Stanford Program in Biodesign A Chaney P Yock Founder, Director T Krummel Co-Director J Makower Mentor Co- Founder T Andriacchi S Delp R Popp Director G Gurtner P WangS Zenios Todd Brinton Fellowship Director M Gertner Mentor Raj Doshi Exec Director (U.S.) Balram Bhargava Exec Director (India) Craig Milroy Director Ethics, PolicyFellowship Stanford-India BiodesignCollaboratory Leadership Core Faculty Tech Tx “Shrink” J Gorodsky

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

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

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

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