16. Ireland 75 1.2 17. China 6 0.3 17. China 37 0.6 Note: Figures for 1980 exclude diagnostic products, whereas 1990 figures are estimates based on preliminary data. Source: U.S. Department of Commerce unpublished data. 44 Table 10 U.S. MEDICAL PRODUCTS IMPORTS BY SELECTED COUNTRIES 1980 and 1990 ($ millions) 1980 As Percent 1990 As Percent U.S. Imports of Total U.S. Imports of Total 1. West Germany 225 35.4 1. West Germany 818 24.9 2. Japan 117 18.3 2. Japan 794 24.2 3. U.K. 38 6.0 3. Mexico 254 7.7 4. Netherlands 32 5.1 4. U.K. 214 6.5 5. Canada 32 5.0 5. France 166 5.1 6. Switzerland 29 4.5 6. Netherlands 141 4.3 7. Sweden 25 3.9 7. Sweden 111 3.4 8. France 24 3.7 8. Canada 93 2.8 9. Ireland 11 1.7 9. Switzerland 74 2.3 10. Mexico 11 1.7 10. Ireland 66 2.0 11. Belg. & Lux. 8 1.3 11. Italy 51 1.6 12. Italy 8 1.2 12. Taiwan 39 1.2 13. Australia 6 0.9 13. China 28 0.9 14. Brazil 5 0.8 14. S. Korea 16 0.5 15. Taiwan 2 0.3 15. Belg. & Lux. 10 0.3 16. S. Korea 1 0.2 16. Australia 8 0.2 17. China - 0.1 17. Brazil 3 0.1 Note: Figures for 1980 exclude diagnostic products, whereas 1990 figures are estimates based on preliminary data. Source: U.S. Department of Commerce unpublished data. 45 Table 11 HEALTH CARE TECHNOLOGY PRODUCTS TRADE BALANCE BY MAJOR PRODUCT GROUPS 1980 -1990 ($ millions) Average Annual Growth Exports 1980 1987 1988 1989 1990* 1988-1990 Medical devices 1,663 3,170 4,045 4,785 5,686 21.6 Surgical/medical instru. 485 765 963 1,497 1,853 35.0 Surgical supplies 213 521 668 899 1,116 25.3 Dental equipment 129 272 322 281 358 10.9 X-ray & electromedical 839 - - - - - X-ray apparatus - 338 410 505 566 18.9 Electromedical - 1,274 1,682 1,603 1,793 13.0 Diagnostic products 219 469 606 671 773 18.4 TOTAL EXPORTS 1,882 3,639 4,651 5,456 6,459 21.2 Average Annual Growth Imports 1980 1987 1988 1989 1990* 1988-1990 Medical devices 636 2,557 2,995 3,009 3,156 7.5 Surgical/medical instru. 180 676 792 671 744 10.0 Surgical supplies 96 338 393 372 391 5.2 Dental equipment 42 104 112 141 161 15.9 X-ray & electromedical 319 - - - - - X-ray apparatus - 763 860 873 878 4.9 Electromedical - 676 838 951 982 13.6 Diagnostic products 9 34 47 106 124 60.3 TOTAL IMPORTS 645 2,591 3,042 3,115 3,280 8.4 Balance 1980 1987 1988 1989 1990* Medical devices 1,027 613 1,050 1,776 2,530 Surgical/medical instru. 305 89 172 826 1,109 Surgical supplies 117 184 275 527 725 Dental equipment 84 168 210 140 197 X-ray & electromedical 520 - - - - X-ray apparatus - -425 -450 -369 -312 Electromedical - 598 844 652 811 Diagnostic products 210 435 559 565 649 TOTAL BALANCE 1,237 1,048 1,609 2,341 3,179 * Estimate. Source: U.S. Department of Commerce unpublished data. 46 Table 12 COMPOSITION OF U.S. MEDICAL PRODUCTS EXPORTS 1980 1990 ($ millions) Average Annual Growth Exports 1980 1987 1988 1989 1990* 1988-1990 Medical devices 1,663 3,170 4,045 4,785 5,686 21.6 Surgical/medical instru. 485 765 963 1,497 1,853 35.0 Surgical supplies 213 521 668 899 1,116 25.3 Dental equipment 129 272 322 281 358 10.9 X-ray & electromedical 839 - - - - - X-ray apparatus - 338 410 505 566 18.9 Electromedical - 1,274 1,682 1,603 1,793 13.0 Diagnostic products 219 469 606 671 773 18.4 TOTAL EXPORTS 1,882 3,639 4,651 5,456 6,459 21.2 Percentage of Total Exports 1980 1987 1988 1989 1990* Medical devices 88.4 87.1 87.0 87.7 88.0 Surgical/medical instru. 25.8 21.0 20.7 27.4 28.7 Surgical supplies 11.3 14.3 14.4 16.5 17.3 Dental equipment 6.7 7.5 6.9 5.2 5.5 X-ray & electromedical 44.6 - - - - X-ray apparatus - 9.3 8.8 9.3 8.8 Electromedical - 35.0 36.2 29.4 27.8 Diagnostic products 11.6 12.9 13.0 12.3 12.0 * Estimate. Source: U.S. Department of Commerce unpublished data. 47 Table 13 COMPOSITION OF U.S. MEDICAL PRODUCTS IMPORTS 1980-1990 ($ millions) Average Annual Growth Imports 1980 1987 1988 1989 1990* 1988-1990 Medical devices 636 2,557 2,995 3,009 3,156 7.5 Surgical/medical instru. 180 676 792 671 744 10.0 Surgical supplies 96 338 393 372 391 5.2 Dental equipment 42 104 112 141 161 15.9 X-ray & electromedical 319 - - - - - X-ray apparatus - 763 860 873 878 4.9 Electromedical - 676 838 951 982 13.6 Diagnostic products 9 34 47 106 124 60.3 TOTAL IMPORTS 645 2,591 3,042 3,115 3,280 8.4 Percentage of Total Imports 1980 1987 1988 1989 1990* Medical devices 98.6 98.7 98.4 96.6 96.2 Surgical/medical instru. 27.8 26.1 26.0 21.5 22.7 Surgical supplies 14.8 13.0 12.9 11.9 11.9 Dental equipment 6.5 4.0 3.7 4.5 4.9 X-ray & electromedical 49.4 - - - - X-ray apparatus - 29.5 28.3 28.0 26.8 Electromedical - 26.1 27.6 30.5 29.9 Diagnostic products 1.4 1.3 1.6 3.4 3.8 * Estimate. Source: U.S. Department of Commerce unpublished data. 48 Table 14 EXPORT INTENSITY AND IMPORT PENETRATION RATIOS 1975-1990 Exports as a Percentage of Shipments 1975 1980 1985 1987 1988 1989 1990* Medical devices 15.5 17.2 13.8 14.7 17.4 18.7 20.5 Surgical/medical instru. 19.4 17.5 13.0 10.6 12.1 17.2 19.4 Surgical supplies 7.5 6.2 6.9 6.5 7.8 9.7 11.1 Dental equipment 15.0 11.6 12.7 22.4 26.3 22.4 26.6 X-ray & electromedical 26.5 34.7 25.3 - - - - X-ray apparatus - - - 21.7 26.9 29.5 30.4 Electromedical - - - 36.3 42.1 34.9 36.1 Diagnostic products 11.1 25.5 17.2 17.5 21.0 21.5 22.7 ALL MEDICAL PRODUCTS 15.4 17.8 14.1 15.0 17.8 19.0 20.7 Imports as a Percentage of Consumption 1975 1980 1985 1987 1988 1989 1990* Medical devices 7.2 7.4 10.3 12.2 13.5 12.7 12.5 Surgical/medical instru. 5.8 7.3 8.7 9.5 10.1 8.5 8.8 Surgical supplies 1.8 2.9 2.5 4.3 4.8 4.2 4.0 Dental equipment 4.1 4.2 7.9 9.9 11.0 12.6 14.0 X-ray & electromedical 24.1 16.8 24.0 - - - - X-ray apparatus - - - 38.5 43.6 42.0 40.4 Electromedical - - - 23.2 26.6 24.1 23.6 Diagnostic products 1.1 1.4 2.3 1.5 2.0 4.1 4.5 ALL MEDICAL PRODUCTS 7.0 6.9 9.7 11.2 12.4 11.8 11.7 * Estimate. Source: U.S. Department of Commerce unpublished data, 1990. 49 Table 15 R&D AS A PERCENTAGE OF SALES IN MEDICAL PRODUCTS AND OTHER INDUSTRIES 1988 and 1989 Industry 1988 1989 All-industry composite 3.4 3.4 Health care 8.2 8.6 Medical products and services 6.2 6.2 Drugs and research 10.0 10.1 Aerospace 4.1 4.1 Automotive 3.2 3.4 Chemicals 3.6 3.8 Electrical and electronics 5.3 5.4 Source: Business Week, "R&D Scoreboard," 1989-1990. 50 Table 16 U.S. HEALTH R&D COMPARED TO TOTAL U.S. R&D 1978-1989 ($ billions, current $) Health R&D as a Percentage of Year Health R&D Total R&D Total R&D 1978 6.3 48.1 13.1 1980 7.9 62.6 12.6 1985 13.5 113.6 11.8 1986 14.8 119.6 12.4 1987 16.8 127.5 13.2 1988 18.8 134.2 14.0 1989 20.8 141.8 14.7 Average Annual Percent Growth 1985-89 11.4 7.0 Source: National Institutes of Health, National Institutes of Health Data Book, 1988 and 1990. 51 Table 17 FDA PREMARKET NOTIFICATIONS, 510(K)S FY 1985-FY 1990 Action FY 85 FY 86 FY 87 FY 88 FY 89 FY 90 Number received 5,254 5,063 5,265 5,536 7,022 5,831 Number of decisions: Substantially equivalent 4,491 4,388 4,105 4,432 4,867 4,748 Not substantially equivalent 132 98 103 82 92 117 Other¹ 472 873 784 999 1,177 1,332 Total 5,095 5,359 4,992 5,513 6,136 6,197 Percent not substantially equivalent² 2.8 2.2 2.1 1.8 1.9 2.4 Average review time (days): Total time 76 72 69 78 82 98 FDA N/A³ 66 56 64 66 78 1 Includes withdrawals, deletions and other administrative actions. 2 Based on "substantially equivalent" and "not substantially equivalent" decisions only. 3 Not available. Sources: FDA Center for Devices and Radiological Health, Office of Device Evaluation, Annual Report, Fiscal Year 1990, p. 57. 52 Table 18 FDA ORIGINAL PREMARKET APPROVAL (PMA) APPLICATIONS FY 1985-FY 1990 Action FY 85 FY 86 FY 87 FY 88 FY 89 FY 90 Number received 97 69 81 96 84 79 Number of final approvals 37 72 46 46 56 47 Average review time (days) for final approvals:* FDA 347 395 337 (257) 262 (142) 247 (145) 302 (228) Non-FDA 43 44 81 (27) 75 (17) 101 (42) 113 (55) Total 390 439 418 (284) 337 (159) 348 (187) 415 (283) * Average review times in parentheses are calculated under the Premarket Approval of Medical Devices Regulation (21 CFR Part 814). Sources: FDA Center for Devices and Radiological Health, Office of Device Evaluation, Annual Report, Fiscal Year 1990, p. 52. 53 Table 19 OWNERSHIP OF U.S. MEDICAL DEVICE PATENTS 1980-1990 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990* Total U.S. 1,494 1,438 1,272 1,242 1,554 1,775 2,040 2,406 2,203 2,886 2,858 Foreign Japan 122 155 154 148 186 218 230 338 322 453 398 Germany 152 186 122 122 147 157 186 229 174 286 236 United Kingdom 49 57 53 56 56 73 80 101 78 124 132 France 44 42 35 33 54 59 62 91 89 133 106 54 Canada 39 39 27 20 43 40 34 53 50 64 62 Other 154 177 143 144 178 213 276 317 285 340 388 Total foreign 560 656 534 523 664 760 868 1,129 998 1,400 1,322 Total patents 2,054 2,094 1,806 1,765 2,218 2,535 2,908 3,535 3,201 4,286 4,180 Percent foreign 27.3 31.3 29.6 29.6 29.9 30.0 29.8 31.9 31.2 32.7 31.6 * Estimate. Source: U.S. Department of Commerce/Patent and Trademark Office unpublished data, 1991. Table 20 PROJECTED INDUSTRY PERFORMANCE 1989-1995 ($ billions) Average Annual Growth 1989¹ 1990² 1991 1992 1993 1994 1995 1990-1995 Production 28.7 31.0 33.3 35.7 38.2 41.0 43.9 7.4% Exports 5.5 6.5 7.5 8.6 9.9 11.4 13.1 15.5% Imports 3.1 3.3 3.6 3.8 4.1 4.4 4.7 6.9% Trade surplus 2.3 3.2 3.9 4.8 5.8 7.0 8.4 24.3% Market size 26.3 27.8 29.4 30.9 32.4 34.2 35.5 5.1% Production (under the 28.7 29.3 29.9 30.5 31.1 31.7 32.3 2.0% negative scenario) 1 Figures for 1989 represent actual production and trade levels. 2 HIMA projections for 1990-1995 based on U.S. Department of Commerce historical data and projections, with a 10 percent reduction for 1990 and a 20 percent reduction for 1991-1995 to reflect an expected sluggish U.S. economy. Sources: U.S. Department of Commerce unpublished data; industry sources. 55 VII. NOTES 1. All trade data and forecast 6. Export intensity measures the 13. National Advisory Council on assumptions are based on U.S. percentage of total domestic Health Care Technology Assess- Department of Commerce trade production that is exported. ment, The Medicare Coverage statistics and forecasts unless Import penetration measures the Process, September 14, 1988. otherwise noted. Due to changes percentage of consumption that is in the Standard Industrial supplied by imports. 14. Prospective Payment Assessment Classification (SIC) system and Commission, Report and Recom- the recent U.S. conversion to the 7. U.S. Industrial Outlook, 1990, mendations to the Secretary, U.S. Harmonized Tariff System (HS), p. 51-7. Department of Health and Human trade data for periods prior to Services, March 1, 1990, p. 59. 1989 are not directly comparable 8. "Wall Street's View of the Health to data for 1989-1990. However, Industry Manufacturing Compa- 15. U.S. Department of Commerce, they are reflective of overall nies," John Balkoski, Medical Technology Administration, trends and are useful for compari- Venture Holdings, presentation to Emerging Technologies: A Survey son purposes. All data are on a HIMA's First Global Medical of Technical and Economic current dollar basis unless Device Conference, October Opportunities, Spring 1990. otherwise noted. 1990. 16. George C. Lodge, Perestroika for 2. Prospective Payment Assessment 9. National Institutes of Health, America: Restructuring Business- Commission, Medicare Prospec- National Institutes of Health Data Government Relations for World tive Payment and the American Book, 1990, p. 1. Competitiveness, Harvard Health Care System: Report to Business School Press, Boston, the Congress, June 1990, p. 12. 10. The U.S. Patent and Trademark MA, 1991, pp. 146-147. Office does not provide a specific 3. Consumption is calculated by category that encompasses taking overall annual production medical devices. HIMA evalu- in the U.S., adding import flows ated those categories that should into the U.S. during the year and be considered medical devices for subtracting exports shipped to its analysis of these patents. overseas markets. 11. U.S. Department of Commerce, 4. A listing of the products con- Patent and Trademark Office, tained in these SIC groupings is unpublished data, 1991. contained in Appendix B. 12. "The Effect of the Medicare 5. Some of the few U.S. industries Prospective Payment System on running consistently large trade the Adoption of New Technol- surpluses include aerospace ogy," New England Journal of products, coal mining, plastics Medicine, Vol. 321, November materials and resins, chemicals 16, 1989, pp. 1,378-1,383. and allied products, and computers. 56 ABOUT THE HEALTH INDUSTRY MANUFACTURERS ASSOCIATION The Health Industry Manufacturers Association (HIMA) is a national trade association representing more than 300 manufacturers of medical devices, diagnostics, and health care information systems. HIMA is the principal voice of the industry, and actively describes the benefits of innovative medical technologies to national, local and international legislative and regulatory agencies, and to the health care and business communities. The Association is dedicated to representing the long- term interests, concerns, and needs of the health care technology industry through education programs that encourage high quality, cost-effective health care. HIMA HEALTH INDUSTRY MANUFACTURERS ASSOCIATION 1030 15TH STREET, N.W., SUITE 1100 WASHINGTON, D.C. 20005-1598 (202) 452-8240 FAX (202) 289-1978