Accelerating Medical Device Development While Improving Compliance

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

Copyright2016AaronJosephConsulGng 2

LeanandagilemethodscanaddressalloftheseproblemsbutincorporaGngthemintothehighlyregulatedmedicaldeviceindustrypresentsmulGplechallenges

Outline1.  TheStoryof2projects(comparinglean-agileapproachto

tradiGonal)2.  AgileSWmethodsadaptedtomedicaldevicesoQware3.  AdapGnglean-agilemethodstoregulatedindustry4.  AdapGngqualitysystemprocedurestosupportlean-agilemethods5.  ConsideraGonsforDHFdocumentaGonandSWtools6.  SummaryandQ&A


Balancing 3 Customers


MedicalDevice

Development

ProductUsers(clinicians&paGents)

Manufacturing

Regulators(FDA,etc.)

TheStory:Real-life(hypotheGcal)Comparison


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?


Concept Planning Pre-Produc.on Produc.onDevelopment Verifica.on

Knowledge-Driven Product Development


•  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

$$$$$$$


Problems with Tradi'onal (waterfall) Approach

GAT

E

GAT

E

GAT

E

GAT

E

Comparison: A Story of 2 Projects Areal-lifeexampleof(hypotheGcal)productdevelopmentproject


TheStory:Real-life(hypotheGcal)Comparison


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


Grace’sTeam•  Beginhigh-levelprojectplanning•  BeginwriGngpreliminaryrequirements•  Performhazardanalysis•  IdenGficaGonofknowledgegaps:

•  PlantesGngofnewpumpmechanism•  PlantesGngofnewbaAery•  PlantesGngofUIdesigns

Year1 Year2

+Setupproject“WarRoom”(obeya)

Expensive!TesGngusesupGmeandscarce

resources


ComparisonStory:Year1-Q1Walter’sTeam

•  Comprehensivedetailedprojectplanning•  Comprehensiveproductrequirementsand

soQwarerequirements•  Performhazardanalysis•  Phase1/Gate1completed✔


Grace’sTeam•  High-levelprojectplanning•  Preliminaryrequirementsandhazardanalysis•  Closingknowledgegaps:

•  EvaluaGonofnewpumpmechanism•  EvaluaGonofnewbaAery•  EvaluaGonofUIdesigns

•  MulGpletripstohospitalstoobserveuseofdruginfusionpumps

•  SoQwareteamsprintsproducedseriesofroughSWdemosforevaluaGon

Year1 Year2

Agile SoKware Development ExampleofintegraGngnewmethodsintoahighlyregulatedenvironment


Agile has many proven advantages for SW


Agileimproves:•  VisibilityofSWprojectto

stakeholders•  Flexibilityinrespondingto

changinguserneeds•  ManagingSWprojectrisks•  QualityofreleasedSW

The Agile Manifesto (2001)


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


5.6SWIntegraGon&

IntegraGonTesGng

5.7SWSystemTesGng

5.8SWRelease

7.RiskMgmt

7.RiskMgmt

7.RiskMgmt

TransposingWaterfalltoAgile(IEC62304MedicalSWStandard)

5.1SWDevelopmentPlanning(sprintplanning)

5.2SWRequirementsAnalysis

5.3SWArchitecturalDesign

5.4SWDetailedDesign


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


Agile Cycles and Design Planning


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









DesignInputAc.vi.es

DesignInputAc.vi.es

DesignInputAc.vi.es

DesignInputAc.vi.es

DesignInputAc.vi.es

… …


DesignOutputAc.vi.esDesignInputAc.vi.es





Waterfall(batch)

Agile

Copyright2016AaronJosephConsulGng

The Story Con'nues “Aninvestmentinknowledgepaysthebestinterest”–BenjaminFranklin


SuccessA

ssured

!

Knowledge First (then everything else)

Concept

LearningDominant

Focuso

fProjectTeam

Prod

uctLau

nch

Planning Pre-Produc.on



TaskDominant

100%

Produc.onDevelopment Verifica.on


•  Hardwaredesigncompleted(mech/elec)✔•  Prototypebuildcompleted✔•  SoQwareteamdoingintegraGon•  Detailedriskanalysiscompleted(dFMEA)✔•  Testmethoddevelopmentunderway•  Manufacturingprocessdevelopmentunderway,

includingqualificaGonofsuppliers•  PreparingdocumentsforGate2


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


TheFacts:

26

•  Lean-agilemethodsdonotconflictwiththerequirementsofFDAregulaGons,ISO13485,IEC62304,orothermedicaldevicestandards

•  Lean-agilemethodsdoconflictwiththequalitysystemsofmanymedicaldevicecompanies

• Qualitysystemproceduresmustbeadaptedforlean-agilemethodsandlikewisethemethodsmustbeadaptedforcompliance(addiGonaldocumentaGonandapprovalsteps)


Design Controls – Elements

DesignPlanning

DesignTransfer

DesignOutput

DesignInput

DesignValida.on

DesignReviewUser

Needs

DesignVerifica.on

27Lean/agile/hybridapproachesvsWaterfall–companieshaveflexibilityinimplemenGngregulaGons


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


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


PhaseswithoutGates•  PhasesorganizelargenumbersofinterrelatedacGviGesanddeliverables(good!)

-BUT-•  “RigidGates”(determiningwhetherteamcanproceed)assumeproductdevelopmentispurelysequenGalandinsGtutebatchedhand-offswherelotsofworkandlotsofknowledgeistransferredatoneGmeacrossgroups:


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.)


DesignHistoryFile(DHF)•  DHFshouldserveasaknowledgerepository,notjustcompliancedocumentaGon

•  IncluderaGonalefordesignrequirements,backgroundfortestmethods,etc.•  OrganizeforeasyretrievalofinformaGon(searchable,cross-linked)

•  ManageDHFdocumentaGonsothatworkcanbedoneonmanydocumentssimultaneously(de-centralized)withmanyiteraGons,whilesGllmaintainingintegrityandconsistencyandtraceability

•  IteraGonsduringearlydevelopmentcanimprovecompliance:•  Everyonelearnsmoreaboutthequalitysystemprocesses•  Helpsensurethefinaloutputiscompleteandconsistent•  Methodscanberefinedasneededbeforeproductisfinalized

•  ExponenGalincreaseincompliance/documentaGoneffortnearproductlaunch(don’titerateatthispoint!!!)


=relaGonaldatabase

The Story Finishes WhatcanwelearnfromWalterandGrace’steams?



•  Phase2/Gate2completed✔•  Phase3integraGontesGngandsystemtesGng

revealedproblemwithbaAeryoverheaGng;teamhasbeguninvesGgaGngalternaGvedesigns

•  SoQwaretesGngrevealedalargenumberofbugs(SoQwareteamnowfixingthem)

•  HumanfactorstesGngdelayedunGlSWfixed•  TestprotocolsbeingwriAenforV&VtesGng•  ManufacturingprocessdevelopmentconGnuing


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?


•  Lean-AgilemethodsencouragerapididenGficaGonofdesignissuesearlyindevelopment(andthereforemorerapidsoluGons)

•  PeakproblemsolvingacGvityinthetradiGonalapproach(blue)happensneartheendofdevelopmentandoQenextendsbeyondthedeadline(“100%”)

BasedonpresentaGonbyTakashiTanaka-LeanSummit2011(LeanEnterpriseAcademy)

Grace’sTeam

Walter’sTeam

DiscoveringproblemslatermeanstheyhavetobefixedlaterwhichleadstolotsoflastminutefirefighGng.ThisnotonlydelaysthatproductbutalsounderminesthenextproductdevelopmentprojectbecausekeyresourcesarebusyfirefighGng.

TheMoraloftheStory


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


IsItReallyFaster?KeywaysthatLean-AgilemethodsshortenGmetomarket:1.  IdenGfyknowledgegapsearlyandtacklethem

aggressively(avoidlate-breakingproblemsthatleadtobigdelays)

2.  Atamedicaldevicecompanylate-breakingproblemscantriggeracascadeofissues—canleadtoregulatoryproblemsontopoftechnicalproblems(re-submit,etc.)

3.  FrequenttesGngandfeedbacktofinddesigndefectsearlyandadjustdevelopmentaccordingly

4.  OnlyspendGmeonwhatcustomersreallyneedandwant(freeupengineeringGmefromnon-valueaddedtasks)


+therearemorewaysthatLean-Agilemethodsaccelerateproductdevelopmentwhicharenotasstraighzorwardtosee(e.g.,beAercommunicaGon,increasedmoGvaGon,processopGmizaGon,etc.)

CostofDelay=$$$

Knowledge-Driven Product Development


•  Successfulnewproductdevelopmentdemandsdeepknowledgeof:1.  ProductapplicaGon2.  Producttechnology3.  Manufacturingprocesstechnology

•  ForMedicalDevices:4.  RegulatoryApproval(approvalprocessandkey

concernsofregulators)5.  Compliance(requirementsofallapplicable

regulaGonsandstandards)

MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians

Challenges in Adop'ng Lean and Agile Methods


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


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


1.Leanandagilemethods

+

2.LeveragingHW/SWtechnologyplazorms

3.Streamlinedcompliance

(thispresentaGon)

ADDITIONAL SLIDES


Two Different Approaches for Product Development

TradiGonal(waterfall)• Designthentest• Upfrontplanning• ManagetaskcompleGon• Worktransferredinlargebatches

• MaximizeuGlizaGon

Lean-Agile•  Testthendesign• Rollingwaveplanning• ManageknowledgecompleGon• Worktransferredinsmallbatchesonacadence

• Maximizethroughput• ConGnuousimprovement


Lean Principles: Value & Waste

Value-Added

TotalWorkPerformed

TypeIWaste(necessary)

TypeIIWaste(unnecessary)

Value-Added TypeIWaste(necessary)

ELIMINATE!


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

Accelerating Medical Device Development While Improving Compliance

Devices & Hardware