Introduction to Biodesign - Stanford University - Ravi Pamnani
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Transcript of Introduction to Biodesign - Stanford University - Ravi Pamnani
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Introduction to the
Stanford Biodesign Program
Ravi Pamnani
Research Affiliate, Stanford University
Sr. Manager, Marketing & Medical Affairs, Transcend Medical
27 August 2014
MD&M Brazil, São Paulo
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How Does Innovation Happen?
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Innovation is a Process
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I have not failed. I've just found 10,000 ways that won't work.
Thomas Edison,
Really, Really Persistent
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4
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 SCREENING ID
EN
TIF
Y
INV
EN
T
IMP
LE
ME
NT
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
4
The Biodesign Process
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To develop leaders in biomedical technology innovation
Educate. Collaborate. Innovate.
Mission of the Biodesign Program
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Stanford Biodesign White Team – 2010-2011 6
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• Introduction to Program
• Clinical and Innovation Lectures
• Meetings with Mentors
• Introduction to Sponsors
Intensive Background Learning –1 month
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Become a Mini-Clinical Expert
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Become a Mini-Biodesign Expert
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Start with the Unmet Need
I find out what the world needs. Then, I go ahead and invent it.
Thomas Edison,
Good Inventor,
Better Need Finder
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Clinical Immersion – 2 months
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Identify >200 Needs and Rank Them
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1. Clinical / User impact • Convenience • Life-saving
2. Prevalence/Incidence
• Birth defects • Headaches
3. Economic impact
• Sometimes a function of #1 above
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13
needs
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
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Concept Generation - Brainstorming
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The best way to have a good idea is to have lots of ideas. Linus Pauling, Had lots of really good ideas
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needs concepts
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
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Concept Selection and Prototyping
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1. Predicted efficacy
2. Estimated technical feasibility
3. Intellectual property
4. Regulatory pathway established
5. Payment / business model known
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17
needs concepts
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
NEED
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
CONCEPT
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Development Strategy & Planning
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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
5.8
Sales & Distribution
Strategy
5.9 Competitive
Advantage & Business
Strategy
IMP
LE
ME
NT
5.7 Marketing &
Stakeholder Strategy
5.4
Regulatory Strategy
18
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Integration
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6. INTEGRATION
6.2
Business Plan
Development
6.3
Funding Sources
6.1
Operating Plan & Financial
Model
6.4 Licensing & Alternate
Pathways
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20
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 SCREENING ID
EN
TIF
Y
INV
EN
T
IMP
LE
ME
NT
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
20
The Biodesign Process
20
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Biodesign Year
OUS, US
Clinical Status Business Status
Acquired 1-C
1-F
1-F
2-F
2-C
5-F
5-C
6-F
OUS, US
OUS, US
OUS, US
OUS
OUS, US
OUS
Preclinical
Acquired
Acquired
Acquired
Series B
Series D
Series C
SBIR Ph. 1
5-C Series A Preclinical
5-F Preclinical Series A
Fellow and Student Companies
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Biodesign Year Clinical Status Business Status
6-C
8-F
8-I
6-F
8-F
7-F Series A
Seed
Series A
Seed
Angel
Angel
FIH
OUS
Approved
US
Preclinical
OUS
6-C OUS Series C
6-F OUS Series B
6-C Series B Preclinical
8-F Seed Preclinical
Fellow and Student Companies
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Biodesign Year Clinical Status Business Status
9-F Seed Preclinical
10-C
10-F
Series A
Series A
Seed US
Preclinical
11-F FIH
9-C Seed US
9-F Series A Preclinical BioTrace Medical
9-F Series B US
Seed 11-F Preclinical SFDA
Series A 12-F FIH
10-F OUS Series B
Fellow and Student Companies
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Obrigado!
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