 Copyright 2008 by Axendia, Inc. 1 Prepared for Advamed 2008 What You Should Know About Launching Medical Devices in the North American Market By Daniel R. Matlis President, Axendia Inc. September 21, phone:(215) website: Journal:

 Copyright 2008 by Axendia, Inc.2 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.3 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.4 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.5 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.6 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.7 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.8 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.9 Prepared for Advamed 2008 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)

 Copyright 2008 by Axendia, Inc.10 Prepared for Advamed 2008 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)

 Copyright 2008 by Axendia, Inc.11 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.12 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.13 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.14 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.15 Prepared for Advamed 2008 Quality System Regulation (QSR) 21 CFR Part 820 QSR Compliance begins at Design Input, NOT Manufacturing 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

 Copyright 2008 by Axendia, Inc.16 Prepared for Advamed 2008 Define Post Approval Strategy Manufacturing and Distribution Internal Outsourced Combination Reporting Field Inquiries Adverse Events

 Copyright 2008 by Axendia, Inc.17 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.18 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.19 Prepared for Advamed 2008 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?

 Copyright 2008 by Axendia, Inc.20 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.21 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.22 Prepared for Advamed 2008 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

 Copyright 2008 by Axendia, Inc.23 Prepared for Advamed 2008 Thank You Daniel R. Matlis phone:(215) website: Journal: