Design for Agile Manufacturing: Product Design Principles ...
Webinar: Agile Design Controls Part 3 · 2019. 4. 30. · Webinar: Agile Design Controls Part 3 ......
Transcript of Webinar: Agile Design Controls Part 3 · 2019. 4. 30. · Webinar: Agile Design Controls Part 3 ......
Webinar: Agile Design Controls Part 3
PaperlessV&VtoSupportRapidDesignItera6onswithMedicalDevices
April30,2019
30-APR-2019 Copyright2019|MatrixRequirementsGmbH|SunstonePilot,Inc. 1
ArnaudAlberts WolfgangHuber AaronJosephMatrixRequirementsGmbH MatrixRequirementsGmbH
SunstonePilot,Inc.
Aaron Joseph Principal Consultant – Sunstone Pilot, Inc.
• 20+yearsmedicaldevicedevelopmentoverawiderangeofproducts:• surgicalrobo6cssystems,digitalx-rayfluoroscopysystem,druginhalerdevices,robo6ccathetersystem,x-raycatheterforbrachytherapy,lasereyesurgerysystem,heart-lungbypassmachine,andmul6plewearable/IOTdevices
• Assistclientswithallaspectsofdesigncontrols:riskmanagement,requirementsmanagement,V&Vtes6ng,refiningdesigncontrolsprocedures,andtrainingR&Dstaff• Avidpromoterofleanandagilemethodsformedicaldevicedevelopment• BSEE-RiceUniversityandMSBioengineering-UniversityofWashington• BasedinSiliconValley
2Copyright2019|MatrixRequirementsGmbH|SunstonePilot,Inc.30-APR-2019
Arnaud Alberts Growth Manager – Matrix Requirements GmbH
• Helpingmedicaldevicecompaniestobuildtheirdeviceinanagilewayfacilita6ngthemanagement,thedocumenta6onandthecer6fica6onoftheirproductwithMatrixRequirementsapplica6ons.• QAengineerandProductManagementinaStartupMedicalDevicecompany
• Hardware+so^wareclass2MedicalDevice• BuildingtheQAsystemformarketintroduc6on• Valida6on,Riskassessmentandtes6ng• Productenhancement,releases,documenta6on
• M.Sc.Bio-Engineering–ULBBrussels• BasedinBrussels-Belgium
3Copyright2019|MatrixRequirementsGmbH|SunstonePilot,Inc.30-APR-2019
Wolfgang Huber Co-Founder - Matrix Requirements GmbH • FounderMatrixRequirements• 15+yearsmanagingmedicaldevicedevelopment• 10+yearsdevelopingversioncontrolanddocumentmanagementsystems• 30yearsexperienceprofessionalso^waredevelopment• Earlyadaptorofagilemethodologies• M.Sc.ComputerScience–KarlsruheUniversity• BasedinMunich,Germany||Beziers,France
4Copyright2019|MatrixRequirementsGmbH|SunstonePilot,Inc.30-APR-2019
Webinar Outline 1. Shortcomingsoftradi6onalV&Vtes6ngonpaper2. Structuringrequirementsandtes6ngforV&V3. TestmanagementwithMatrixALMandJira4. Examplechangescenarioandre-tes6ng5. Computersystemvalida6on6. Q&A
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V&V TesOng Challenges • Highlytechnicalandprocessintensive(cross-func6onalsynchroniza6on)• Modern,so^ware-intensivemedicaldevicesmakeV&Vevenmoredifficult:• Greatercomplexity• Moreso^warecomponents• Morechangeslateindevelopmentanda^erproductlaunch
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DesignVerifica6on:ShowthatdesignoutputsconformtodesigninputsTestagainstdesignrequirements“Didwemakethedeviceright?”
DesignValida6on:ShowthatdesignmeetsuserneedsClinicaltes6ngorsimulatedclinicalusage“Didwemaketherightdevice?”
TradiOonal V&V TesOng on Paper
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Paperisdifficult!Shortcomings:• Errorprone--poorhandwri6ng,crossedouttestresults,resultswrimeninwrongplace
• Needtoscanpapersandamachtotestreports
• Difficulttotranslateintootherlanguages• Cannotelectronicallysearchresults
?
Test Report Generated by a Test Management Tool
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New Way: Product DocumentaOon Stored as Objects Export a set of docum
ents from the database
for submissions
DocumentsaregroupingsofDHFelements
SW Requirements
Risk Analysis
Product Reqts
SW Test Protocol SW Test Report
PR1020: System shall provide …
Text of requirement
AZributes (status, etc.)
Revision control per document and per element
TestProtocol
TestProtocol
Dynamic management of product data
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Example Connected Medical Device
Firmwareonwatch
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• Wearabledevice+mobileapp+cloud• Heartmonitor(includinganalysisofotherpa6entdata)• Distributedarchitecturewithmul6pleso^wareplaqorms
Mobileapponsmartphone
Dataanalysisandstorageoncloudplaqorm
Browserorclientapponlaptop
V-Model integrated in Matrix tree
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V-Model integrated in Matrix tree
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V-Model integrated in Matrix tree
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V-Model integrated in Matrix tree
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V-Model integrated in Matrix tree
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So]ware Trace Matrix
andre-tes6ng
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Design Changes with Example Medical Device
Firmwareonwatch
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Mobileapponsmartphone
Dataanalysisandstorageoncloudplaqorm
Browserorclientapponlaptop
Change:lateindevelopment,theteamdiscoversaproblemduringusabilitytes6ng(FAILURE)ànecessitateschangestoGUIonwatchandsmartphoneandretes6ng
DHFdocuments
ValidaOon Test failed
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SPEC updated, TC verificaOon
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Prepare for new Test Run
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DocumentaOon: V&V Plan
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DocumentaOon: Summary report
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DocumentaOon: E-signature
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Computer System ValidaOon • Valida6ngSWtoolsusedingenera6ngandapprovingdesigncontrolsdocumenta6on• Needtovalidatesystemandmaintainavalidatedstate
• CompliancewithFDAPart11forelectronicrecords&electronicsignatures• RelyingonSWtooltoprovide“objec6veevidence”todemonstratesafeandeffec6vemedicaldevice• Userisk-basedapproachtoplanthevalida6on
Goodguide:AAMITIR36:2007ValidaBonofSoDwareforRegulatedProcesses
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Summary • PaperlessV&V:
• Recordtestresultselectronicallyinsteadofonpaper• SWtools:integratedtestmgmtwithrequirementsmgmt• Highlyconfigurablerepor6ngtogenerateDHFdocumentsautoma6cally,includingtracematrix• Electronicsignaturesandaudittrail(FDAPart11compliant)
• Integra6onoftes6nganddefecttracking• Structuredrequirementstosupportrigorousre-tes6ng• Well-definedproceduresforSWconfigura6onandreleasemgmt
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Arnaud Alberts Wolfgang Huber Matrix Requirements GmbH - matrixreq.com
Aaron Joseph Sunstone Pilot, Inc. - sunstonepilot.com
Q & A