Webinar: Agile Design Controls Part 3

PaperlessV&VtoSupportRapidDesignItera6onswithMedicalDevices

April30,2019

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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

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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

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Wolfgang Huber Co-Founder - Matrix Requirements GmbH •  FounderMatrixRequirements•  15+yearsmanagingmedicaldevicedevelopment•  10+yearsdevelopingversioncontrolanddocumentmanagementsystems•  30yearsexperienceprofessionalso^waredevelopment•  Earlyadaptorofagilemethodologies• M.Sc.ComputerScience–KarlsruheUniversity•  BasedinMunich,Germany||Beziers,France

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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