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’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’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
