Innovation and Invention in Medical Devices : Workshop Summary.

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Material from a recent workshop is summarized here, examining the nature of innovation in the field and the social and economic infrastructure that supports innovation and invention in medical devices, identifying unmet clinical needs, and considering barriers to the application of new technologies...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Hanna, Kathi E. (Editor ), Manning, Frederick J. (Editor ), Bouxsein, Peter (Editor ), Pope, Andrew (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: National Academies Press 2001.
Colección:Compass series (Washington, D.C.)
Temas:
Medical innovations > Congresses.
Medical instruments and apparatus > Congresses.
Diffusion of innovations.
Equipment and Supplies
Diffusion of Innovation
Médecine > Innovations > Congrès.
Médecine > Appareils et instruments > Congrès.
Innovations > Diffusion.
Diffusion of innovations
Medical innovations
Medical instruments and apparatus
Congress
Electronic resource.
proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Cover
  • Copyright
  • Reviewers
  • Foreword
  • Preface
  • Acronyms and Abbreviations
  • Table of Contents
  • 1 Introductory Overview
  • OVERVIEW
  • CHALLENGES TO INNOVATION
  • REGULATORY ISSUES
  • PAYMENT ISSUES
  • VALUE AND CONSEQUENCES FOR INNOVATION
  • CONCLUSIONS
  • 2 Keynote Session
  • HISTORICAL PERSPECTIVE ON IOM'S ROLE IN PROVIDING A FORUM FOR DISCUSSION
  • A REGULATORY PERSPECTIVE
  • AN INDUSTRY PERSPECTIVE: CHALLENGES IN THE DEVELOPMENT AND REGULATION OF DRUG-DEVICE COMBINATION PRODUCTS
  • AN EVALUATOR'S PERSPECTIVE
  • INNOVATION AND INVENTION IN MEDICAL DEVICES: IMPLANTABLE DEFIBRILLATORS
  • GENERAL DISCUSSION OF THE KEYNOTE SESSION
  • 3 The Nature of Medical Innovation
  • THE INNOVATIVE PROCESS FOR MEDICAL DEVICES: A NASA PERSPECTIVE
  • Medical Device Case Studies
  • Benefits of the NASA Process
  • ENDOVASCULAR DEVICES
  • GENE ARRAYS
  • INHALED INSULIN
  • IMAGING THE MICROVASCULATURE
  • GENERAL DISCUSSION OF THE NATURE OF MEDICAL INNOVATION
  • 4 Sources and Support of Medical Devices Innovation
  • AN OVERVIEW OF PUBLIC AND PRIVATE FACTORS AFFECTING MEDICAL DEVICE INNOVATION
  • THE FEDERAL RESEARCH ROLE
  • THE FEDERAL REGULATORY ROLE
  • THE ACADEMIC ROLE IN INNOVATION
  • THE ACADEMIC HEALTH CENTER ENVIRONMENT
  • THE ROLE OF SMALL MEDICAL COMPANIES
  • THE ROLE OF LARGE MEDICAL COMPANIES
  • THE ROLE OF PUBLIC AND PRIVATE CAPITAL
  • GENERAL DISCUSSION OF SOURCES AND SUPPORT OF MEDICAL DEVICE INNOVATION
  • 5 The Challenges Ahead
  • UNMET CLINICAL NEEDS: CARDIOVASCULAR DISEASE
  • UNMET CLINICAL NEEDS: CLINICAL TRIALS
  • BARRIERS AND ISSUES IN DEVICE INNOVATION: REIMBURSEMENT
  • GENERAL DISCUSSION OF THE CHALLENGES AHEAD
  • 6 Summary and Conclusions
  • Appendixes
  • Appendix A Workshop Agenda Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
  • AGENDA
  • Appendix B Speakers' Biographical Sketches.

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