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What You Should Know About Launching Medical Devices in the North American Market

What You Should Know About Launching Medical Devices in the North American Market. By Daniel R. Matlis President, Axendia Inc. September 21, 2008 email: dmatlis@axendia.com phone: (215) 262-8037 website: www.axendia.com Journal: http://LSP.axendia.com. Agenda.

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What You Should Know About Launching Medical Devices in the North American Market

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  1. What You Should Know About Launching Medical Devices in the North American Market By Daniel R. Matlis President, Axendia Inc. September 21, 2008 email: dmatlis@axendia.com phone: (215) 262-8037 website: www.axendia.com Journal: http://LSP.axendia.com

  2. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  3. Start with the End in Mind • What is your Exit Strategy? • Merger & Acquisition • Self funded organic growth • Externally funded growth • Partnerships • Each calls for a different strategy

  4. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  5. Secure Your IP • Protect your IP before you disclose it • Peer Reviews • Publications • Presentations • Get professional help • You go the a doctor for your health issues • Go to an IP Attorney for you Patent

  6. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  7. Build the Right Team • Identify complimentary skills • Business • Finance • Business Development • Sales and Marketing • Operations / Supply Chain • Technology • Product • Process • Regulatory • Design Controls • Submissions • Quality System Regulations • Post Market • Other applicable regulations

  8. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  9. Regulatory Requirements for Medical Devices • Manufacturers and Importers of medical devices distributed in the U.S. must comply with: • Premarket Approval (PMA) or Premarket Notification 510(k), unless exempt • Establishment registration on form FDA-2891 • Medical Device Listing on form FDA-2892 • Quality System Regulation 21 CFR § 820 (QSR) • Labeling Requirements • Medical Device Reporting (MDR)

  10. Patchwork of Regulatory Requirements • Food and Drug Administration • Safety • Effectiveness • Clinical utility • Hospital and Clinical Laboratory • FDA • Health Care Financing Administration (HCFA) • Clinical Laboratory Improvement Amendments (CLIA) • Mammography Quality Standards Act (MQSA) • Other Authorities • Federal Communications Commission (wireless, telemetry) • Nuclear Regulatory Commission (Nuclear radiation)

  11. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  12. Don’t Wait for Perfect! • Know when to stop • Draw the line in the sand • Safe and effective • Be strict on setting release date goals

  13. Same or Novel • The 510(k) paradox • Proving Equivalency • Different but not too different • If you goal is to run a business • Let the pendulum swing to approvable • Then iterate for improvements • Systems Approach to bringing device to market • Involve all the key stake holder from the beginning

  14. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  15. Quality System Regulation (QSR) 21 CFR Part 820 • QSR Compliance begins at Design Input, NOTManufacturing • Regulates methods and controls used for: • Designing • Changing • Purchasing • Manufacturing • Packaging • Labeling • Storing • Installing • Servicing • License holders will undergo FDA inspections to assure compliance with the QSR

  16. Define Post Approval Strategy • Manufacturing and Distribution • Internal • Outsourced • Combination • Reporting • Field Inquiries • Adverse Events

  17. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • Do you want to get paid? • If you built it, they still won’t come

  18. Do You Want to Get Paid? • Then your device must be covered by health plans • Reimbursement plays a key role in the success and valuation of Devices • Focus on achieving milestones during the reimbursement process • Position your device’s optimal market launch • Define and provide a realistic and credible idea of the value of their technology

  19. Reimbursement Strategy • Reimbursement planning should be conducted along with FDA approval: • Ensure the data captured addresses the demands of the FDA • Requirements of the major insurance carriers to enable a favorable coverage decision. • Things to consider in developing a reimbursement strategy • Who will benefit most? • Seniors, children, women, others? • Where will the benefit be delivered? • Institutions, outpatient, home care? • What are the expected clinical outcomes? • Are there services that are comparable, but inferior or superior? • How much is the expected financial impact for the payer/consumer? • Are there Immediate v. long-term benefits?

  20. Agenda • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  21. Go to Market Strategy • No mater how great your device is, It will not sell itself • How will you sell the product? • Direct Sales Force • Partnership • Contract Sales Organization • Hybrid

  22. Summary • Start with the end in mind • Secure your IP • Build the right team • Navigating the FDA approval roadmap • Don’t wait for perfect! • Build in Quality Now (QSR) • You want to get paid? • If you built it, they still won’t come

  23. Thank You • Daniel R. Matlis • email: dmatlis@axendia.com • phone: (215) 262-8037 • website: www.axendia.com • Journal: http://LSP.axendia.com

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