stanford program in biodesign
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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”