Full Description
Innovation in Emergency Medicine: Technology Development and Commercialization Handbook is a step-by-step guide to emergency medicine technology innovation reflecting recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering, and business experts, the authors provide a comprehensive resource that leads engineers, clinicians, students, researchers, and entrepreneurs through a clear process for the identification, invention, and implementation of new solutions. Case studies on innovative products from around the world, successes and failures, practical advice, and end-of-chapter 'Getting Started' sections encourage readers to learn from real projects and apply important lessons to their own work. This new volume in the Clinical and Medical Innovation Series will be of interest to every biomedical engineer and those working in emergency medicine who has ever had a good idea for an invention but does not know where and how to start bringing it to the bedside.
Contents
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
