MedicalDeviceTrialIntegrationExpertisethathelpseliminatedevicestudyriskTableofcontentsGettingyourmedicaldevicetrialrightateverystageiscritical3Insightandinnovationmakethedifference4Specialconsiderationsformedicaldevicestudies41TitleofBrochureUditAliquaePliqueLantGettingyourmedicaldevicetrialrightateverystageiscriticalTheaveragetotalcostforacompanytomovealow-tomoderate-risk510(k)productfromconcepttoclearanceisabout$31million.Forahigher-riskPMAproduct,thatfigureskyrocketsto$94million1Cardiodevices.Spinebreakthroughs.Kneepatientunpredictabilityiscommon.Andmanydeviceadvancements.Eachmedicaldeviceishighlyuniquestudiesarechallengingtoblind,randomize,andcontrol.andthesameistrueofeverydevicetrial.TechnologyConsiderin-trialdevicemodifications,ever-changingadvancementsarenovelandinnovative,andstudyFDAregulations,uniquepatientchallengeslikedeviceparametersvarywidely.What’smore,devicestudysizing,anddiversephysiciantechniques,andyou’vegotgroupstendtobesmallerthandrugtrialgroups,yetachallengingstudyonyourhands.1FDAImpactonUSMedicalTechnologyInnovation;ASurveyofover200MedicalTechnologyCompanies,byTheAdvancedMedicalTechnologyAssociation(“AdvaMed”),preparedbyJoshMakower,M.D.,consultingProfessorofMedicine,StanfordUniversityandFounder,President&ChiefExecutiveOfficerofExploraMedDevelopmentiqvia.com3InsightandinnovationmakeAN...
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