Innovation in Nephrology

Dr 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 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, 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, 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.

• 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