Medical Innovation - 1st Edition - ISBN: 9780128149263

Medical Innovation

1st Edition

Concept to Commercializarion

Editors: Bruce Gingles Kevin Behrns Michael Sarr
Paperback ISBN: 9780128149263
Imprint: Academic Press
Page Count: 224
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Development of Innovations and Devices in Medicine and Surgery: A Primer is a practical step-by-step approach to moving a novel concept through development to realize a commercially successful product. Real world experience cases and experienced contributors provide lessons that cover the practices of diverse organizations and multiple products. This importance reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians.

Key Features

  • Provides multiple considerations and comprehensive lessons from varied organizations, researchers and products within a single volume
  • Designed to help address topics that will improve success and avoid the high cost of innovation failure in today’s marketplace
  • 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

Table of Contents

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


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© Academic Press 2018
Academic Press
Paperback ISBN:

About the Editor

Bruce Gingles

After earning a bachelor’s degree in biology from Indiana University, Bruce Gingles joined Cook Medical in in 1979, when relocated to Los Angeles to be the company’s first sales representative for the newly formed Critical Care division. He moved to Northern California (Mountain View) in 1984 as regional manager, and to Bloomington, Indiana, in 1991 as director of sales and marketing. Mr. Gingles was promoted to global business leader and vice president in 1999. He now represents Cook in the areas of translational research, commercial regulation and technology assessment. The ethical foundation of commercial relationships and translational algorithms are personal interests. Mr. Gingles serves on the external advisory committee for the Indiana University and UCSF (devices) CTSIs. He has been invited to discuss translational research and medical device innovation at more than 30 CME/CLE-accredited programs in the Asia, Europe and the United States.

Affiliations and Expertise

Vice President, Global Technology Assessment and Health Policy, Cook Medical Incorporated

Kevin Behrns

Behrns has more than 20 years of experience as a highly accomplished educator, researcher, physician and administrator. He currently oversees the educational, research, clinical and service activities of SLU’s nationally ranked School of Medicine. The CEO of SLUCare, the University’s physician practice, reports to Behrns, who also serves as a key liaison with SSM Health, which owns and operates SSM Health Saint Louis University Hospital.

Affiliations and Expertise

Chairman, Edward R. Woodward Professor, Department of Surgery, University of Florida, Gainesville, Florida, USA

Michael Sarr

Sarr is the emeritus professor of surgery at the Mayo Clinic. He has hundreds of papers published in peer reviewed journals. He is on the Mayo Clinic Scientific Advisory Council. He is a member of 10+ editorial boards. He is the co-editor of two peer reviewed journals. He is the recipient of James C. Masson Professor of Surgery from the Mayo Clinic College of Medicine and the winner of the International Health Professional of the Year award from the International Biographical Centre of Cambridge.

Affiliations and Expertise

Emeritus Professor of Surgery, Department of Surgery, Mayo Clinic