Innovation and invention in medical devices [[electronic resource] ] : workshop summary / / Kathi E. Hanna ... [et al.] editors ; based on a workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Board on Health Sciences Policy, Institute of Medicine

• Record Nr.: UNINA9910455795903321
• Pubbl/distr/stampa: Washington, D.C., : National Academy Press, 2001
• ISBN: 1-280-18409-4; 9786610184095; 0-309-56588-X
• Descrizione fisica: 1 online resource (112 p.)
• Collana: Compass series
• Altri autori (Persone): HannaKathi E
• Disciplina: 681
• Soggetti: Medical instruments and apparatus; Medical innovations; Electronic books.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: ""Innovation and Invention In Medical Devices""; ""Copyright""; ""Preface""; ""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""; ""Cardiac Monitor""; ""Heart Imaging System""; ""Heart Assist Pump""; ""Telemedicine Instrumentation Pack""; ""Pill Telemetry Technologies""; ""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 ""; ""Appendix A Workshop Agenda Roundtable on Research and Development of Drugs, Biologics, and Medical Devices""; ""AGENDA""; ""Opening Session""; ""Keynote Session""; ""Session I: The Nature of Medical Innovation""; ""Session II: Sources and Support of Medical Device Innovation""; ""Session III: The Challenges Ahead""; ""Summary and Conclusions""; ""Appendix B Speakers' Biographical Sketches ""; ""Appendix C Registered Participants ""