Mapping the Medical Device Development Process

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1、Runninghead:MAPPINGMEDICALDEVICEDEVELOPMENTMappingtheMedicalDeviceDevelopmentProcessScottT.HamIndustrialTechnologyCaliforniaPolytechnicStateUniversityJune4,2010MAPPINGMEDICALDEVICEDEVELOPMENTiiABSTRACTThisprojectexaminedtheuseofprocessmappingasatooltoshowtheprocessofdevelopingmedical

2、devicesfromabroadperspectivethatincludesresearch,innovation,development,regulation,andmarketing.Themedicaldevicedevelopmentcycle,onabroadscope,isnotwelldefined.Thelackofauniversallanguagewithwhichtodescribethisprocesshasmadeitdifficulttounderstandandcommunicate.Inthisproject,datawasc

3、ollectedfrompeer-reviewedsources,summarizedinaliteraturereview,drawnoutbyhandintoaseriesoflower-levelprocessmapsandfinallyassembledintoasingleprocessmap.Thisprojectisanattempttoworktowardsestablishingageneralframeworkthatcanbeusedtobetterunderstandhowmedicaldevicesaredevelopedandmark

4、eted.Itsupportsthatprocessmappingmayhavepotentialforbeingusedonahigherlevelthanitistraditionallyused.Thefinalprocessmapproducedinthisprojecthaslimitations.Themapgivesabasicunderstandingofthebroaderdevelopmentprocess.Thelevelofdetailandaccuracyoftheprocessmapislimitedbythetimeandcosto

5、fprocessmapping.MAPPINGMEDICALDEVICEDEVELOPMENTiiiACKNOWLEDGEMENTSIwouldliketothankDr.LouTornatzkyforassistingmebymakingrecommendationsforthedirectionoftheproject.Dr.Tornatzkyprovidedseveralsourcesofliterature,aswellashisownknowledgebaseontheinnovationprocessthathelpedmebetterunderst

6、andthetopicofmedicaldevicedevelopmentasawhole.MAPPINGMEDICALDEVICEDEVELOPMENTivTABLEOFCONTENTSPAGEABSTRACT………………………………………………………………………………………iiACKNOWLEDGEMENTS………………………………………………………………………iiiLISTOFFIGURES……………………………………………………………………………....ivSECTIONI.INTRODUCTION………………………………………………………………………1

7、II.LITERATUREREVIEW………………………………………………………………6III.PROCEDURE………………………………………………………………………..14IV.RESULTS………………………………………………………………………..…..15V.CONCLUSIONS………………………………………………………………..……16VI.REFERENCES………………………………………………………………...…….17APPENDIXA.FINALPROCESSMAP……………………………………………………………..20B.HAND-DRAWN

8、PROCESSMAPEX