New Medical Devices -- Copyright -- FOREWORD -- PREFACE AND ACKNOWLEDGMENTS -- CONTENTS -- PART 1 MEDICAL DEVICES 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 -- The Invention Process -- Financing and Marketing -- INVENTION OF AN ELECTRONIC RETINOSCOPE -- THE FIRST SUCCESSFUL IMPLANTABLE CARDIAC PACEMAKER -- WHEELCHAIRS FOR THE THIRD WORLD -- Nicaragua Wheelchair Project -- Evolution of the Design -- The Future -- 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.

Overview of Reform Proposal -- The Stages Described: Issues for Debate -- Stage 1 -- Stage 2 -- Stage 3 -- CONCLUSION -- NOTES -- Bibliography -- Impact of the Changing Medical Payment System on Technological Innovation and Utilization -- PROSPECTIVE PAYMENT SYSTEM -- New Incentives under the Prospective Payment System -- MEDICAL TECHNOLOGIES, HEALTH CARE COSTS, AND THE ROLE OF PROPAC -- Cardiac Pacemakers -- Magnetic Resonance Imaging -- Penile Prostheses -- IMPACT OF PPS ON MEDICAL TECHNOLOGY -- CONCLUSIONS -- A Conflict: Medical Innovation, Access and Cost Containment -- INCENTIVES AND DISINCENTIVES FOR MEDICAL DEVICE INNOVATION -- The Prospective Payment System -- The Health Care Finance Administration Decision-Making Process -- Innovation under Alternative Health Care Delivery Systems -- FUTURE DIRECTIONS -- REFORM PROPOSALS -- Technology Assessment -- Priority List of Candidate Topics for Assessment and Policy Actions -- Interim Coverage Policy -- Periodic Payment Adjustments -- Greater Public Input into Coverage Decision Making -- Identification of Outmoded, Ineffective, and Overutilized Existing Technologies -- 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 -- How We Deal with Risk -- Responsibilities in the Health Care Arena -- Informed Consent -- A Perspective on Future Challenges -- References -- THE PERSPECTIVE OF THE MEDICAL DEVICE INDUSTRY -- Ten Stages in the Innovation of Medical Devices -- Factors Influencing the Ten Stages in Medical Device Innovation -- Some Suggestions for Change -- PROSPECTIVE PAYMENT -- Regulation and Product Liability.

Biomedical Innovation -- Evaluating Medical Devices -- HOW TRENDS WILL INTERACT: THE PERSPECTIVE OF THE GOVERNMENT -- The Government's Role in Research -- The Government's Role in Financing Health Care -- The Government as Guardian of the Public Interest -- The Stage is Set -- The Government as Reconciler of Conflicting Interests, Including Its Own -- Changes in the Payment System -- Information for Making Choices -- Possible Role for the Institute of Medicine -- References -- Summarizing Reflections -- SALIENT TRENDS IN HEALTH CARE -- THE FLOW OF INNOVATION -- HEALTH OF THE DEVICES ENTERPRISE ITSELF -- INSTITUTIONAL AND INFRASTRACTURAL ISSUES -- REGULATORY CONTROL VERSUS TORT LIABILITY -- ECONOMICS -- DIFFUSION -- CURRENT RESEARCH DIRECTIONS -- IDENTIFYING NEEDS AND OPPORTUNITIES -- ENVOI -- CONTRIBUTORS -- INDEX.