NATIONAL ACADEMY PRESS
2101 Constitution Avenue, N.W. Washington, D.C. 20418
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 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
The Committee on Technological Innovation in Medicine was established in 1988 by the Institute of Medicine to design a series of workshops that would (a) provide more fundamental knowledge of the process by which biomedical research findings are translated into clinical practice and (b) address opportunities for improving the rationality and efficiency of the process. This volume consists of the proceedings of the fifth workshop in the series, "The University-Industry Interface and Medical Innovation," held in Stanford, California, on February 21–23, 1993. This workshop and its proceedings were supported by the Howard Hughes Medical Institute and Pfizer. The opinions and conclusions expressed here are those of the authors and do not necessarily represent the views of the National Academy of Sciences, any of its constituent parts, or the organizations providing support.
Library of Congress Cataloging-in-Publication Data
Sources of medical technology: universities and industry / Annetine C. Gelijns and Nathan Rosenberg, editors; Committee on Technological Innovation in Medicine, Institute of Medicine.
p. cm. — (Medical innovation at the crossroads; v. 5)
Includes bibliographical references and index.
ISBN 0-309-05189-4
1. Medical innovations. 2. Medicine—Research. I. Gelijns, Annetine. II. Rosenberg, Nathan. III. Institute of Medicine (U.S.). Committee on Technological Innovation in Medicine. IV. Series.
[DNLM: 1. Diffusion of Innovation. 2. Technology, Medical. 3. Research Support—United States. W1 ME342f v. 5 1994 / W 20.5 S724 1994]
RA418.5.M4S68 1994
610'.72—dc20
DNLM/DLC
for Library of Congress 94-43303
CIP
Copyright 1995 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held at the Staatlichemuseen in Berlin.
Committee on Technological Innovation in Medicine
GERALD D. LAUBACH, Chair, Former President,
Pfizer, Inc.
SUSAN BARTLETT FOOTE, Health Advisor,
Office of Senator Dave Durenberger, U.S. Senate
BEN L. HOLMES, Vice President and General Manager,
Medical Products Group, Hewlett-Packard Company
WILLIAM N. HUBBARD, JR., Former President,
the Upjohn Company
LUCIAN L. LEAPE, Lecturer on Health Policy,
Harvard School of Public Health
KENNETH L. MELMON, Professor of Medicine and of Pharmacology,
Department of Medicine, Stanford University School of Medicine
H. RICHARD NESSON, President,
Brigham and Women's Hospital
UWE E. REINHARDT, James Madison Professor of Political Economy,
Woodrow Wilson School of Public and International Affairs, Princeton University
NATHAN ROSENBERG, Professor of Economics,
Stanford University
MICHAEL R. SOPER, Former National Medical Director,
CIGNA
JOHN E. WENNBERG, Professor of Epidemiology,
Department of Community and Family Medicine, Dartmouth Medical School
Project Staff
Program on Technological Innovation in Medicine
ANNETINE C. GELIJNS, Program Director (until February, 1993)
HOLLY DAWKINS, Research Assistant
HELEN C. ROGERS, Senior Project Assistant
Acknowledgments
The Committee on Technological Innovation in Medicine wishes to acknowledge and thank the many individuals and organizations who contributed their time, knowledge, and energy to the production of this volume. First and foremost, the committee thanks the authors of the chapters in this book; early drafts of these chapters were originally presented at the Institute of Medicine (IOM) workshop entitled "The University-Industry Interface" (see Appendix A for the agenda of this meeting) but much thought and effort went into their further development. The committee also expresses its gratitude to the meeting moderators, discussants, and participants. Great appreciation is also due to Dana O'Neil, who worked hard to coordinate the on-site workshop logistics, and Kenneth Melmon and Nathan Rosenberg, the "local" committee members, on whom we imposed with various demands, of varied urgency, both before and during the workshop.
The intellectual origins of this volume are found in the interests of Kenneth Melmon and Nathan Rosenberg in examining the interdisciplinary and interinstitutional aspects of medical innovation, to whom the committee is deeply indebted. The committee also expresses its gratitude to Annetine C. Gelijns, who, as the past program director, dedicated much time, thought, and energy to developing and refining the volume's focus. Others, however, were also critical: Kathleen N. Lohr, director of the Division of Health Care Services; Enriqueta Bond, the IOM's executive director until mid-1994; Karl D. Yordy, previous director of the Division; and the current and past IOM Presidents Kenneth I. Shine and
Samuel O. Thier all spring to mind for their generous and steady support of the program.
Among the IOM project staff who worked on this volume, the committee particularly recognizes Holly Dawkins, whose commitment and contributions to the series since its inception have been a vital factor in its production, and Helen Rogers, recognized for her superb management of the workshop logistics and her skilled support of the committee's work. Other staff members to be thanked are Don Tiller, who added the administrative tasks of this volume to his already heaped pile of tasks and put in weekend hours to assure its timely delivery to the press; Mike Edington, honored as the Institute of Medicine's managing editor, who swept away or diminished the various obstacles in the staffs' path; Nina Spruill, who has managed the complicated financial aspects of Medical Innovation at the Crossroads with good will and extraordinary ability for nigh on five years; and Susan Knasiak and Jay Ball, both of whom provided able and critical secretarial assistance during production of this book.
The committee thanks various organizations for their financial support of the workshop and of the Medical Innovation at the Crossroads series. This volume would not exist without the continued support of the Howard Hughes Medical Institute and Pfizer.
In closing, the committee recognizes that today's rapid changes in the financing and delivery of U.S. health care may well have a significant effect on the incentives for universities and industrial firms to generate new medical technologies. This volume examines the changing roles and interactions of these two critical participants in technological change. It is this committee's hope that this book provides a starting point for further research on these critical, but often neglected, institutional interactions in the innovation process.
Gerald D. Laubach
Chair
Committee on Technological Innovation in Medicine
Contents
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THE CHANGING NATURE OF MEDICAL TECHNOLOGY DEVELOPMENT |
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RECENT TRENDS IN SUPPORT FOR BIOMEDICAL RESEARCH AND DEVELOPMENT |
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PHYSICIANS AND PHYSICISTS: THE INTERDISCIPLINARY INTRODUCTION OF THE LASER TO MEDICINE |
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FROM THE SCALPEL TO THE SCOPE: ENDOSCOPIC INNOVATIONS IN GASTROENTEROLOGY, GYNECOLOGY, AND SURGERY |
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COCHLEAR IMPLANTATION: ESTABLISHING CLINICAL FEASIBILITY, 1957-1982 |
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INNOVATION IN CARDIAC IMAGING |
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INCENTIVES AND FOCUS IN UNIVERSITY AND INDUSTRIAL RESEARCH: THE CASE OF SYNTHETIC INSULIN |
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THE DIVISION OF INNOVATIVE LABOR IN BIOTECHNOLOGY |
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PERSPECTIVES ON INDUSTRIAL R&D MANAGEMENT |
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THE INTERTWINING OF PUBLIC AND PROPRIETARY IN MEDICAL TECHNOLOGY |
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List of Tables and Figures
TABLES
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2-1 |
Estimated R&D in the National Institutes of Health (in million dollars) |
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2-2 |
Estimated Federal Spending for Medical Device-related R&D (in million dollars) |
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2-3 |
Biotechnology Drugs Currently in Development |
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2-4 |
Biotechnology Medicines or Vaccines Approved by the Food and Drug Administration, 1993 |
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2-5 |
Selected Large-scale Relationships Between Universities/Academic Health Centers and Industry in Biomedical Research (in million dollars) |
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3-1 |
Rate of Laser Penetration by Specialty, 1985-1990 |
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3-2 |
Judgments of Effectiveness of Medical Applications of Lasers |
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3-3 |
Laser Sales (in million dollars) |
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4-1 |
Top 12 Laparoscopic or Endoscopic Procedures by Volume, 1991 |
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6-1 |
Selected Innovations in Cardiac Imaging |
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6-2 |
Innovation Lifecycle |
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8-1 |
Composition of the Biotechnology Industry |
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9-1 |
Major Acquisitions and Mergers of U.S. Pharmaceutical and Biotechnology Companies 1993 (in million dollars) |
FIGURES
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2-3 |
Trends in sources of funding for biomedical R&D as a percent of total R&D funds, 1983-1993 |
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2-4 |
Distribution of federal health R&d funding by performer, 1992 |
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2-5 |
Distribution of industry health R&D funding by performer, 1992 |
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2-6 |
Total R&D spending, Pharmaceutical Manufacturers Association member companies, 1990-1993 |
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2-7 |
Average number of clinical trials per New Drug Application to the Food and Drug Administration |
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2-8 |
Average number of patients per clinical trial |
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3-A1 |
Molecular absorption and emission processes |
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3-A2 |
''Colors" of light produced by lasers with different wavelengths |
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6-1 |
Institutional drivers of the innovation process |
List of Abbreviations
ACP
American College of Physicians
ACMI
American Cystoscope Makers, Inc.
AIRs
Academy Industry Relations
AO
American Optical
AQ
acoustic quantification
beta-gal
beta-galactosidase
CCD
charge couple device
cDNA
complementary deoxyribonucleic acid
CO2
carbon dioxide
CRADAs
cooperative research and development agreements
CSFs
colony stimulating factors
CT
computerized tomography
DHSS
British Department of Health
DOA
Department of Agriculture
ENT
ear, nose, and throat
EPO
erythropoietin
ERCP
endoscopic retrograde cholangiopancreatography
FDA
Food and Drug Administration
GI
gastrointestinal
HCFA
Health Care Financing Administration
HIMA
Health Industry Manufacturers Association
HP
Hewlett-Packard
HPLC
high-performance liquid chromatography
IBA
Industrial Biotechnology Association
IEEE
Institute of Electronics and Electrical Engineers
JSEP
Joint Services Electronics Program
LASER
light amplification by stimulated emission of radiation
MIS
minimally invasive surgery
MIT
Massachusetts Institute of Technology
MRC
Medical Research Council
MRI
magnetic resonance imaging
mRNA
messenger ribonucleic acid
NBFs
new biotechnology firms
ND3
deuterated ammonia
Nd:YAG
neodymium-doped yttrium-aluminum-garnet
NEN
New England Nuclear
NIH
National Institutes of Health
NIST
National Institute of Standards and Technology
NSF
National Science Foundation
NTIS
National Technical Information Service
OSTP
Office of Science and Technology Policy
PET
positron emission tomography
PPS
Prospective Payment System
R&D
research and development
RAC
Recombinant DNA Advisory Committee
rDNA
recombinant deoxyribonucleic acid
SBA
Small Business Administration
SPECT
single photon emission computerized tomography
Tc
technetium-99
TC
tissue characterization
TEE
transesophageal echocardiography
t-PA
tissue plasminogen activator
TRG
technical research group
UCSF
University of California, San Francisco
