PROBLEM 1. Identifying an unmet need 2. Validate, refine, define the problem to be solved 3. Market analysis--a problem worth solving 4. Competition analysis CONCEPT 5. Product requirements 6. Partner with a successful expert 7. Conceptualizing the solution 8.

Prior art search 9. Concept testing and selection--where and why will it fail PROOF OF CONCEPT 10. What to prototype 11. How to prototype--design and engineering resources 12. Using a medical device engineering firm 13. Patent strategy--patent types and timing 14. Medical device development 15. Pilot study PATHWAYS 16.

Comparison of licensing, joint venture, building a company 17. Licensing--how to, terms, expectations, examples 18. Joint venture BUILDING A COMPANY 19. Funding approaches 20. The investor's perspective 21. Personnel--team members needed, roles 22. Corporate legal REGULATORY 23. FDA clearance process 24.

Manufacturing 25. Step-by-step guide for FDA listing, 510(k), PMA 26. Post-approval strategy LAUNCH 27. Reimbursement basics 28. Business models 29. Marketing, sales, and distribution 30. Business strategy 31. Business operations 32.

Post-launch physician relationships 33. Successful exit CASE STUDIES 34. Case study #1 35. Case study #2 36. Case study #3 37. Case study #4 38. Case study #5 39. Case study #6 40.

Case study #7 41. Case study #8 42. Case study #9 43. Case study #10.