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8/13/2019 Design Verification White Paper
1/12
DesignVerificationTheCaseforVerification,NotValidation
Page1of12
MEDIcept,Inc. 200HomerAvenue Ashland,MA01721
MaynotbereprintedorcopiedwithoutexpressedpermissionfromMEDIcept 11/2010
Overview:The
FDA
requires
medical
device
companies
to
verify
that
all
the
design
outputs
meet
the
design
inputs.
TheFDAalsorequiresthatthefinalmedicaldevicemustbevalidatedtotheuserneeds.Whenthereare
somanymoredesigninputsandoutputsthanspecificuserneeds,whydocompaniesspendsolittle
timeverifyingthedeviceandsomuchtimeandmoneyonvalidation?Andwhatistheroleofrisk
managementindeterminingtheamountoftestingrequired?Thispresentationwilldemonstratethatif
developersconductmorecompleteverificationsofdesignoutputsandriskmitigations,validationscan
becompletedinashortertime,morereliably,andmoresuccessfully.
Introduction:InourexperienceworkingwithmedicaldevicemanufacturerstoimprovetheirQualityManagement
Systemsandtogainregulatoryclearanceofnewdevices,wehavefoundthatDesignVerificationisan
oftenunderutilizedtoolforensuringsuccessduringthelatterstagesofdevicedevelopmentefforts.In
manycases,limitedverificationeffortsrepresentalostopportunitytosignificantlyreducethescopeof
validationeffortsandtherebyreducetimetomarketanddevelopmentcosts.
ThispaperexplorestheuseandmisuseofDesignVerificationandhowdevicemanufacturescangetthe
mostoutoftheirverificationefforts. Butfirst,somebackground...
Background:Medicaldevicemanufacturershavebeenworkingtoaligntheirdesignanddevelopmentsystemswith
theFDAsdesigncontrolregulations(21CFR820.30)sincetheirreleasein1996.Theregulationsare
structuredtoensurethatdevicemanufacturersmaintaincontrolovertheirdesignsthroughoutthe
developmentprocessandthatthemarketeddeviceissafeandeffectiveforitsintendeduse. Attheir
mostbasiclevel,theregulationsrequirethatmanufacturers:
Clearlystatewhattheyintendtoproduce(PlanningandDesignInputs);
Developa
design
that
meets
those
needs
(Design
Outputs
and
Design
Review);
Confirmthatthedesignmeetstheoriginalintent(Verification);
Confirmthatmanufacturedproductcanbeproducedreliablyandachievethedesiredresult
(TransferandValidation);and
8/13/2019 Design Verification White Paper
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DesignVerificationTheCaseforVerification,NotValidation
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Maintainrecordsofkeydevelopmentactivitiesanddecisions(DesignChangesandDesign
HistoryFile)
Itwouldbehardtoarguethatanyofthesestepsshouldbeexcludedfromanydevelopmenteffort.
Whetheryouarebuildingabridge,acellphone,orasurgicaltool,thiscombinationofstepshasalogical
flowthatmostengineerswouldsimplyconsidertobegoodpractice.
Thechallengeariseswhenyoumovefromtheconceptualworld,whereproductdevelopmentcanbe
seenassinglestreamofwaterflowingdownahill:steadilymovingfromonepointtothenextwithout
interuption;totherealworld,fullofrapids,eddies,branchingstreams,and (occasionally)deeppoolsof
waterthatdontseemtobemovingatall.Inthisturbulentenvironment,itscanbedifficulttomaintain
adisciplineddesignapproachparticularlywhenbusinessschedulesdemandrapidprogressandany
delaysinmovingontothenextdevelopmentphaseriskaffectingprojectmilestonesanddevelopment
staffdeploymentplans.Thesechallengesaremultipliedwhenthedevicehasmultiplecomponentsand
integrationpointsthatmustbemanagedthroughoutthedevelopmentprocess.
Muchhasbeenwrittenabouttheimportanceofearlystageplanningandproblemsolvingtospeed
timetomarketandreducedevelopmentcostsandthevalueofclearDesignandDevelopmentPlans
andwelldefinedDesignInputscannotbeoverstated.Anequalamountofattentionhasbeenfocused
onDesignTransferandValidationactivities.Atthislatestageofadevelopmenteffort,theprojectscope
willhaveexpandedtoincludemoreactiveinvolvementofClinical,OperationsandMarketingstaff.In
addition,thecostofvalidationstudiesandthemakeorbreakaspectofthesestudiesrequireagreat
dealofattentionandcompanyresources.Problemsatthevalidationstagewillhaveseriousimplications
forthe
success
of
the
project
and
especially
for
small
companies
could
determine
the
fate
of
the
wholecompany.
Comparedtotheseearly andlatestageactivities,theimportanceofDesignVerificationtendstobe
overlooked.Thereareseveralreasonswhy:
Definitions:Manypractitioners(andestablishedQualitySystems)continuetohavetroubledefiningexactlywhatverificationis,andhowitfitsintothedesigncontrolprocess.Thetermis
oftenconsideredtobesynonymouswithvalidation andthedevelopmentofcombined
V&Vplansthatdonotestablishacleardistinctionbetweentheobjectivesofthetwoefforts
dont
help.
[Note:
when
discussing
verification
with
the
FDA,
its
best
not
to
talk
about
your
V&Vplanincreasingly,inspectorspreferencesaretoaddressthetwoactivitiesseparately.]
Timeframe:Verificationisoftenanongoingeffortconductedthroughoutthedevelopmentofoutputs.So,agreatdealoftimemaypassbetweenwhenthefirstandlastoutputisverified.
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DesignVerificationTheCaseforVerification,NotValidation
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Withthisextendedtimeframe,verificationactivitiescangetlostwithinallofthechurning
associatedwithdevelopingfinaloutputs.
Approaches:Thereareavarietyofwaystocompletetheverificationforanoutput,soitcanbe
difficulttocommunicatethatalloftheseactivities,asagroup,representthedesignverification.
Theproblemwiththislackofattentionisthatitweakensacriticallinkinthedesigncontrolchain,
affectingthestrengthoftheoveralldesigncontroleffort.Poordesignverificationcanleadtoproblems
duringdesigntransferandvalidation,andcanreduceyourabilitytotrackdownandcorrectproblemsif
(andwhen)theyoccur.Justasimportantly,itmayrepresentalostopportunitytooptimizevalidation
activities,reducetimetomarket,andincreaseyouroverallconfidenceinthesafetyandefficacyofyour
products.
KeyConcepts:Tomakesurethatwerealignedontheproperuseofthetermverification,hereareafewkeypoints
fromtheFDAsDesignControlGuidanceForMedicalDeviceManufacturers: Definition:Verificationmeansconfirmationbyexaminationandprovisionofobjectiveevidencethatspecifiedrequirementshavebeenfulfilled[820.3(aa)].
TypesofVerificationActivities: Verificationactivitiesareconductedatallstagesandlevelsofdevicedesign.Thebasisofverificationisathreeprongedapproachinvolving: tests,inspections,
andanalyses.
Anyapproachwhichestablishesconformancewithadesigninputrequirementisanacceptable
meansofverifyingthedesignwithrespecttothatrequirement.Inmanycases,avarietyof
approachesarepossible...themanufacturershouldselectandapplyappropriateverification
techniquesbasedonthegenerallyacceptedpracticesforthetechnologiesemployedintheir
products.Table
1
provides
some
examples
of
the
types
of
verification
activities
that
device
manufacturers
often
employ.
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Table 1: Types of Verification Activities
Tests Inspections Analyses
o Material performance /fatigue tests
o Package integrity tests*o Biocompatibility testing of
materials*o Bioburden testing of products
to be sterilized*
o First article inspectiono Comparison of a design to a
previous product having anestablished history ofsuccessful use*
o Worst case analysis of anassembly to verify thatcomponents are deratedproperly and not subject tooverstress during handlingand use*
o Thermal analysis of anassembly to assure thatinternal or surfacetemperatures do not exceed
specified limits*o Fault tree analysis of a
process or design*o Failure modes and effects
analysis*o Engineering analyses:
o Finite Element Analysis(FEA)
o Computational FluidDynamics (CFD)
o Tolerance stack-up
*Source:DesignControlGuidanceForMedicalDeviceManufacturers(1997)
Akeydistinctionbetweendesignverificationanddesignvalidationactivitiesisthatverificationonly
requiresthatasingleunitbeassessed.Whatconstitutesthatsingleunitwillvarydependingonthe
intentoftheverification.Itmightbeonebatchofrawmaterial(formaterialperformancetests),one
machinedpart(forfirstarticleinspection),ononepackagesample(forintegritytests).Theintentof
verificationistoconfirmthatthedesignoutputs(i.e.,thematerialsorcomponentsspecifiedindesign
documents)meetthedesigninputrequirements.
Validations,on
the
other
hand,
require
that
studies
be
conducted
to
ensure
that
the
device
can
be
manufacturedtomeetdesignspecificationsonaconsistentbasis(i.e.,processvalidation),andtoensure
thatthefinisheddeviceissafeandeffectiveforitsintendedpurpose(i.e.,designvalidation).Forthe
processvalidation,multipledevicesmustbemanufacturedandevaluatedtoconfirmthatthe
productionprocessiscapableofproducingdeviceswithinspecificationsonaconsistentbasis.Forthe
designvalidation,multipledevicesmustbeusedtotreatmultiplepatientstoconfirmthatthetreatment
issafeandeffective.
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DesignVerificationTheCaseforVerification,NotValidation
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Thenumberofdevicesthatneedtobeproducedandthenumberofpatientsthatneedtobetreatedis
afunctionoftheriskassociatedwiththeparticularaspectofthedeviceandtheneedtoestablish
confidencein
the
study
results.
As
we
will
see,
the
effective
use
of
risk
analysis
tools
and
solid
verificationresultscanhelptoreducethesizeofthevalidationstudieswithoutnegativelyaffectingthe
confidenceinthestudyresults.
WhatGoesWrong?Asdescribedabove,toooftendesignverificationdoesnotreceivetheamountofattentionneededto
ensuresuccessinthelatterstagesofadevicedevelopmentprogram.Whilenotaperfectrepresentation
ofwhatgoesoninalldevicecompanies,itisinterestingtolookattheFDAsdesigncontrolaudit
findingstoseewhatproblemstheyhavefoundwithcompaniesdesignverificationprograms.Figure1,
showsthenumberofwarninglettersintheFDAsdatabasethatincludefindingsrelatedtospecific
sectionsoftheDesignControlregulation(21CFR820.30).
Figure1:DesignControlWarningLetters
8/13/2019 Design Verification White Paper
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DesignVerificationTheCaseforVerification,NotValidation
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Interestingly,themostobservationswerefoundwithregardtotheDesignChange,DesignValidation,
andtheGeneraldesigncontrolsubheadings(theGeneralfindingssuggestanoverallfailureofthe
companysdesign
control
process).
We
argue
that
failures
in
these
three
areas
are
largely
the
result
of
poorperformanceintheearlierstagesoftheprogram(e.g.,validationfailuresduetopoorlystructured
inputrequirements,outputsandincompleteverification;anddesignchangefailuresduetoan
ineffectivesystemtoupdateverificationsandvalidationswhenchangesaremade).
Oftheremainingcategories,mostwarningletterscite21CFR820.30(f)DesignVerification.Inthese64warningletters,theFDAidentifiedthatthemanufacturerdidnotcompleteallrequiredverificationsin
nearly45%ofthecases.Alackof(orsignificantgapsin)verificationprocedureswereidentifiedinabout
25%ofthewarningletters.Inaddition,outofspecificationresults,alackofrecordsintheDHF,anda
lackofacceptancecriteriawerefoundin16%,14%,and14%ofthesecompanies,respectively.Figure2
providesa
breakdown
of
all
of
the
types
of
violations
identified
in
these
warning
letters.
Figure2:TypesofDesignVerificationViolations
8/13/2019 Design Verification White Paper
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DesignVerificationTheCaseforVerification,NotValidation
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Note:92separateviolationswereidentifiedinthe64warningletters.
Why
are
these
failures
occurring?
One
possibility
is
that
by
viewing
verification
as
a
regulation,
device
developersarelosingsightofthefactthatconductingverificationsissimplygoodengineering.For
example,itmakesnosensetomoveforwardwiththedevelopmentofacomponentbeforeyouaresure
thatthematerialpropertiesmeettheperformanceandsafetyrequirementsestablishedinthedesign
inputs.
Thismeetingtheregulationsmindsetcanleadengineerstoviewdesignverificationsimplyasatask
thatmustbecheckedoffbyQAinsteadofvaluabletoolforbuildingknowledgeabouttheirdevice.
Failuresoccurbecausesometimesthecheckoffsgetmissed.
Evenwhenalltheboxesarechecked,theregulationmindsetcandriveengineerstofocusonlythe
minimumnumber
of
verification
activities
needed
to
satisfy
the
design
control
requirements.
While
this
approachmayhelpsatisfyshorttermbudgetorscheduleconstraints,thedevelopmentteamwilllose
theopportunitytolearnpotentiallyimportantinformationabouttheperformanceandbehaviorofits
deviceanditscomponents.Ifthatlearningisputofftothevalidationstage,thecostoffailurecangrow
dramatically.
WhatToDo?Thereareavarietyoftoolsthatdeveloperscanusetoimprovetheeffectivenessoftheirdesign
verificationprocess.Inthispaperwediscussthreetoolsthatcanhelpensurethatverificationactivities
areappropriateandcompleteand,ifwelldocumented,canprovideregulatorswithsufficient
confidenceinthedesignthatexcessivevalidationcanbeavoided.Thethreetoolsare
TraceabiltyMatrix
FailureModesandEffectsAnalysis(FMEA)
FaultTreeofDesignInputs
TraceabilityMatrix:Thetraceability(trace)matrixisabasicdesigncontroltoolthatalldevicedevelopers
should
use
throughout
the
design
control
process
to
establish
clear
linkages
between
Design
Inputs,Outputs,Verifications,ValidationsandRiskAnalyses.ToooftenthetracematrixisleftforQAto
completejustintimeforthefinaldesignreview.However,ifitisbegunassoonasDesignInputsare
approvedandmanagedthroughoutthedevelopmenteffort,thetracematrixprovidedanexcellent
roadmapguidingdevelopersthroughkeystepsofthedesigncontrolprocessandensuringthat
requireddocumentationiscreatedandcontrolled.
8/13/2019 Design Verification White Paper
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Toillustratehowthetracematrixcanbeused,Table2showswhatonerowinatracematrixmightlook
likewhenthematrixisfirstdevelopedandapproved.Atthisstageofthedevelopmenteffort,thematrix
issolely
a
list
of
the
design
inputs
(the
reference
number
from
the
Product
Requirements
Document,
andadescription).Atthisstagethereisnoinformationabouthowthatdesigninputwillbesatisfied,but
itprovidesaroadmapforwhatquestionsneedtobeaskedandwhatdocumentsneedtobedeveloped.
Astheprojectproceedsthroughthedevelopstages,subsequentcellswillbefilledin,identifyinghow
thedesigninputisbeingmet.
Table2:TraceabilityMatrixatDesignInputsStageTraceabilityMatrixDesignReq.No.
DesignInput(Requirement) DesignOutput
(Specification)
RiskAnalyses
Verification ProcessValidation DesignValidation Comments
1.1.1 CanbeETO
sterilized
Table3illustrateshowarowofatracematrixmightlookwhenbeingreviewedattheFinalDesign
Review. Atthispointthedesignoutputshavebeenapprovedandtherequirementthatthematerialin
questionisappropriateforETOsterilizationisestablishedinDrawingNo.1.2.Thematrixalsoidentifies
thatidentifiedrisksassociatedwiththedevicehavebeenmitigated(inpart)throughtheuseofthis
material.The
references
to
design
FMEA
1.3
and
process
FMEA
5.4
identify
two
places
where
this
materialisaddressed.Verificationwasachievedbyconfirmingthatthespecifiedmaterialisincludedin
thepurchasingbillofmaterial(BOM2.3).TheProcessValidationcolumnidentifiesthatproductionof
thematerialwasassessedinanoperationqualification(OQStudy3.5)andaperformancequalification
(PQStudy4.3).Finally,itshowsthatadesignvalidation(SterilizationStudy2.1)wasconductedto
confirmthatthefinalmanufactureddevicecouldinfactbeeffectivelysterilizedusingETO.
Table3:TraceabilityMatrixatFinalDesignReviewTraceabilityMatrixDesignReq.No.
DesignInput(Requirement) DesignOutput
(Specification)
RiskAnalyses
Verification ProcessValidation DesignValidation Comments
1.1.1 CanbeETO
sterilized
MaterialA
(Dwg1.2)
dFMEA
1.3
pFMEA
5.4
BOM2.3 OQStudy
3.5
PQStudy
4.3
Sterilization
Study2.1
None
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Thetracematrixnowservesasaclearrecordofthechainofanalysesandstudiesusedtoensurethat
thespecificdesigninputismet.Allofthedocumentsreferencedinthetracematrixareincludedinyour
designhistory
file
(DHF),
so
if
a
question
arises
regarding
any
stage
in
the
process,
the
trace
matrix
pointstothekeydocumentationdevelopedatthatstage.
Whilethetracematrixisanecessaryandvaluabletool,itlargelyservesjustarecordkeepingrole.Itdoes
nothingtoinformtheteamabouthowtoprioritizeverificationandvalidationefforts.Forthatinput,risk
analysesareneeded.
FMEA:Likethetracematrix,riskanalysesneedtobestartedearlyinthedesignanddevelopment
processandfilledinandenhancedasprojectproceeds.Whilethispaperwillnotdiscussthedetailsof
theapplicationofriskanalyses,andFMEAsinparticular,wewilladdressthelinkbetweenFMEAsand
verification.
Toooften,riskanalysesareconductedinisolationfromtheotherdesigncontrolactivities.Asdiscussed
earlier,theregulationmindsetcanleadtotheperspectivethatriskanalysesarejustarequiredtaskto
becompletedandnotastoolstosupportdecisionmakingwhichtheyare.
FMEAsareconductedtoprovidedeveloperswithasharedunderstandingoftherisksassociatedwith
theirdeviceusuallyfromthreeperspectives:design,use/application,andprocessing.Theresultofthis
tool,asillustratedinFigure1,istheclassificationofriskstopeople,property,andtheenvironmentinto
threecategories:BroadlyAcceptable,AsLowasReasonablyPracticle(ALARP),andIntolerable.Typically,
applicationofthistoolfocusesontheIntolerablerisksandthedevelopmentofmitigationstrategiesto
reducethe
probability
of
occurrence
for
those
risks,
bringing
them
into
the
ALARP
region.
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Figure2:RiskClassification
Whileriskidentificationandmitigationisclearlytheprimaryobjectiveoftheriskmanagementactivity,
theseanalysescanalsobeusedtofocusverificationandvalidationefforts.Forexample,considera
devicethat
includes
two
components,
one
affects
how
the
device
is
held
by
the
user
and
the
other
comesintocontactwiththepatient.Bothcomponentshaveasimilarnumberofphysicaldimensionsto
verify,butrisksassociatedwiththeuserfacingcomponentareBroadlyAcceptable,whilethepatient
facingcomponentrisksareALARP.WhileaFirstArticleinspectionoftheuserfacingcomponentmay
beappropriate,amorethoroughanalysisofthepatientfacingcomponentmaybewarranted.This
analysiscouldincludeatoleranceanalysisortheinspectionofmultiplepiecestoprovideabetter
indicationofthepotentialcapabilitytoproducethecomponentwithinspecification.
Whiletheadditionaleffortsdescribedabovemaynotberequiredattheverificationstage(conductinga
FirstArticlewouldbesufficienttoclaimthattheverificationiscomplete),theALARPriskclassificationis
an
indication
that
validation
of
this
component
may
be
challenging.
The
more
you
learn
about
this
componentduringverification,thebetterpreparedyouwillbeonceyougettothevalidation.Iffact,if
theverificationisthorough,itmayeliminatetheneedforsomeaspectsofvalidationsavingtimeand
moneylaterinthedevelopmenteffort.
Thekeypointisthatincompleteorminimalverificationsmaynotprovideasufficientunderstandingof
thelikelyperformanceofadeviceduringvalidation,andexcessiveverificationcanbeawasteof
resources.Toeffectivefocusyourverificationefforts,riskanalyses,andFMEAsinparticular,canprovide
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aclearrationaleforhowtofocusyourtimeandresourcespotentiallyreducingvalidation
requirements.
FaultTreeAnalysis:WhileFMEAsareawellacceptedriskanalysistool,oneweaknessoftheapproachisthateachriskisconsideredinisolation.Thereisnoabilitytoassesstheriskoftwoindependentfailures
(i.e.,dimensionAistooshortandtheuserappliestoomuchforce).AsillustratedinFigure3,Faulttree
analysis(FTA)allowsyoutoconsidertheriskoftwoindependentfailuresoccurringinparallel(the
AND),andtheriskofanyoneofaseriesoffailures(theOR).Forexample,inthisBadCoffee
example,addingOldCreamrequiresthecreamtobepastitsexpirationdateANDforthecoffee
drinkernottoreadthedate.Unsatisfactoryservingtemperaturecouldbeduetothecoffeebeingeither
toohotORtoocold.
Figure3:FaultTreeAnalysis
WhilemorechallengingtostructureandassessthananFMEA,theFTAprovidesabetterunderstanding
oftherisksassociatedwiththesystem.Sincetheperformanceofthesystemistheobjectiveof
validationactivities,FTAisanidealtooltoprepareforvalidations.Withthetopofthefaulttree
representingtheintendeduseofthedevice,thistoolallowsdevicedeveloperstofilloutthetree
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identifyingthatrangeofdesignorusagefaultsthatcouldleadtoaproblem.JustastheFMEAhelpedto
focusattentiononindependentrisks,theFTAhelpstofocusonsystemrisks.
Oncethebranchesofatreeassociatedwithasignificantriskareidentified,additionalverification
resourcescanbefocusedonverifyingthedesignofcomponentslinkedtothatrisk.Again,theobjective
ofverificationandvalidationactivitiesistobuildconfidencewithinyourorganizationandwith
regulatorsthatyourdeviceisgoingtobesafeandeffective.AwellstructureFTAcombinedwith
thoroughverificationsofkeycomponentscanbeinstrumentalintheidentificationandresolutionof
problemsearlyinthedevelopmentprocess,allowingyourteamtoenterintothevalidationphaseofthe
processwithconfidenceintheperformanceofthedeviceandtofocusitsvalidationonthosesystem
elementsthatmostdirectlyaffectuserneeds.
WhataretheBenefits?Whileitcansometimesgetlostinthechurningofengineeringprocess,verificationisacriticalelement
ofthedesigncontrolprocess.Whilemeetingthethresholdrequirementofdocumentingaverification
foreachdesigninputmayhelptomovethedesignthroughthedevelopmentstages,suchanapproach
doesnotprovidethevaluethatastrongverificationeffortcouldprovide.Bydevelopingatracematrix
toensurethatalldesigninputsareproperlyaddressedandleveragingriskanalysistools,medicaldevice
developerswouldbebetterabletofocusscarceresourcesonthoseverificationactivitiesthatwill
providethegreatestbenefit.Wellstructuredverificationactivitiesprovidethefoundationfor
validations.Iftheverificationsaresound,validationscanbebetterfocused,helpingtoreducethescope
oftheseactivitiesreducingvalidationcostsandacceleratingtimetomarket.
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