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Stanford Program in Biodesign

Leadership. P Yock Founder, Director. T Krummel Co-Director. Core Faculty. “Shrink”. Tech Tx. P Wang. S Zenios. S Delp. T Andriacchi. G Gurtner. A Chaney. J Gorodsky. Ethics, Policy. Fellowship. Stanford-India Biodesign. Collaboratory. M Gertner Mentor. J Makower Mentor

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Stanford Program in Biodesign

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  1. Leadership P YockFounder, Director T KrummelCo-Director Core Faculty “Shrink” Tech Tx P Wang S Zenios S Delp T Andriacchi G Gurtner A Chaney J Gorodsky Ethics, Policy Fellowship Stanford-India Biodesign Collaboratory M GertnerMentor J MakowerMentor Co-Founder Todd BrintonFellowship Director Craig MilroyDirector R PoppDirector Balram BhargavaExec Director(India) Raj DoshiExec Director(U.S.) Stanford Program in Biodesign

  2. Basic Format for Fellowship Two teams of 4 U.S. fellows (also India team) 10.5 months (August 1 – June 15); optional second year with funding Selection by national search Needs generated by fellows from new clinical area each year Local mentors, advisors (150 plus) Major deliverable = project plans

  3. IDENTIFY 1. NEEDS FINDING 2. NEEDS SCREENING AND SPECIFICATION 1.1 Strategic Focus 2.1 Disease State Fundamentals 2.3 Stakeholder Analysis 2.5 Needs Filtering 1.2 Observation & Problem Identification 1.3 Need Statement Development Need Statement 2.2 Treatment Options 2.4 Market Analysis Need Specification INVENT 3. CONCEPT GENERATION 4. CONCEPT SELECTION 4.1 Intellectual Property 3.1 Brainstorming 3.2 Concept Screening 4.3 Regulatory 4.5 Early Stage Design & Prototyping 4.6 Concept Selection Multiple Concepts 4.4 Business Models Final Concept & Prototype 4.2 Reimbursement IMPLEMENT 6. DEVELOPMENT PLAN 5. DEVELOPMENT STRATEGY 5.1 IP Strategy 5.3 Regulatory Strategy 6.1 R&D / Engineering Plan 6.4 Operating Plan & Milestones 6.7 Business Plan Development 5.6 Competitive Advantage & Value Proposition 5.2 Reimbursement Strategy 5.4 Stakeholder / Political Strategy Business Plan 6.2 Clinical Trial Design 6.5 Financial Modeling & Proxy Validation Competitive Advantage Statement 5.5 Clinical & Marketing Strategy 6.3 Sales & Marketing Plan 6.6 Funding Sources Unique Features of Program • Access to mentors • Strong regional medtech industry • Proximity of schools, hospitals, faculty • Entrepreneurship welcome • Synergy with graduate class • Well-developed curriculum

  4. Challenges Consistent mentoring approach Sustainable funding Whither U.S. medtech industry?

  5. >21,000 patients treated… Our real “product” Examples of fellow and student companies…. Biodesign Year Clinical Status Business Status Acquired 1 OUS, US Acquired 2 OUS, US Series C 1 OUS, US Acquired 1 OUS, US Series A 4 Clinicals Series B 6 OUS, US Series B 4 Clinicals SBIR Ph. 1 7 Pre-Trial SBIR Ph. 1 7 OUS Series B 7 OUS

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