Commercial Options for Medical Devices Bill Gibbons Cook Medical

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

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

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

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

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

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

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

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!

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!!!

THE presentation Know the device Know the market Know your situation 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

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

Summary Understand what you have Patent, patent, patent 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!