Designing safety critical medical devices


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Sebastien Cuvelier Mussalian presented at a joint QNX/ARM conference on designing safety critical medical devices in June 2011

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Designing safety critical medical devices

  1. 1. Designing Safety Critical Medical DevicesSebastien Cuvelier Mussalian
  2. 2. SummaryTeam Consulting, Who we are, What we do?Case Study: Normothermic Liver Perfusion System Class III Investigative DeviceA bright idea that worksIntellectual property, business plan & fundingProduct design lifecycleRegulatory frameworkFDA submission recommendationThe importance of human factorsMedical system architecture
  3. 3. Team Consulting – Who are we, What we do
  4. 4. Team Consulting - Why Us Injectors Inhalers Nasal drug delivery Dermal Dispensing and packagingCompliance monitoring Diagnostics Medical technology Research instrumentation Metrology Surgical Implantables Regenerative medicine Optyse Services
  5. 5. Team Consulting - Why UsWe can handle the whole jobA broad team with broad skillsWe understand the industryLife science specialistsEnsuring appealing productsthat workWe balance creativity with rigourWe can plan a project tomeet your requirementsExperienced and flexible
  6. 6. Team Consulting – Our Team
  7. 7. Team Consulting - Established & Global • Established 1986, based in Cambridge UK ISO: 13485 2003 9001 2000 • Working with global client base • Leading healthcare entirely focused in lifesciences
  8. 8.
  9. 9. Regenerative Medicine:Normothermic Liver Perfusion SystemPrototype system design and development Development consistent with performance, cost, usability, regulatory and transport needs System enables organ auto-regulation, perfusion and oxygen delivery for metabolism at body temp Led development of new technologies, and integration with established technologies Utilised embedded, safety critical control systems with advanced GUI Achievement of quality delivery against budget and timescales releases next funding tranche
  10. 10. Regenerative Medicine:Normothermic Liver Perfusion System
  11. 11. Regenerative Medicine:Normothermic Liver Perfusion System
  12. 12. US Clinical Research OrganisationMedtech: Class III Investigative DeviceSystem design and development Replacement required for out-dated clinical research devices – equivalence essential Integration of new and established technologies, with established user interaction and procedures Includes in-line use of electro-chemical sensor for continual blood parameter monitoring Utilises embedded, safety critical control systems with advanced GUI Data integrity 21 CFR Part 11 compliant
  13. 13. US Clinical Research OrganisationMedtech: Class III Investigative Device
  14. 14. A bright idea that worksWhat have you got? Successful research results New scientific discovery Something that you have developed for another market but could find an application in the medical market. A new procedure A new tool As far as a proof of conceptWe have something that we believe in…
  15. 15. Intellectual PropertyBusiness PlanProject BriefQuote & proposalsFunding
  16. 16. Product design lifecycle
  17. 17. Regulatory Framework US & EU Framework – FDA Vs. CE marking 510k vs. PMA, 90d vs. 1yr Must be defined at the beginning and on- going process Define your medical classification Build your Design History File Use of requirement tracking system and test procedure Risk mgt file (60601 3rd ed) Beware of SOUP Design for clinical trials
  18. 18. FDA submission recommendations
  19. 19. FDA submission recommendationConcise Claims – Step by step approachClinical Trial in the USDiscuss Clinical Trial before submissionDiscuss Statistics before submissionContract a statisticianEnsure trials compare with an FDA predicate– Think equivalenceBe patient, work with the FDA so they buildup trustBe ready for delay in project plan – 90 daysmeans 90 days when the FDA are workingAppoint a regulatory manager Recommendation from presentation Barrie Hayes-Gill, Monica Healthcare
  20. 20. The importance of human factorsHE 75 … new AAMI standardISO 62366User Research Who is my end user? What functions do users need? What do they want it to look like? Does it fit with my regulatory approval?Usability Research Can they use the functions? What kind of user interface? Does it fit with my regulatory approval? Exploratory Research & Statistical Research
  21. 21. Medical system architecture
  22. 22. If you have any questions please contact usTel: +44 (0) 1799 532768Email: scm@team-consulting.comThank