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New medical devices : invention, development, and use / Karen B. Ekelman, editor.
- Format:
- Book
- Series:
- Series on technology and social priorities.
- Series on technology and social priorities
- Language:
- English
- Subjects (All):
- Medical instruments and apparatus--Evaluation--Congresses.
- Medical instruments and apparatus.
- Medical innovations--Economic aspects--Congresses.
- Medical innovations.
- Physical Description:
- 1 online resource (xiv, 186 pages) : illustrations.
- Edition:
- 1st ed.
- Place of Publication:
- Washington, D.C. : National Academy Press, 1988.
- Summary:
- 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:
- 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?
- 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
- Private Investment in Medical Device Innovation
- DECISIONS ABOUT R&
- D
- TECHNICAL FACTORS
- MARKET FACTORS
- CONCLUSIONS
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- Notes:
- 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:
- 9786610214891
- 9781280214899
- 1280214899
- 9780309581936
- 0309581931
- OCLC:
- 43477219
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