Medical Innovation

Medical Innovation: Concept to Commercialization is a practical, step-by-step approach on how to move a novel concept through development to realize a commercially successful product. Real-world experience cases and knowledgeable contributors provide lessons that cover the practices of diverse organizations and multiple products. This important reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians.

• Provides multiple considerations and comprehensive lessons from varied organizations, researchers and products
• Designed to help address topics that improve success and avoid the high cost of innovation failure
• Recommends the practical steps needed to move a novel, non-developed concept into a tangible, realistic and commercially successful product

Translational researchers, medical school educators, business school entrepreneurship programs, biomedical engineering students/faculty, aspiring physician entrepreneurs

1. Preface
2. Introduction: The role of innovation in improving health outcomes
3. Patent law basics: Strategies for entrepreneurs and start up enterprises
4. Business law basics for new businesses
5. Navigating federal regulation and FDA
6. The role of university technology transfer
7. Can innovation occur in a rural setting
8. Licensing medical devices to manufacturers
9. Understanding health industry venture capital
10. An introduction to the national Institutes of Health SBIR/STTR programs
11. Avoiding common mistakes
12. Medical device clinical trials
13. Managing institutional barriers to physician entrepreneurship
14. Conflict of interest and the "pharmaphobia" narrative
15. Accelerating physician entrepreneurship: Perspective of a recently graduated medical student
16. Accelerating physician entrepreneurship: Perspective of a trainee entrepreneur
17. Preparing America’s entrepreneurial workforce: Reinventing the medical curriculum
18. A Dean’s Perspective on Entrepreneurship in the University
19. An Editor’s perspective on publishing entrepreneurial submissions
20. The role of foundations and professional medical societies in fostering medical innovation
21. Lessons from a serial entrepreneur
22. The CFO as the customer in the process of market adoption in the operating room
23. Technology adoption: Appealing to hospital and health system value analysis
24. Technology adoption: Appealing to payers and capturing economic value
25. Expanding the entrepreneurial workforce
26. Epilogue