Pragmatic Device Risk Management


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In this presentation, which was recorded at the 2013 Medical Devices Summit West in San Francisco, David Vogel of Intertech Engineering and Aimee Raymond of Cordis discuss some current problems and solutions in medical device development, including how to:

- Manage the real hierarchy of harms, hazards, and causes
- Prioritize and manage risk
- Implement traceability to ensure risk controls have been implemented correctly
- Deal with overall risk assessment and residual risk

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Pragmatic Device Risk Management

  1. 1. info@inea.comBoston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290Pragmatic Medical Device Risk ManagementCurrent Problems and SolutionsDavid A. Vogel, Ph.D. – President – Intertech Engineering Associates, Inc.Aimee Raymond – Principal Quality Engineer – Cordis®- a Johnson & Johnson company© 2013 – Intertech Engineering Associates, Inc.sponsored by
  2. 2. • David Vogel, Ph.D.President and FounderIntertech Engineering Associates, Inc.Dave has been helping medical device companies bring quality products to market for over 30 years, with a 100%safety record with his company. He has participated in joint AAMI/FDA workgroups to develop standards for validationand risk management, like IEC 62304, TIR32:2004, and TIR36:2007. As an AAMI instructor and respected industryexpert, he was named by MD&DI magazine as one of the “100 Notable People in the Medical Device Industry” in2008.Dave published “Medical Device Software: Verification, Validation, and Compliance” in late 2010, which isconsidered a must-read by most in the medical device industry, especially since it’s much easier to read andunderstand than our government regulations and recommendations.• Aimee RaymondPrincipal Quality EngineerCordis®- a Johnson & Johnson companyAs a Bay-area professional with over 20 years of experience in product development and systems engineering,Aimee has helped bring many medical products to market with an emphasis on good processes and strong qualitycontrol. Armed with a Six Sigma Black Belt, she has been successful with deriving requirements and driving them tomeasurable data points for better decision making in the development of her projects. As part of her current role atCordis, she has implemented an integrated and traceable solution for design and risk control.Aimee recently received a Masters of Science in Systems Engineering.About Speakers© 2013 – Intertech Engineering Associates, Inc.
  3. 3. More detail …3© 2013 – Intertech Engineering Associates, Inc.Much of the content of this talk is covered in more detailin Chapters 8 and 18 of this textbook.For more information, see
  4. 4. Zoom Out on Risk Management• Do we as an industry really know what weare doing with Risk Management?• With all the regulatory “help”, standards,technical information reports, guidances,webinars, workshops … has the industryreally improved?© 2013 – Intertech Engineering Associates, Inc.
  5. 5. Why Formal Risk Managementis Needed1. As a design and development tool2. As a focus for continued post-market attention to RM3. As a communication toola. Internallyb. With regulatorsWhich of these makes the devices safer?Which are necessary for compliance?Which do many companies worry about more?© 2013 – Intertech Engineering Associates, Inc.
  6. 6. Many Types of Risk• Safety Risk• Business Risk– Project Risk– Sales and Marketing Risk– Image and Reputation Risk• Regulatory Risk© 2013 – Intertech Engineering Associates, Inc.
  7. 7. Risk Hierarchy14971 Standard defines or mentions:– Risk– Hazard– Hazardous Situation– CauseReal projects easily identify complexhierarchies that don’t fit these definitions© 2013 – Intertech Engineering Associates, Inc.
  8. 8. Requirements & RiskWork Together Requirement management drivesproduct development User Needs/Intended Use [UR]-> Product Requirements [DI]-> Detail Design Specification [DO]-> PRC, DWG, BOM, DOC (code) Risk management asks what happens ifthe requirement is not satisfied
  9. 9. Typical Requirement CascadeRequirementDocumentSample RequirementIntended Use to improve long-term vascular patency followingangioplasty by releasing drug locally into the vesselwall to inhibit neointimal hyperplasia.User Requirement[UR]Stent reservoirs must contain similar drug API dosageas current marketed product.ProductRequirement [DI]Provide API drug dose of X.X µg/mm2Detail Design [DO] Every reservoir contains Y.YYY µg of drug.API concentration in drug solution shall be ZZ%Process Spec[PRC]Deposit X layers of drug solution.Place Y to Z drops of drug solution per reservoir perlayer.
  10. 10. Risks Cascade via Cause & EffectRequirementDocumentRiskDocumentLinks ToEffectLinks FromCauseExampleEffectExampleCauseIFU Harms list PatientharmedNot (UR) Increase inneohyperplasiaNot X.Xµg/mm2User Need(UR)aFMEA Not (UR) Not (DI) Not X.Xµg/mm2drugNot Y.YYµg/reservoirProd Req (DI) dFMEA Not (DI) Not (DO) Not Y.YYµg/reservoirBad sealDetail Design(DO)pFMEA Not (DO) Not (PRC) Bad seal Open crimpsProcess Spec(PRC)Control Plan Not (PRC) Not (RCM) Open crimps Crimp force <Z.zControls(RCM)Not(RCMl) Crimp force <Z.zWrong pingage
  11. 11. Advanced RM ToolsMake it Happen in Real-TimeConfigure the Requirement Types,Custom Data Fields and the Link Types
  12. 12. Lack of Requirements Corrupts Without requirements, then nothing totrace Between requirement types To testing To risks & issues To changes Risks are another type of requirement Traces are the glue holding the systemtogether
  13. 13. Questions for YouHas anyone ever heard of someone “fudging” therisk priority numbers?Why do “they” do that?Maybe something is wrong with the way weprioritize risks© 2013 – Intertech Engineering Associates, Inc.
  14. 14. The FMEA Model is Overused• Risk = “combination of Severity (S) andProbability (P)”• Often Detectability (D) also included• Quantitative FMEA calculates Risk PriorityNumber (RPN) asRPN = S x P x f(D)• Risk controls are prioritized based on RPN© 2013 – Intertech Engineering Associates, Inc.
  15. 15. What’s Wrong with Severity?Common Severity Scale1. Discomfort2. Reversible Injury3. Permanent Injury4. DeathScaling is linearIf you would pay me $1 not to pinch you (discomfort),would you only pay me $4 not to kill you?© 2013 – Intertech Engineering Associates, Inc.
  16. 16. What’s Wrong with Probability?• Historically used for probability of processfailure, mechanical failure, electricalfailure, where probability has real meaningbased on measurements or experience.• Design failure (esp. software) is theprobability that the engineer made amistake … what kind of number do we puton that?© 2013 – Intertech Engineering Associates, Inc.
  17. 17. Detectability• Holdover from Process FMEA, with built inassumption that trained process operatorsknow remedial action upon detection.• Very often misapplied to devices– Detectability is worthless unless a correctiverisk control is triggered in response.– A car rolling over a cliff ishighly detectable, but …© 2013 – Intertech Engineering Associates, Inc.
  18. 18. Risk Quantification Templates Templates for Probability of Occurrence (Po)and Consequence of Occurrence (Co)Consequence ofOccurrenceLow Minor Moderate Significant HighProductPerformanceImpactNo illness or injury topatient or user(inconvenience; delay tostart; procedure wassuccessful, but slow toperform).May cause transient self-limiting illness or injury topatient or user (fever,bruise, or other conditionnot requiring medicalintervention).May cause significant butrecoverable injury topatient or user (allergicreaction, or othercondition requiringmedical intervention).May cause permanentimpairment to patient oruser (loss of limb orbodily function).Potential for death.Failure in the device orthe procedure can lead topatient or user death.Regulatory ImpactPotential for issueresolvable with normalquality systemprocedures.Potential for minordeficiency or violation ofquality system.Potential for regulatorywarning, product deemedmisbranded oradulterated.Potential for significantregulatory observation,including warning letterPotential recall regardlessof clinical severity.Potential adverse impactto regulatory status ofproductSchedule ImpactImpact to project criticalpath < 1 monthImpact to project criticalpath >= 1 monthImpact to project criticalpath >= 3 monthsImpact to project criticalpath >= 6 monthsImpact to project criticalpath >= 12 monthsCost ImpactCost variance < 10% or <0.1M USD of total budgetCost variance >= 10% or>= 0.1M USD of totalbudgetCost variance >= 20% or>= 1M USD of totalbudgetCost variance >= 50% or>= 5M USD of totalbudgetCost variance >= 100% or>= 10M USD of totalbudgetProbability ofOccurrenceA B CProbability of RootCause OccurringLikely Maybe Remote
  19. 19. Risk Scoring Matrix Customize Risk Quantification templates Risk Score Matrix based on Probability ofOccurrence (Po) and Consequence ofOccurrence (Co)ConsequenceProbabilityA B CLow 1 1 2Minor 1 2 3Moderate 2 3 4Significant 3 4 4High 3 4 5  High  Moderate  Low
  20. 20. How Do You Know You HaveAddressed All Risks in Your DeviceRisk Management Process is effective inplanning risk controls How can you know that the controls havebeen implemented … correctlyTraceability can be the answer. How isthat implemented?
  21. 21. Integrated RM Tools Give Visibility Apply Risk Score to each hazard Consider number of “AND” conditions Apply Bayes’ Theorem of conditional probabilities
  22. 22. Dealing with OverallRisk Assessment• 14971 – “There is no preferred method forevaluating overall residual risk and themanufacturer is responsible fordetermining an appropriate method”That is … you’re on your own.• For some reason, devices don’t deal withresidual risk as objectively as pharma …there seems to be a presumption ofachievable perfection© 2013 – Intertech Engineering Associates, Inc.
  23. 23. info@inea.comBoston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290Questions & AnswersStop by Seapines booth in the exhibit hall for your chance to win an iPad Mini!All you have to do is complete a brief, three-question survey.© 2013 – Intertech Engineering Associates, Inc.sponsored by