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CambashiIncP.OBox463CummaquidMA02637,USATel:[phone]Fax:[phone]©2012CambashiInc.andUBMCanonCambashiFederalIDNo.26-2432982.Registeredofficeasabove.BeyondTrade-offs:HowMedicalDeviceManufacturerscanBalanceInnovation,QualityandComplianceWhileImprovingProfitComprehensiveFindingsReportPrimaryResearchConductedinConjunctionwithDate:July2012Author:JulieFraserBeyondTrade-offsforMedicalDeviceManufacturers©2012CambashiInc.andUBMCanon2ContentsExecutiveSummary..............................................................................................4IndustryContext&Strategies..............................................................................5Quality&ProfitChallenges..................................................................................7AdvancersShowWhat’sPossible.....................................................................10Advancers:QbDinPractice...............................................................................12MakingInformationFlow....................................................................................14MovingBeyondTrade-offs.................................................................................17MethodologyandResponseDemographics....................................................20AbouttheSponsor..............................................................................................22AboutUBMCanonMedicalDeviceMediaGroupboilerplateandlogo..........23AboutCambashiboilerplateandlogo...............................................................23CambashiReport#J3089BeyondTrade-offsinMedicalDeviceManufacturing:BalancingInnovation,QualityandComplianceWhileImprovingProfit.Copyright©2012Distributionrightslimitedtothesponsorslistedherein:Apriso,DassaultSystèmesandEpicor.TheinformationinthisreportisfromawidevarietyofsourcesthatrepresentthebestinformationavailabletoCambashiInc.Thisreportincludesourinterpretationofinformationinthepublicdomainorreleasedbyresponsibleofficersinrelevantorganizations.Someinformationisfromsourceswecannotverify.Wesurveyjudgmentsamples,andresultsarenotstatisticallysignificantunlesssostated.CambashiInc.cannotguaranteethatthereportisaccurateorcomplete.Informationchangeswithtime.Theanalysis,opinionsandestimatesinthisreportreflectourjudgmentsasofwritingbutaresubjecttochangewithoutnotice.CambashiInc.shallnotbeliableforanylossorinjuryresultingfromuseofthisinformation.Alltrademarksarethepropertyoftheirrespectiveowners.CambashiInc.mayhaveaconsultingrelationshipwithacompanybeingreportedon.Itisnotanoffertosellorasolicitationofanoffertobuyanysecurities.CambashiInc,itsstaff,theirfamiliesandassociatesmayormaynothaveapositioninorwithrespecttoanysecuritiesmentionedherein.BeyondTrade-offsforMedicalDeviceManufacturers©2012CambashiInc.andUBMCanon3PremiumSponsorBeyondTrade-offsforMedicalDeviceManufacturers©2012CambashiInc.andUBMCanon4ExecutiveSummaryThemedicaldeviceindustryhasalwaysbeendependentuponproductinnovationtodrivegrowth.Withtoday’sagingglobalpopulationandexpectationsforlivingtoanolderage,themedicaldeviceindustryispoisedforasustainedperiodofextremegrowthfueledbyalevelofinnovationthatisscheduledtoaccelerate.Mostcompaniesaregrowing.Nearlyallareinnovatingatanincreasingpace.Thecommonchallengeishowmedicaldevicemanufacturersandtheirsupplierscansimultaneouslyimprovetheirfinancialperformance,productinnovationandqualitywhilegrowingatasignificantspeed.Cambashianditspartnersconductedamarketstudytoaddressthischallenge,withanobjectivetoseekoutwhatbestpracticescouldbefollowedtomaximizethechanceforsuccess–improvingprofitabilitywithinanenvironmentofacceleratingnewproductintroductionswhilemaintaininghighqualitystandards.Basedonthesurveyresults,onlyaquarteroftherespondentsareabletoachievethislevelofperformance.Mostcompaniesinsteadmadetrade-offs,focusingonimprovedmarginsorproductinnovation.Thetopfourfactorsthatcompaniesexpectwillimprovetheirsuccessareproductdesign,developmentandintroduction;thenexttwofactorsrelatetoproductquality.Thereisanapparenttrade-offbetweeninnovationandquality:thetopinhibitorstoqualityimprovementareregulatoryandproductchanges.Othertrade-offsabound,suchasthosebetweenqualityandsupplychaincomplexity,andqualityandconcernaboutstaffskills.Thisreportisbasedonprimaryresearchconductedduringthefirsthalfof2012,withresponsesfrommedicaldeviceandlifesciencemanufacturersandtheirsuppliers.Itincludesfreshdatafromarepresentativecross-sectionofthisindustry.Includedareseveralsetsofinformationdesignedtoassisttheindustryincraftingstrategiestonotonlygrow,buttosimultaneouslyincreasebusinessperformanceinareassuchascosts,earnings,netoperatingprofit,andreturnonassets.1.Profileof“Advancers”Thissetofdatahighlightsdifferencesbetweenthequarterofrespondentswhobothgrewandmademajorimprovementsinbusinessperformanceandothers.Theshortanswer:theyfocusonwhatcustomerscareabout,theyinnovateaggressively,andtheyhaveimprovedattheoperationallevelinmanufacturing,planninganddevelopment.Perhapsaboveall,Advancershaveimplementedmeasurement,production,andma