Cover
Title
Copyright
Preface
Contributor List
Table of Contents
Chapter 1. Identifying an Unmet Need
Chapter 2. Market Analysis—Determining Market Size
Chapter 3. Competitive Analysis: Understanding Your Unique Market Position
Chapter 4. Forming a Solution: Defining Product Requirements Before Concept Development
Chapter 5. Vetting the Concept
Chapter 6. Prior Art Search: Can Your Solution be Patented?
Chapter 7. Concept Development, Selection, and Testing—Passion and Planning Go Hand-in-Hand
Chapter 8. Engineering Resources: First Steps to Making a Tangible Prototype
Chapter 9. Patent Strategy: How do You Protect Your Intellectual Property?
Chapter 10. Regulatory Basics: What Does it Take to Start Selling Your Device?
Chapter 11. Research and Development and The Importance of Testing
Chapter 12. What is Needed to Produce Medical Devices in Large Volumes?
Chapter 13. FDA Marketing Authorization: How to Get Your Device on The US Market
Chapter 14. Reimbursement Basics: Who is The Customer and How Will You Profit?
Chapter 15. Business Models
Chapter 16. Marketing, Sales, and Distribution
Chapter 17. Business Operations: What is Needed For Sustainable Revenues
Chapter 18. Funding Approaches: Who, When, Why, and in Exchange For What?
Chapter 19. Alternative Pathways: Reconsidering Licensing and/or Codevelopment
Chapter 20. Postlaunch Physician Relationships: How You Maintain Loyalty?
Chapter 21. Successful Exit: Acquisition Considerations
Chapter 22. Concept to Commercialization Case #1: Pioneering The X-Stop Interspinous Decompression Device
Chapter 23. IlluminOss: The World’s First Patient-Conforming Polymer Intramedullary Implant
Chapter 24. Concept to Commercialization: SOMAVAC® Sustained Vacuum System
Glossary
Index