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.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Technology Landscape - p. 5 3. Part I. Problem - p. 13 4. Chapter 3. Identifying an Unmet Need - p. 15 5. Chapter 4. Define, Validate, and Refine the Problem to be Solved - p. 23 6. Chapter 5. Market Analysis: A Problem Worth Solving - p. 31 7. Chapter 6. Competitive Analysis - p. 45 8. Part II. Health Economics - p. 53 9. Chapter 7. Health Economic and Commercial Value - p. 55 10. Chapter 8. Economics in Dialysis - p. 68 11. Part III. Concept - p. 81 12. Chapter 9. Customer Requirements - p. 83 13. Chapter 10. Partnering With a Successful Expert - p. 93 14. Chapter 11. Conceptualizing the Solution - p. 101 15. Chapter 12. Prior Art Search - p. 109 16. Part IV. Proof of Concept - p. 125 17. Chapter 13. What to Prototype - p. 127 18. Chapter 14. How to Prototype—Design and Engineering Resources - p. 135 19. Chapter 15. Hiring a Medical Device Development Firm∗ - p. 145 20. Chapter 16. Patent Strategy—Patent Types and Considerations - p. 153 21. Chapter 17. Medical Device Development - p. 165 22. Chapter 18. Pilot Studies - p. 175 23. Part V. Pathways - p. 189 24. Chapter 19. Comparison of Licensing and Building a Company - p. 191 25. Chapter 20. Licensing—Key Terms and Considerations - p. 199 26. Part VI. Building a Company - p. 207 27. Chapter 21. Funding Approaches - p. 209 28. Chapter 22. The Investor’s Perspective - p. 219 29. Chapter 23. Personnel—Team Members Needed, Roles - p. 229 30. Chapter 24. Key Corporate Law Considerations for Medtech Startups - p. 241 31. Part VII. Regulatory - p. 253 32. Chapter 25. Overview of FDA Regulation—History and Perspective - p. 255 33. Chapter 26. Quality System Regulation and Manufacturing - p. 267 34. Chapter 27. Risk-Based Classification - p. 279 35. Chapter 28. Postmarket Regulatory Strategy - p. 297 36. Part VIII. Launch - p. 315 37. Chapter 29. Reimbursement Basics - p. 317 38. Chapter 30. Business Models - p. 331 39. Chapter 31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use - p. 347 40. Chapter 32. How GPO's Drive Revenue for Life Science Innovators - p. 373 41. Chapter 33. Marketing, Sales, and Distribution - p. 381 42. Chapter 34. Business Strategy - p. 399 43. Chapter 35. Business Operations - p. 409 44. Chapter 36. Postlaunch Physician Relationships - p. 419 45. Chapter 37. Successful Exit - p. 429 46. Part IX. Case Studies - p. 437 47. Chapter 38. Case Study #1: Diatiro - p. 439 48. Chapter 39. Case Study #2: Hemodialysis Axxess Systems - p. 449 49. Chapter 40. Case Study #3: Everyplace Labs - p. 457 50. Chapter 41. Case Study #4: Invizius - p. 463 51. Chapter 42. Case Study #5: OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients - p. 471 52. Chapter 43. Case Study #6: Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions - p. 481 53. Chapter 44. Case Study #7: Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform - p. 491 54. Chapter 45. Case Study #8: Accuryn Medical, Inc. - p. 501 55. Index - p. 511
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.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Technology Landscape - p. 5 3. Part I. Problem - p. 13 4. Chapter 3. Identifying an Unmet Need - p. 15 5. Chapter 4. Define, Validate, and Refine the Problem to be Solved - p. 23 6. Chapter 5. Market Analysis: A Problem Worth Solving - p. 31 7. Chapter 6. Competitive Analysis - p. 45 8. Part II. Health Economics - p. 53 9. Chapter 7. Health Economic and Commercial Value - p. 55 10. Chapter 8. Economics in Dialysis - p. 68 11. Part III. Concept - p. 81 12. Chapter 9. Customer Requirements - p. 83 13. Chapter 10. Partnering With a Successful Expert - p. 93 14. Chapter 11. Conceptualizing the Solution - p. 101 15. Chapter 12. Prior Art Search - p. 109 16. Part IV. Proof of Concept - p. 125 17. Chapter 13. What to Prototype - p. 127 18. Chapter 14. How to Prototype—Design and Engineering Resources - p. 135 19. Chapter 15. Hiring a Medical Device Development Firm∗ - p. 145 20. Chapter 16. Patent Strategy—Patent Types and Considerations - p. 153 21. Chapter 17. Medical Device Development - p. 165 22. Chapter 18. Pilot Studies - p. 175 23. Part V. Pathways - p. 189 24. Chapter 19. Comparison of Licensing and Building a Company - p. 191 25. Chapter 20. Licensing—Key Terms and Considerations - p. 199 26. Part VI. Building a Company - p. 207 27. Chapter 21. Funding Approaches - p. 209 28. Chapter 22. The Investor’s Perspective - p. 219 29. Chapter 23. Personnel—Team Members Needed, Roles - p. 229 30. Chapter 24. Key Corporate Law Considerations for Medtech Startups - p. 241 31. Part VII. Regulatory - p. 253 32. Chapter 25. Overview of FDA Regulation—History and Perspective - p. 255 33. Chapter 26. Quality System Regulation and Manufacturing - p. 267 34. Chapter 27. Risk-Based Classification - p. 279 35. Chapter 28. Postmarket Regulatory Strategy - p. 297 36. Part VIII. Launch - p. 315 37. Chapter 29. Reimbursement Basics - p. 317 38. Chapter 30. Business Models - p. 331 39. Chapter 31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use - p. 347 40. Chapter 32. How GPO's Drive Revenue for Life Science Innovators - p. 373 41. Chapter 33. Marketing, Sales, and Distribution - p. 381 42. Chapter 34. Business Strategy - p. 399 43. Chapter 35. Business Operations - p. 409 44. Chapter 36. Postlaunch Physician Relationships - p. 419 45. Chapter 37. Successful Exit - p. 429 46. Part IX. Case Studies - p. 437 47. Chapter 38. Case Study #1: Diatiro - p. 439 48. Chapter 39. Case Study #2: Hemodialysis Axxess Systems - p. 449 49. Chapter 40. Case Study #3: Everyplace Labs - p. 457 50. Chapter 41. Case Study #4: Invizius - p. 463 51. Chapter 42. Case Study #5: OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients - p. 471 52. Chapter 43. Case Study #6: Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions - p. 481 53. Chapter 44. Case Study #7: Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform - p. 491 54. Chapter 45. Case Study #8: Accuryn Medical, Inc. - p. 501 55. Index - p. 511
