Innovation in Emergency Medicine
Technology Development and Commercialization Handbook
- 1st Edition - February 1, 2026
- Editors: Nancy Patterson, Sam H Shen, Ryan Ribeira, Adam E.M. Eltorai
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 1 4 0 9 8 - 3
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 4 0 9 9 - 0
Innovation in Emergency Medicine: Technology Development and Commercialization Handbook is a step-by-step guide to emergency medicine technology innovation reflecting recent tr… Read more
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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.
- The only book that helps readers understand everything involved in bring a clinical and medical innovation in emergency medicine from concept to market
- Features case studies on innovative products from around the world
- End-of-chapter ‘Getting Started’ sections encourage readers to learn from real projects and apply important lessons to their own work
Biomedical engineers interested in bringing their devices to market, 2) large and rapidly increasing number of masters programs in regulatory affairs, clinicians in emergency medicine along with their affiliated professional associations for bulk purchases and/or co-branding/marketing/distribution through well subscribed research journals and conferences
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
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
- Edition: 1
- Published: February 1, 2026
- Language: English
NP
Nancy Patterson
Nancy Patterson is a Venture Analyst and the President and CEO and Founder of Strategy Inc. (in 2000), a lifescience market analysis and valuation company for US and International clients. She has over 18 years’ experience in senior business development and marketing roles with emerging technology medical device companies. Patterson is an immunologist from University of Michigan and also has an MBA from University of Southern California.
Affiliations and expertise
President and CEO Strategy Inc., Texas, USASH
Sam H Shen
Dr. Sam Shen is currently Interim Chair for Dept of Emergency Medicine at Stanford University School of Medicine as well as Vice Chair Clinical Affairs, and Clinical Associate Professor. Dr. Shen received his MD and MBA from UCLA and is trained at Harvard Affiliated Emergency Medicine Residency at Beth Israel Deaconess Medical Center in Boston. His current research interests include emergency department process improvement, digital health, ED operations, and ED innovations
Affiliations and expertise
Clinical Professor, Stanford University, Department of Emergency Medicine, California, USARR
Ryan Ribeira
Affiliations and expertise
Stanford Dept of Emergency Medicine, USAAE
Adam E.M. Eltorai
Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.
Affiliations and expertise
Harvard Medical School, Boston, MA, USA