Innovation in Nephrology: Technology Development and Commercialization Handbook: Clinical and Medical Innovation
Editat de Adam E.M. Eltorai, Nancy Patterson, Sushrut S Waikar, Xixi Zhaoen Limba Engleză Paperback – 28 noi 2024
- 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
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Specificații
ISBN-13: 9780323956802
ISBN-10: 0323956807
Pagini: 560
Dimensiuni: 191 x 235 mm
Greutate: 0.45 kg
Editura: ELSEVIER SCIENCE
Seria Clinical and Medical Innovation
ISBN-10: 0323956807
Pagini: 560
Dimensiuni: 191 x 235 mm
Greutate: 0.45 kg
Editura: ELSEVIER SCIENCE
Seria Clinical and Medical Innovation
Cuprins
I: Problem
1. Introduction
2. Technology Landscape
3. Identifying an Unmet Need
4. Define, Validate, and Refine the Problem to be Solved
5. Market Analysis: A Problem Worth Solving
6. Competitive Analysis
II: Health Economics
7. Health Economic and Commercial Value
8. Economics in Dialysis
III: Concept
9. Customer Requirements
10. Partnering With a Successful Expert
11. Conceptualizing the Solution
12. Prior Art Search
IV: Proof of Concept
13. What to Prototype
14. How to PrototypedDesign and Engineering Resources
15. Hiring a Medical Device Development Firm
16. Patent StrategydPatent Types and Considerations
17. Medical Device Development
18. Pilot Studies
V: Pathways
19. Comparison of Licensing and Building a Company
20. LicensingdKey Terms and Considerations
VI: Building a Company
21. Funding approaches
22. The Investor’s Perspective
23. PersonneldTeam Members Needed, Roles
24. Key Corporate Law Considerations for Medtech Startups
VII: Regulatory
25. Overview of FDA RegulationdHistory and Perspective
26. Quality System Regulation and Manufacturing
27. Risk-Based Classification
28. Postmarket Regulatory Strategy
VIII: Launch
29. Reimbursement Basics
30. Business Models
31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use
32. How GPO’s Drive Revenue for Life Science Innovators
33. Marketing, Sales, and Distribution
34. Business Strategy
35. Business Operations
36. Postlaunch Physician Relationships
37. Successful Exit
IX: Case Studies
38. Diatiro
39. Hemodialysis Axxess Systems
40. Everyplace Labs Case Study
41. Invizius
42. Case Study, OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients
43. Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions
44. Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform
45. Accuryn medical
1. Introduction
2. Technology Landscape
3. Identifying an Unmet Need
4. Define, Validate, and Refine the Problem to be Solved
5. Market Analysis: A Problem Worth Solving
6. Competitive Analysis
II: Health Economics
7. Health Economic and Commercial Value
8. Economics in Dialysis
III: Concept
9. Customer Requirements
10. Partnering With a Successful Expert
11. Conceptualizing the Solution
12. Prior Art Search
IV: Proof of Concept
13. What to Prototype
14. How to PrototypedDesign and Engineering Resources
15. Hiring a Medical Device Development Firm
16. Patent StrategydPatent Types and Considerations
17. Medical Device Development
18. Pilot Studies
V: Pathways
19. Comparison of Licensing and Building a Company
20. LicensingdKey Terms and Considerations
VI: Building a Company
21. Funding approaches
22. The Investor’s Perspective
23. PersonneldTeam Members Needed, Roles
24. Key Corporate Law Considerations for Medtech Startups
VII: Regulatory
25. Overview of FDA RegulationdHistory and Perspective
26. Quality System Regulation and Manufacturing
27. Risk-Based Classification
28. Postmarket Regulatory Strategy
VIII: Launch
29. Reimbursement Basics
30. Business Models
31. Value Analysis Committee Approval: How to Ensure Your Innovation is Approved for Facility Use
32. How GPO’s Drive Revenue for Life Science Innovators
33. Marketing, Sales, and Distribution
34. Business Strategy
35. Business Operations
36. Postlaunch Physician Relationships
37. Successful Exit
IX: Case Studies
38. Diatiro
39. Hemodialysis Axxess Systems
40. Everyplace Labs Case Study
41. Invizius
42. Case Study, OpticLine: From a Class Project to a Novel Screening Device for Early Peritonitis Infection in Peritoneal Dialysis Patients
43. Building a Kidney-Chip to Improve Drug Development and Nephrotoxicity Predictions
44. Population Screening and Monitoring of CKD With the Carna Health-Nova Biomedical Platform
45. Accuryn medical