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

How Does Innovation Happen?

2

Innovation is a Process

3

I have not failed. I've just found 10,000 ways that won't work.

Thomas Edison,

Really, Really Persistent

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

4

To develop leaders in biomedical technology innovation

Educate. Collaborate. Innovate.

Mission of the Biodesign Program

Stanford Biodesign White Team – 2010-2011 6

• Introduction to Program

• Clinical and Innovation Lectures

• Meetings with Mentors

• Introduction to Sponsors

Intensive Background Learning –1 month

7

Become a Mini-Clinical Expert

8

Become a Mini-Biodesign Expert

9

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

10

Clinical Immersion – 2 months

11

Identify >200 Needs and Rank Them

12

1. Clinical / User impact • Convenience • Life-saving

2. Prevalence/Incidence

• Birth defects • Headaches

3. Economic impact

• Sometimes a function of #1 above

13

needs

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

Concept Generation - Brainstorming

14

The best way to have a good idea is to have lots of ideas. Linus Pauling, Had lots of really good ideas

15

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 Selection and Prototyping

16

1. Predicted efficacy

2. Estimated technical feasibility

3. Intellectual property

4. Regulatory pathway established

5. Payment / business model known

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

Development Strategy & Planning

18

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

Integration

19

6. INTEGRATION

6.2

Business Plan

Development

6.3

Funding Sources

6.1

Operating Plan & Financial

Model

6.4 Licensing & Alternate

Pathways

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

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

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

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

Obrigado!

24