Medical Device Idea Generation

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

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

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

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

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

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

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

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

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

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

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 Barricade Light Pacemaker

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

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 Patent your Product or Idea • 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.

21. Advance Your Ideas Required Accomplishments • 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.

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 Start-up Funds • Self • Family • Friends • Credit Cards • Angel Investors (usually local) • State Seed Money

25. Fund Your Ideas Funding the Growth and Transition • 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

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

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

28. Be Persistent Companies that succeeded after being told that they would not make it • 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

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