2010 10 07 Octane Ofi Presentation

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Octane OFI Presentation given by Blaine Murakami and Jahnavi Lokre at Aubrey Group (10/07/2010)

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2010 10 07 Octane Ofi Presentation

  1. 1. 10/10/2010 From Bench to BedsideRapid Medical Device Development Strategies OCTANe Foundation for Innovation Building Blocks Series October 7, 2010 1
  2. 2. 10/10/2010Overview Define the medical device product development model Statistics Takeaway Points Goal: Help entrepreneurs develop strategies that accelerate their medical device development and commercialization10/07/2010 2 2
  3. 3. 10/10/2010Medical Device Development Model “Study on Medical Device Development Models.”  Prepared for InHealth – The Institute for Health Technology Studies  September, September 2007  Stanford Biodesign (Linehan J.H., Pate-Cornell E., Yock P., Pietzsch J.B. )  Link: http://www.inhealth.org/doc/PDF.asp?PageID=DOC000016 Stage-Gate Process for the Development of Medical Devices g p  Journal of Medical Devices  Pietzsch J.B., Shluzas L.A  June 2009 (Vol 3, Issue 2)  Link: http://asmedl.aip.org/getabs/servlet/GetabsServlet?prog=normal&id=JMDOA4000003000002021004000001&idtype=cvips&gifs=Yes&ref= no Stanford Biodesign  Link: http://biodesign.stanford.edu/bdn/index.jsp10/07/2010 3 3
  4. 4. 10/10/201010/07/2010 4 -” Medical Device Development Models” Stanford Biodesign 2007 4
  5. 5. 10/10/2010Phase I - Initiation Market Opportunity Competitive Analysis p y IP Freedom to Operate Regulatory Approach Reimbursement Path10/07/2010 5 5
  6. 6. 10/10/2010Regulatory Review – FDA (US) Classification  Class I, II or III  Design Control Requirements Based on Classification  Link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/UCM051668 Regulatory Pathway  Exempt  510(k)  Traditional, Special, Abbreviated, De Novo , p , ,  Predicate Device  Clinical Data Required  Pre-Market Approval  Humanitarian Device Exemptions (< 4000 new cases/yr) Risk Analysis  Risk G id Ri k Guidance Document – ISO 14971 2007 D t 14971:2007  FDA – Medical Device Reporting (MDR) Review of Similar Devices  Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm?searchoptions=110/07/2010 6 6
  7. 7. 10/10/2010Regulatory Review – Europe Medical Devices Directive 93/42/EEC (MDD)  Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)  Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF In-Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)  Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20090807:en:PDF Classification (Annex IX)  Class I, IIa, IIb, III CE Mark10/07/2010 7 7
  8. 8. 10/10/2010Marketing/Reimbursement Review What you should consider:  Who will pay for your product?  Patient paid  User paid  Medicare/Medicaid/Insurance Reimbursement  How are they incentivized to purchase your product?  How will you distribute your product?  What is the distribution business model?  What is the purchased good?  Pay per use?  Disposable or capital equipment + disposable?  Reusable?  What is your reimbursement plan?  Is there an existing reimbursement code?  CCenters f M di t for Medicare & Medicaid Services (CMS) M di id S i  American Medical Association – Current Procedural Terminology (CPT)  CPT Lookup Link: https://catalog.ama-assn.org/Catalog/cpt/cpt_home.jsp10/07/2010 8 8
  9. 9. 10/10/2010Phase II - Feasibility Core Team Feasibility and Risk Reduction y Voice of the Customer  Clinical Advisory Board10/07/2010 9 9
  10. 10. 10/10/2010Risk Reduction Technology Risk  Define the high risk technical challenges and address those risks first  Sometimes risks should be addressed individually instead of at the system level Manufacturing Risk  Integrate design for manufacturing requirements into product design  Develop supply chain requirements including audit of critical suppliers  Determine long-lead time parts and materials and investigate potential electronic part obsolecence Regulatory Risk  Initiate preliminary meetings with FDA prior to submission of approval material  Meet with safety agency representative to review development strategy Adoption Risk  Solicit feedback from clinical reviewers (voice of the customer) Intellectual Property Risk Reimbursement Risk10/07/2010 10 10
  11. 11. 10/10/2010Voice of the Customer Clinician/User Review Board  Solicit early feedback on use of the device  Involve clinicians/users in cadaver/animal/bench studies User Workflow  Surgeons are increasingly impatient with device operation  Think end-to-end  How does the device get to the user?  How is it un-packaged and presented to the user?  Is it compatible with other common devices/tools?  How is it cleaned? User Interface  Similar to existing tools, technologies aids acceptance  Simple!  Compliance to required standards (alert, alarm requirements, etc.)10/07/2010 11 11
  12. 12. 10/10/2010Phase III – Design Dev. And V&V Define Requirements Allocate Resources Device Design and Development  Research Vs. Development Paradigm Operating Under Formal Design Controls – Design History File Design For Manufacturing Verification and Validation Regulatory/Safety Submission10/07/2010 12 12
  13. 13. 10/10/2010Design Paradigms Research Development •Brainstorming •Design Controls •Multiple Test Outcomes Multiple •Pass Fail Test Outcomes •Rapid Change •Limited Change10/07/2010 13 13
  14. 14. 10/10/2010Design Paradigms - Research Marketing Technology Idea Approach Re Re- Product Definition IP imbursement Voice of Regulatory Customer10/07/2010 14 14
  15. 15. 10/10/2010Design Paradigms - Development Design g Design Design Input i Output10/07/2010 15 15
  16. 16. 10/10/2010Design Paradigms - Development Regulatory R l t Technology Design Design Input i Output Marketing M k ti10/07/2010 16 16
  17. 17. 10/10/2010Allocate Resources What resources do I need?  Capabilities?  Systems?  Approvals? Do I hire or do I outsource? What to look for?  Individual Consultants or T I di id l C l Team? ?  Manufacturing Capability?10/07/2010 17 17
  18. 18. 10/10/2010Prototypes/Builds Understand the purpose of prototypes/builds  Different uses require different levels of control  Clinical prototypes require traceability Determine minimum required features for product release Determine features that can be added as letters to file vs. new approval submission to FDA When is a new 510(k) necessary?  Link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080243.pdf10/07/2010 18 18
  19. 19. 10/10/2010Industrial Design Source: Aubrey Group, Inc. Source: Aubrey Group, Inc.10/07/2010 19 19
  20. 20. 10/10/2010Phase IV and V – Product Launch and Post Market Activities DHF Complete Manufacturing and Operations scale up g p p Marketing branding Establish distribution channels Obtain regulatory approval Finalize reimbursement strategy Product enhancements Post market surveillance Continued clinical validation10/07/2010 20 20
  21. 21. 10/10/2010Planning for Features Are you a one product company? Differentiate “new features” from “new products” p Be planning the evolution of your product  Market future add-ons?  Develop a Next Generation Product?  Develop a Product Platform?10/07/2010 21 21
  22. 22. 10/10/2010Some Statistics Design Controls  20-30% of the total development resources Development Time  3 to 9 months for a Class I device  6 to 12+ months for a Class II device  24 to 36+ months for a Class III device Source: Aubrey Group, Inc.10/07/2010 22 22
  23. 23. 10/10/2010Typical Phase III Breakdown 7% Requirements 14% Definition Engineering Design 9% Prototype test, Verification d V ifi i and Validation Manufacturing 49% Development & 21% Transfer Project Managemnt, Quality & Support Source: Aubrey Group, 201010/07/2010 23 23
  24. 24. 10/10/2010Functional Breakdown per Phase Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign10/07/2010 24 24
  25. 25. 10/10/2010FDA Approval Type Distribution -”Office of Device Evaluation Annual Performance Report FY09” FDA10/07/2010 25 25
  26. 26. 10/10/2010FDA Approval Type Distribution Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign (From FDA Data)10/07/2010 26 26
  27. 27. 10/10/2010Average Time for PMA -”Office of Device Evaluation Annual Performance Report FY09” FDA10/07/2010 27 27
  28. 28. 10/10/2010Average Time for 510(k) -”Office of Device Evaluation Annual Performance Report FY09” FDA10/07/2010 28 28
  29. 29. 10/10/2010Average Time for IDE -”Office of Device Evaluation Annual Performance Report FY09” FDA10/07/2010 29 29
  30. 30. 10/10/2010Role of Funding When to Raise Money?  How far will your initial funding even take you?  What are the expected milestones for increasing valuation?  Technology (Bench Top) Demonstration  Successful Clinical Trial  FDA Approval  First Revenue Generating Sale Generally you will be reducing risks and putting more money to work as you complete each phase Venture Capital Trends  Rounds  Tranches10/07/2010 30 30
  31. 31. 10/10/2010Takeaways Have a clear regulatory/reimbursement strategy Reduce risks early y Research vs. development paradigm Have a plan for prototypes Develop a product pipeline/portfolio10/07/2010 31 31
  32. 32. 10/10/2010Contact Information Aubrey Group  6 Cromwell Suite 100, Irvine, CA 92618  PH: 949-581-0188  FAX: 949-581-0177 FAX 949 581 0177 Jahnavi Lokre – Director of Software Engineering/Marketing  jlokre@aubreygroup.com Blaine Murakami – Project Manager  blainemurakami@aubreygroup.com10/07/2010 32 32
  33. 33. 10/10/2010Questions?10/07/2010 33 33

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