Innovation in Nephrology
Technology Development and Commercialization Handbook
- 1st Edition - December 1, 2024
- Editors: Nancy Patterson, Sushrut S Waikar, Xixi Zhao, Adam E.M. Eltorai
- Language: English
- Paperback ISBN:9 7 8 - 0 - 3 2 3 - 9 5 6 8 0 - 2
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 5 6 8 1 - 9
Innovation in Nephrology: Technology Development and Commercialization Handbook is a step-by-step guide to nephrology technology innovation reflects recent trends of industry… Read more
Purchase options
Institutional subscription on ScienceDirect
Request a sales quoteInnovation in Nephrology: Technology Development and Commercialization Handbook is a step-by-step guide to nephrology technology innovation reflects 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 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. In short, this book will be of interest to every nephrologist 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 nephrology 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 bring their devices to market, large and rapidly increasing number of masters programs in regulatory affairs, clinicians in that specialty along with their affiliated professional associations for bulk purchases and/or co-branding/marketing/distribution through well subscribed research journals and conferences
1. Preface
2. Introduction
3. Technology landscape
4. Identifying an unmet need
5. Validate, refine, define the problem to be solved
6. Market analysis—a problem worth solving
7. Competition analysis
8. Product requirements
9. Partner with a successful expert
10. Conceptualizing the solution
11. Prior art search
12. Concept testing and selection—where and why will it fail
13. What to prototype
14. How to prototype—design and engineering resources
15. Using a medical device engineering firm
16. Patent strategy—patent types and timing
17. Medical device development
18. Technology readiness level
19. Pilot study
20. Comparison of licensing, joint venture, building a company
21. Licensing—how to, terms, expectations, examples
22. Joint venture
23. Funding approaches
24. The VC’s perspective
25. Personnel—team members needed, roles
26. Corporate legal
27. FDA clearance process
28. Manufacturing
29. Step-by-step guide for FDA listing, 510(k), PMA
30. Post-approval strategy
31. Reimbursement basics
32. Business models
33. Marketing, sales, and distribution
34. Business strategy
35. Business operations
36. Post-launch physician relationships
37. Successful exit
38. Case study #1
39. Case study #2
40. Case study #3
41. Case study #4
42. Case study #5
43. Case study #6
44. Case study #7
45. Case study #8
46. Case study #9
47. Case study #10
2. Introduction
3. Technology landscape
4. Identifying an unmet need
5. Validate, refine, define the problem to be solved
6. Market analysis—a problem worth solving
7. Competition analysis
8. Product requirements
9. Partner with a successful expert
10. Conceptualizing the solution
11. Prior art search
12. Concept testing and selection—where and why will it fail
13. What to prototype
14. How to prototype—design and engineering resources
15. Using a medical device engineering firm
16. Patent strategy—patent types and timing
17. Medical device development
18. Technology readiness level
19. Pilot study
20. Comparison of licensing, joint venture, building a company
21. Licensing—how to, terms, expectations, examples
22. Joint venture
23. Funding approaches
24. The VC’s perspective
25. Personnel—team members needed, roles
26. Corporate legal
27. FDA clearance process
28. Manufacturing
29. Step-by-step guide for FDA listing, 510(k), PMA
30. Post-approval strategy
31. Reimbursement basics
32. Business models
33. Marketing, sales, and distribution
34. Business strategy
35. Business operations
36. Post-launch physician relationships
37. Successful exit
38. Case study #1
39. Case study #2
40. Case study #3
41. Case study #4
42. Case study #5
43. Case study #6
44. Case study #7
45. Case study #8
46. Case study #9
47. Case study #10
- No. of pages: 220
- Language: English
- Edition: 1
- Published: December 1, 2024
- Imprint: Academic Press
- Paperback ISBN: 9780323956802
NP
Nancy Patterson
Ms. Patterson is a Venture Analyst and the President and CEO and Founder of Strategy Inc. (in 2000) for global clients. Ms. Patterson has operational experience leading companies to be acquired by medical multinationals for up to $508M. Ms. Patterson has held the position as the Vice President, Commercialization for the Alfred Mann Foundation for Biomedical Engineering identifying entities to be awarded investments from the $2B fund. From 2006 to 2015, she was a guest lecturer in the Medical School at the UCLA core Business of Science program. This graduate school program, one of the most popular in the medical school, teaches about the path to successful commercialization for life science technology. Ms. 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, USASW
Sushrut S Waikar
Sushrut S. Waikar, MD, MPH received a BA in English and Neuroscience at Amherst College, his MD at Yale, and an MPH at Harvard. He is the Norman G. Levinsky Professor of Medicine at Boston University School of Medicine and Chief of Nephrology at Boston Medical Center. Dr. Waikar’s research interests and active projects include biomarker discovery/validation, non-invasive biomarkers of kidney histopathology, renal functional reserve, kidney functional MRI, oxalate nephropathy, and clinical trials in CKD. He is a Principal Investigator of several NIH grants including the Kidney Precision Medicine Project (UH3DK114915), the Chronic Kidney Disease of Uncertain Etiology Consortium (U01DK130060), the Boston University Kidney and Medical Engineering Program (R25DK128858), Metablomics of Renal Functional Reserve (R21DK119751), and Biomarkers of Chronic Kidney Disease (U01DK085660).
Affiliations and expertise
Boston University, Massachusetts, USAXZ
Xixi Zhao
Xixi Zhao is an adult and pediatric nephrology fellow at Stanford University and a recent graduate from the Stanford Biodesign Innovation Fellowship. Xixi has a passionate vision for transforming medicine through technology and is currently working with multiple collaborators to bring artificial intelligence to nephrology. Her interests include predictive modeling of intradialytic hypotension in children requiring hemodialysis and risk stratification for hemodialysis patients with atrial fibrillation. She is the lead author of several publications and frequent speaker at conferences.
Affiliations and expertise
Adult and Pediatric Nephrology Fellow PGY-8Rosa A. Wann and Marjorie Shannon Endowed Postdoctoral Fellow, Department of Medicine and Department of Pediatrics, Division of Nephrology and Division of Pediatric Nephrology, Stanford UniversityAE
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