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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 Evaluation—Congresses.
2. Medical innovations—Economic aspects—Congresses. I. Ekelman,
Karen B. II. National Academy of Engineering. III. Institute of
Medicine (U.S.) IV. Series.
[DNLM: 1. Equipment and supplies—congresses. W 26 N532 1987]
R856.A2N495 1988
610' .28—dcl9
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
OCR for page R3
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, develops—whether by a
purely mechanical process, a purely biological process, or a combi-
nation of the two—is 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 biology—some 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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