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.

Contents

• SYMPOSIUM ADVISORY COMITTEE
• Foreword
• Preface and Acknowledgments
• Part 1. Medical Device Innovation and Health Care
  • New Medical Devices and Health Care
    • SCREENING
    • DIAGNOSIS
    • THERAPY
    • REHABILITATION
    • REFERENCES
  • Inventing Medical Devices: Five Inventors' Stories
    • Development of Technicon's Auto Analyzer
    • Plasmapheresis
    • Pneumatic Extradural Intracranial Pressure Monitor
    • Invention of an Electronic Retinoscope
    • The First Successful Implantable Cardiac Pacemaker
    • Wheelchairs for the Third World
  • Technological Innovation and Medical Devices
    • WHAT IS TECHNOLOGICAL INNOVATION IN MEDICAL DEVICES?
    • WHO BRINGS ABOUT MEDICAL DEVICE INNOVATIONS?
    • WHICH COMPANIES CONTRIBUTE TO MEDICAL DEVICE INNOVATIONS?
    • HOW DO FDA REGULATIONS AFFECT MEDICAL DEVICE INNOVATION?
    • WHAT IS THE ROLE OF THE LARGER COMPANY IN MEDICAL DEVICE INNOVATION?
    • REFERENCES
• Part 2. Current Trends
  • Federal Support of Medical Device Innovation
    • SYSTEMS PHYSIOLOGY AND MODELING
    • NEURAL PROSTHESES FOR HUMAN REHABILITATION
    • BIOMECHANICS
    • BIOMATERIALS
    • BIOSENSORS
    • METABOLIC IMAGING
    • MINIMALLY INVASIVE PROCEDURES
    • ARTIFICIAL ORGANS
    • FEDERAL SUPPORT FOR BIOMEDICAL ENGINEERING RESEARCH
    • CONCLUSION
    • REFERENCES
  • Private Investment in Medical Device Innovation
    • DECISIONS ABOUT R&D
    • TECHNICAL FACTORS
    • MARKET FACTORS
    • CONCLUSIONS
    • REFERENCES
  • Product Liability and Medical Device Regulation: Proposal for Reform
    • INDIVIDUAL AND SOCIAL FUNCTIONS: THE LIMITS OF REGULATION AND PRODUCT LIABILITY
    • DISTORTIONS CAUSED BY INCONSISTENCIES BETWEEN REGULATION AND PRODUCT LIABILITY
    • MEDICAL DEVICES AS A SPECIAL KIND OF CONSUMER PRODUCT: A FRAMEWORK FOR APPROACHING REFORM
    • CONCLUSION
    • BIBLIOGRAPHY
  • Impact of the Changing Medical Payment System on Technological Innovation and Utilization
    • PROSPECTIVE PAYMENT SYSTEM
    • MEDICAL TECHNOLOGIES, HEALTH CARE COSTS, AND THE ROLE OF ProPAC
    • IMPACT OF PPS ON MEDICAL TECHNOLOGY
    • CONCLUSIONS
  • A Conflict: Medical Innovation, Access and Cost Containment
    • INCENTIVES AND DISINCENTIVES FOR MEDICAL DEVICE INNOVATION
    • FUTURE DIRECTIONS
    • REFORM PROPOSALS
    • CONCLUSION
    • REFERENCES
• Part 3. How Trends Will Interact
  • How Trends Will Interact: The Perspective of the Hospital
    • THE PERSPECTIVE OF HEALTH CARE PAYERS
    • THE PERSPECTIVE OF THE HOSPITAL
    • CONCLUSION
    • REFERENCES
  • Perspectives of Industry, the Physician, and Government
    • Responsibility, Risk, and Informed Consent
    • The Perspective of the Medical Device Industry
    • Prospective Payment
    • How Trends Will Interact: The Perspective of the Government
  • Summarizing Reflections
    • SALIENT TRENDS IN HEALTH CARE
    • THE FLOW OF INNOVATION
    • HEALTH OF THE DEVICE ENTERPRISE ITSELF
    • INSTITUTIONAL AND INFRASTRUCTURAL ISSUES
    • REGULATORY CONTROL VERSUS TORT LIABILITY
    • ECONOMICS
    • DIFFUSION
    • CURRENT RESEARCH DIRECTIONS
    • IDENTIFYING NEEDS AND OPPORTUNITIES
    • ENVOI
• Contributors

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.

This publication has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee. The interpretations and conclusions 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.

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.

Based on a symposium held at the National Academy of Sciences, Washington, D.C., Mar. 9–10, 1987.