Ikeno F - AIMRADIAL 2014 - Devices
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Biodesign and cardiovascular devices
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Ikeno F - AIMRADIAL 2014 - Devices
- 1. biodesign FUMIAKI IKENO, M.D. Global PDP Liaison, Stanford Biodesign Research Associate Division of Cardiology, Stanford University Biodesign and Cardiovascular Devices
- 2. Disclosure I don’t have any conflict of interest in this talk.
- 3. Enough TLA* already! *Technology Looking for Application
- 5. “If I had an hour to solve a problem, I'd spend 55 minutes thinking about the problem and 5 minutes thinking about solutions.” Albert Einstein
- 6. Why does this work? “A well-‐characterized need is the DNA of a great inven<on”
- 7. Since 2001
- 8. Paul G. Yock, MD Program Director
- 9. To develop leaders in biomedical technology innovation Mission Educate. Collaborate. Innovate.
- 10. Making needs and concepts compete..
- 11. 2 months clinical immersion…
- 12. Clinical Immersion • Team “lives” in hospital and clinics • Observe with fresh eyes, ask “naïve” questions • Develop list of >200 needs
- 13. “If I had asked my customers what they wanted, they’d have said a faster horse” The need was to get from point A to point B faster, cheaper, and reliably.
- 19. Disease State Fundamentals Existing Treatments Stakeholder Evaluation Market Evaluation Clinical Need Need Scoping & Validation
- 20. needs finding need need need need need need need need need need need need need need need need need need need need need needs screening and specification need need need
- 23. Brainstorm solutions for the best needs “Given enough time, sugar and caffeine, you will invent something”
- 28. concept selection concept generation needs finding needs screening & specification identifyinvent You should understand:
- 29. 1.1 Strategic Focus 1.2 Observation & Problem Identification 1.3 Need Statement Development 2.1 Disease State Fundamentals 2.2 Treatment Options 2.3 Stakeholder Analysis 2.4 Market Analysis 2.5 Needs Filtering 4.6 Final Concept Selection 1. NEEDS FINDING 3. CONCEPT GENERATION 5. DEVELOPMENT STRATEGY & PLANNING 5.1 IP Strategy 5.3 Clinical Strategy 5.6 Reimbursement Strategy 5.5 Quality & Process Management 5.2 R&D Strategy 6. INTEGRATION 5.8 Sales & Distribution Strategy 6.2 Business Plan Development 6.3 Funding Sources 5.9 Competitive Advantage & Business Strategy 6.1 Operating Plan & Financial Model 2. NEEDS SCREENINGIDENTIFYINVENTIMPLEMENT 3.1 Ideation & Brainstorming 4.1 Intellectual Property Basics 4.5 Prototyping 4.2 Regulatory Basics 4.3 Reimbursement Basics 4.4 Business Models 3.2 Concept Screening 4. CONCEPT SELECTION 5.7 Marketing & Stakeholder Strategy 6.4 Licensing & Alternate Pathways 5.4 Regulatory Strategy 29
- 30. Opportunities… 1. Technologies that take cost out of system • keep patients out of hospital • downshift delivery across provider spectrum: specialists – generalists – nurses – aids
- 31. The Need: A more cost-effective approach to arrhythmia detection • Smart bandage • Netflix model… Concept:
- 33. filing the patent First-generation patch
- 34. Since 2001
- 35. Biodesign Innova<on Fellowships Technology Transla<on Metrics As of June, 2014: • over 275,000 pa<ents treated • 600 new jobs created • over 400 patents filed by fellows • 33 companies spin-‐out