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Commercial Options for Medical Devices

Commercial Options for Medical Devices. Bill Gibbons Cook Medical. “Eureka!”. You have the next great… Material Device Coating Properties known Clear understanding of method of use Patents filed (with university) Now some choices…. Options. License the idea

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Commercial Options for Medical Devices

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  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!

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