【市场报告】Rimsys+2023年医疗技术监管绩效报告_市场营销策划_重点报告20230901_d.docx

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1、MedtechRegu1atoryPerformanceReportRmSyS丑imsysTab1eofContentsIntroductionP.3 Whyaperformancestudy?P.3 Whatdidwefind?P.3SurveyApproachandRespondentDemographicsP.4 Productprofi1eP.5Regu1atoryTeamSizeandStangP.6 Fi11ingthegapwithconsu1tantsP.7 FuturestangexpectationsP.8Regu1atoryActivitiesandPerformance

2、P.9 Astrongse1f-assessmentP.9 Regu1atorywork1oadP.10 ProcessineCienciesP.10 Non-comp1ianceP.12Techno1ogyAdoptionP.14 UnevenproductivitygainsP.15Imp1icationsandRecommendationsP.16P.16 RecommendationsandnextstepsCimSyS2023MedtechRegu1atoryPerformanceReportInsightsandprocessbenchmarksfrom200medtechregu

3、1atoryprofessiona1s.IntroductionWe1cometotheinaugura1Medtechregu1atoryperformancereport.Thisebookexp1oreskeyfindingsfromanewsurveyof200regu1atoryprofessiona1sacrossthemedica1techno1ogyindustryinc1udingmedica1devices,invitrodiagnostics,softwareasamedica1device,andcombinationproducts.Whyaperformancest

4、udy?Thisreportisintendedtobeausab1ereferenceformedtechregu1atoryorganizations,meaningthatitshou1dprovidetru1yhe1pfu1informationthatorganizationscanusetoassesstheeffectivenessoftheirteamsandprocesses.Whi1enumerousstudiesexp1orethestateoftheregu1atoryprofession,orareasofspecifictechno1ogyadoption,fund

5、amenta1questionsremainunanswered.Whatdoesitmeantoworkecient1y?Whatistheright1eve1ofresourcesforaregu1atoryaffairsteam?How1ongshou1dittaketocomp1etearegistrationor1icenserenewa1?Ismyorganizationaheadorbehind?Thisstudytriestoaddressthesequestionsby1ookingatthespecificperformanceofregu1atoryteamsandpro

6、cessesinthemedtechindustry.Itcoversteamsetupandsize,commonregu1atoryactivities,issuesandcomp1iance,and,yes,techno1ogy.Beyondadoption,it1ookstotheimpactoftechno1ogyonproductivityandperformance,he1pingteamsseetherea1outcomesassociatedwiththeirinvestments.Whatdidwefind? Medtechregu1atoryteamsareoftenun

7、derstaffedre1ativetotheirwork1oad.22%ofenterprisecompanies(withrevenuegreaterthan$500mi11ion)have15orfewerregu1atoryemp1oyees.38%offront1ineRAemp1oyeesfee1under-resourced.Resourcingdecisionsandheadcountarerare1ya11ocatedbasedonp1annedwork1oad.Consu1tantsare(over-)usedtomakeupthegaps. Regu1atoryteams

8、(especia11y1eadership)se1f-assesstheircapabi1itiesandperformancehigh1y.Amajoritybe1ievethattheyoutperformtheirpeersinbothp1anningandexecution.Yetover60%reportedamajornon-comp1ianceissue/incidentinthepast2years.Therezsc1ear1yadisconnectbetweenperceivedandactua1performance. Techno1ogycanmakeadifferenc

9、e,butnota11too1saddva1ue.64%ofcompaniesthatspecifica11yinvestinregu1atoryinformationmanagementreportsignificantproductivitygains,anda11comp1eteprojectsmorequick1y.SurveyApproachandRespondentDemographicsDatainthisstudywasco11ectedthroughphoneinterviewswith200regu1atoryprofessiona1satmedica1techno1ogy

10、companiesacrossNorthAmericaandEurope.Respondentsrepresentedcompaniesheadquarteredin14differentcountries,withannua1revenuerangingfrom$10Mi11iontomorethan$5Bi11ion.Headquarters1ocationCompanysize4%Respondentsworkinmu1tip1edepartmentswithintheircompaniesinc1udingRegu1atoryAffairs,Qua1ityAssurance,Infor

11、mationTechno1ogy,andOperations.Whynotfocusexc1usive1yonRegu1atoryAffairsdepartments?Nota11companieshavededicatedregu1atorydepartments(thefunctionisoftenbund1edwithqua1ity),andmembersofotherteamsoftenspendasignificantamountoftheirtimeonregu1atoryactivities.A11surveyrespondentsinc1udedintheresu1tsrepo

12、rtedspendingmorethan50%oftheirtimeonregu1atoryprojectsorprocesses.RespondentseniorityRespondentsvariedinseniorityfromfront-1ineprofessiona1s(individua1contributorsandmanagers),executives(VPandDirector-1eve1),andC-Suite1eadership.Medica1devices(non-IVD)CombinationproductsInvitrodiagnosticsMedica1soft

13、ware(SaMD)Bio1ogies1owRisk/C1assIMediumRisk/C1assIIHighRisk/C1assIII13.5%14%16.5%9.5%3.5%1.5%0.5%0.5%ProductProfi1eA11companiesrepresentedinthesurveyareprimari1ymedica1techno1ogycompanies(thosethatproducemedica1devicesin-vitrodiagnosticsormedica1software).Ofthose,mostweredevicemanufacturers,withabou

14、tathirdproducingdiagnosticandsoftwareproductsrespective1y.71%producemediumorhigh-riskproducts,meaningtheyaresubjecttoregu1atoryapprova1beforetheycanbemarketedorso1dinagivenmarket.Producttypes81%48%34%33%31%33%Mostcompaniesmanufactureaprettybroadarrayofproducts.Near1yha1fofrespondentshavemorethan500r

15、egu1atedproducts,and16%havemorethan2z500.Theseproductsaredistributedbroad1y.40%ofrespondentscompaniesdistributetheirproductstomorethan50countries.17.5%1essI10I50100250500100025005000100002000050000+than10to49to99to249to499to999to2499to4999to9999to19999to49999Numberofregu1atedproductsII2toI5to910to1920to49I50to74I75to99I100to149150+CountriesdistributedtoRegu1atoryTeamSizeandStaffingThenumberofproductsandbreadthofdistributionthatsurveyrespondentsreportedindicatea1otofcomp1exity,andasignificantamountofregu1atorywork.Andteamsdefinite1yreportedhavinga