Stanford Program in BiodesignA Chaney

P YockFounder, Director

T KrummelCo-Director

J MakowerMentor

Co-Founder

T Andriacchi

S Delp

R PoppDirector

G Gurtner P Wang S Zenios

Todd BrintonFellowship Director

M GertnerMentor

Raj DoshiExec Director(U.S.)

Balram BhargavaExec Director(India)

Craig MilroyDirector

Ethics, Policy Fellowship

Stanford-India Biodesign Collaboratory

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 Program1.1 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

5.1IP Strategy

5.3 Regulatory Strategy

5.5 Clinical & Marketing Strategy

5.4Stakeholder /

Political Strategy

5.2Reimbursement

Strategy

6. DEVELOPMENT PLAN

6.2 Clinical Trial

Design

6.1 R&D /Engineering

Plan

6.4Operating Plan & Milestones

6.6Funding Sources

6.7 Business Plan Development

6.3 Sales &

Marketing Plan

6.5 Financial Modeling &

Proxy Validation

2. NEEDS SCREENING AND SPECIFICATIONID

EN

TIF

YIN

VE

NT

IMP

LE

ME

NT

3.1Brainstorming

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

MultipleConcepts

FinalConcept

& Prototype

Competitive AdvantageStatement

BusinessPlan

3. CONCEPT GENERATION

Challenges

• Consistent mentoring approach

• Sustainable funding

• Whither U.S. medtech industry?

Biodesign Year

OUS, US

Clinical Status Business Status

Acquired1

2

1

1

4

6

4

7

7

7

OUS, US

OUS, US

OUS, US

Clinicals

OUS, US

Clinicals

Pre-Trial

OUS

OUS

Acquired

Series C

Acquired

Series A

Series B

Series B

SBIR Ph. 1

SBIR Ph. 1

Series B

Examples of fellow and student companies….

>21,000 patients treated…

Our real “product”