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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
