04448nam 2200637Ia 450 991078014570332120230607213817.00-309-18320-01-280-18409-497866101840950-309-56588-X(CKB)111069351125334(EBL)3564062(SSID)ssj0000179470(PQKBManifestationID)11177412(PQKBTitleCode)TC0000179470(PQKBWorkID)10138711(PQKB)10797084(MiAaPQ)EBC3564062(Au-PeEL)EBL3564062(CaPaEBR)ebr10068504(OCoLC)748530719(EXLCZ)9911106935112533420011204d2001 uy 0engurcn|||||||||txtccrInnovation 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 MedicineWashington, D.C. National Academy Press20011 online resource (112 p.)Compass seriesDescription based upon print version of record.0-309-08255-2 Includes bibliographical references.""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 ""Compass series (Washington, D.C.)Medical instruments and apparatusCongressesMedical innovationsCongressesMedical instruments and apparatusMedical innovations681Hanna Kathi E1093170Institute of Medicine (U.S.).Roundtable on Research and Development of Drugs, Biologics, and Medical Devices.MiAaPQMiAaPQMiAaPQBOOK9910780145703321Innovation and invention in medical devices3716981UNINA