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Series on Technology and Social Priorities NATIONAL ACADEMY OF ENGINEERING INSTITUTE OF MEDICINE New Medical Devices Invention, Development, and Use Karen B. Ekelman Editor NATIONAL ACADEMY PRESS Washington, D.C. 1988

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National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Robert M. White is president of the National Academy of Engineering. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1983 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Samuel O. Thier is president of the Institute of Medicine. This publication has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee. The interpretations and conclu- sions in this publication are those of the authors and do not purport to represent the views of the councils, officers, or staff of the National Academy of Engineering or the Institute of Medicine. Funds for the National Academy of Engineering's Symposium Series on Technology and Social Priorities are provided by the Andrew W. Mellon Foundation, Carnegie Corporation of New York, and the Academy's Technology Agenda Program. Library of Congress Catalog~ng-in-Publication Data New medical devices: factors influencing invention, development, and use/Karen B. Ekelman, editor. p. cm. - Series on technology and social priorities) At head of title: National Academy of Engineering; Institute of Medicine. Based on a symposium held at the National Academy of Sciences, Washington, D.C., Mar. 9-10, 1987. Includes index. ISBN 0-309-03847-2. ISBN 0-309-03846-4 (pbk.) 1. Medical instruments and apparatus EvaluationCongresses. 2. Medical innovationsEconomic aspectsCongresses. I. Ekelman, Karen B. II. National Academy of Engineering. III. Institute of Medicine (U.S.) IV. Series. [DNLM: 1. Equipment and suppliescongresses. W 26 N532 1987] R856.A2N495 1988 610' .28dcl9 DNLM/DLC for Library of Congress Copyright ~ 1988 by the National Academy of Sciences 88-12580 CIP No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use without written permission from the publisher, except for the purposes of official use by the U.S. government. Printed in the United States of America

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SYMPOSIUM ADVISORY COMI(TEE Cochairmen ROBERT W. MANN, Massachusetts Institute Of Technology WALTER L. ROBB, General Electric Company Members J. D. ANDRADE, University of Utah SUSAN BARTLETT FOOTE, University of California, Berkeley JOHN H. GIBBONS, Office of Technology Assessment, U.s. Congress RUTH S. HANFT, George Washington University PETER BARTON MUTT, Covington and Burling, Washington, D.C. WILLIAM W. LOWRANCE, The Rockefeller University LARRY MI1KE, Office of Technology Assessment, U.s. Congress FREDERICK C. ROBBINS, Case Western University GEORGE E. THIBAULT, Massachusetts General Hospital Staff KAREN B . EKELMAN, NAE Fellow NANCY B. ISENBERG, NAE Fellow

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Foreword The impressive breadth and comprehensiveness of the collective contributions to the symposium on which this book is based preclude any but a sharp focus for these foreword comments. But if a single word had to stand for the conference, and for what this professor wished to emphasize, it would be "interdisciplinary." The dynamic of the meeting, inevitably restrained in printed form, is indebted to the informed presentations and vigorous discussions of the participants and to the committee and staff who designed the program. We ranged over the device spectrum from origin to obso- lescence and heard from representatives of numerous university de- partments and professional schools and spokespersons from industry, finance, government, and the several customers physicians and hos- pitals. Again invoking personal experience, I concentrate on the innovation stage of an intrinsically interdisciplinary process. Samuel Thier, in his thoughtful and candid overview, elects to focus on the scientific base of medical devices. But that historic source of innovation seemed of little relevancy in the engaging stories of the determined and pragmatic inventors. Edward Roberts expressed a similar view in his conclusion that "innovation in medical devices is usually based on engineering problem solving by individuals or small firms, is often incremental rather than radical, seldom depends on the results of long-term research in the basic sciences, and generally does not reflect the recent generation of fundamental new knowledge." Frank Samuel coalesces both positions that of the inventors and of management science by asserting, "We cannot worry very effectively

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FOREWORD about the discovery of new knowledge...." From the perspective of government, Louise Russell agreed with Anthony Romeo's conclusion that increased federal funding for research is not warranted at present, although Dr. Romeo did note that "R&D is an investment [that] depends heavily on the federal government" and that "private industry cannot be relied on to do basic research." William Lowrance observes in his summarizing remarks, "We should not feel too bad about the accomplishment so far" and "few if any lines of medical technology development have been stifled." He notes that "unlike Chrysler, the steel manufacturers, and the railroads, the medical manufacturers . . . have not begged for federal bailout or special treatment." On the issues of the national economy and international competi- tiveness, I would argue that medical technology could easily experience the same wearisome decline endemic now across so many once American-dominated product lines. The assaults will come both from lower-cost replication from the Pacific Rim nations and from interna- tional competitors who do invest in R&D and successfully manage technology transfer. The ultrasound lithotriptor, a device that obviates the hazards and long hospital recovery periods associated with surgical removal of gall stones, is produced in the Federal Republic of Germany, where it emerged from research on the effects of hailstones on aircraft. We are seeing cochlear implants of superior effectiveness based on Australian research. Philips A. G. of the Netherlands, which supple- ments its consumer electronics products with medical technology, tops in dollar volume all comparable Japanese firms exporting to the United States. So, whatever the economic and regulatory tensions we expe- rience in this country, we had best not rest on our R&D oars lest medical devices join the decline of U.S. automobiles, steel, and railroads. In my opinion, the research areas grievously underserved are interdisciplinary questions undergirding future medical devices. We have run the string of devices nostalgically described by our inventors. Future medical technology will increasingly require more fundamental understanding at the organ, cell, and subcellular levels, and it will be based on collaborative biological and physical science research. Leo Thomas, in his review of the study mandated by the National Science Foundation (NSF), outlines a number of such areas biomaterials, biosensors, artificial organs, functional neurostimulation. All of these topics deal intimately with the biological state but address questions framed largely in physical science and engineering terms. Such non- parochial research is not likely to be done anywhere but in a university setting, but even here traditional department organization frequently

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FOREWORD . . impedes the essential collaboration among persons skilled in their respective realms. Even more disturbing to this observer is the accelerating trend toward biological research focusing heavily, if not exclusively, at the molecular level. Physics has traditionally taken a reductionist view of science, and biologists are following that pathway admittedly with great success. Left vacant, however, are vast research areas of interest and promise at the subcellular, cellular, and organ levels where neither biologists nor physicists and engineers alone are well equipped to frame and address important questions. The artificial heart program- however its economic and social viability are assessed~ould be a paradigm of this dilemma. The problem of long-term biomaterial blood compatibility, obvious two decades ago, still severely limits longevity. How to control a replacement heart in a physiologically appropriate manner has hardly been addressed. How the wear and tear of articular cartilage, the clinical sign of osteoarthritis, developswhether by a purely mechanical process, a purely biological process, or a combi- nation of the twois an open question despite the wide prevalence and expensive morbidity of the disease, and thus far, too narrowly focused research. A myriad of similar questions can be posed at the interface between physics and biologysome to explicate pathology where devices may prove inappropriate; others to lay firm foundations on which to develop new technology. The awareness of this interdisciplinary knowledge gap and its significance is just beginning to be discerned. Sigma Xi's recent centennial report, A New Agenda for Science, stresses the need for, and opportunities in, "interdisciplinary science." Leo Thomas de- scribes in this volume the National Research Council (NRC) Engi- neering Research Board study sponsored by NSF. The National Academies of Sciences and Engineering and the Institute of Medicine jointly have sponsored a government-university-industry research roundtable entitled "Multidisciplinary Research and Education Pro- grams in Universities: Making Them Work." NSF has just announced a new initiative in "Emerging Technologies" with "Tissue Engineer- ing" among its first two targets, and the Institute of Medicine has joined with the Commission on Physical Sciences, Mathematics, and Resources of the NRC in a Committee on Fostering Research Collab- oration Among the Physical and Engineering Sciences and the Biolog- ical and Clinical Sciences. University departmental faculty organization and curricula pedagogy tend to "parochialize nature." These new initiatives in interdisciplinary science must identify and promote new models for the conduct of

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. . . FORK WORD research essential to the undergirding of future medical technology. On a longer time frame, but even more vital, they must develop the educational strategies necessary to equip humans with the rigor of the several underlying disciplines, coupled with the skills and perspectives to attack problems which promote, regain, and extend human health. ROBERT W. MANN Cochairman Symposium Advisory Committee In an era when virtually every discussion of U.S. technology relates to concern over our slipping global position, it is good to see the National Academy of Engineering and the Institute of Medicine examine the complexities of a U.S. success story: medical devices, a market in which the nation has both the technical and manufacturing lead. Admittedly our nation has the highest level of use of such devices and the correspondingly highest cost, but they help give us the best and most widely available health care in the world. Although we have not invented all the winning products, we have a reasonable share, and we have responded effectively to interventions made elsewhere. The United States has done well, and done it in diverse ways: through the efforts of entrepreneurs, through developments carried out by big companies, and through collaboration between university and industry. That diversity of successful approaches makes for complications. But it also gives our system a hybrid vigor that it might otherwise lack. As long as we do not destroy any of these comple- mentary routes, the U.S. system of medical device innovation should remain strong. We should not, however, complacently assume that the future will remain the same as the past. In the next generation of innovation, the emphasis may be on lowering cost and increasing ease of use, rather than providing wholly new diagnostic modes or major performance improvements in existing ones. Such an emphasis on productivity and effectiveness might favor overseas rivals who have excelled in lower cost, higher quality design in other fields. We could lose our industrial position in spite of a continuing strength in research and invention, improved specifications, or even new capabilities. So the future presents both positives and negatives. On the plus side, the United States will remain the number one market for medical

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FOREWORD MIX diagnostic equipment because of our nation's willingness to fund a high level of health care, the strength of our medical professions, and our excellent medical schools. And we retain a range of companies eager to serve that market. On the minus side must be counted our litigious society; the difficulty of making objective health care assessments that will define when devices are really cost effective; and those past weaknesses in cost- and quality-conscious manufacturing, which U.S. industries are now overcoming, but perhaps not fast enough. In the light of these uncertainties, and given the complexity of the problems, it is not surprising that the conference on which this book is based had difficulty in coming up with crisp conclusions or recom- mendations. But William Lowrance has provided a set of "Summarizing Reflections" that ought to be required reading for anyone in, or preparing to enter, the medical equipment business. What a complex field yet, for one who has been there, what an exciting and satisfying field! So may this compilation of the conference not scare away aspiring scientist-physician-entrepreneur-businessmen. Rather, may it increase their knowledge, stimulate their ambition, excite their senses, and, above all, help ensure the continuance of strong U.S. leadership in the development, sales, and proper use of medical devices. WALTER L. ROBB Cochairman Symposium Advisory Committee

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Preface and Acknowledgments Scientifically based disease prevention and health promotion have been made possible by the numerous scientific and technological advances that have redefined medicine in the twentieth century. One of the important influences in this process is the subject of this volume, the development and use of new medical devices. As in other areas of technological advance, the benefits of new medical devices are not without cost and raise many issues for study. We know, as Samuel O. Thier, president of the Institute of Medicine, points out in this book, that certain medical devices, such as the computed tomographic scanner, have reduced the net cost of treating some diseases. But how are other new technologies related to the rising cost of health care, and how can we ensure the most cost- effective use of new equipment? How can we promote innovation in medical technologies when the trends in the judicial application of tort law have made industries hesitant to develop products for which profits may be modest and liabilities severe? To explore these important issues and better understand the inter- relationship of engineering, medicine, invention, and public policy, the National Academy of Engineering (NAE) and the Institute of Medicine (IOM) jointly convened the symposium "New Medical Devices: Factors Influencing Invention, Development, and Use" on March 3- 4, 1987. The symposium brought physicians, engineers, and scientists together with industry executives, lawyers, ethicists, economists, and government officials to explore key factors that will influence devel- opment and use of innovative medical devices during the next decade. Symposium participants identified current trends in federal and private support of technological innovation, medical device regulation, product liability, and health care reimbursement. In addition, participants addressed important general issues, such as how to sustain technolog- x'

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X1 ~ PREFACE AND ACKNOWLEDGMENTS ical innovation and health care quality in a rapidly changing health care environment and how to encourage and support inventors. After a highly successful symposium characterized by discussion that was as fruitful and wide-ranging as would be expected of a diverse and knowledgeable assembly, we set about transforming the presen- tations and discussion into their present form. The symposium consid- ered topics in three general areas, which make up the three major divisions of this volume. These topics are (1) innovation and use of new medical devices; (2) current trends in federal and private support of technological innovation, medical device regulation, product liabil- ity, and health care reimbursement; and (3) several perspectives on how these trends interact to influence the availability and appropriate use of new medical devices. The symposium and this volume are particularly noteworthy in that they represent the first major collaborative effort undertaken by the NAE and the IOM. This activity could not have been completed successfully without such collaboration, and I would like especially to thank Samuel O. Thier and Frederick C. Robbins, current and former IOM presidents, respectively, for their continued enthusiasm and support for this project. We are indebted to John H. Gibbons and Larry Miike of the congressional Office of Technology Assessment for making available to us in draft form a collection of vignettes in which a number of inventors described their experience in the innovation process for specific medical technologies. This book includes five of these vignettes by inventors whose personal presentations at the symposium were among its high points. Many people contributed to the success of the symposium and to the publication of this volume. I would like especially to thank cochairmen Robert W. Mann and Walter L. Robb and the other members of the symposium advisory committee: J. D. Andrade, Susan Bartlett Foote, John H. Gibbons, Ruth S. Hanft, Peter Barton Hutt, William W. Lowrance, Larry Miike, and George E. Thibault. Special appreciation is due to Karen B. Ekelman, NAE Fellow, who served as staff director for the symposium and editor of this volume. Thanks are also due to the many people in the NAE and the IOM who played constructive roles, including Caroline G. Anderson, Jesse H. Ausubel, Enriqueta C. Bond, Penelope J. Gibbs, Clifford S. Goodman, Karen B. Ekelman, Nancy B. Isenberg, H. Dale Langford, Sandra H. Matthews, and Wallace K. Waterfall. ROBERT M. WHITE President National Academy of Engineering

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Contents Part I Medical Device Innovation and Health Care New Medical Devices and Health Care 3 Samuel 0. Thier Inventing Medical Devices: Five Inventors' Stories Edwin C. Whitehead, Alan R. Kahn, Aran Safr, Wilson Greatbatch, and Ralf Hotchkiss Technological Innovation and Medical Devices Edward B. Roberts Part 2 Current Trends Federal Support of Medical Device Innovation Leo ]. Thomas, Jr. Private Investment in Medical Device Innovation Anthony A. Romeo Product Liability and Medical Device Regulation: Proposal for Reform............................ Susan Bartlett Foote x''~ ...... 13 35 51 . ...... 62 ~3 , ~ . . - - .

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x/v impact of the Changing Medical Payment System on Technological Innovation and Utilization . Stuart H. Altman A Conflict: Medical Innovation, Access and Cost Containment ...................................... Seymour Perry and Flora Chu Part 3 How Trends Will Interact How Trends Will Interact: The Perspective of the Hospital........................................ John H. Moxiey Ill and Penelope C. Roeder Perspectives of Industry, the Physician, and Government ............................ Peter F. Carpenter, Frank E. Samuel, Jr., Harvey V. Fineberg, and Louise B. Russell Summarizing Reflections William W. [owrance Contributors Index ........ CONTENTS ... 93 .... 104 127 .............. 138 1S4 175 .... 183

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New Meclical Devices

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