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Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Page 180
Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Page 181
Suggested Citation:"Contributors." National Academy of Engineering and Institute of Medicine. 1988. New Medical Devices: Invention, Development, and Use. Washington, DC: The National Academies Press. doi: 10.17226/1099.
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Contributors STUART H. ALTMAN is dean of the Florence Helter Graduate School for Social Policy, Brandeis University, and Sol C. Chaikin Professor of National Health Policy. Dr. Altman is an economist whose research interests are primarily in the area of federal health policy. He serves as chairman of the Prospective Payment Assessment Commission responsible for overseeing the Medicare Diagnostic Related Groups (DRG) Hospital Payment System, chairman on the board of the Health Policy Center at Brandeis University, and as a member of the board of trustees of Beth Israel Hospital. Dr. Altman is a member of the National Academy of Sciences and the Institute of Medicine, where he has served on the governing council. Between 1971 and 1976, Dr. Altman served as deputy assistant secretary for planning and evalua- tion/health at the Department of Health, Education, and Welfare. From 1973 to 1974 he also served as deputy director for health on the President's Cost-of-Living Council. Dr. Altman holds M.A. and Ph.D. degrees in economics from the University of California, Los Angeles. PETER F. CARPENTER is executive vice president of ALZA Corporation in Palo Alto, California. Before joining ALZA in 1976, Mr. Carpenter was executive director of Stanford University Medical Center, assistant vice president for medical affairs at Stanford University, and deputy executive director of the U.S. Price Commission. He also served as assistant director of the Center for Materials Research at Stanford University and as program manager for the Advanced Research Projects Agency of the Office of the Secretary of Defense. Mr. Carpenter is 175

176 CONTRIB UTORS currently chairman of the board of directors of the American Foun- dation for A.I.D.S. Research and cochairman of the Policy Advisory Board to the McGill University Collaborative Programme in Pharmaco- epidemiology. Mr. Carpenter received a bachelor's degree in chemistry from Harvard University and an M.B.A. from the University of Chicago. FLORA CHU is director of medical affairs at the Medical Technology and Practice Patterns Institute in Washington, D.C. At the time of the symposium, she was a medical consultant to the Program in Technology and Health Care in the Institute for Health Policy Analysis at George- town University Medical Center. Dr. Chu's research interests include collection of data on the utilization and cost of medical technologies and evaluation of national health policy issues. Dr. Chu holds a bachelor's degree from the University of Pennsylvania and an M.D. degree from the University of Maryland. HARVEY V. FINEBERG is dean of the Harvard School of Public Health and professor of health policy and management at Harvard University. Dr. Fineberg's interests in health policy include clinical decision making, public health programs, health resource allocation, assessment of medical technology, and dissemination of medical innovations. Among his publications are two jointly authored books Clinical De- cision Analysis and The Epidemic That Never WAS, an analysis of the controversial federal immunization program against swine flu in 1976. He is a member of the Institute of Medicine. Dr. Fineberg received his A.B., M.D., and Ph.D. degrees from Harvard University. SUSAN BARTLETT FOOTE is assistant professor at the School of Business Administration and faculty member of the graduate program in health services management at the University of California, Berkeley. Ms. Foote is author of numerous papers and law review articles on drug and medical device regulation. She is a member of the Forum on Drug Development and Regulation of the Institute of Medicine. She recently served on several Food and Drug Administration panels that reviewed manufacturers' premarket approval applications for newly developed neurological, anesthesia, and general hospital devices and was a member of the advisory panel for the Office of Technology Assessment project on "Medical Technology and DRG's: Evaluating Medicare's Prospective Payment System." Ms. Foote holds B.A. and M.A. degrees in history from Case Western Reserve University and a J.D. degree from the Boalt School of Law at the University of California, Berkeley.

CONTRIBUTOR* 177 WILSON GREATBATCH is chairman of the board of Greatbatch GEN- AID, Ltd. Mr. Greatbatch is the coinventor of the Chardack-Greatbatch implantable cardiac pacemaker. He is author of many scientific articles and book chapters on medical electronics and '`Implantable Active Devices," a book commemorating the twenty-fifth anniversary of the implantable cardiac pacemaker. He is a fellow of the Institute of Electrical and Electronics Engineers, the American Association for the Advancement of Science, the American College of Cardiology, and the British Royal Society of Health and is a member of the National Academy of Engineering. Mr. Greatbatch received his B.E.E. degree from Cornell University and an M.S. in electrical engineering from the University of Buffalo. He has received honorary doctorate degrees from four universities and is named inventor or coinventor on more than 150 U.S. and foreign patents. RALF D. HOTCHKISS is an independent engineer and designer of products for the handicapped. Mr. Hotchkiss developed many of the innovations in wheelchair design and continues to work on wheelchair improvements under the sponsorship of the Office for Economic Opportunity, the Veterans Administration, and private sources. From 1971 to 1980, he was director of the Center for Concerned Engineering, a consulting group started with the help of Ralph Nader to work on product safety and ethical problems in engineering, where he contrib- uted to public policy efforts related to consumer safety in automobiles and mobile homes and to the development of technologies for the handicapped. He has been a lecturer on wheelchair design and a consultant to wheelchair manufacturers and has given testimony to congressional and conference panels on the subjects of consumer safety' public access for the handicapped, wheelchair safety and dependability. He is author and coauthor of a number of articles and books on consumer safety issues. Mr. Hotchkiss majored in physics at Oberlin College. ALAN R. KAHN is research professor of electrical and computer engineering at the University of Cincinnati. Dr. Kahn is a physician and private consultant with extensive experience in biomedical engi- neering applications in the development of new products for clinical use. His research interests include the application of new research in brain physiology, artificial intelligence, human behavior, and com- munications. Prom 1982 to 1985, he served on a pane! assessing federal policies and the medical device industry for the Office of Technology Assessment of the U.S. Congress. He also helped organize the Alliance of Engineering in Biology and Medicine and served as its third president

178 CONTRIBUTORS in 1973. From 1970 to 1977, Dr. Kahn was senior vice president for research and development at Medtronic, Inc., in Minneapolis, Min- nesota. Dr. Kahn is a fellow of the Institute of Electrical and Electronics Engineers, the American College of Cardiology, and the American College of Chest Physicians. WILLIAM W. LOWRANCE is senior fellow and director of the Life Sciences and Public Policy Program at The Rockefeller University. Dr. Lowrance serves on a number of national committees, including the executive committee of the Environmental Protection Agency Science Advisory Board. His research interests include national and international science policy, decisions regarding public health risks, and ethical responsibilities of technical experts. He is author of Modern Science and Human Values and Of Acceptable Risk: Science and the Determination of Safety. From 1973 to 1975, he served as a resident fellow at the National Academy of Sciences; from 1976 to 1977, as a research fellow in the Program in Science and International Affairs at Harvard University; and from 1977 to 1979, as a special assistant to the under secretary of state. From 1979 to 1981, he taught health and environmental policy as a visiting associate professor in the Program in Human Biology at Stanford University. Dr. Lowrance holds a Ph.D. degree in organic and biological chemistry from The Rockefeller University. ROBERT W. MANN is Whitaker Professor of biomedical engineering at the Massachusetts Institute of Technology. Dr. Mann's research interests include the biomechanics of synovial joints, the etiology of osteoarthritis, and computer-aided simulation of orthopedic surgery. He is a member of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine and a fellow of the American Academy of Arts and Sciences, the Institute of Electrical and Electronics Engineers, the American Society of Me- chanical Engineers, and the American Association for the Advance- ment of Science. Dr. Mann received his S.B., S.M., and Sc.D. degrees in mechanical engineering from the Massachusetts Institute of Tech- nology. JOHN H. Mox~EY III was senior vice president for corporate planning and alternative services for American Medical International, Inc., at the time of the symposium. Currently he is president of MetaMedical Inc., a diversified health-care company. Dr. Moxley's research interests are in oncology and the organization and delivery of health care. He is a member of the Council on Scientific Affairs of the American

CONTRlB UTORS 179 Medical Association, the Institute of Medicine, the National Academy of Sciences, the American Hospital Association, and the American Association of Medical Colleges. He has served as dean at both the University of Maryland and the University of California at San Diego medical schools, assistant secretary of defense for health affairs at the Pentagon, and clinical associate at the National Cancer Institute. Dr. Moxley received his bachelor's degree from Williams College and M.D. degree from the Colorado School of Medicine. SEYMOUR PERRY is deputy director of the Institute for Health Policy Analysis at Georgetown University Medical Center, where he holds dual appointments as professor of medicine and professor of community and family medicine. Dr. Perry was active in cancer research for 14 years before he was appointed associate director of the National Institutes of Health in 1975 and initiated the formation of the NIH Consensus Development Program, which he headed for the first 3 years of its existence. In 1978, he was appointed an assistant Surgeon General in the Commissioned Corps of the U.S. Public Health Service and designated director of the National Center for Health Care Technology, an agency created by congressional legislation in 1978 to provide assessment of major medical technologies. When the Center was terminated in 1981, he joined the Georgetown University Medical Center. In 1985, he was one of the founders of the International Society of Technology Assessment in Health Care and was its first president. Dr. Perry is a consultant to several government agencies and serves on a number of the advisory and editorial boards. He is a member of the Institute of Medicine and the National Academy of Sciences. WALTER L. ROBB is senior vice president for corporate research and development of General Electric and a member of the company's Corporate Executive Council. Dr. Robb started his career with General Electric in 1951 as a chemical engineer at the Knolls Atomic Power Laboratory, became head of the Medical Systems Division in 1973, and assumed his present position in 1986. He holds patents related to permeable membranes and separation processes and is widely published in the professional literature. He was vice chairman of the board of regents of the Milwaukee School of Engineering, served on the board of directors of the Health Industry Manufacturers Association, and is a member of the National Academy of Engineering. Dr. Robb holds a B. S. degree in chemical engineering from Pennsylvania State University and M.S. and Ph.D. degrees in chemical engineering from the Uni- versity of Illinois.

180 CONTRIBUTORS EDWARD B. ROBERTS is David Sarnoff Professor of the Management of Technology at the Massachusetts Institute of Technology's Sloan School of Management. Dr. Roberts' research interests in R&D organizations include the dynamics of health care management and policy, R&D management, technological innovation, entrepreneurship, and new venture activities. He is author of eight books and more than 100 journal articles. In 1958 he became a founding member of the M.I.T. System Dynamics Group, cofounded the M.I.T. Research Program on the Management of Science and Technology in 1961, and became the director of the new interdisciplinary master's degree program in the management of technology in 1980. In 1963 and 1969, respectively, he cofounded Pugh-Roberts Assoc., Inc., an international technology management consulting firm, and Medical Information Technology, Inc. (MEDITECH), a hospital information systems com- pany. In 1982, he became a founding general partner of Zero Stage Capital, a venture capital fund specializing in high-technology startups in the Boston area. Dr. Roberts holds four degrees, including the Ph.D., in engineering, management, and economics from M.I.T. PENELOPE C. ROEDER was director of corporate planning for American Medical International, Inc., at the time of the symposium. She is currently an independent consultant working with hospitals and phy- sician groups on their strategic planning. Ms. Roeder received a bachelor's degree from Bennington College and an M.B.A. from New York University. ANTHONY A. ROMEO is chief industrial economist at Unilever in London, England. Dr. Romeo has been a consultant to various private firms and government agencies, including the United Nations, the congressional Office of Technology Assessment, the Federal Trade Commission, the Center for Health Services Research, the National Science Foundation, and the Small Business Administration. From 1971 to 1985, he was on the faculty of the University of Connecticut, where he became professor of economics, with a joint appointment in the Department of Behaviorial Sciences and Community Health. He is author and coauthor of numerous professional articles and two books on the economics of innovation. Dr. Romeo received a B.A. degree in economics from Johns Hopkins University and a Ph.D. degree in economics from the University of Pennsylvania. Louise B. Russets is research professor at the Institute for Health, Health Care Policy and Aging Research and professor in the Department of Economics at Rutgers University. Dr. Russell's research interests

CONTRIB UTORS 181 in medical policy are related to medical care and the economic effects of demographic trends. Before joining the university, she was a senior fellow in the Economic Studies Program at the Brookings Institution, where she authored three books, Is Prevention Better Than Cure?, Evaluating Preventive Care, The Baby Boom Generation and the Economy, and Technology in Hospitals: Medical Advances and Their Diffusion. She has also published numerous articles on economics and medical care and a book on the federal health budget, based on her work as a research economist both in government and in the private sector. Dr. Russell is a member of the Institute of Medicine and served on the Institute's Committee for the Study of the Future of Public Health. She is also a member of the U.S. Preventive Services Task Force convened by the Department of Health and Human Services. Dr. Russell received her Ph.D. degree in economics from Harvard University. ARAN SAFIR lives in Cambridge, Massachusetts, and divides his time between the practice of ophthalmology, invention of medical devices, and consultation with industry. His research interests include the optics of the eye, ophthalmic diagnostic and surgical instruments, computers in medicine, and the visual system as an information processor. In addition to holding professional positions in ophthalmology at several medical schools, Dr. Safir participated in numerous committees of the Department of Health, Education, and Welfare during the 1960s and 1970s. From 1975 to 1980, he was director of the Mount Sinai Institute of Computer Science in New York City. He is a fellow of the Academy of Ophthalmology and the American College of Surgeons. Dr. Safir studied electrical engineering at Cornell University, and holds B.S. and M.D. degrees from New York University. FRANK E. SAMUEL, JR., is president of the Health Industry Manufac- turers Association (HIMA). Before joining HIMA in 1984, Mr. Samuel was a partner with the law firm of Dickstein, Shapiro & Morin and held several executive positions in government, including the Depart- ment of Health, Education, and Welfare and the Agency for Interna- tional Development. Mr. Samuel is author of several articles on the health care industry, including several opinion articles. He received a B.A. degree from Hiram College, was a Fulbright Scholar in law and government at the University of Leiden in the Netherlands, and received an L1.B. degree from Harvard Law School. SAMUEL 0. THIER is president of the Institute of Medicine. Dr. Thier's past appointments include Sterling Professor and chairman of the

182 CONTRIB UTORS Department of Internal Medicine at Yale University School of medicine, vice chairman and professor of medicine at the University of Penn- sylvania Medical School, and chief of the renal unit and assistant professor of medicine at Harvard Medical School. Dr. Thier did research at the National Institutes of Health from 1962 to 1964 and served on the director's Advisory Committee from 1980 to 1984. He is author of numerous articles on renal physiology, inherited diseases of the kidney, and kidney stones and is coauthor of a textbook on pathophysiology. Dr. Thier has served as president of the American College of Physicians and chairman of the American Board of Internal Medicine. He received an undergraduate degree from Cornell Univer- sity and an M.D. degree from the State University of New York at Syracuse. LEO J. THOMAS is a senior vice president and general manager of life sciences at Eastman Kodak Company and vice chairman of Sterling Drug Inc. Dr. Thomas serves on the board of directors of the Rochester Telephone Corporation and Norstar Bank. He is a member of numerous professional societies, including the American Institute of Chemical Engineers, the American Association for the Advancement of Science, the American Chemical Society, and the Engineering Research Board. He is a member of the National Academy of Engineering and is currently chairman of the Bioengineering Peer Committee. He is also a member of the Board of Chemical Sciences and Technology of the National Research Council. Dr. Thomas received a B.S. degree in chemical engineering from the University of Minnesota and M.S. and Ph.D. degrees in chemical engineering from the University of Illinois. EDWIN C. WHITEHEAD is founder and chairman of Whiteheab Asso- ciates, a venture capital and investment company developing biological and chemical products to control or cure disease. Mr. Whitehead is also founder of the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts, and cofounder of Technicon Corporation, where he was chain and chief executive officer. He holds nearly 20 patents on devices such as the direct-writing electrocardiograph, the portable respirator, the automatic fraction collector, the automatic tissue processor, and automated blood analyzer.

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In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

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