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

PATCA-2/9/17 Copyright2016-2017AaronJosephConsulVng 2

Outline1.  TheStoryof2projects(comparinglean-agileapproachto

tradiVonal)2.  AgileSWmethodsadaptedtomedicaldevicesoRware3.  AdapVnglean-agilemethodstoregulatedindustry4.  AdapVngqualitysystemprocedurestosupportlean-agilemethods5.  ConsideraVonsforDHFdocumentaVonandSWtools6.  SummaryandQ&A


Balancing 3 Customers

MedicalDevice

Development

ProductUsers(clinicians&paVents)

Manufacturing

Regulators(FDA,etc.)


TheStory:Real-life(hypotheVcal)Comparison

Walter’sTeam•  Tradi.onal(waterfall)approach

Grace’sTeam•  Lean-AgileapproachNEW!

• CompanywantstodevelopanextgeneraVoninfusionpump

• Keyproductpillars:smaller,lighter,easiertouse

• Aggressiveschedule:24monthstolaunch;16monthstosubmission

•  Twoteams:


Lean: methods to maximize value and minimize waste

Value-Added

TotalWorkPerformed

TypeIWaste(necessary)

TypeIIWaste(unnecessary)

Value-Added TypeIWaste(necessary)

ELIMINATE!


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


Knowledge-Driven Product Development •  Successfulnewproductdevelopmentdemandsdeepknowledgeof:1.  ProductapplicaVon2.  Producttechnology3.  Manufacturingprocesstechnology

•  ForMedicalDevices:4.  RegulatoryApproval(approvalprocessandkey

concernsofregulators)5.  Compliance(requirementsofallapplicable

regulaVonsandstandards)

MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians


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


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


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


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


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



ComparisonStory:Year1-Q1Walter’sTeam

•  Comprehensivedetailedprojectplanning•  Comprehensiveproductrequirementsand

soRwarerequirements•  Performhazardanalysis•  Phase1/Gate1completed✔

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

•  EvaluaVonofnewpumpmechanism•  EvaluaVonofnewbaDery•  EvaluaVonofUIdesigns

•  MulVpletripstohospitalstoobserveuseofdruginfusionpumps

•  SoRwareteamsprintsproducedseriesofroughSWdemosforevaluaVon

Year1 Year2


Agile SoLware Development ExampleofintegraVngnewmethodsintoahighlyregulatedenvironment


Agile has many proven advantages for SW

Agileimproves:•  VisibilityofSWprojectto

stakeholders•  Flexibilityinrespondingto

changinguserneeds•  ManagingSWprojectrisks•  QualityofreleasedSW


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


2-weekSprint

Agile Scrum: Developing SoLware in Short Sprints

ProductBacklog

SprintBacklog SprintTasks

DailyScrum DailyScrum:team

sharesstatusandidenVfiesissues

ReviewofSWwithstakeholders+SprintRetrospec.ve

SprintPlanning:defineworktasksfornextsprint

Highestpriorityfeatures Working

SoRware


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


5.1SWDevelopmentPlanning

5.2SWRequirements

Analysis

5.3SWArchitectural

Design

5.4SWDetailedDesign


5.6SWIntegraVon&

IntegraVonTesVng

5.7SWSystemTesVng

5.8SWRelease

7.RiskMgmt

7.RiskMgmt

7.RiskMgmt

TransposingWaterfalltoAgile(IEC62304MedicalSWStandard)

5.1SWDevelopmentPlanning(sprintplanning)

5.2SWRequirementsAnalysis

5.3SWArchitecturalDesign

5.4SWDetailedDesign


5.6SWIntegraVon&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


Agile Cycles and Design Planning

DayPlan

SprintPlan

ReleasePlan

ProjectPlan•  DesigncontrolsareorganizedaroundmulVplecycles(layers)

•  Project=oneormoreReleases•  Release=oneormoreSprints•  Planningperformedatalllayers•  UVlizesrollingwaveplanning•  RegularupdatestoDHFdocumentaVon


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









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


DesignInputAc.vi.es DesignOutputAc.vi.es



Waterfall(batch)

Agile


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✔•  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


Quality System Adapta'ons MakeyourSOPsandLean-Agilemethodsfittogether


TheFacts:•  Lean-agilemethodsdonotconflictwiththerequirementsofFDAregulaVons,ISO13485,IEC62304,orothermedicaldevicestandards

•  Lean-agilemethodsdoconflictwiththequalitysystemsofmanymedicaldevicecompanies

• Qualitysystemproceduresmustbeadaptedforlean-agilemethodsandlikewisethemethodsmustbeadaptedforcompliance(addiVonaldocumentaVonandapprovalsteps)


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


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


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


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.)


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


The Story Finishes WhatcanwelearnfromWalterandGrace’steams?



•  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


When were design issues iden'fied? •  Lean-Agilemethodsencouragerapid

idenVficaVonofdesignissuesearlyindevelopment(andthereforemorerapidsoluVons)

•  PeakproblemsolvingacVvityinthetradiVonalapproach(blue)happensneartheendofdevelopmentandoRenextendsbeyondthedeadline(“100%”)

BasedonpresentaVonbyTakashiTanaka-LeanSummit2011(LeanEnterpriseAcademy)

Grace’sTeam

Walter’sTeam


TheMoraloftheStory

Walter’sTeam•  Tradi.onal(waterfall)approach

Grace’sTeam•  Lean-AgileapproachNEW!•  Regulatorysubmissionon.me✔•  Productlaunchon.me✔

•  InnovaVvenewproductdevelopmentalwaysinvolvesrisks

•  Focusingearlyeffortsonprojectrisksmakeslaterstagespredictable(fastlearningtocloseknowledgegaps)

•  Aprojectthatisonscheduleduringitsearlyphasesdoesnotmeanitwilldeliveronscheduleattheend


SuccessA

ssured

!

Product Development with “Two Minds”

Concept

LearningDominant

Focuso

fProjectTeam

Prod

uctLau

nch

Planning Pre-Produc.on


TaskDominant

100%

Produc.onDevelopment Verifica.on


Summary “AbadsystemwillbeatagoodpersoneveryVme.”–W.EdwardsDeming


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=$$$


Knowledge-Driven Product Development •  Successfulnewproductdevelopmentdemandsdeepknowledgeof:1.  ProductapplicaVon2.  Producttechnology3.  Manufacturingprocesstechnology

•  ForMedicalDevices:4.  RegulatoryApproval(approvalprocessandkey

concernsofregulators)5.  Compliance(requirementsofallapplicable

regulaVonsandstandards)

MedicalDevices:understandtheclinicalenvironmentandtheneedsofclinicians


Challenges in Adop'ng Lean and Agile Methods

UnderminingLean-AgileMethods:•  DecisionbyHiPPO•  Employeeturnover•  Knowledgehandoffs(scaDer)•  Overloadedengineers•  Responsibilityseparatedfrom

control•  Fear

WhydosomeorganizaVonsfeelthreatenedbytheseprinciplesoflean-agilemethods?•  Designdecisionsbasedonknowledge•  VisualizaVon(transparency)ofproductdevelopment


Lean-AgileMethodsforMedicalDeviceDevelopment

1. Lean-agilemethodsacceleratemedicaldevicedevelopment

2. Iftheteamcan’tsolvethetechnicalchallengeof‘X’thenallotherworkontheproductisuseless

3. Focusonknowledge,notjusttasks

4. MinimizingtesVng=minimizingknowledgegained

5. Qualitysystemproceduresneedtobeadaptedtosupportlean-agilemethods


Two Different Approaches for Product Development

TradiVonal(waterfall)• Designthentest• Upfrontplanning• ManagetaskcompleVon• Worktransferredinlargebatches

• MaximizeuVlizaVon

Lean-Agile•  Testthendesign• Rollingwaveplanning• ManageknowledgecompleVon• Worktransferredinsmallbatchesonacadence

• Maximizethroughput• ConVnuousimprovement


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


3WaystoSystemaVcallyAccelerateMedicalDeviceDevelopment

Copyright2016-2017AaronJosephConsulVng 47

1.Leanandagilemethods

+

2.LeveragingHW/SWtechnologyplayorms

+

3.Streamlinedcompliance

(thispresentaVon)

SeehDp://consensiainc.com/zipquality/

ADDITIONAL SLIDES


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

Lean agile feb2017-patca_a_joseph_ss

Engineering

Transcript of Lean agile feb2017-patca_a_joseph_ss