accelerating medical device development while improving compliance
TRANSCRIPT
Accelera'ng Medical Device Development While Improving Compliance
October13,2016
AaronJosephMedicalDevicesConsultant
Consensia,Inc.-hAp://consensiainc.com/
Irwin&Associates,Inc.-hAp://www.irwinmeddevicesoluGons.com/
What’stheProblem?
• Designflawsdiscoveredlateindevelopmentleadingtoexpensivedelays
• ScheduleoverrunswithsoQwaredevelopment• Complianceproblemswithdesigncontrols• Highmanufacturingcosts• Productrecalls
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LeanandagilemethodscanaddressalloftheseproblemsbutincorporaGngthemintothehighlyregulatedmedicaldeviceindustrypresentsmulGplechallenges
Outline1. TheStoryof2projects(comparinglean-agileapproachto
tradiGonal)2. AgileSWmethodsadaptedtomedicaldevicesoQware3. AdapGnglean-agilemethodstoregulatedindustry4. AdapGngqualitysystemprocedurestosupportlean-agilemethods5. ConsideraGonsforDHFdocumentaGonandSWtools6. SummaryandQ&A
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Balancing 3 Customers
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MedicalDevice
Development
ProductUsers(clinicians&paGents)
Manufacturing
Regulators(FDA,etc.)
TheStory:Real-life(hypotheGcal)Comparison
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Walter’sTeam• Tradi.onal(waterfall)approach
Grace’sTeam• Lean-AgileapproachNEW!
• CompanywantstodevelopanextgeneraGoninfusionpump
• Keyproductpillars:smaller,lighter,easiertouse
• Aggressiveschedule:24monthstolaunch;16monthstosubmission
• Twoteams:
The Knowledge Timeline
Don’tforceteamtomakekeydecisionsearlybasedonincompleteknowledge
Know
lege
Prod
uctLau
nch
ProductDevelopmentTimeline
Whathappenstotheknowledgea0erproductlaunch?
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Concept Planning Pre-Produc.on Produc.onDevelopment Verifica.on
Knowledge-Driven Product Development
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• Successfulnewproductdevelopmentdemandsdeepknowledgeof:1. ProductapplicaGon2. Producttechnology3. Manufacturingprocesstechnology
• +forMedicalDevices:4. RegulatoryApproval(approvalprocessandkey
concernsofregulators)5. Compliance(requirementsofallapplicable
regulaGonsandstandards)
MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians
Expensive design and process changes (loopbacks) caused by late learning
ConceptPhase
FeasibilityPhase
DevelopmentPhase
Valida.onPhase
Produc.onPhase
IdenGfyafewproductconcepts
Selectoneconcept
Performdetaileddesign;buildprototypesandtest
Pilotmfg;ClinicaltesGng
ProducGoninvolume
Learnaboutproblemswithdesignofproductandmanufacturingprocesses
$$$$$$$
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Problems with Tradi'onal (waterfall) Approach
GAT
E
GAT
E
GAT
E
GAT
E
Comparison: A Story of 2 Projects Areal-lifeexampleof(hypotheGcal)productdevelopmentproject
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TheStory:Real-life(hypotheGcal)Comparison
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Walter’sTeam• Experiencedprojectlead• Fullyresourcedcross-funcGonalteam(ME,EE,
SW,clinical,UX,Mfg,Quality,Purchasing,Regulatory,etc.)
• Tradi.onal(waterfall)approach
Grace’sTeam• Experiencedprojectlead• Fullyresourcedcross-funcGonalteam(ME,EE,
SW,clinical,UX,Mfg,Quality,Purchasing,Regulatory,etc.)
• Lean-AgileapproachNEW!
• AdvancedResearchDept.:• designedanewpumpmechanismthatismorepreciseandlowerpowerthanexisGngtechnology
• IdenGfiednewbaLerytechnology(smaller,fastercharging)
• Launchin2years
Product Development Phases 3
Verifica.on4
Pre-Produc.on5
Produc.on0
Concept
510ksu
bmission
Prod
uctLaunch
ProjectbeginsatPlanningPhasewiththefollowingkeyinputs:• Productintendeduseanduserneeds• BusinesscaseincludingMarkeGng,Legal,
Regulatory,Financial,andTechnologicalconsideraGons
• ProductConcept
GAT
E
GAT
E
1Planning
2Development
GAT
E
GAT
E
-Productdevelopmentplanning,-HazardAnalysis,-Requirements&architecture-Regulatorystrategy
MfgProcessvalida.on+Launchreadiness
-HW&SWdesign,-DetailedRiskAnalysis,-Prototyping-Testmethoddevelopment-Mfgprocessdevelopment
-Designfreeze-Designverifica.on-Mfgprocessdevelopment
-Clinicaltes.ng,-Humanfactorstes.ng-Preparesubmission
ComparisonStory:StartWalter’sTeam
• Begindetailedprojectplanning• BeginwriGngproductrequirementsand
soQwarerequirements• Performhazardanalysis
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Grace’sTeam• Beginhigh-levelprojectplanning• BeginwriGngpreliminaryrequirements• Performhazardanalysis• IdenGficaGonofknowledgegaps:
• PlantesGngofnewpumpmechanism• PlantesGngofnewbaAery• PlantesGngofUIdesigns
Year1 Year2
+Setupproject“WarRoom”(obeya)
Expensive!TesGngusesupGmeandscarce
resources
ProductDevelopmentTimeline
ComparisonStory:Year1-Q1Walter’sTeam
• Comprehensivedetailedprojectplanning• Comprehensiveproductrequirementsand
soQwarerequirements• Performhazardanalysis• Phase1/Gate1completed✔
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Grace’sTeam• High-levelprojectplanning• Preliminaryrequirementsandhazardanalysis• Closingknowledgegaps:
• EvaluaGonofnewpumpmechanism• EvaluaGonofnewbaAery• EvaluaGonofUIdesigns
• MulGpletripstohospitalstoobserveuseofdruginfusionpumps
• SoQwareteamsprintsproducedseriesofroughSWdemosforevaluaGon
Year1 Year2
Agile SoKware Development ExampleofintegraGngnewmethodsintoahighlyregulatedenvironment
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Agile has many proven advantages for SW
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Agileimproves:• VisibilityofSWprojectto
stakeholders• Flexibilityinrespondingto
changinguserneeds• ManagingSWprojectrisks• QualityofreleasedSW
The Agile Manifesto (2001)
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WeareuncoveringbeAerwaysofdevelopingsoQwarebydoingitandhelpingothersdoit.Throughthisworkwehavecometovalue:
Individualsandinterac.onsoverprocessesandtoolsWorkingso]wareovercomprehensivedocumentaGon
Customercollabora.onovercontractnegoGaGonRespondingtochangeoverfollowingaplan
Thatis,whilethereisvalueintheitemsontheright,
wevaluetheitemsontheleQmore.
Feb.2001-hAp://agilemanifesto.org/
MedicalDeviceRegulaGonsèprocesses&documentaGonSoluGon:findabalancetomaintainbenefitsofAgilewhilesGllfulfillingregulatoryrequirements
AAMITIR45:2012–GuidanceonUseofAgileforMedicalDeviceSo]ware
2-weekSprint
Agile Scrum: Developing SoKware in Short Sprints
ProductBacklog
SprintBacklog SprintTasks
DailyScrum DailyScrum:team
sharesstatusandidenGfiesissues
ReviewofSWwithstakeholders+SprintRetrospec.ve
SprintPlanning:defineworktasksfornextsprint
Highestpriorityfeatures Working
SoQware
Waterfalls
FDA Design Controls (21CFR820.30)
IEC62304MedicalDeviceSo]wareStandard
5.1SWDevelopmentPlanning
5.2SWRequirements
Analysis
5.3SWArchitectural
Design
5.4SWDetailedDesign
5.5SWUnitImplementaGon&VerificaGon
5.6SWIntegraGon&
IntegraGonTesGng
5.7SWSystemTesGng
5.8SWRelease
18Copyright2016AaronJosephConsulGng
5.1SWDevelopmentPlanning
5.2SWRequirements
Analysis
5.3SWArchitectural
Design
5.4SWDetailedDesign
5.5SWUnitImplementaGon&VerificaGon
5.6SWIntegraGon&
IntegraGonTesGng
5.7SWSystemTesGng
5.8SWRelease
7.RiskMgmt
7.RiskMgmt
7.RiskMgmt
TransposingWaterfalltoAgile(IEC62304MedicalSWStandard)
5.1SWDevelopmentPlanning(sprintplanning)
5.2SWRequirementsAnalysis
5.3SWArchitecturalDesign
5.4SWDetailedDesign
5.5SWUnitImplementaGon&VerificaGon
5.6SWIntegraGon&IntegraGonTesGng
5.7SWSystemTesGng&RegressionTesGng
5.8SWRelease
ForeachSprint
AAMITIR45:2012–GuidanceonUseofAgileforMedicalDeviceSo]ware
ForeachRelease
5.7SWSystemTesGng
5.1SWDevelopmentPlanning(releaseplanning)
ForeachProject 5.1SWDevelopmentPlanning(project)
5.2SWRequirementsAnalysis(high-level,backlogmgmt)
5.3SWArchitecturalDesign(infrastructure)
5.6SWIntegraGon&
IntegraGonTesGng
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Agile Cycles and Design Planning
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DayPlan
SprintPlan
ReleasePlan
ProjectPlan• DesigncontrolsareorganizedaroundmulGplecycles(layers)
• Project=oneormoreReleases• Release=oneormoreSprints• Planningperformedatalllayers• UGlizesrollingwaveplanning• RegularupdatestoDHFdocumentaGon
Agile Methods Break Up the Work
21
DesignInputAc.vi.es DesignOutputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignOutputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
DesignInputAc.vi.es
… …
DesignInputAc.vi.es DesignOutputAc.vi.es
DesignOutputAc.vi.esDesignInputAc.vi.es
DesignOutputAc.vi.esDesignInputAc.vi.es
DesignInputAc.vi.es DesignOutputAc.vi.es
DesignOutputAc.vi.esDesignInputAc.vi.es
DesignOutputAc.vi.esDesignInputAc.vi.es
Waterfall(batch)
Agile
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The Story Con'nues “Aninvestmentinknowledgepaysthebestinterest”–BenjaminFranklin
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SuccessA
ssured
!
Knowledge First (then everything else)
Concept
LearningDominant
Focuso
fProjectTeam
Prod
uctLau
nch
Planning Pre-Produc.on
ProductDevelopmentTimeline
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TaskDominant
100%
Produc.onDevelopment Verifica.on
ComparisonStory:Year1-Q3Walter’sTeam
• Hardwaredesigncompleted(mech/elec)✔• Prototypebuildcompleted✔• SoQwareteamdoingintegraGon• Detailedriskanalysiscompleted(dFMEA)✔• Testmethoddevelopmentunderway• Manufacturingprocessdevelopmentunderway,
includingqualificaGonofsuppliers• PreparingdocumentsforGate2
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Grace’sTeam• FinishedextensivetesGngofnewpumpmechanism
aswellas2backupdesigns• FinishedextensivetesGngofnewbaAeryaswellas
3backupdesigns• ConductedmulGpleformaGvehumanfactorstests
ofUIdesigns,usingprototypesoQwaregeneratedevery2weeksrunningonHWtestbed
• Phase1/Gate1completed✔
PROBLEMSdiscovered!1. Reliability:newpumpmechanismsomeGmesfailsaQer3000cycles2. OverheaGng:newbaAeriesoverheatwhenfullyassembledinproduct
housing3. UserInterface:firstandseconddesignswereafailure(butthirddesign
testswellwithlotsofposiGveuserfeedback)
Year1 Year2
IsGrace’steamreallybehindschedule?
Quality System Adapta'ons MakeyourSOPsandLean-Agilemethodsfittogether
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TheFacts:
26
• Lean-agilemethodsdonotconflictwiththerequirementsofFDAregulaGons,ISO13485,IEC62304,orothermedicaldevicestandards
• Lean-agilemethodsdoconflictwiththequalitysystemsofmanymedicaldevicecompanies
• Qualitysystemproceduresmustbeadaptedforlean-agilemethodsandlikewisethemethodsmustbeadaptedforcompliance(addiGonaldocumentaGonandapprovalsteps)
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Design Controls – Elements
DesignPlanning
DesignTransfer
DesignOutput
DesignInput
DesignValida.on
DesignReviewUser
Needs
DesignVerifica.on
27Lean/agile/hybridapproachesvsWaterfall–companieshaveflexibilityinimplemenGngregulaGons
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Yourqualitysystemmustaddresseveryelementofdesigncontrolsbutyoudon’tneedtodoitinawaterfallfashion—youcanorganizetheelementsinawaythatmakesthemostsenseforyourproductsandyourorganizaGon
BusinessCase&ProductConcept
IntendedUseClinicalpurpose,typesofusers/paGents,usageenvironment
RegulatoryStrategy
HazardAnalysis
DesignRequirements Tes.ng
DesignIteraGons
Desig
nSpaceLimits
ApplicableStandards
4 Key Areas Establish Regulatory Framework for Medical Device Product Development
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RiskManagement(ProductSafety)• Need‘upfront’riskassessment:
• needstobefastbutcomprehensiveandcannotrequiredetaileddesign• High-level/top-down• Example:“SystemHazardAnalysis”providestheframeworkandiscomplementarytosubsequentdetailedriskassessments(dFMEA,uFMEA,pFMEA)
• Lean-agilemethodsimproveriskmanagement:• IteraGonsimproveidenGficaGonandassessmentofrisks• IteraGonsimprovedesignandtesGngofmiGgaGons• UseerrorandmiGgaGonscanbeaddressedearlyindevelopment
• Risktraceabilityneedstobemaintainedthroughoutdevelopment(riskàreqtàdesignàtest);–don’ttrytodotracingjustattheend
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PhaseswithoutGates• PhasesorganizelargenumbersofinterrelatedacGviGesanddeliverables(good!)
-BUT-• “RigidGates”(determiningwhetherteamcanproceed)assumeproductdevelopmentispurelysequenGalandinsGtutebatchedhand-offswherelotsofworkandlotsofknowledgeistransferredatoneGmeacrossgroups:
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Planning Pre-Produc.on Produc.onDevelopment Verifica.on
• Instead,allowworktobedoneinmulGplephasessimultaneously;usePhaseEndReviewtomarksuccessfulcompleGonofeachphase:
GAT
E
GAT
E
GAT
E
GAT
EPlanning
Pre-Produc.on Produc.on
Development
Verifica.on
AdapGngDesignControlsforLean-AgileDesignControl
ElementAdapta.ons
DesignPlanning High-levelplanningcoveringenGreproject;detailedplanningonlyforshort-term;makeplanningVISUAL—allteammembersandstakeholderscanclearlyseeallkeyaspectsofprojectatallGmes
Requirements Don’tmandatecompleteanddetailedrequirementstostartproject;allowrequirementstobeelaboratedandrefinedthroughoutdevelopment
DesignV&VTesGng Don’tmandatethatallverificaGontesGngbecompletedbeforevalidaGonbegins;allowforstageddesignfreezewhereverificaGoncanbeperformedonsomepartsofproductwhileotherpartsofdesignarebeingfinalized(allowsmaximumflexibilitytotheprojectteamtomakedesignchangesuptothe“lastresponsiblemoment”)
Regulatorysubmissions CommunicateearlytoenGreteameverythingrequiredforthesubmission(alltestevidence,keyareasofconcern,etc.)
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DesignHistoryFile(DHF)• DHFshouldserveasaknowledgerepository,notjustcompliancedocumentaGon
• IncluderaGonalefordesignrequirements,backgroundfortestmethods,etc.• OrganizeforeasyretrievalofinformaGon(searchable,cross-linked)
• ManageDHFdocumentaGonsothatworkcanbedoneonmanydocumentssimultaneously(de-centralized)withmanyiteraGons,whilesGllmaintainingintegrityandconsistencyandtraceability
• IteraGonsduringearlydevelopmentcanimprovecompliance:• Everyonelearnsmoreaboutthequalitysystemprocesses• Helpsensurethefinaloutputiscompleteandconsistent• Methodscanberefinedasneededbeforeproductisfinalized
• ExponenGalincreaseincompliance/documentaGoneffortnearproductlaunch(don’titerateatthispoint!!!)
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=relaGonaldatabase
ComparisonStory:Year2-Q1Walter’sTeam
• Phase2/Gate2completed✔• Phase3integraGontesGngandsystemtesGng
revealedproblemwithbaAeryoverheaGng;teamhasbeguninvesGgaGngalternaGvedesigns
• SoQwaretesGngrevealedalargenumberofbugs(SoQwareteamnowfixingthem)
• HumanfactorstesGngdelayedunGlSWfixed• TestprotocolsbeingwriAenforV&VtesGng• ManufacturingprocessdevelopmentconGnuing
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Grace’sTeam• Phase2/Gate2completed✔• DesignverificaGontesGngcompleted,including
60601cerGficaGon(elecsafety,EMC,etc.)• Phase3/Gate3completed✔• PreparingforPhase4validaGontesGng
PROBLEMS(Grace’steamalreadydiscoveredandresolved)1. Reliability:newpumpmechanismsomeGmesfailsaQer3000cycles2. OverheaGng:newbaAeriesoverheatwhenfullyassembledinproduct
housing3. UserInterface:firstandseconddesignswereafailure(butthirddesign
testswellwithlotsofposiGveuserfeedback)Whenw
illWalter’steam
discover
theproble
mswithth
epump
mechanism
andUIde
sign?
Year1 Year2
When were design issues iden'fied?
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• Lean-AgilemethodsencouragerapididenGficaGonofdesignissuesearlyindevelopment(andthereforemorerapidsoluGons)
• PeakproblemsolvingacGvityinthetradiGonalapproach(blue)happensneartheendofdevelopmentandoQenextendsbeyondthedeadline(“100%”)
BasedonpresentaGonbyTakashiTanaka-LeanSummit2011(LeanEnterpriseAcademy)
Grace’sTeam
Walter’sTeam
DiscoveringproblemslatermeanstheyhavetobefixedlaterwhichleadstolotsoflastminutefirefighGng.ThisnotonlydelaysthatproductbutalsounderminesthenextproductdevelopmentprojectbecausekeyresourcesarebusyfirefighGng.
TheMoraloftheStory
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Walter’sTeam• Tradi.onal(waterfall)approach
Grace’sTeam• Lean-AgileapproachNEW!• Regulatorysubmissionon.me✔• Productlaunchon.me✔
• InnovaGvenewproductdevelopmentalwaysinvolvesrisks
• Focusingearlyeffortsonprojectrisksmakeslaterstagespredictable(fastlearningtocloseknowledgegaps)
• Aprojectthatisonscheduleduringitsearlyphasesdoesnotmeanitwilldeliveronscheduleattheend
SuccessA
ssured
!
Product Development with “Two Minds”
Concept
LearningDominant
Focuso
fProjectTeam
Prod
uctLau
nch
Planning Pre-Produc.on
ProductDevelopmentTimelineCopyright2016AaronJosephConsulGng 37
TaskDominant
100%
Produc.onDevelopment Verifica.on
Mindset:highlyflexible,rapid
exploraGon,rapidchanges
Mindset:Rigorous,efficient,
standardized,systemaGc
Summary “AbadsystemwillbeatagoodpersoneveryGme.”–W.EdwardsDeming
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IsItReallyFaster?KeywaysthatLean-AgilemethodsshortenGmetomarket:1. IdenGfyknowledgegapsearlyandtacklethem
aggressively(avoidlate-breakingproblemsthatleadtobigdelays)
2. Atamedicaldevicecompanylate-breakingproblemscantriggeracascadeofissues—canleadtoregulatoryproblemsontopoftechnicalproblems(re-submit,etc.)
3. FrequenttesGngandfeedbacktofinddesigndefectsearlyandadjustdevelopmentaccordingly
4. OnlyspendGmeonwhatcustomersreallyneedandwant(freeupengineeringGmefromnon-valueaddedtasks)
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+therearemorewaysthatLean-Agilemethodsaccelerateproductdevelopmentwhicharenotasstraighzorwardtosee(e.g.,beAercommunicaGon,increasedmoGvaGon,processopGmizaGon,etc.)
CostofDelay=$$$
Knowledge-Driven Product Development
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• Successfulnewproductdevelopmentdemandsdeepknowledgeof:1. ProductapplicaGon2. Producttechnology3. Manufacturingprocesstechnology
• ForMedicalDevices:4. RegulatoryApproval(approvalprocessandkey
concernsofregulators)5. Compliance(requirementsofallapplicable
regulaGonsandstandards)
MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians
Challenges in Adop'ng Lean and Agile Methods
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UnderminingLean-AgileMethods:• DecisionbyHiPPO• Employeeturnover• Knowledgehandoffs(scaAer)• Overloadedengineers• Responsibilityseparatedfrom
control• Fear
WhydosomeorganizaGonsfeelthreatenedbytheseprinciplesoflean-agilemethods?• Designdecisionsbasedonknowledge• VisualizaGon(transparency)ofproductdevelopment
Lean-AgileMethodsforMedicalDeviceDevelopment
1. Lean-agilemethodscanacceleratemedicaldevicedevelopment
2. Iftheteamcan’tsolvethetechnicalchallengeof‘X’thenallotherworkontheproductisuseless
3. Focusonknowledge,notjusttasks
4. MinimizingtesGng=minimizingknowledgegained
5. Qualitysystemproceduresneedtobeadaptedtosupportlean-agilemethods
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SuggestedResourcesforLeanandAgileProductDevelopmentWebsites:
• hAp://www.leanprimer.com/downloads/lean_primer.pdf-goodoverviewofleanprincipleswriAenbytwosoQwaremanagementconsultants(CraigLarmanandBasVodde)whoincludeaspectsofsoQwareagilemethodsaswell
• hAp://theleanthinker.com/-ablogbyMikeRotherwithlotsofgoodobservaGonsandreal-lifeissuesinvolvedinchanginganorganizaGontolean
• hAp://www.coe.montana.edu/IE/faculty/sobek/A3/index.htm-ashorttutorialontheToyotaA3techniqueforproblemsolvingbyDurwardSobek
• hAp://www.lean.org/-LeanEnterpriseInsGtute(consulGngfirmandforum);largecollecGonofarGclesandonlineforumsdiscussingaspectsofleanproductdevelopment,leanmfg,andleanservices
• hAp://theleanedge.org/-aforumfordiscussionsofleanmanagementissueswithcontribuGonsfrommanyofthethoughtleadersintheleancommunity
• hAp://playbookhq.co/blog/-lotsofgoodblogposGngsonconceptsandmethodsforlean-agileproductdevelopment;linkstolotsofaddiGonalresources
• hAps://www.scrumalliance.org-ScrumAllianceisanon-profitorganizaGon;hasarGclesandlinksonagilemethods
• hAps://www.mountaingoatsoQware.com/agile-extensivesetofblogposGngsonmulGpleaspectsofagilesoQwaredevelopmentbyconsultantMikeCohn
• hAps://less.works/-LargeScaleScrum(LeSS)frameworkforlargescaleprojects
• hAp://www.scaledagileframework.com/-amanagementsystemforlargescaleprojects(SaFE)43 Copyright2016AaronJosephConsulGng
SuggestedResourcesforLeanandAgileProductDevelopmentBooks:
• "MasteringLeanProductDevelopment"byRonaldMascitelli-acollecGonofpracGcalmethodstoimproveeverythingaproductdevelopmentorganizaGondoesfromproductstrategytorunningefficientdesignreviews(includesextensivebibliography).
• "ThePrinciplesofProductDevelopmentFlow"byDonaldReinertsen-detailedexplanaGonsofkeyprinciplestoacceleratedproductdevelopment,basedonTheoryofConstraints,queuingtheory,andmore.
• "LeanProductandProcessDevelopment"byAllenCWard-aspiritedpresentaGonofthephilosophyandtechniquesforleanproductdevelopmentfromtheguywhoinspiredmanyothers(publishedposthumously)
• "Ready,Set,Dominate"byMichaelKennedyetal-amoreevolvedpresentaGonoftheideasfromWard'sbook,basedonthereal-lifeexperiencesofKennedy'sconsulGngclients.IncludescasestudiesoftwocompaniesgoingthroughleantransformaGons.
• “ManagingtoLearn”byJohnShook–anexcellentintroducGontotheuseofthe‘A3method’forproblemsolving,communicaGon,learning,andleanmanagement.
• “TheLeanStartup”byEricRies–amustreadforentrepreneursandanyonemanagingprojectstocreatesomethingnewundercondiGonsofextremeuncertainty.
• “TheElementsofScrum”byChrisSimsandHillaryLouiseJohnson–asimplebutcomprehensivedescripGonofoneofthemostpopularaspectsofagilemethodsforsoQwaredevelopment
44 Copyright2016AaronJosephConsulGng
3WaystoSystemaGcallyAccelerateMedicalDeviceDevelopment
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1.Leanandagilemethods
+
2.LeveragingHW/SWtechnologyplazorms
3.Streamlinedcompliance
(thispresentaGon)
Two Different Approaches for Product Development
TradiGonal(waterfall)• Designthentest• Upfrontplanning• ManagetaskcompleGon• Worktransferredinlargebatches
• MaximizeuGlizaGon
Lean-Agile• Testthendesign• Rollingwaveplanning• ManageknowledgecompleGon• Worktransferredinsmallbatchesonacadence
• Maximizethroughput• ConGnuousimprovement
Copyright2016AaronJosephConsulGng 47
Lean Principles: Value & Waste
Value-Added
TotalWorkPerformed
TypeIWaste(necessary)
TypeIIWaste(unnecessary)
Value-Added TypeIWaste(necessary)
ELIMINATE!
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Documents are Not a Good Way to Manage Product Documenta'on
ManagingdesignrequirementsandotherproductdevelopmentinformaGonintextorspreadsheetdocuments(MSWordorExcel)isacommonapproachbuthastheseseriousdrawbacks:• Nosupportforprocessworkflow:whocanchangewhatandwhen?WhatinformaGonmustbelinked
andchangedtogether?• TraceabilityisstaGc—becausetracesmustbemaintainedmanually,thesearetypicallydefined
retrospecGvely(aQertheworkisdone)insteadofprospecGvely;traceinformaGonislikelytodegradeoverGmewithchangestotheproduct(post-launch)
• Difficulttomanagechangespost-launch,toknowallthedocumentsaffectedbyachange• Difficulttosearchacrossdocuments• Changecontrolisperdocument—difficulttotrackwhichrequirementschanged,whochangedthem,and
when• Nowaytoefficientlymanageproductvariantswherethereisalotofoverlapofrisks/requirements/tests
+document-centricapproachtendstoreinforcea“batchmindset”whichiscontrarytoleanandagilemethods
Old Way: Product Documenta'on Stored in Documents
RiskAnalysis
SWReqts
TestProtocol
ProductReqts
TestReport
Revisioncontrolperdocument
DHF
TestProtocol
New Way: Product Documenta'on Stored in a Rela'onal Database
RiskAnalysis
SWReqts
SWTestProtocol
ProductReqts
SWTestReport
Revisioncontrolperdocumentandperelement
DocumentsaregroupingsofDHFelements
PR-1020:Systemshallprovide…
Textofrequirement
TestProtocol
AAributes(status,etc.)
Exportasetofdocumentsfromthedatabaseforsubmissions