A little clarification

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A little clarification
Biotech Drugs based on molecular/gene
discovery (company examples Amgen, Genentech)
Medtech Devices and diagnostics implants,
catheters, etc (company examples Medtronic,
Stryker)
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medtech vs. biotech
medtech
biotech
FDA approval
2-4 years
8-12 years
40-60M
800M 1B
investment
pipeline, generics
reimburse, FDA
big issues
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Stanford and Med Tech
Over 50 Stanford faculty founded or contributed
primary IP to med tech companies
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Medical device companies based on Stanford
student/faculty technology
Accuray, Advanced Cardiovascular Systems/Guidant,
AneuRx/Medtronic, AVE/Medtronic, Avatar, Bacchus
Vascular, Cardiometrics/EndoSonics, CVIS/Boston
Scientific, Cepheid, CoApt, Cohesion, Collagen,
Corazon Technologies, CSFluids, Devices for
Vascular Intervention/Guidant, Eclipse Surgical
Technologies, Fox Hollow Technologies, General
Surgical Innovations (Tyco/US Surgical)
HeartPort, Imetrx, InterVentional Technologies,
Intravascular Research Ltd., IsoStent,
Laserscope LocalMed, Lumend, Natus Medical,
Nellcor, Neocardia/Guidant, NeoGuide, Norian,
Novacept, NovaCor/Baxter,OsteoNet,
PerClose/Abbott, Pulmonx , Quanam, Raytel
Medical, ReSound, Rx Sound, SoundPort,
Ventritex/St. Jude, Versaflex/Medtronic
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Program in Biodesign
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1. NEEDS FINDING
2. NEEDS SCREENING AND SPECIFICATION
IDENTIFY
1.1 Strategic Focus
1.2 Observation Problem Identification
1.3 Need Statement Development
2.1 Disease State Fundamentals
2.3 Stakeholder Analysis
2.5 Needs Filtering
2.2 Treatment Options
2.4 Market Analysis
Need Statement
Need Specification
INVENT
4. CONCEPT SELECTION
3. CONCEPT GENERATION
4.1 Intellectual Property
4.6 Concept Selection
3.1 Brainstorming
4.5 Early Stage Design Prototyping
4.3 Regulatory
3.2 Concept Screening
4.4 Business Models
Multiple Concepts
Final Concept Prototype
4.2 Reimbursement
IMPLEMENT
6. DEVELOPMENT PLAN
5. DEVELOPMENT STRATEGY
5.1 IP Strategy
5.3 Regulatory Strategy
6.1 RD / Engineering Plan
6.4 Operating Plan Milestones
6.7 Business Plan Development
5.6 Competitive Advantage Value Proposition
5.4 Stakeholder / Political Strategy
5.2 Reimbursement Strategy
Business Plan
6.2 Clinical Trial Design
6.5 Financial Modeling Proxy Validation
Competitive Advantage Statement
5.5 Clinical Marketing Strategy
6.6 Funding Sources
6.3 Sales Marketing Plan
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1. NEEDS FINDING
2. NEEDS SCREENING AND SPECIFICATION
IDENTIFY
1.1 Strategic Focus
1.2 Observation Problem Identification
1.3 Need Statement Development
2.1 Disease State Fundamentals
2.3 Stakeholder Analysis
2.5 Needs Filtering
2.2 Treatment Options
2.4 Market Analysis
Need Statement
Need Specification
INVENT
4. CONCEPT SELECTION
3. CONCEPT GENERATION
4.1 Intellectual Property
4.6 Concept Selection
3.1 Brainstorming
4.5 Early Stage Design Prototyping
4.3 Regulatory
3.2 Concept Screening
4.4 Business Models
Multiple Concepts
Final Concept Prototype
4.2 Reimbursement
IMPLEMENT
6. DEVELOPMENT PLAN
5. DEVELOPMENT STRATEGY
5.1 IP Strategy
5.3 Regulatory Strategy
6.1 RD / Engineering Plan
6.4 Operating Plan Milestones
6.7 Business Plan Development
5.6 Competitive Advantage Value Proposition
5.4 Stakeholder / Political Strategy
5.2 Reimbursement Strategy
Business Plan
6.2 Clinical Trial Design
6.5 Financial Modeling Proxy Validation
Competitive Advantage Statement
5.5 Clinical Marketing Strategy
6.6 Funding Sources
6.3 Sales Marketing Plan
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Biodesign Innovation Fellowships
Biodesign Innovation Fellowships
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Start with at least 200 needs
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1. NEEDS FINDING
2. NEEDS SCREENING AND SPECIFICATION
IDENTIFY
1.1 Strategic Focus
1.2 Observation Problem Identification
1.3 Need Statement Development
2.1 Disease State Fundamentals
2.3 Stakeholder Analysis
2.5 Needs Filtering
2.2 Treatment Options
2.4 Market Analysis
Need Statement
Need Specification
INVENT
4. CONCEPT SELECTION
3. CONCEPT GENERATION
4.1 Intellectual Property
4.6 Concept Selection
3.1 Brainstorming
4.5 Early Stage Design Prototyping
4.3 Regulatory
3.2 Concept Screening
4.4 Business Models
Multiple Concepts
Final Concept Prototype
4.2 Reimbursement
IMPLEMENT
6. DEVELOPMENT PLAN
5. DEVELOPMENT STRATEGY
5.1 IP Strategy
5.3 Regulatory Strategy
6.1 RD / Engineering Plan
6.4 Operating Plan Milestones
6.7 Business Plan Development
5.6 Competitive Advantage Value Proposition
5.4 Stakeholder / Political Strategy
5.2 Reimbursement Strategy
Business Plan
6.2 Clinical Trial Design
6.5 Financial Modeling Proxy Validation
Competitive Advantage Statement
5.5 Clinical Marketing Strategy
6.6 Funding Sources
6.3 Sales Marketing Plan
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Concept Selection
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Go for quantity of ideas
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1. NEEDS FINDING
2. NEEDS SCREENING AND SPECIFICATION
IDENTIFY
1.1 Strategic Focus
1.2 Observation Problem Identification
1.3 Need Statement Development
2.1 Disease State Fundamentals
2.3 Stakeholder Analysis
2.5 Needs Filtering
2.2 Treatment Options
2.4 Market Analysis
Need Statement
Need Specification
INVENT
4. CONCEPT SELECTION
3. CONCEPT GENERATION
4.1 Intellectual Property
4.6 Concept Selection
3.1 Brainstorming
4.5 Early Stage Design Prototyping
4.3 Regulatory
3.2 Concept Screening
4.4 Business Models
Multiple Concepts
Final Concept Prototype
4.2 Reimbursement
IMPLEMENT
6. DEVELOPMENT PLAN
5. DEVELOPMENT STRATEGY
5.1 IP Strategy
5.3 Regulatory Strategy
6.1 RD / Engineering Plan
6.4 Operating Plan Milestones
6.7 Business Plan Development
5.6 Competitive Advantage Value Proposition
5.4 Stakeholder / Political Strategy
5.2 Reimbursement Strategy
Business Plan
6.2 Clinical Trial Design
6.5 Financial Modeling Proxy Validation
Competitive Advantage Statement
5.5 Clinical Marketing Strategy
6.6 Funding Sources
6.3 Sales Marketing Plan
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Fellow and student companies.
Biodesign Year
Clinical Status
Business Status
Acquired
OUS, US
1
Series C
2
OUS, US
Series B
1
OUS, US
Acquired
1
OUS, US
Series A
4
Clinicals
Series A
6
Pre-Trial
Series A
4
Pre-Trial
SBIR Ph. 1
7
Pre-Trial
SBIR Ph. 1
7
Pre-Trial
Series A
7
Pre-Trial
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John MacMahon Tom Goff (01 students)
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rinspiration for thombus dissolution
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Amir Belson (02 Fellow)
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Stanford-India Biodesign
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