Download - Lean agile feb2017-patca_a_joseph_ss
Accelera'ng Medical Device Development with Lean and Agile Methods
PresentedtoPATCA-February9,2017
AaronJosephMedicalDevicesConsultant
Consensia,Inc.-hDp://consensiainc.com/zipquality/
What’stheProblem?
• Designflawsdiscoveredlateindevelopmentleadingtoexpensivedelays
• ScheduleoverrunswithsoRwaredevelopment• Complianceproblemswithdesigncontrols• Highmanufacturingcosts• Productrecalls
LeanandagilemethodscanaddressalloftheseproblemsbutincorporaVngthemintothehighlyregulatedmedicaldeviceindustrypresentsmulVplechallenges
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Outline1. TheStoryof2projects(comparinglean-agileapproachto
tradiVonal)2. AgileSWmethodsadaptedtomedicaldevicesoRware3. AdapVnglean-agilemethodstoregulatedindustry4. AdapVngqualitysystemprocedurestosupportlean-agilemethods5. ConsideraVonsforDHFdocumentaVonandSWtools6. SummaryandQ&A
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Balancing 3 Customers
MedicalDevice
Development
ProductUsers(clinicians&paVents)
Manufacturing
Regulators(FDA,etc.)
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TheStory:Real-life(hypotheVcal)Comparison
Walter’sTeam• Tradi.onal(waterfall)approach
Grace’sTeam• Lean-AgileapproachNEW!
• CompanywantstodevelopanextgeneraVoninfusionpump
• Keyproductpillars:smaller,lighter,easiertouse
• Aggressiveschedule:24monthstolaunch;16monthstosubmission
• Twoteams:
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Lean: methods to maximize value and minimize waste
Value-Added
TotalWorkPerformed
TypeIWaste(necessary)
TypeIIWaste(unnecessary)
Value-Added TypeIWaste(necessary)
ELIMINATE!
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KnowledgeManagement
Agile: methods for rapid learning and communica'on (highly itera've)
BothLeanandAgilearebasedon
The Knowledge Timeline
Don’tforceteamtomakekeydecisionsearlybasedonincompleteknowledge
Know
lege
Prod
uctLau
nch
ProductDevelopmentTimeline
Whathappenstotheknowledgea0erproductlaunch?
Concept Planning Pre-Produc.on Produc.onDevelopment Verifica.on
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Knowledge-Driven Product Development • Successfulnewproductdevelopmentdemandsdeepknowledgeof:1. ProductapplicaVon2. Producttechnology3. Manufacturingprocesstechnology
• ForMedicalDevices:4. RegulatoryApproval(approvalprocessandkey
concernsofregulators)5. Compliance(requirementsofallapplicable
regulaVonsandstandards)
MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians
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Expensive design and process changes (loopbacks) caused by late learning
ConceptPhase
FeasibilityPhase
DevelopmentPhase
Valida.onPhase
Produc.onPhase
IdenVfyafewproductconcepts
Selectoneconcept
Performdetaileddesign;buildprototypesandtest
Pilotmfg;ClinicaltesVng
ProducVoninvolume
Learnaboutproblemswithdesignofproductandmanufacturingprocesses
$$$$$$$
Problems with Tradi'onal (waterfall) Approach
GAT
E
GAT
E
GAT
E
GAT
E
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Comparison: A Story of 2 Projects Areal-lifeexampleof(hypotheVcal)productdevelopmentproject
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TheStory:Real-life(hypotheVcal)Comparison
Walter’sTeam• Experiencedprojectlead• Fullyresourcedcross-funcVonalteam(ME,EE,
SW,clinical,UX,Mfg,Quality,Purchasing,Regulatory,etc.)
• Tradi.onal(waterfall)approach
Grace’sTeam• Experiencedprojectlead• Fullyresourcedcross-funcVonalteam(ME,EE,
SW,clinical,UX,Mfg,Quality,Purchasing,Regulatory,etc.)
• Lean-AgileapproachNEW!
• AdvancedResearchDept.:• designedanewpumpmechanismthatismorepreciseandlowerpowerthanexisVngtechnology
• IdenVfiednewbaNerytechnology(smaller,fastercharging)
• Launchin2years
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Product Development Phases 3
Verifica.on4
Pre-Produc.on5
Produc.on0
Concept
510ksu
bmission
Prod
uctLaunch
ProjectbeginsatPlanningPhasewiththefollowingkeyinputs:• Productintendeduseanduserneeds• BusinesscaseincludingMarkeVng,Legal,
Regulatory,Financial,andTechnologicalconsideraVons
• 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
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ComparisonStory:StartWalter’sTeam
• Begindetailedprojectplanning• BeginwriVngproductrequirementsand
soRwarerequirements• Performhazardanalysis
Grace’sTeam• Beginhigh-levelprojectplanning• BeginwriVngpreliminaryrequirements• Performhazardanalysis• IdenVficaVonofknowledgegaps:
• PlantesVngofnewpumpmechanism• PlantesVngofnewbaDery• PlantesVngofUIdesigns
Year1 Year2
+Setupproject“WarRoom”(obeya)
Expensive!TesVngusesupVmeandscarce
resources
ProductDevelopmentTimeline
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ComparisonStory:Year1-Q1Walter’sTeam
• Comprehensivedetailedprojectplanning• Comprehensiveproductrequirementsand
soRwarerequirements• Performhazardanalysis• Phase1/Gate1completed✔
Grace’sTeam• High-levelprojectplanning• Preliminaryrequirementsandhazardanalysis• Closingknowledgegaps:
• EvaluaVonofnewpumpmechanism• EvaluaVonofnewbaDery• EvaluaVonofUIdesigns
• MulVpletripstohospitalstoobserveuseofdruginfusionpumps
• SoRwareteamsprintsproducedseriesofroughSWdemosforevaluaVon
Year1 Year2
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Agile SoLware Development ExampleofintegraVngnewmethodsintoahighlyregulatedenvironment
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Agile has many proven advantages for SW
Agileimproves:• VisibilityofSWprojectto
stakeholders• Flexibilityinrespondingto
changinguserneeds• ManagingSWprojectrisks• QualityofreleasedSW
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The Agile Manifesto (2001) WeareuncoveringbeDerwaysofdevelopingsoRwarebydoingitandhelping
othersdoit.Throughthisworkwehavecometovalue:
Individualsandinterac.onsoverprocessesandtoolsWorkingso]wareovercomprehensivedocumentaVon
Customercollabora.onovercontractnegoVaVonRespondingtochangeoverfollowingaplan
Thatis,whilethereisvalueintheitemsontheright,
wevaluetheitemsontheleRmore.
Feb.2001-hDp://agilemanifesto.org/
MedicalDeviceRegulaVonsèprocesses&documentaVonSoluVon:findabalancetomaintainbenefitsofAgilewhilesVllfulfillingregulatoryrequirements
AAMITIR45:2012–GuidanceonUseofAgileforMedicalDeviceSo]ware
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2-weekSprint
Agile Scrum: Developing SoLware in Short Sprints
ProductBacklog
SprintBacklog SprintTasks
DailyScrum DailyScrum:team
sharesstatusandidenVfiesissues
ReviewofSWwithstakeholders+SprintRetrospec.ve
SprintPlanning:defineworktasksfornextsprint
Highestpriorityfeatures Working
SoRware
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Waterfalls
FDA Design Controls (21CFR820.30)
IEC62304MedicalDeviceSo]wareStandard
5.1SWDevelopmentPlanning
5.2SWRequirements
Analysis
5.3SWArchitectural
Design
5.4SWDetailedDesign
5.5SWUnitImplementaVon&VerificaVon
5.6SWIntegraVon&
IntegraVonTesVng
5.7SWSystemTesVng
5.8SWRelease
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5.1SWDevelopmentPlanning
5.2SWRequirements
Analysis
5.3SWArchitectural
Design
5.4SWDetailedDesign
5.5SWUnitImplementaVon&VerificaVon
5.6SWIntegraVon&
IntegraVonTesVng
5.7SWSystemTesVng
5.8SWRelease
7.RiskMgmt
7.RiskMgmt
7.RiskMgmt
TransposingWaterfalltoAgile(IEC62304MedicalSWStandard)
5.1SWDevelopmentPlanning(sprintplanning)
5.2SWRequirementsAnalysis
5.3SWArchitecturalDesign
5.4SWDetailedDesign
5.5SWUnitImplementaVon&VerificaVon
5.6SWIntegraVon&IntegraVonTesVng
5.7SWSystemTesVng&RegressionTesVng
5.8SWRelease
ForeachSprint
AAMITIR45:2012–GuidanceonUseofAgileforMedicalDeviceSo]ware
ForeachRelease
5.7SWSystemTesVng
5.1SWDevelopmentPlanning(releaseplanning)
ForeachProject 5.1SWDevelopmentPlanning(project)
5.2SWRequirementsAnalysis(high-level,backlogmgmt)
5.3SWArchitecturalDesign(infrastructure)
5.6SWIntegraVon&
IntegraVonTesVng
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Agile Cycles and Design Planning
DayPlan
SprintPlan
ReleasePlan
ProjectPlan• DesigncontrolsareorganizedaroundmulVplecycles(layers)
• Project=oneormoreReleases• Release=oneormoreSprints• Planningperformedatalllayers• UVlizesrollingwaveplanning• RegularupdatestoDHFdocumentaVon
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Agile Methods Break Up the Work 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
TaskDominant
100%
Produc.onDevelopment Verifica.on
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ComparisonStory:Year1-Q3Walter’sTeam
• Hardwaredesigncompleted(mech/elec)✔• Prototypebuildcompleted✔• SoRwareteamdoingintegraVon• Detailedriskanalysiscompleted(dFMEA)✔• Testmethoddevelopmentunderway• Manufacturingprocessdevelopmentunderway,
includingqualificaVonofsuppliers• PreparingdocumentsforGate2
Grace’sTeam• FinishedextensivetesVngofnewpumpmechanism
aswellas2backupdesigns• FinishedextensivetesVngofnewbaDeryaswellas
3backupdesigns• ConductedmulVpleformaVvehumanfactorstests
ofUIdesigns,usingprototypesoRwaregeneratedevery2weeksrunningonHWtestbed
• Phase1/Gate1completed✔
WhyisGrace
’steamso
farbehind?
PROBLEMS!1. Reliability:newpumpmechanismsomeVmesfailsaRer3000cycles2. OverheaVng:newbaDeriesoverheatwhenfullyassembledinproduct
housing3. UserInterface:firstandseconddesignswereafailure(butthirddesign
testswellwithlotsofposiVveuserfeedback)
Year1 Year2
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Quality System Adapta'ons MakeyourSOPsandLean-Agilemethodsfittogether
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TheFacts:• Lean-agilemethodsdonotconflictwiththerequirementsofFDAregulaVons,ISO13485,IEC62304,orothermedicaldevicestandards
• Lean-agilemethodsdoconflictwiththequalitysystemsofmanymedicaldevicecompanies
• Qualitysystemproceduresmustbeadaptedforlean-agilemethodsandlikewisethemethodsmustbeadaptedforcompliance(addiVonaldocumentaVonandapprovalsteps)
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Design Controls – Elements
DesignPlanning
DesignTransfer
DesignOutput
DesignInput
DesignValida.on
DesignReviewUser
Needs
DesignVerifica.on
Lean/agile/hybridapproachesvsWaterfall–companieshaveflexibilityinimplemenVngregulaVonsPATCA-2/9/17 Copyright2016-2017AaronJosephConsulVng 28
BusinessCase&ProductConcept
IntendedUseClinicalpurpose,typesofusers/paVents,usageenvironment
RegulatoryStrategy
HazardAnalysis
DesignRequirements Tes.ng
DesignIteraVons
Desig
nSpaceLimits
ApplicableStandards
Establish Regulatory-Risk Framework First
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RiskManagement(ProductSafety)• Need‘upfront’riskassessment:
• needstobefastbutcomprehensiveandcannotrequiredetaileddesign• High-level/top-down• Example:“SystemHazardAnalysis”providestheframeworkandiscomplementarytosubsequentdetailedriskassessments(dFMEA,uFMEA,pFMEA)
• Lean-agilemethodsimproveriskmanagement:• IteraVonsimproveidenVficaVonandassessmentofrisks• IteraVonsimprovedesignandtesVngofmiVgaVons• UseerrorandmiVgaVonscanbeaddressedearlyindevelopment
• Risktraceabilityneedstobemaintainedthroughoutdevelopment(riskàreqtàdesignàtest);–don’ttrytodotracingjustattheend
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PhaseswithoutGates• PhasesorganizelargenumbersofinterrelatedacVviVesanddeliverables(good!)
-BUT-• “RigidGates”(determiningwhetherteamcanproceed)assumeproductdevelopmentispurelysequenValandinsVtutebatchedhand-offswherelotsofworkandlotsofknowledgeistransferredatoneVmeacrossgroups:
Planning Pre-Produc.on Produc.onDevelopment Verifica.on
• Instead,allowworktobedoneinmulVplephasessimultaneously;usePhaseEndReviewtomarksuccessfulcompleVonofeachphase:
GAT
E
GAT
E
GAT
E
GAT
EPlanning
Pre-Produc.on Produc.on
Development
Verifica.on
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AdapVngDesignControlsforLean-AgileDesignControl
ElementAdapta.ons
DesignPlanning High-levelplanningcoveringenVreproject;detailedplanningonlyforshort-term;makeplanningVISUAL—allteammembersandstakeholderscanclearlyseeallkeyaspectsofprojectatallVmes
Requirements Don’tmandatecompleteanddetailedrequirementstostartproject;allowrequirementstobeelaboratedandrefinedthroughoutdevelopment
DesignV&VTesVng Don’tmandatethatallverificaVontesVngbecompletedbeforevalidaVonbegins;allowforstageddesignfreezewhereverificaVoncanbeperformedonsomepartsofproductwhileotherpartsofdesignarebeingfinalized(allowsmaximumflexibilitytotheprojectteamtomakedesignchangesuptothe“lastresponsiblemoment”)
Regulatorysubmissions CommunicateearlytoenVreteameverythingrequiredforthesubmission(alltestevidence,keyareasofconcern,etc.)
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DesignHistoryFile(DHF)• DHFshouldserveasaknowledgerepository,notjustcompliancedocumentaVon
• IncluderaVonalefordesignrequirements,backgroundfortestmethods,etc.• OrganizeforeasyretrievalofinformaVon(searchable,cross-linked)
• ManageDHFdocumentaVonsothatworkcanbedoneonmanydocumentssimultaneously(de-centralized)withmanyiteraVons,whilesVllmaintainingintegrityandconsistencyandtraceability
• IteraVonsduringearlydevelopmentcanimprovecompliance:• Everyonelearnsmoreaboutthequalitysystemprocesses• Helpsensurethefinaloutputiscompleteandconsistent• Methodscanberefinedasneededbeforeproductisfinalized
• ExponenValincreaseincompliance/documentaVoneffortnearproductlaunch(don’titerateatthispoint!!!)
=relaVonaldatabase
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The Story Finishes WhatcanwelearnfromWalterandGrace’steams?
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ComparisonStory:Year2-Q1Walter’sTeam
• Phase2/Gate2completed✔• Phase3integraVontesVngandsystemtesVng
revealedproblemwithbaDeryoverheaVng;teamhasbeguninvesVgaVngalternaVvedesigns
• SoRwaretesVngrevealedalargenumberofbugs(SoRwareteamnowfixingthem)
• HumanfactorstesVngdelayedunVlSWfixed• TestprotocolsbeingwriDenforV&VtesVng• ManufacturingprocessdevelopmentconVnuing
Grace’sTeam• Phase2/Gate2completed✔• DesignverificaVontesVngcompleted,including
60601cerVficaVon(elecsafety,EMC,etc.)• Phase3/Gate3completed✔• PreparingforPhase4validaVontesVng
PROBLEMS!1. Reliability:newpumpmechanismsomeVmesfailsaRer3000cycles2. OverheaVng:newbaDeriesoverheatwhenfullyassembledinproduct
housing3. UserInterface:firstandseconddesignswereafailure(butthirddesign
testswellwithlotsofposiVveuserfeedback)Whenw
illWalter’steam
discover
theproble
mswithth
epump
mechanism
andUIde
sign?
Year1 Year2
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When were design issues iden'fied? • Lean-Agilemethodsencouragerapid
idenVficaVonofdesignissuesearlyindevelopment(andthereforemorerapidsoluVons)
• PeakproblemsolvingacVvityinthetradiVonalapproach(blue)happensneartheendofdevelopmentandoRenextendsbeyondthedeadline(“100%”)
BasedonpresentaVonbyTakashiTanaka-LeanSummit2011(LeanEnterpriseAcademy)
Grace’sTeam
Walter’sTeam
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TheMoraloftheStory
Walter’sTeam• Tradi.onal(waterfall)approach
Grace’sTeam• Lean-AgileapproachNEW!• Regulatorysubmissionon.me✔• Productlaunchon.me✔
• InnovaVvenewproductdevelopmentalwaysinvolvesrisks
• Focusingearlyeffortsonprojectrisksmakeslaterstagespredictable(fastlearningtocloseknowledgegaps)
• Aprojectthatisonscheduleduringitsearlyphasesdoesnotmeanitwilldeliveronscheduleattheend
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SuccessA
ssured
!
Product Development with “Two Minds”
Concept
LearningDominant
Focuso
fProjectTeam
Prod
uctLau
nch
Planning Pre-Produc.on
ProductDevelopmentTimeline
TaskDominant
100%
Produc.onDevelopment Verifica.on
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Summary “AbadsystemwillbeatagoodpersoneveryVme.”–W.EdwardsDeming
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IsItReallyFaster?KeywaysthatLean-AgilemethodsshortenVmetomarket:1. IdenVfyknowledgegapsearlyandtacklethem
aggressively(avoidlate-breakingproblemsthatleadtobigdelays)
2. Atamedicaldevicecompanylate-breakingproblemscantriggeracascadeofissues—canleadtoregulatoryproblemsontopoftechnicalproblems(re-submit,etc.)
3. FrequenttesVngandfeedbacktofinddesigndefectsearlyandadjustdevelopmentaccordingly
4. OnlyspendVmeonwhatcustomersreallyneedandwant(freeupengineeringVmefromnon-valueaddedtasks)
+therearemorewaysthatLean-Agilemethodsaccelerateproductdevelopmentwhicharenotasstraighyorwardtosee(e.g.,beDercommunicaVon,increasedmoVvaVon,processopVmizaVon,etc.)
CostofDelay=$$$
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Knowledge-Driven Product Development • Successfulnewproductdevelopmentdemandsdeepknowledgeof:1. ProductapplicaVon2. Producttechnology3. Manufacturingprocesstechnology
• ForMedicalDevices:4. RegulatoryApproval(approvalprocessandkey
concernsofregulators)5. Compliance(requirementsofallapplicable
regulaVonsandstandards)
MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians
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Challenges in Adop'ng Lean and Agile Methods
UnderminingLean-AgileMethods:• DecisionbyHiPPO• Employeeturnover• Knowledgehandoffs(scaDer)• Overloadedengineers• Responsibilityseparatedfrom
control• Fear
WhydosomeorganizaVonsfeelthreatenedbytheseprinciplesoflean-agilemethods?• Designdecisionsbasedonknowledge• VisualizaVon(transparency)ofproductdevelopment
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Lean-AgileMethodsforMedicalDeviceDevelopment
1. Lean-agilemethodsacceleratemedicaldevicedevelopment
2. Iftheteamcan’tsolvethetechnicalchallengeof‘X’thenallotherworkontheproductisuseless
3. Focusonknowledge,notjusttasks
4. MinimizingtesVng=minimizingknowledgegained
5. Qualitysystemproceduresneedtobeadaptedtosupportlean-agilemethods
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Two Different Approaches for Product Development
TradiVonal(waterfall)• Designthentest• Upfrontplanning• ManagetaskcompleVon• Worktransferredinlargebatches
• MaximizeuVlizaVon
Lean-Agile• Testthendesign• Rollingwaveplanning• ManageknowledgecompleVon• Worktransferredinsmallbatchesonacadence
• Maximizethroughput• ConVnuousimprovement
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SuggestedResourcesforLeanandAgileProductDevelopmentWebsites:
• hDp://www.leanprimer.com/downloads/lean_primer.pdf-goodoverviewofleanprincipleswriDenbytwosoRwaremanagementconsultants(CraigLarmanandBasVodde)whoincludeaspectsofsoRwareagilemethodsaswell.
• hDp://theleanthinker.com/-ablogbyMikeRotherwithlotsofgoodobservaVonsandreal-lifeissuesinvolvedinchanginganorganizaVontolean
• hDp://www.coe.montana.edu/IE/faculty/sobek/A3/index.htm-ashorttutorialontheToyotaA3techniqueforproblemsolvingbyDurwardSobek
• hDp://www.lean.org/-LeanEnterpriseInsVtute(consulVngfirmandforum);largecollecVonofarVclesandonlineforumsdiscussingaspectsofleanproductdevelopment,leanmfg,andleanservices
• hDp://theleanedge.org/-aforumfordiscussionsofleanmanagementissueswithcontribuVonsfrommanyofthethoughtleadersintheleancommunity
• hDp://playbookhq.co/blog/-lotsofgoodblogposVngsonconceptsandmethodsforlean-agileproductdevelopment;linkstolotsofaddiVonalresources
• hDps://www.scrumalliance.org-ScrumAllianceisanon-profitorganizaVon;hasarVclesandlinksonagilemethods
• hDps://www.mountaingoatsoRware.com/agile-extensivesetofblogposVngsonmulVpleaspectsofagilesoRwaredevelopmentbyconsultantMikeCohn
• hDps://less.works/-LargeScaleScrum(LeSS)frameworkforlargescaleprojects
• hDp://www.scaledagileframework.com/-amanagementsystemforlargescaleprojects(SaFE)PATCA-2/9/17 Copyright2016-2017AaronJosephConsulVng 45
SuggestedResourcesforLeanandAgileProductDevelopmentBooks:
• "MasteringLeanProductDevelopment"byRonaldMascitelli-acollecVonofpracVcalmethodstoimproveeverythingaproductdevelopmentorganizaVondoesfromproductstrategytorunningefficientdesignreviews(includesextensivebibliography).
• "ThePrinciplesofProductDevelopmentFlow"byDonaldReinertsen-detailedexplanaVonsofkeyprinciplestoacceleratedproductdevelopment,basedonTheoryofConstraints,queuingtheory,andmore.
• "LeanProductandProcessDevelopment"byAllenCWard-aspiritedpresentaVonofthephilosophyandtechniquesforleanproductdevelopmentfromtheguywhoinspiredmanyothers(publishedposthumously)
• "Ready,Set,Dominate"byMichaelKennedyetal-amoreevolvedpresentaVonoftheideasfromWard'sbook,basedonthereal-lifeexperiencesofKennedy'sconsulVngclients.IncludescasestudiesoftwocompaniesgoingthroughleantransformaVons.
• “ManagingtoLearn”byJohnShook–anexcellentintroducVontotheuseofthe‘A3method’forproblemsolving,communicaVon,learning,andleanmanagement.
• “TheLeanStartup”byEricRies–amustreadforentrepreneursandanyonemanagingprojectstocreatesomethingnewundercondiVonsofextremeuncertainty.
• “TheElementsofScrum”byChrisSimsandHillaryLouiseJohnson–asimplebutcomprehensivedescripVonofoneofthemostpopularaspectsofagilemethodsforsoRwaredevelopment
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3WaystoSystemaVcallyAccelerateMedicalDeviceDevelopment
Copyright2016-2017AaronJosephConsulVng 47
1.Leanandagilemethods
+
2.LeveragingHW/SWtechnologyplayorms
+
3.Streamlinedcompliance
(thispresentaVon)
SeehDp://consensiainc.com/zipquality/
ADDITIONAL SLIDES
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Old Way: Product Documenta'on Stored in Documents
RiskAnalysis
SWReqts
TestProtocol
ProductReqts
TestReport
Revisioncontrolperdocument
DHF
Documents are Not a Good Way to Manage Product Documenta'on
ManagingdesignrequirementsandotherproductdevelopmentinformaVonintextorspreadsheetdocuments(MSWordorExcel)isacommonapproachbuthastheseseriousdrawbacks:• TraceabilityisstaVc—becausetracesmustbemaintainedmanually,thesearetypicallydefined
retrospecVvely(aRertheworkisdone)insteadofprospecVvely;traceinformaVonislikelytodegradeoverVmewithchangestotheproduct(post-launch)
• Nosupportforprocessworkflow:whocanchangewhatandwhen?WhatinformaVonmustbelinkedandchangedtogether?
• Difficulttomanagechangespost-launch,toknowallthedocumentsaffectedbyachange• Difficulttosearchacrossdocuments• Changecontrolisperdocument—difficulttotrackwhichrequirementschanged,whochangedthem,and
when• Nowaytoefficientlymanageproductvariantswherethereisalotofoverlapofrisks/requirements/tests
+document-centricapproachtendstoreinforcea“batchmindset”whichiscontrarytoleanandagilemethods
TestProtocol
New Way: Product Documenta'on Stored in a Rela'onal Database
RiskAnalysis
SWReqts
SWTestProtocol
ProductReqts
SWTestReport
Revisioncontrolperdocumentandperelement
DocumentsaregroupingsofDHFelements
PR-1020:Systemshallprovide…
Textofrequirement
TestProtocol
ADributes(status,etc.)
Exportasetofdocumentsfromthedatabaseforsubmissions