LEADER 04448nam 2200637Ia 450 001 9910780145703321 005 20230607213817.0 010 $a0-309-18320-0 010 $a1-280-18409-4 010 $a9786610184095 010 $a0-309-56588-X 035 $a(CKB)111069351125334 035 $a(EBL)3564062 035 $a(SSID)ssj0000179470 035 $a(PQKBManifestationID)11177412 035 $a(PQKBTitleCode)TC0000179470 035 $a(PQKBWorkID)10138711 035 $a(PQKB)10797084 035 $a(MiAaPQ)EBC3564062 035 $a(Au-PeEL)EBL3564062 035 $a(CaPaEBR)ebr10068504 035 $a(OCoLC)748530719 035 $a(EXLCZ)99111069351125334 100 $a20011204d2001 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aInnovation and invention in medical devices$b[electronic resource] $eworkshop summary /$fKathi 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 210 $aWashington, D.C. $cNational Academy Press$d2001 215 $a1 online resource (112 p.) 225 1 $aCompass series 300 $aDescription based upon print version of record. 311 $a0-309-08255-2 320 $aIncludes bibliographical references. 327 $a""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"" 327 $a""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"" 327 $a""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"" 327 $a""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 "" 327 $a""Appendix C Registered Participants "" 410 0$aCompass series (Washington, D.C.) 606 $aMedical instruments and apparatus$vCongresses 606 $aMedical innovations$vCongresses 615 0$aMedical instruments and apparatus 615 0$aMedical innovations 676 $a681 701 $aHanna$b Kathi E$01093170 712 02$aInstitute of Medicine (U.S.).$bRoundtable on Research and Development of Drugs, Biologics, and Medical Devices. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910780145703321 996 $aInnovation and invention in medical devices$93716981 997 $aUNINA