1. Medical Device Idea Generation Fred B. Dinger, III President & CEO ENTrigue Surgical and C2M Medical Stanford Taiwan Biomedical Conference September 2008

2. Generating Ideas Solving existing problems Solving problems not yet realized Creating new ideas using existing technologies How are ideas generated?

3. Generating Ideas Problem – passing suture through tissue during shoulder surgery Solving Existing Problems

4. Generating Ideas Solution - ExpresSew™ Suture Passer Solving Existing Problems

5. Generating Ideas Problem – difficult to tie knots in suture to hold tissue in place during rotator cuff surgery Solving Existing Problems

6. Generating Ideas Solution - Opus™ Knotless Suture Anchor Solving Existing Problems

7. Generating Ideas Problem – nasal sinus cavities are difficult to access with standard hand-held instruments Solving Existing Problems

8. Generating Ideas Solution - SerpENT™ Articulating Instrument Solving Existing Problems

9. Generating Ideas Problem – difficult and time consuming to suture septum in place after septoplasty surgery Solving Existing Problems

10. Generating Ideas Solution - ENTact™ Septal Stapler Solving Existing Problems

11. Generating Ideas Solving Problems Not Yet Realized Problem – using hand-held instruments to remove tissue from joints or sinus cavities (effective, but took a lot of effort and was time consuming)

12. Generating Ideas Solving Problems Not Yet Realized Solution – using powered rotary shavers to rapidly remove tissue from joints and sinus cavities

13. Generating Ideas Solving Problems Not Yet Realized Problem – using pre-operative x-rays to estimate the location of instruments during surgery. As tissue was removed, the location landmarks changed.

14. Generating Ideas Solving Problems Not Yet Realized Solution – using image guided surgery systems to provide real-time feedback of location of instruments

15. Generating Ideas Ideas only need to be original in their applications

16. Generating Ideas Creating New Products from Existing Technologies Pacemaker Barricade Light

17. Generating Ideas Creating New Products from Existing Technologies Suture Anchor Tent Stake Harpoon

18. Generating Ideas Keep your solutions as simple as possible! The best ideas are often the most simple and straight forward

19. Generating Ideas

20. Protect Your Ideas Keep detailed notes (with dates) Use a Patent Attorney Consider how you would work around the patent, then patent those ideas as well to further protect your idea. Be selective – don’t waste money filing patents on non-feasible ideas. Patent your Product or Idea

21. Advance Your Ideas Reduce your patents to practice with prototypes, working models, etc. Obtain data to prove feasibility File for the applicable government or regulatory clearances/approvals. Avoid the temptation to broaden your scope – stay focused on primary goal. Required Accomplishments

22. Classify Your Device Class I – most are exempt from Premarket Notification 510(k) Hand-held instruments, elastic bandages, exam gloves, enema kits, etc. Class II –require a Premarket Notification 510(k) Powered wheelchairs, surgical drapes, external infusion pumps, bone void fillers, powered cutting instruments, etc. Class III – most require Premarket Approval (PMA) Pacemakers, heart valves, hip and knee replacements, spinal implants, etc.

23. FDA Device Applications in 2005

24. Fund Your Ideas Self Family Friends Credit Cards Angel Investors (usually local) State Seed Money Start-up Funds

25. Fund Your Ideas Prove your concept Formalize your Business Plan Investigate State Funding options Network with people to get appointments with Venture Capital Fund managers and Business Development managers from large companies Funding the Growth and Transition

26. Create Value Start with a technical team Keep team focused on important tasks Add employees logically (and slowly) Creating Value from the beginning

27. Create Value Revenue from commercial products Patent Portfolio (owned and licensed) R&D Product Pipeline Key Employees Value Builders for a Start-up Company

28. Be Persistent FedEx – deemed to be unfeasible MTV – was told their concept would never work OBI – could not get anyone to believe its products would work Xomed Surgical – market analysts determined that there was no growth opportunity for them Companies that succeeded after being told that they would not make it

29. Idea Generation Summary Create ways to solve problems Patent your product ideas Reduce your ideas to practice Fund your ideas / company Be focused and persistent

30. Stanford Taiwan Biomedical Conference Thank You