This document provides an overview of key aspects of medical device product development including planning, design controls, design history files, design inputs and outputs, design reviews, verification and validation testing, design changes, and design transfer. It analyzes the processes used by Company A for their stalled medical device project, finding that while they had documented processes, planning was not fully executed, technical risks were not identified, and formal verification and validation testing had not commenced. This likely contributed to the project not making progress towards its goals.

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Medical Device Challenge – What It Takes (A)
The smell of garlicfilledthe room. MB (hisnickname) satata table inthe back of a small Italian
restaurant. He enjoyseverythingItalian;food,music,jewelry,andof course the redwine. He was
invitedtothe restaurantbyhisformeremployer (referredtoas CompanyA). He hadrecently resigned
as he was frustratedwiththe stalledproductdevelopment. Withthe currentdevelopmentprocess,he
didnot see a paththat woulddeliverthe producttomarketwhich he hadput so much effort. The
formeremployercontactedMBas a co-workerhadtoldseniormanagement,whomwasalsofrustrated
withthe project,thatMB had ideason how to get the projectdelivered. MB agreedto a dinnermeeting
to share hisinsightson whatto change in orderto helpthemachieve success.
MB wasverycomfortable athisnew company (referredtoas CompanyB) whichwas a world-
wide,highlyrecognized,large medical device company. The productat the formermid-sizedcompany
was a non-compete tohiscurrentcompany,sohe couldhelpthemgettheirproductreleasedwithout
legal liability. He wantedtosee the projectreleasedsincehe hadputin yearsof effort.
Whenhe arrivedat the restauranthe saw the formerco-workerwithanothergentleman;the
newVice Presidentof R&D. Dinnerwasgreat and ideaswere flowing. While waitingfordesertanother
personarrives,itisthe CEO of the company. He sitsdownand listenstoall the new approachesto
ensure success. The CEO appearspleasedthatthe meetingwassuccessful and believes the projectcan
getback on track. Then,he doesthe unexpected. He asksMB to returnto the companyto leadthe
effort. Shouldhe return? Athiscurrent company,he is the divisionrepresentative foracorporate
initiativetocreate a commondevelopmentprocessacrossthe entire corporation. Shouldhe returnto
CompanyA?
The Quality System Regulation
Medical device companiesare requiredbylaw toadhere tothe Food andDrug Administration
(FDA) Part820 QualitySystemRegulation(QSR) of the 21 Code of Federal Regulation (CFR). Forproduct
development,the mostimportantsectioninthe QSRiscalledDesignControls(Sub-part820.30). Design
controlsare composedof statementson whatthe companymust do; DesignPlanning, DesignHistory
File, DesignInput,DesignOutput, DesignReview,DesignVerification,DesignValidation, DesignChanges,
and DesignTransfer. The entire regulationcanbe foundonthe FDA web-site, www.fda.gov. The
statementsare clearandconcise,buttheydo not explainhowtobe complianttothe regulation. In
orderto help corporationsandtheirowninvestigators,the FDA createdguidance documentstohelp
industry. However,evenwiththe guidancedocuments,itisstill vague forwhatisactuallyneededand
opento interpretation. Thisisstill aproblemforindustrytoday. Thisisespeciallytrue withincreasing
worldwide competitionandthe need forcompanies tocontinuallylowercostwithgreatersystem
functionalitytostaycompetitive. Whatisthe most effective developmentprocesstocreate a high
qualityinstrumentthatisfullycomplianttothe QSR? Why wasCompanyA not makingprogress?
Processes

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Everymedical device companyhasadocumentedprocessfor howto create the medical
product,referredto as the Corporate QualitySystem. Fromthe highestlevel the developmentprocess
iseitherprojectbasedorcorporate based. Projectbasedproceduresallow eachprojecttotailorhow
theirprojectwill achievethe FDA deliverables. Thisprovidesthe most flexibilitytogetthe jobdone,but
alsohas the most inconsistencyachievingcorporate goalsbetweenprojects. One projectcanbe on
budget,onschedule,withhighqualitywhileasecondcan be a complete disasterplaguedwithquality
problems. Corporate basedproceduresprovideconsistencybetweeneachproject,buttypicallyatthe
expense of time tomarket. Withoutthe flexibilitytotailor projectrelatedoperations,stepssuchas
requirementsgatheringcantake longerto achieve. Whichprocessis better? Ingeneral,projectbased
developmentproceduresprovide the highersuccessrate fora corporation since theyare agile. MB
prefersthe projectbasedapproachas itallowsthe teamto adaptas theyencounterobstacles. Thiswas
the developmentprocessforCompanyA,sowhatwentwrong? Since the teamcan adapt,why
wouldn’tthe teamalwayssucceed?
Design Planning
Projectplanningisvital tothe successof any development. A goodacronymto rememberisthe
six Ps;Prior ProperPlanningPrevents PresentProblems. MB isa huge believerinplanningand
communicatingthe visiontothe team. Thisstartswitha documentedplanbutcontinuesonadaily
basisto keepthe teamfocused. FDA realizesthe factthatplanningisessential whichiswhyitisfirstin
the DesignControls. The ProjectPlandocuments howthe projectisgoingto complywiththe Corporate
QualitySystem. Itidentifiesanddescribesthe deliverablesfromthe projectteamandthe tools,
techniques,andmethodologiesthat the projectteamandthe corporation will followtodeliverthe
product. A complete projectplanisa collectionof sub-plansforkeydevelopmentareas. A typical
projectplanconsistsof:
 Organizational plan
 Personnel plan
 Requirementsmanagementplan
 Riskmanagementplan
 Issue managementplan
 Configurationmanagementplan
 Release managementplan
 Transferto manufacturingplan
 Reliabilityplan
 Qualityplan
 Verification&validation(V&V) plan

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In the initial planning,the projectscheduleisalsodevelopedwhichidentifies the majorsystem
milestonesforthe project. The projectschedule shouldnotonlyconsiderwhenfeatureswill be
delivered,butalsothe numberof requireddevices,theirconfiguration,andtheirmanufacturer(R&D,
Manufacturing, or both). Thisisa device (Prototype &Pilot) planthatmustaccompanythe schedule.
Once a goodplanis developedbyacompanythat demonstratessuccess,portionscanbe re-usedfor
future projectswhichcanhelpto decrease the planningphase of the nextproject. Inaddition,whena
planis re-used,itcanhelptoincrease the probabilityof success anddecrease the variabilityof success
betweenprojects. Itcannotguarantee successas there is alwaysthe technologyandpeoplefactorof
development.
Planningalone will notguarantee victory;strongvertical andhorizontal communicationsare a
mustacross the organization. The challenge here witheverycorporationistohave flowing
communicationbetweenthe project,seniormanagement,anddepartmentmanagers without
numerousmeetings. Meetingsmusthave completeattendance of onlythe essential personnel thatcan
spreadthe knowledge. Meetingsmustalsobe asshortas possible conveyingthe maximal amountof
keyinformation. The opposite of thismethodisconstant,mandatorycommunicationswithentire
teamswhichisa recipe fordisaster. DidCompanyAhave a product developmentplan? Yes. For
communications,the projectforCompanyAhad weeklyprojectmeetings withtechnical leads andwas
representedbythe Vice Presidentof R&Din monthlyseniormanagementmeetings.
Design History File
Duringthe planningstage,the locationof the DesignHistoryFile (DHF) andthe processfor
accessingthe DHF are defined. The DHFis the locationfor placingall records(evidence). The contentof
the DHF is the proof that the product wasdesignedinaccordance withthe CompanyQualitySystemand
ProductDevelopmentPlan. All recordsinthe file mustbe signedanddated tomake themlegal
documents(evidence). Buildingacomplete DHFisimportantinthe eventthatlegal actionistaken
againstthe product. Legal actioncan occur inthe case of patentinfringement,harmtoa patient,or
harm to the operator. There are twomethodsforaccessingthe DHF; openandclosed. Openaccess
meansthat the filesare locatedina place were eitherall teammembersordesignatedteammembers
can place and remove itemsfromthe file. Thisprovidesopennessforsharingdocuments, butposes a
securityproblemif adocumentisremoved,butnotreturned. Closedaccessisdefinedasa limited
groupof one or two people withaccesstoa secure (locked) location. Closedaccessensuresthe
contentsof the DHF, but createsa challenge forsharingdocumentsamongteammembers. CompanyA
usedan openDHF process forthe project.
A DHF can be extremelyvoluminoussinceall technical review,testreports,verificationresults,
and validationsummariesare maintainedfor the entire development(concepttoretirement).
Therefore,itisimportantthatthe structure of the file allowsforaccurate andfastaccess. If askedto
produce a piece of evidence (record) toaFDA inspector/reviewerorlegal personnel,the document
shouldbe producedquickly. CompanyAutilizedfile cabinetsthatwere labeledexternally.Eachcabinet
was accompaniedwith adocumentthatdefinedthe drawercontents.

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Design Input
What isDesignInput? A bettertermforDesignInputisRequirements Management.
RequirementsManagementconsistsof RequirementsGathering,HumanFactorsAnalysis,and
Traceability. A projectstartswitha conceptspecificationwhichidentifiesthe intendeduse of the
device,marketanalysis,andfinancial returnoninvestment. Conceptspecificationscanbe createdfor
newinnovative productsormarketreplacementproducts. The concept specificationwithanoutlined
projectplanmustget approval forfundingfrominvestorsforstartuporganizations orsenior
managementforestablished corporations. Once fundingissecured,the projectofficiallystartswiththe
marketingspecification. The marketingspecificationisthe initial requirement gatheringdocumentand
isessentiallyadescription of the devicesintendeduse, technical specificationsthe device mustmeet,
and a highlevel description of the featuresrequiredforthe product. Sometimesamarketing
specificationmayidentify whichfeatures are essentialforproductlaunchand whichfeatures are for
post-launchreleases. Multipleplannedreleases create aphase release plan. Fromthe bulletlistof
features,the projectteamwill identifyandcreate detailedrequirementspecificationsandfunctional
specifications. The requirementsfromthese specificationsmusttrace toa requirementinahigherlevel
specification,suchasthe marketingspecification. Thisensuresthatall requirementsneededbythe
productare delivered. Requirementgatheringisperformedfromthe conceptphase of aproduct to the
retirementof the product. Itis a continual processtoadd featurestothe productto make it
competitive. Toverifythatthe correct requirementdocumentsare created,itisgood,commonpractice
to create a documenttree whichshowsthe documentrelationships anddependencies inavisual
manner. Did CompanyA have a documenttree? Yes.
Design Output
DesignOutputisthe implementationof the requirementsfromFunctional Specificationsto
SystemSpecificationstoMarketingRequirementstothe ConceptSpecification. Of the DesignOutput
deliverables,the mostimportantare the architecture documents. The architecture documentsare the
blueprintsof the device. The systemarchitecture documentshouldbe createdinparalleltothe
marketingrequirementsandconceptspecification. The architecture isthe identificationof functional
blocksto breakdownasystemintosmaller,simplersub-systems. The architecture takesahighly
complex problemanddividesitintosmaller,manageable,testable entities. Toperforma system
function,all of these entitiesmustworktogetherinunison. The workloadmustbe balancedbetween
the entitiesandtheirinterfacetoone anothermustbe minimized. If one entityisdoingall the workfor
the device,performancecould be jeopardized. Performance canalsobe compromiseddue to high
dependence betweenentities. A poorarchitecture will require acontinuous workloadforthe life of the
projectwhichcoulddraincompanyresources andreduce returnon investment. A strongarchitecture
will reduce the probabilityforprojectproblems,increase the abilitytoidentifyandresolve problems,
and couldallowdevelopmentof derivative productsbasedon the original design. The system
architecture forthe product for CompanyA was well thoughtoutanddetailed.
Design Review

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DesignReviewsare veryimportanttoidentifydefectspriortoproductrelease. Reviewsshould
be performedearlyinthe designprocessandrepeatedduringthe developmentcycle asthe design
iterates. A designreviewisapeerexaminationof material thatispart of the device design. This
includes planningdocuments, requirementspecifications,designdocuments,testprocedures,
componentanalysis,etc. Designreviewsinclude the owner(orauthor),a technical leader,all
stakeholders,andanindependentreviewer. Whenadesignreview isperformed,the material shouldbe
sharedwithall the reviewersinadvance of the meetingwithadequatetime toperformadetailed
analysis. Inaddition,if the amountof the material islarge,thenthe material shouldbe separatedinto
multiple reviewmeetings. A designreview typicallyidentifiesone of the reviewersas a moderatorand
anotheras a recorder. The moderatorconductsthe meetingandmaintainsorder. The recorderwrites
downall suggestionsandproblemswiththe designthatwere discoveredbythe reviewers. Atthe
conclusionof the meetingall the attendeesmustsignanddate the recordedissues. The listof issuesis
giventothe designownerforresolution. Afterresolutionanindividual isassignedtoverifythat the
issuesare resolved. The DesignReviewprocesswasdocumentedat CompanyAand reviewswere
performedaccordingtothe procedure.
Design Verification and Validation
DesignVerificationisthe testingtoconfirmthatthe designmeetsorexceedsthe designintent
to comply withthe requirements. DesignValidationisthe testingtoconfirmthatthe final design
producedbymanufacturing meetsthe intendeduse of the deviceinasafe and effective manner. To
performeitherverificationorvalidationtesting,testprotocols(and/ortestcases) mustbe created.
These protocolsspecifythe methodologyandprocedure toensure eachrequirementinthe
requirementsspecificationsiscorrect. In addition,andmore important,there isatestprotocol to
ensure correctnessof the device againsthazardsidentifiedinriskanalysis. Atthe conclusionof testing,
a test summaryreportiscreatedwhichprovidesahighlevel summaryof all the testingperformedand
the resultof the testing. It isimportantto note thatall the testingdoesnothave tohave a Passstatusin
orderto receive approval fromthe FDA. All testingagainsthazardsmustPass,however,if non- essential
featureshave aFail status,the product can still be released. The testsummaryreportisthe vehicle
usedto documentthe analysisandjustificationof eachfailure.
Priorto the formal verificationandvalidationtesting, itisimportantthatdesignerstestthe parts
of the device astheybecome available. Testingshouldbe performedearlyandoftentoensure
correctnessof eachsub-systemasitis built. If thistestingisnotperformedupfront,thenthe
complexityof problemidentificationislarge andthe potential solutionstoresolveproblemsare
minimized. Testingbythe designersshouldalsobe prioritizedwithall the technical riskstestedfirst.
Technical risksshouldbe identifiedearlyinthe projectandcommunicatedacrossthe team, soeach
designerunderstandstheirrole inprovidingasolution.
For the projectat CompanyA, formal verificationandvalidation testinghadnotcommenced
and the technical riskhadnot beenidentified. However,some designertestingwasperformed,butit
was notuniversal acrossthe team. Designertestingwasbasedonthe commitmenttoqualityof each
individual.

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Design Changes
DesignChange isthe evaluationof changestothe designpriortotheirimplementation. The
evaluationof adesignchange examinesthe customerneed,the level of efforttothe business,andany
potential hazardsthatcan be introducedbyimplementingthe change. DesignChangescome intwo
forms;Priorto Product Release andPostProductRelease. Of these twoformsthe more importantisthe
DesignChange of productsalreadyreleased. In manyorganizations,anEngineeringChange Order
(ECO) isthe procedure usedtomake changestoproducts that have alreadybeenreleased. The
EngineeringChange Orderisapprovedbyall departmentsof the organizationincludingQualityto
ensure thateach change isproperlyevaluated inaccordance withthe corporate QualitySystem.
CompanyA has bothan ECO processand a Corrective AndPreventiveAction(CAPA) process.
Since CompanyAhas a projectbaseddevelopmentprocess,eachprojectmanagerdefinedhow
to manage design change duringdevelopmentof the device. ForMB’s project,changeswere proposed
and evaluatedbyagroup of three technical leadsandthe programmanager. Basedon the meeting,the
technical leadswouldcommunicate anyapprovedchangestotheirteamverballyorviae-mail.
Design Transfer
DesignTransferisthe processof moving the designfromR&D to manufacturing. Every
individualpartof the designmustbe recordedunderdocumentationcontrol. Then,all the partsthat
make up a largerpart (assembly) are groupedtogetherunderaBill Of Material (BOM). Then,BOMs are
groupedtogethertomake largerassemblies. Inaddition,eachassemblywill have anassembly
procedure forhowto put the parts together. Inmanufacturing,eachassemblyistestedtoverifyits
correctness. Each testprocedure shouldbe writtentogetherbyR&Dand manufacturingengineers to
ensure complete coverage. The lotinformationforthe partsusedinthe device anditstest resultsare
recordedintoa Device HistoryRecord(DHR) forthe device. The DHRprovidesthe abilitytorecall any
devicesfromcustomersthatmaymalfunctioninthe fielddue toa non-conformance partfora givenlot.
Whenshoulddesign transferbegin? The answeris“assoon as possible”. Whenanassemblyis
functional,verified, andhasa highprobabilityfornochange aftertransfer,itsparts andcomponents
shouldbe releasedtodocumentationcontrol withassemblyandtestprocedures. ForMB’sproject,
CompanyA wasnot close to designtransfer. The lasttransfertomanufacturingfora device designedby
R&D was MB’s prior project.
Take the Challenge
Projectsuccessisnot basedonprocessalone. Success= People * (Process+ Technology). The
firstreasona team can fail isthat the technologyisnotyetfeasible. Thiscan mostlyoccur instart-up
organizationsorcorporationstryingtobringin a new technology. MBhas experiencedthisonce inhis
careerand it isnot motivational forthe teamthat puttheirheart intothe development. Ultimately,
people are the majorfactor andvariable forsuccess. Theyare responsible forthe applicationof both
the processand the technology. Intoday’sworld,the complexityof the humanfactoris increaseddue
to worldwide,multinational teamscreatingproducttogetherovermultiple time zonesandcultures.

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ShouldMB take the challenge andreturnto CompanyA? He wouldneedtoleada cultural
change in orderto turn aroundthe spiralingproject. The commitmentwouldbe monumental,butthe
personal rewardwouldbe great. Whatabout CompanyB? CompanyB was verysupportive toMB and
providingvisiblecorporate goals. There wasnostressat CompanyB. Everyone worked9to 5, sowhy
not stayat CompanyB withgreatbenefits,greatpay,andlow stress. Ashe enjoyedhiscappuccinohe
made hisdecision.
RefertoPart B of the case studyto get the answer.