2010 10 07 Octane Ofi Presentation
- 1. 10/10/2010 From Bench to Bedside Rapid Medical Device Development Strategies OCTANe Foundation for Innovation Building Blocks Series October 7, 2010 1
- 2. 10/10/2010 Overview Define the medical device product development model Statistics Takeaway Points Goal: Help entrepreneurs develop strategies that accelerate their medical device development and commercialization 10/07/2010 2 2
- 3. 10/10/2010 Medical 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.jsp 10/07/2010 3 3
- 4. 10/10/2010 10/07/2010 4 -” Medical Device Development Models” Stanford Biodesign 2007 4
- 5. 10/10/2010 Phase I - Initiation Market Opportunity Competitive Analysis p y IP Freedom to Operate Regulatory Approach Reimbursement Path 10/07/2010 5 5
- 6. 10/10/2010 Regulatory 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=1 10/07/2010 6 6
- 7. 10/10/2010 Regulatory 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 Mark 10/07/2010 7 7
- 8. 10/10/2010 Marketing/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.jsp 10/07/2010 8 8
- 9. 10/10/2010 Phase II - Feasibility Core Team Feasibility and Risk Reduction y Voice of the Customer Clinical Advisory Board 10/07/2010 9 9
- 10. 10/10/2010 Risk 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 Risk 10/07/2010 10 10
- 11. 10/10/2010 Voice 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. 10/10/2010 Phase 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 Submission 10/07/2010 12 12
- 13. 10/10/2010 Design Paradigms Research Development •Brainstorming •Design Controls •Multiple Test Outcomes Multiple •Pass Fail Test Outcomes •Rapid Change •Limited Change 10/07/2010 13 13
- 14. 10/10/2010 Design Paradigms - Research Marketing Technology Idea Approach Re Re- Product Definition IP imbursement Voice of Regulatory Customer 10/07/2010 14 14
- 15. 10/10/2010 Design Paradigms - Development Design g Design Design Input i Output 10/07/2010 15 15
- 16. 10/10/2010 Design Paradigms - Development Regulatory R l t Technology Design Design Input i Output Marketing M k ti 10/07/2010 16 16
- 17. 10/10/2010 Allocate 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. 10/10/2010 Prototypes/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.pdf 10/07/2010 18 18
- 19. 10/10/2010 Industrial Design Source: Aubrey Group, Inc. Source: Aubrey Group, Inc. 10/07/2010 19 19
- 20. 10/10/2010 Phase 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 validation 10/07/2010 20 20
- 21. 10/10/2010 Planning 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. 10/10/2010 Some 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. 10/10/2010 Typical 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, 2010 10/07/2010 23 23
- 24. 10/10/2010 Functional Breakdown per Phase Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign 10/07/2010 24 24
- 25. 10/10/2010 FDA Approval Type Distribution -”Office of Device Evaluation Annual Performance Report FY09” FDA 10/07/2010 25 25
- 26. 10/10/2010 FDA Approval Type Distribution Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign (From FDA Data) 10/07/2010 26 26
- 27. 10/10/2010 Average Time for PMA -”Office of Device Evaluation Annual Performance Report FY09” FDA 10/07/2010 27 27
- 28. 10/10/2010 Average Time for 510(k) -”Office of Device Evaluation Annual Performance Report FY09” FDA 10/07/2010 28 28
- 29. 10/10/2010 Average Time for IDE -”Office of Device Evaluation Annual Performance Report FY09” FDA 10/07/2010 29 29
- 30. 10/10/2010 Role 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 Tranches 10/07/2010 30 30
- 31. 10/10/2010 Takeaways Have a clear regulatory/reimbursement strategy Reduce risks early y Research vs. development paradigm Have a plan for prototypes Develop a product pipeline/portfolio 10/07/2010 31 31
- 32. 10/10/2010 Contact 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.com 10/07/2010 32 32
- 33. 10/10/2010 Questions? 10/07/2010 33 33