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Innovation in Nephrology

Technology Development and Commercialization Handbook

Paperback Engels 2024 9780323956802
€ 168,99
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Samenvatting

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.

Specificaties

ISBN13:9780323956802
Taal:Engels
Bindwijze:Paperback

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Inhoudsopgave

I: Problem<br>1. Introduction<br>2. Technology Landscape<br>3. Identifying an Unmet Need<br>4. Define, Validate, and Refine the Problem to be Solved<br>5. Market Analysis: A Problem Worth Solving<br>6. Competitive Analysis<br>II: Health Economics<br>7. Health Economic and Commercial Value<br>8. Economics in Dialysis<br>III: Concept<br>9. Customer Requirements<br>10. Partnering With a Successful Expert<br>11. Conceptualizing the Solution<br>12. Prior Art Search<br>IV: Proof of Concept<br>13. What to Prototype<br>14. How to PrototypedDesign and Engineering Resources<br>15. Hiring a Medical Device Development Firm<br>16. Patent StrategydPatent Types and Considerations<br>17. Medical Device Development<br>18. Pilot Studies<br>V: Pathways<br>19. Comparison of Licensing and Building a Company<br>20. LicensingdKey Terms and Considerations<br>VI: Building a Company<br>21. Funding approaches<br>22. The Investor&rsquo;s Perspective<br>23. PersonneldTeam Members Needed, Roles<br>24. Key Corporate Law Considerations for Medtech Startups<br>VII: Regulatory<br>25. Overview of FDA RegulationdHistory and Perspective<br>26. Quality System Regulation and Manufacturing<br>27. Risk-Based Classification<br>28. Postmarket Regulatory Strategy<br>VIII: Launch<br>29. Reimbursement Basics<br>30. Business Models<br>31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use<br>32. How GPO&rsquo;s Drive Revenue for Life Science Innovators<br>33. Marketing, Sales, and Distribution<br>34. Business Strategy<br>35. Business Operations<br>36. Postlaunch Physician Relationships<br>37. Successful Exit<br>IX: Case Studies<br>38. Diatiro<br>39. Hemodialysis Axxess Systems<br>40. Everyplace Labs Case Study<br>41. Invizius<br>42. Case Study, OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients<br>43. Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions<br>44. Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform<br>45. Accuryn medical

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