腎臓学におけるイノベーション：技術開発と商業化ハンドブック Innovation in Nephrology : Technology Development and Commercialization Handbook

著者名：Eltorai, Adam E.M. (EDT)/Patterson, Nancy (EDT)/Waikar, Sushrut S (EDT)/Zhao, Xixi (EDT)

Academic Press（2024/11/21発売）

• 言語：ENG
• ISBN：9780323956802
• eISBN：9780323956819

Description

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.- 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

Table of Contents

I: Problem1. Introduction2. Technology Landscape3. Identifying an Unmet Need4. Define, Validate, and Refine the Problem to be Solved5. Market Analysis: A Problem Worth Solving6. Competitive AnalysisII: Health Economics7. Health Economic and Commercial Value8. Economics in DialysisIII: Concept9. Customer Requirements10. Partnering With a Successful Expert11. Conceptualizing the Solution12. Prior Art SearchIV: Proof of Concept13. What to Prototype14. How to PrototypedDesign and Engineering Resources15. Hiring a Medical Device Development Firm16. Patent StrategydPatent Types and Considerations17. Medical Device Development18. Pilot StudiesV: Pathways19. Comparison of Licensing and Building a Company20. LicensingdKey Terms and ConsiderationsVI: Building a Company21. Funding approaches22. The Investor's Perspective23. PersonneldTeam Members Needed, Roles24. Key Corporate Law Considerations for Medtech StartupsVII: Regulatory25. Overview of FDA RegulationdHistory and Perspective26. Quality System Regulation and Manufacturing27. Risk-Based Classification28. Postmarket Regulatory StrategyVIII: Launch29. Reimbursement Basics30. Business Models31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use32. How GPO's Drive Revenue for Life Science Innovators33. Marketing, Sales, and Distribution34. Business Strategy35. Business Operations36. Postlaunch Physician Relationships37. Successful ExitIX: Case Studies38. Diatiro39. Hemodialysis Axxess Systems40. Everyplace Labs Case Study41. Invizius42. Case Study, OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients43. Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions44. Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform45. Accuryn medical