Innovation 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.
Table of Contents
I: Problem1. Introduction
2. Technology Landscape
3. Identifying an Unmet Need
4. Define, Validate, and Refine the Problem to be Solved
5. Market Analysis: A Problem Worth Solving
6. Competitive Analysis
II: Health Economics
7. Health Economic and Commercial Value
8. Economics in Dialysis
III: Concept
9. Customer Requirements
10. Partnering With a Successful Expert
11. Conceptualizing the Solution
12. Prior Art Search
IV: Proof of Concept
13. What to Prototype
14. How to PrototypedDesign and Engineering Resources
15. Hiring a Medical Device Development Firm
16. Patent StrategydPatent Types and Considerations
17. Medical Device Development
18. Pilot Studies
V: Pathways
19. Comparison of Licensing and Building a Company
20. LicensingdKey Terms and Considerations
VI: Building a Company
21. Funding approaches
22. The Investor’s Perspective
23. PersonneldTeam Members Needed, Roles
24. Key Corporate Law Considerations for Medtech Startups
VII: Regulatory
25. Overview of FDA RegulationdHistory and Perspective
26. Quality System Regulation and Manufacturing
27. Risk-Based Classification
28. Postmarket Regulatory Strategy
VIII: Launch
29. Reimbursement Basics
30. Business Models
31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use
32. How GPO’s Drive Revenue for Life Science Innovators
33. Marketing, Sales, and Distribution
34. Business Strategy
35. Business Operations
36. Postlaunch Physician Relationships
37. Successful Exit
IX: Case Studies
38. Diatiro
39. Hemodialysis Axxess Systems
40. Everyplace Labs Case Study
41. Invizius
42. Case Study, OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients
43. Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions
44. Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform
45. Accuryn medical
Authors
Adam E.M. Eltorai Harvard Medical School, Boston, MA, USA.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.
Nancy Patterson President and CEO Strategy Inc., Texas, USA.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.
Sushrut S Waikar Boston Medical Center and Boston University Chobanian & Avedisian School of Medicine, Boston, MA, United States.Sushrut S. Waikar, MD, MPH is a clinician-scientist and nephrologist at Boston University Chobanian & Avedisian School of Medicine and Boston Medical Center, where he is Chief of Nephrology and the Norman G. Levinsky Professor of Medicine. Dr. Waikar's research interests and active projects include biomarker discovery/validation, complications of renal replacement therapy, kidney functional reserve, kidney functional MRI, and clinical trials in CKD.
Xixi Zhao US Department of Veteran Affairs Palo Alto, CA.Xixi Zhao, MD is an adult and pediatric nephrologist. She is a recent graduate of the Stanford Adult and Pediatric Nephrology Fellowship and Stanford Biodesign Innovation Fellowship. Dr. Zhao has a passionate vision for transforming medicine through technology and innovation. She is the lead author of several publications and a frequent speaker at conferences.
