Strategic Decisions for Medical Device Innovations

1. Commercial Options for Medical Devices Bill Gibbons Cook Medical

2. “Eureka!” • You have the next great… • Material • Device • Coating • Properties known • Clear understanding of method of use • Patents filed (with university) • Now some choices…

3. Options • License the idea • Develop a technology & sell it • Develop a device & sell it to a company • Start a company

4. License the idea • Patent applications in place • Work through Technology Transfer at the University to understand the terms of licensure • Overhead • Money to the department/lab/your salary • Personal gain • Network to companies OTT knows • Personal contacts

5. Terms of licensure • Usually low or now upfront money • Expect royalty on sales (i.e. commercial success) • Quality/breadth of idea • Development timeline • Participation (i.e. further research) possible • Understand the terms of research with University • Overhead charges • Time allotment • Expected cost for development to saleable point

6. Develop a technology & sell it • Idea that has been developed further • Understand the uses of the technology • Understand its benefits • Understand its shortcomings • More likely to lead to research funding • More valuable to a company (higher royalty?) • Licensure by field? • Bigger company with be able to utilize technology more widely

7. Develop a Device • Turn an idea into something real • Make prototypes • Functional • To scale • Bench-top tested • Understand competitive landscape • Understand the functional advantage & disadvantage • Expect some upfront payment (likely low) • Royalty on sales

8. Start a company • Turn your ideas into a company • $$$$ • Seed • Angel • Venture Capital (“VC”) • Staff • Leader first! (and most expensive) • Technical • Financial • Regulatory (FDA, Europe, & Japan) • Can be consultants

9. Start a company-Expectations • Detailed business plan • Understanding of the marketplace • Positioning of company/products • Clinical trials complete • FDA/EU availability • Testimonials from thought leaders • Pathway to market • Exit strategy • Your company has to be a threat!

10. Start a company-Considerations • Facilities • Name (incorporation) • Detailed business plan • Go to market strategy • Funding in 2010 is extremely slim • Going public is not an option today • Understand the expected return from each investor • Understand the value of the company • Funding≠value!!!

11. THE presentation • Know the device • Usage/procedure/context • Understand the risks • Understand both advantages and disadvantages • Know the market • Size • Competition • Pricing/costs • Know your situation • Patents • OTT expectations • Your availability and process

12. The deadly sins • Lack of knowledge • Know the strengths • Know the weaknesses • Exaggeration • Know your audience • Myopia • Greed • University • Personal

13. Summary • Understand what you have • Idea, technology, or device(s) • Market-competition, pricing, advantages • Work the details • Patent, patent, patent • Work closely with Tech Tranfer • Know your objective • Call Cook first!