Rimsys+2023年医疗技术监管绩效报告

2023

MedtechRegulatoryPerformanceReport

Imsys

TableofContents

Introduction

•Whyaperformancestudy?

•Whatdidwefind?

SurveyApproachandRespondentDemographics

•Productprofile

RegulatoryTeamSizeandStang

•Fillingthegapwithconsultants

•Futurestaingexpectations

RegulatoryActivitiesandPerformance

•Astrongself-assessment

•Regulatoryworkload

•Processineiciencies

•Non-compliance

TechnologyAdoption

•Unevenproductivitygains

ImplicationsandRecommendations

•Recommendationsandnextsteps

P.3

P.3

P.3

P.4

P.5

P.6

P.7

P.8

P.9

P.9

P.10

P.10

P.12

P.14

P.15

P.16

P.16

Introduction

WelcometotheinauguralMedtechregulatoryperformancereport.Thisebookexploreskeyfindingsfromanewsurveyof200regulatoryprofessionalsacrossthemedicaltechnologyindustryincludingmedicaldevices,invitrodiagnostics,softwareasamedicaldevice,andcombinationproducts.

Whyaperformancestudy?

Thisreportisintendedtobeausablereferenceformedtechregulatory

organizations,meaningthatitshouldprovidetrulyhelpfulinformationthat

organizationscanusetoassesstheefectivenessoftheirteamsandprocesses.

Whilenumerousstudiesexplorethestateoftheregulatoryprofession,orareas

ofspecifictechnologyadoption,fundamentalquestionsremainunanswered.Whatdoesitmeantoworkeiciently?Whatistherightlevelofresourcesforaregulatoryafairsteam?Howlongshouldittaketocompletearegistrationorlicenserenewal?Ismyorganizationaheadorbehind?

Thisstudytriestoaddressthesequestionsbylookingatthespecificperformanceofregulatoryteamsandprocessesinthemedtechindustry.Itcoversteamsetup

andsize,commonregulatoryactivities,issuesandcompliance,and,yes,technology.

Beyondadoption,itlookstotheimpactoftechnologyonproductivityandperformance,helpingteamsseetherealoutcomesassociatedwiththeir

investments.

Whatdidwefind?

•Medtechregulatoryteamsareoftenunderstafedrelativetotheirworkload.

22%ofenterprisecompanies(withrevenuegreaterthan$500million)have

15orfewerregulatoryemployees.38%offrontlineRAemployeesfeel

under-resourced.Resourcingdecisionsandheadcountarerarelyallocated

basedonplannedworkload.Consultantsare(over-)usedtomakeupthegaps.

•Regulatoryteams(especiallyleadership)self-assesstheircapabilitiesand

performancehighly.Amajoritybelievethattheyoutperformtheirpeersin

bothplanningandexecution.Yetover60%reportedamajornon-complianceissue/incidentinthepast2years.There’sclearlyadisconnectbetween

perceivedandactualperformance.

•Technologycanmakeadiference,butnotalltoolsaddvalue.64%of

companiesthatspecificallyinvestinregulatoryinformationmanagement

reportsignificantproductivitygains,andallcompleteprojectsmorequickly.

2023MedtechRegulatoryPerformanceReport

Insightsandprocessbenchmarksfrom200medtechregulatoryprofessionals.

P.3

P.4

EuropeanUnion

Canada

Regulatoryafairs

29.5%

26%

14%12%10.5%

8%

50.5%

38.5%

11%

Qualityassurance

Operations

Informationtechnology

Manufacturing/supplychain

C-Suite/Sr,Leadership

SurveyApproachandRespondentDemographics

Datainthisstudywascollectedthroughphoneinterviewswith200regulatoryprofessionals

atmedicaltechnologycompaniesacrossNorthAmericaandEurope.Respondentsrepresentedcompaniesheadquarteredin14diferentcountries,withannualrevenuerangingfrom$10Milliontomorethan$5Billion.

Headquarterslocation

59.5%

UnitedStates

3%

37.5%

Companysize

4%

Small(<$20M)

37.5%

Medium($20M–$100M)

32.5%

Large($100M–$500M)

30%

Enterprise(>$500M)

RespondentsworkinmultipledepartmentswithintheircompaniesincludingRegulatoryAfairs,

QualityAssurance,InformationTechnology,andOperations.Whynotfocusexclusivelyon

RegulatoryAfairsdepartments?Notallcompanieshavededicatedregulatorydepartments

(thefunctionisoftenbundledwithquality),andmembersofotherteamsoftenspenda

significantamountoftheirtimeonregulatoryactivities.Allsurveyrespondentsincludedin

theresultsreportedspendingmorethan50%oftheirtimeonregulatoryprojectsorprocesses.

Respondentdepartments

Respondentseniority

Manager/Specialist

VP/Director

C-Suite

Respondentsvariedinseniorityfromfront-lineprofessionals(individualcontributorsandmanagers),executives(VPandDirector-level),andC-Suiteleadership.

P.5

81%

48%

34%33%31%

45%

39%

33%

ProductProfile

Allcompaniesrepresentedinthesurveyareprimarilymedicaltechnologycompanies(thosethatproducemedicaldevicesin-vitrodiagnosticsormedicalsoftware).Ofthose,mostweredevice

manufacturers,withaboutathirdproducingdiagnosticandsoftwareproductsrespectively.71%producemediumorhigh-riskproducts,meaningtheyaresubjecttoregulatoryapprovalbeforetheycanbemarketedorsoldinagivenmarket.

Producttypes

Medicaldevices(non-IVD)

Combinationproducts

Invitrodiagnostics

Medicalsoftware(SaMD)

Biologics

Riskclass

LowRisk/ClassI

MediumRisk/ClassII

HighRIsk/ClassIII

Mostcompaniesmanufactureaprettybroadarrayofproducts.Nearlyhalfofrespondentshave

morethan500regulatedproducts,and16%havemorethan2,500.Theseproductsaredistributedbroadly.40%ofrespondents’companiesdistributetheirproductstomorethan50countries.

17.5%

16.5%

13.5%

14%

12%

9.5%

9.5%

3.5%

1.5%

1.5%

0.5%0.5%

than10to49to99to249to499to999to2499to4999to9999to19999to49999

Less1050100250500100025005000100002000050000+

Numberofregulatedproducts

P.6

19.5%

18%

14%14.5%

11.5%

9.5%

8%

3%

2%

1

2to4

5to9

10to19

20to49

50to74

75to99

100to149

150+

Countries

to

distributed

RegulatoryTeamSizeandStang

Thenumberofproductsandbreadthofdistributionthatsurveyrespondentsreportedindicatealotofcomplexity,andasignificantamountofregulatorywork.Andteamsdefinitelyreported

havingahighworkload,whichiscoveredinmoredetailinthenextsection.Yetatthesametime,mostrespondentsreportedthatafairlysmallnumberofemployeeswithintheirorganizations

werededicatedtoregulatoryactivities.

56%ofrespondentsindicatedthattheircompanieshadlessthan10full-timeemployeesfocusedonregulatoryafairs.71%hadlessthan15.

32%

18%

15.5%

7.5%

6%

5.5%

5%

3.5%

2.5%

3%

1.5%

0

5to9

10to14

150+

1to4

15to1920to2425to4950to7475to99100to149

Full-timeregulatoryafairsteammembers

Naturally,thenumberofregulatoryemployeesgrowswithcompanysize,buteventhelargest

companiesreportedarelativelysmallnumberoffull-timeregulatoryemployees.22%ofenterprisecompanies(withmorethan$500millioninrevenue)have15orfewerregulatoryemployees.

Whythediscrepancybetweenstaingandworkload?Partofthereasonseemstobehow

regulatoryheadcountareallocatedwithinorganizations.Headcountplanningandresource

allocationrarelytakeintoaccounttheactualanticipatedworkload.Instead,teamsareassignedprimarilybasedondeviceclassormarketsserved.Thisapproachmaybedueinparttoalackofvisibilityintoupcomingprojectsorneedsonthepartofregulatoryleadership.

P.7

32%

30%

20.5%

13%

4.5%

Howregulatoryafairsstangisallocated

Weallocateheadcountbasedontherisklevelofourregulatedproducts

Weallocateheadcountbasedonthenumberofcountries/regionswehavetosupport

Weallocateheadcountbasedonthenumberofregulatedproducts

Weallocateheadcountbasedonexpectednumberofnewmarket/productsubmissionsandregulatorylicenseupdates/renewals

Weallocateheadcountarbitrarilybasedonavailablebudget

FillingtheGapwithConsultants

Consultantsplayanoutsizedroleacrossthelife-sciencesindustry,andthey’reespeciallyprevalentinmedtechregulatoryafairs.90%ofrespondentsindicatedthattheircompanyreliesonexternalconsultantstocompleteregulatorywork,andthosethatdidn’twereoverwhelminglysmall

companies.Naturally,thenumberofconsultantsusedgrowswithcompanysize,butthey’renotonlyheavilyusedbylargeorganizations.40%ofsmallandmediummedtechcompaniesemploy5ormorefull-timeconsultantstosupportregulatoryafairs.

30%

20%

10%

45910141519202425495099100149150+

01tototototototo7475toto

Consultantsused

SMB(<$100M)

Large($100M–$500M)

Enterprise(>$500M)

Consultantsareafairlyexpensivewaytogetregulatorytaskscompleted.Withhourlyrates

runningfrom$150to$300,thecostofusingconsultantscanpileupquickly.Surveyrespondentsreportedprettysignificantannualexpendituresonconsultants—especiallyinlargeandenterprisecompanies.45%ofenterprisecompaniesspendmorethan$1millionperyearonconsulting,and37%spendmorethan$2million.

P.8

30%

20%

10%

30%

58%

12%

22.2%

37.6%

63.6%52.5%

14.1%

9.9%

$10K

$25K

$50K

$100K

$200K

$1M

$2M+

Less

$500K

than10Kto$24Kto$49Kto$99Kto$199Kto$499Kto$999Kto$1.9M

Annualcontractorbudget

SMB(<$100M)

Enterprise(>$500M)

Large($100M–$500M)

FutureStangExpectations

Despitewhatseemstobeunderstafedregulatoryteams,respondentsweregenerallysatisfiedwithresourcingwithintheirregulatorydepartments.58%ofrespondentsfeltthattheircompanieswereinvestingtherightlevelofresources(includingbudget,staing,andtools)inregulatoryafairs.

However,thereisasatisfactiongapbetweenregulatoryleadersandfront-lineemployees.Front-lineemployeesweremuchmorelikelytoreportfeelingunder-resourcedthanthoseinleadershiproles.

Currentregulatoryresources–allrespondents

Under-resourced

Devotingtheright

amountofresources

Over-resourced/over-spending

Currentregulatoryresources–leadersvsfront-lineemployees

Under-resourced

Devotingtheright

amountofresources

Over-resourced/over-spending

Front-lineEmployees

Leadership(C-suite/VP/Director)

P.9

50.5%

40%

9.5%

Itmaybethatleadersareseeingtheresultsthatcomewithextensivespendingonconsultants,

whilefront-lineemployeesaremanagingtheaddedcomplexityoftryingtostafprojects,and

managinginformationhand-ofswithconsultingteams.Andperhapsthereissomeunderstandingthatcurrentfull-timestainglevelsmaynotbesustainable.Themajority(50.5%)ofrespondentsexpectthattheirregulatoryteamswillgrowinthecomingyear.

Regulatoryteamgrowthin2023

Iexpectourregulatory

afairsteamtogrow

Iexpectourregulatoryafairs

teamtostaythesame

Iexpectourregulatory

afairsteamtoshrink

RegulatoryActivitiesandPerformance

Thestudylooksatregulatoryperformancefrom2dimensions.Respondentswereaskedto

self-assesstheperformanceoftheirregulatoryteamscomparedtotheirpeers.Theywerealso

askedtodetailtheirregulatoryactivities,howtheycompletetheirjobs,andissuesfaced.The

resultsshowedasignificantdiscrepancybetweenhowteamsperceivedthemselvesandhowtheyactuallyperform.

Astrongself-assessment

Respondentsweregenerallyconfidentinallaspectsofregulatoryperformance,believingthat

theyhavethecapabilitiesandprocessesinplacetoexecuteefectively.Over50%ofrespondentsfeltthattheywereeasilyabletoaccesstheinformationtheyneed,hadadequateviabilityinto

upcomingexpirations,anddidagoodjobofmeasuringandassessingtheefectivenessoftheirregulatoryprocesses.

P.10

40.5%

28%9%

22.5%

34%

34.5%

23%

8.5%

20.5%

10.5%

44.5%

24.5%

17.5%39%29.5%14%

13.5%43%30.5%11%2%

Regulatoryself-assessment

Myregulatoryafairsteamiseasilyabletoaccesstheinformationtheyneedtodotheirjobs

Myregulatoryafairsteamhasclearvisibilityintoupcomingregulatoryprojects

Myregulatoryafairsteamregularlymeasuresandassessestheefectivenessofregulatoryactivities

Agree

Neitheragreeordisagree

Disagree

Stronglyagree

Whenaskedtocomparetheirregulatoryperformancetopeerorganizations,respondentsweresimilarlyconfident.Over50%ofrespondentsbelievedthattheirregulatoryafairsteamwasabletoplanmore

efectivelyandexecutemorequicklythanteamsatsimilarorganizations.Apparentlyeverybodyinregulatoryafairsisaboveaverage.

Performancecomparedtopeerorganizations

Rateyourregulatoryafairsteam’sabilitytoplanefectivelycomparedtoteamsatotherorganizations

Rateyourregulatoryafairsteam’sabilitytoexecutequicklycomparedtoteamsatotherorganizations

Muchbetter

Better

Neitherbetterorworse

Worse

Muchworse

P.11

27.5%23.5%33.5%8%4%

3.5%

31%23.5%3%0.5%

6%36%

23.5%7.5%1.5%

35.5%

35%

11%38%30.5%18.5%2%

38%

41.5%

20.5%

5%30%29.5%22.5%13%

RegulatoryWorkload

Despitetherelativelysmallteamsize,respondentsreportedcompletingalargeamountofregulatoryworkinthepastyear.Onaveragecompaniescompleted50licenserenewals,50licenseupdates(notifications

andamendmentsduetodesign,software,legalentity,ormanufacturingupdates),and10newmarketsubmissions(marketclearanceorapprovalapplications).

Activitiescompletedinthepastyear

Numberoflicenserenewals

Numberof

Numberofnewmarketsubmissions

updates

license

0-9

10-49

50-99

100-199

300+

200-299

Thevolumeofworkloadrelativetoteamsizewouldseemtovalidatethestrongself-assessment,butdidtheirprocessesallowthemtocompletetheseactivitieseicientlyandwithouterrors?Onaveragenewsubmissionstookthemosttime,with65%ofrespondentssayingittakestheirorganizationsmore

than4monthstocompleteasubmission,and36%reportingmorethan6monthspersubmission.Howevermorethanhalfindicatedthatitalsotakestheirregulatoryteamsmorethan4monthstocompletealicenserenewalorupdate.

Timetocompleteregulatoryactivities

Averagetimetocompletealicenserenewal

Averagetimetocompletealicenseupdate

Averagetimetocompleteanewmarketsubmission

1-3weeks

1-3months

4-6months

6-12months

Morethan12months

P.12

31%

23.5%

18.5%

ProcessIneciencies

Whatdrivesthelongcompletiontimesforregulatoryactivities?Naturallythesearecomplicatedprocesses,soit’snotsurprisingthatthere’sasignificantamountofworkinvolved.However,thereweresomeclearprocessineicienciesthatsurfacedinthesurveyresults.First,muchoftheworkismanual.70%ofrespondentssaidthattheirregulatoryafairsteamspendsnearlyhalftheirtimeonrepetitive,administrativetasks.

Secondly,poorlymanagedorincompleteinformationrequiresalotofbackandforthwithhealthauthorities.Halfofallnewmarketsubmissionsrequiremorethan7turn-arounds

(correspondence,requestsforadditionalinformation,etc.)withregulatoryauthorities.

36.5%

34.5%

16.5%

8%

4.5%

0%

0to12to45to67to89to10Morethan10

Regulatoryturn-aroundspermarketsubmission

Non-Compliance

Surveyrespondentsalsoreportedasurprisingnumberofnon-complianceissues.61%reportedthattheircompanieshadreceivedaCAPAorauditresultshowingsignificantprocessissuesfromhealthauthorities,hadwithdrawnproductsfromaspecificmarketduetoanexpiredregistration,or

accidentlymarketedproductsintoaregionwheretheydidnothaveclearanceinthepast2years.

Non-complianceissuesinthepast2years

ReceivedaCAPAorauditfindingwithseriousprocessissues

Hadtowithdrawproductsfromaspecificcountry/regionduetoanexpiredregistration

Accidentallysold/marketedproductsintocountriesorregionswithoutproperregulatoryclearance

P.13

28.4%

26.9%

29.9%

13.4%

0.8%

0.8%

While30%ofthosethatreportednon-complianceissuesindicatedthattheycouldn’testimatetheassociatedcosts,75%indicatedthatthecostwasgreaterthan$100,000and15%saidthatthecoststheirorganizationincurredweregreaterthan$1,000,000.Theseestimateslikelydon’ttakeintoaccountthefullimpactofnon-complianceissues.Inadditiontofinesandpenalties

imposedbyhealthauthorities,companiesalsolosesignificantrevenueifproductshavetobepulledfromamarket.Plus,therearegeneralcostsassociatedwithbusinessdisruption,or

additionalworkrequiredfromtheregulatoryteamtore-establishcompliance.

Costsassociatedwithnon-complianceissues

Notsure/can’testimatetheamountincurred

Lessthan$100,000

$100,000to$999,999

$1,000,000to$4,999,999

$5,000,000to$19,999,999

$20,000,000+

Sowhileregulatoryteamsaregenerallysatisfiedwiththeirprocessesandperformance,thereareclearlyopportunitiesforimprovement.Highlymanualprocessesandinformationgapsaredrivinglongexecutiontimes,repetitivework,andleavingregulatoryteamsandtheirbusinessesatriskofnon-compliance.

P.14

40%

48%

7%

5%

36%

35%

34%

30%

TechnologyAdoption

Itseemslikelythatmedtechregulatoryafairsteamsdohaveanawarenessoftheirprocessshortcomings,andareincreasinglyinvestingintechnologyasaresult.40%ofrespondents

expecttheirbudgetforregulatorysoftwaretoincreaseinthecomingyear,withanother48%expectingittostaythesame.

for2023

Softwarebudget

Iexpectthebudgetforsoftwaretoincrease

Iexpectthebudgetforsoftwaretostaythesame

Iexpectthebudgetforsoftwaretodecrease

Ourorganizationdoesnothaveabudgetforregulatorysoftware

Regulatoryafairsteamsareincreasinglymovingawayfromtraditionalproductivitytools

(documents,spreadsheets,email,file-sharingsystems,etc.)andadoptingtoolsthataredesignedtosupportregulatoryandregulatory-adjacentprocessessuchasregulatoryinformation(RIM),

quality(eQMS),andproductlifecycle(PLM)managementsystems.88%ofrespondentsindicatedthattheirregulatoryteamsuseoneormoreofthesespecializedsoftwaretools.

used

Softwaretools

Regulatoryinformationmanagement

Qualitymanagementsystems(eQMS)

Regulatoryintelligenceservices/database

Productlifecyclemanagement(PLM)

P.15

Veryhigh

Verylow

High

Medium

Low

UnevenProductivityGains

Whileadoptionacrossdiferenttoolsisfairlyeven,theproductivitygainsfromthosetoolsare

not.Respondentswereaskedtoratetheimprovementstheysawfromveryhightoverylow.

Whilealltoolsprovidedbenefits,thosethatarespecificallydesignedforregulatoryafairs(RIM,

andregulatoryintelligence)providedthegreatestresults.RIMsystemsdeliveredthehighest

productivitygains,with64%ofrespondentsreportingveryhighgains,andanother20%reportinghighgains.

60%

40%

20%

Softwareproductivitygains

Regulatoryinformationmanagement

Regulatoryintelligenceservices/databases

Qualitymanagementsystems(eQMS)Productlifecyclemanagement(PLM)

Theseresultsmakesense.RIMsystemshelptocentralizeandorganizeregulatoryinformation,makingiteasiertoassemblecompletesubmissionsandotherregulatoryapplicationsthatdon’t

requireasmanyturn-aroundswithhealthauthorities.Andtheycanautomateanumberofwhatwouldotherwiseberepetitive,manualtasks,improvingtheeiciencyofregulatoryteams.

Theimpactofregulatoryinformationmanagementproductivitygainswasclearlyvisiblein

theperformanceofregulatoryactivities.CompaniesthatuseRIMsystemsreportedcompletinglicenserenewals,licenseupdates,andnewmarketsubmissionsmorequicklythanthosethatdonot.RIMusersweremuchmorelikelytoreportanaveragecompletiontimeof3monthsorlessforallprojects.

P.16

56.9%

44.5%

39.6%

37.5%

33.6%34.4%

renewals

product

/market

updates

Registration

License

New

submissions

Averageprojectcompletioninlessthan3months

NoRIM

RIMUsers

ImplicationsandRecommendations

Theregulatoryperformancestudyultimatelyshowsmixedresults.Medtechregulatoryafairs

teamsclearlypunchabovetheirweight,withrelativelysmallteamscompletingaverylargebodyofworkeachyear.Thisperformancevolumeleadsteamstogenerallybelievethattheirprocessesarehighlyefective.Atthesametime,companiesreportedasignificantamountofmanualwork,andinformationmanagementissuesthatrequirealotofturn-aroundswithregulatoryauthorities.

Evenmoreconcerningwastherateofreportednon-complianceissues.Over60%ofcompanies

hadaseriousissueinthepast2years.It’shardtobelievethattheseresultsarecongruentwith

highlyfunctioningregulatoryprocesses.Ultimatelyitdoesseemthatcompaniesareawareof,andattemptingtoaddresssomeoftheseissues.Thegrowingadoptionofregulatory-specificsoftwareshowsthatcompaniesarelookingtotechnologysolutionstoimproveexecution.

Recommendationsandnextsteps

•There’snoreasontounderstafregulatoryteams.Yes,respondentsindicatedthattheir

organizationscanaccomplishalotwithsmallteams,butmuchofthatworkreliesonexpensiveexternalcon