Small Company Perspective 510k vs. PMA Avenue to Market

1. Small Company Perspective510k vs. PMAAvenue to Market Christine W. Meehan General Manager Praxim, Inc.

2. Getting to Market 510k Route versus PMA Route Advantages Disadvantages Issues to Address Reimbursement Considerations

3. Experience Small innovative start-up companies Implantable Pumps and Vascular Access Devices – 510k Non-Surgical Alternatives Microwave for BPH Therapy – PMA High Frequency focused Ultrasound for PCa- PMA Computer Assisted Surgical Navigation Devices for ENT, Neuro, Ortho applications – 510k

4. Advantages of 510k Once file is submitted it can be a 90 day review process Does not require a randomized, statistically significant clinical study…however If the product is a complicated 510k…it can end up feeling like a PMA Clinical information or cadaver study for safety and efficacy may be requested by the FDA ( least burdensome..) Asses your product early – review all other 510ks to see if they were 90 days or 90 days+++ = questions

5. Disadvantages of 510k Once approved, you reach the market without statistical clinical proof of improved outcomes Medical community is very cautious of any new product without well controlled clinical outcomes – Market acceptance is slow The commercial market can now do clinical use/testing without your control and can report results in the literature Positive Negative (Gets published immediately)

6. What to do? Have some kind of clinical experience with the 510k product/prototype as early as possible Collect all clinical experience and database it, company works with clinical site Have lead physician write a white paper, submit abstract to major/minor meeting, submit an article to peer reviewed journal Choose a lead physician who likes to write, publish and speak (include a site with Fellows) Continue clinical study after 510k approval to keep generating clinical results

7. IDE/PMA Required for NEW and INNOVATIVE products Randomized clinical study to show safety and efficacy usually versus the “Gold” or standard treatment option

8. Disadvantages of IDE/PMA Time 1-2 years to complete clinical study Review time of a PMA is on average 1 yr once submitted (includes GMP inspection) Cost Delay to market

9. Advantages of IDE/PMA Statically significant clinical results which can be used to convince medical community Results can be published in peer reviewed literature Has big marketing/launch impact but You must work on this early One year (avg) from submission to publication unless MD agrees to alternative journals = faster Clinical results are the only thing that convince physicians Market acceptance is quicker due to clinical results

10. Advantages of IDE/PMA CMS and Insurance Providers require this kind of clinical data to justify payment Request a “Technology Assessment” Requirement of NCQA Make sure your clinical data is sufficient Powerful marketing and reimbursement tool

11. What to Do - PMA Get your clinical results published soon and often Work with Specialty Group early if you are a new therapy or change to existing practice They will determine if new CPT code is needed Find out who the specialty advisors are to CMS on the state level Have them include your product in their annual billing seminars at annual meeting Amend Clinical Guidelines to include new therapy Not likely but it would be great if they would make a policy statement regarding the therapy Update their Patient Information pamphlets

12. What to Do - PMA Develop a clinically relevant web site Provide “balanced” information for both patient and MD Include all required disclaimers FAQs Links to other sites Where to find a “trained” MD or clinical study site Which insurance companies provide coverage Provide Clinical publications More people go to the web for medical information than for any other reason

13. Reimbursement - 510k or PMA Start as soon as possible Applied for new CPT code if needed (ICD-9) Put together billing information if using existing codes How to bill, not what to bill Work with BC/BS, CMS, Prudential, or others on a “Technology Assessment” Single most important document to help show improved net health outcomes = Reimbursement Review of all the published literature of well controlled studies Plus several other criteria

14. Reimbursement Don’t go it alone Work with competitors and their data on clinical outcomes (its not a competitive issue) Work with Advocacy Groups MassMedic AdvaMed NEMA