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PRACTICALDESIGNCONTROLTRAINING

JohnCrombieUpStartPD,LLC

jcrombie@upstartpd.com

Preparation

• Guidanceforcompanytocreateprocedure

• FDAreferencedocument• ISO13485

• GoalofFDA=Safe&Effective

• RevisionoftheGMP’stoaddressdesign• TheISOequivalenceistheISO13,485

• FrameworkacompanyMUSTbuildupontocreatetheirownspecificprocedure

• Intent=morerigorformorerisk

• Futurerevisions

RiskManagement

• KeydeliverablesorelementsofDesignControl• RiskManagementacrossallelements

• IncorporatedintoNPDProcess

• BasicFDADCProcess

• Requirementsfirst,thendesigns

• Summaryoftheentiredocument

• Unanswerablequestion?UseRiskMgt• RiskMgt=ID,Analyze,Control,Monitor

• Additionalelementsofproductquality

• RenewedFDAfocusduringdesignvalidation

• WhatisaMedicalDevice?Implant,Instrument,Package,andLabel• DifferencesinClassI,II,III?

• FirstdetailedstepnotlimitedtoaGanttChart.

• ProjectManagementbasics

• Projectplanwillreflecttheappropriatelevelofrisk

Design Process

Result!

• DesignInputs=User/Customer/Design/DeviceRequirements• DesignRequirements(DI)aredevelopedintoDesignSpecifications(DO)

• Requirementsbeforedesigns

• TransformUsersNeedsintoEngineeringlevelrequirements(“Strongholdingforce”intofivepoundsoftensilestrength)

• Designrequirementsinputsaretheendresult,notthestartingpoint.

• Prototypestestlimitsofperformanceandgapsinknowledge,tothenrefineDesignInputs.

• Priortosolutions

• Solution-freerequirementsallowsfordifferentdisciplinestodevelopsolutionsfromanewanduniqueperspective

Exercise: Using Solution-Free Requirements From Current Product to New Design User Needs:

•  Body elevated above solid surface below

•  Torso and back supported in upright natural position •  Head positioned to look forward and around •  Legs not fully supporting weight

•  Arms free to move about

•  Comfortable due to cushioned body interface

•  One size fits all

•  Usable for work or leisure

From Current Product to New Design

• Ifaprojecttakes18monthstocomplete,itwouldtake6monthstorefinetherequirementsbeforeidentifyinganysolutions.

• Thedesignoutputwillincludeallphysicalentities

• Devicesshouldbefullydefinedbythespecifications.

• BusinessSpecificationsinpreparationforcommercialization

• TheFDAwillseekdocumentsaswellasthespecificpeoplewhocancommentonthem.

• Techreviewvs.DR

• Mustbecomprehensive

• Howmanyparticipantsneeded?

• Closeouteverything

• “Wemadethepartright”• SpecificationsmeetRequirements

• DifferenceinDesignValidationandProcessValidation(IQ/OQ/PQ)

• Verification(andValidation)cannotoccurinparts• Youshouldconductpre-verificationandpre-validationactivitiesthroughouteachstage.• Atrueverificationandvalidationmustoccurwhenproductionequivalentdevicesareavailable

• Otherexamples

• Lookatthelongimpactofthedevice(FatigueTesting)

• EverycompanyatrackingsystemforDCdeliverables.What’syours?

• “Wemadetherightpart”

• “Objective”evidence,notfromteambias

• “Productionequivalent”partsmustbeused.

• Considersupplychain

• Validateentiremedicaldevice

• CompleteLifeCycleofproductincludingdisposal

• Thedesignspecificationsbecometheprocessrequirementsforthemanufacturertocreateproductionspecifications

• Consideredthesebelow

• Notyourtypicalproductionspecs,butyoumustfullydefinetheproduct.

• Whentransferringyourdesignoutputtothemanufacturesyoumustincorporatemethodsforvalidation

• ThekeytaskofDeignTransfer

• Allchangesmustbetracedanddocumented• Whataboutprototypes?Whatisthepurposeofaprototype?Trackingprototypechangesisimportant

• PriortoandpostDesignTransfer

• Designreviewsmustoccurtoensurethatthetradeoffsareresolved.• Howdoyouanalyzedesigntradeoffs?ByRisk!

• Changecontrolsoccurduringmanufacturing

• TypicallyECR/ECNProcess

• DHFdocumentshowandwhywithtraceability• DMRdocumentsshowhowthedeviceismadeandinspected

• TheDHFislimitedtoFDAauditabledocuments• Theprojectfileisalargerworkingfile• EndofDocument

QUIZ

WHATISTHEDIFFERENCEBETWEENDESIGNVERIFICATION

ANDDESIGNVALIDATION?

jcrombie@upstartpd.com

973-738-4687