Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West...

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Healthcare Innovation: Pathway to Success

Transcript of Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West...

Page 1: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Healthcare Innovation:

Pathway to Success

Page 2: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Chris West

UT: Entrepreneur In Residence

ZeroTo510: President

[email protected]

[email protected]

901.866.1400 x1382

Page 3: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Important entrepreneurial concepts

• Necessity is the mother of invention.

• Most innovations fail

– Use this reality as your null hypothesis

– If it’s going to fail, have it fail fast and cheap!

• Team > I

• The value of your invention is relatively simple:

– P(success) x NPV

• Hurry but don’t rush

• We most value Need, Team, Traction

Page 4: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

STAGE 0

Concept / Feasibility

STAGE 1

Pre-Clinical Develop-

ment

STAGE 2

Safety Studies

(Phase 1)

STAGE 3

POC Studies

(Phase 2a)

STAGE 4

Dose Finding Studies

(Phase 2b)

STAGE 5

Pivotal Studies

(Phase 3)

STAGE 6

Regulatory Submission

STAGE 7

Commercial Launch

STAGE 8

Post-Launch

G 1

G 0

G 2 G 3 G 4 G 5 G 6

INITIATE &PROPOSE

REFRESH &VALIDATE

REFRESH &VALIDATE

REFRESH &VALIDATE

REFRESH &VALIDATE

REFRESH &VALIDATE

P(Success) = P(S1) x P(S2) x P(S3) x …

4

G 7

REFRESH &VALIDATE

REFRESH &VALIDATE

G 8

Page 5: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

MEMPHIS HAS A ROBUST

ENTREPRENEURIAL ECOSYSTEM

Page 6: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

4 Pillars of innovation to reinforce our

economic strengths

• Bioworks: Non-profit with an

entrepreneurial mission

• Innova: Venture Capital Fund

• TriMetis: CRO with 26,000sf pre-

clinical, GLP-compliant lab

• Vertical expertise & contacts

• Support: Labs, Fab Lab,

Incubation Spaces

• Multiple commercialization

models: you can stay in your role

Memphis Bioworks Fdn

ZeroTo510 Medical Device

Logistics AgTech Home Services

Innova Venture Capital

Trimetis Life Sciences

Support Services

Page 7: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

ZeroTo510 is a nationally recognized

Accelerator specializing in Medical Device

Companies Accelerated 24

Investment $13.5M

Got to Market 7

Fails 7

Exits 1

Page 8: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Healthcare innovation presents

unique challenges

• Many/most require regulatory approval

• IP defines and protects your idea, but the

clock starts ticking the day you file

• Relatively long development horizons

• Development can require significant capital

• Reimbursement can be elusive

• Purchasing process can be opaque

Page 9: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Our pathway

1. Customer Discovery: Define the problem/issue

2. User Needs Definition:

– What would the ideal solution look like?

– The Minimal Viable Product (MVP) solution?

3. Product definition: make choices for MVP, chart a course for lifecycle management

4. Design & production: verification/validation

5. Prepare regulatory dossier

6. Launch

Page 10: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Our Business Model Canvas is designed to

help you build a coordinated launch plan

Customer Discovery

Product Definition

User Needs

Mfg/Pkg/Quality

Pre-Clinical Plan

Regulatory Pathway

Launch Features/Claims

Patent Strategy Price/Reimburse. Commercialization Plan

Page 11: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

1. Customer Discovery

What Problem Are You Solving?• What problem are you solving?

– Don’t be a hammer (invention) – looking for a nail (problem)

• Identify the customers:

– Users

– Stakeholders

– Influencers

– Gatekeepers

• Understand their relative “pain”

Page 12: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Hint: you don’t have a problem until

someone will pay for a solution!

Page 13: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Customer Discovery: Cast 21

How did you like your previous cast?

• Love:

• Like:

• Dislike:

• Hate:

Page 14: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

2. User Needs Definition:

How would you improve your cast?

• Have each customer type help you build the

ideal solution

• Try not to limit their creativity

• Do not sell them on your idea!

• Understand the relative importance of each

suggestion

– Expect

– Need

– Want/wish

Page 15: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

A simple table can help you organize

feedback and spot trendsCustomer Type Expects Needs Wants

Steve Patient

Chris Nurse

Stefan Physician

Richard Hospital procurement

Rebecca Office Manager

Lakita IP Attorney

MRC-X Regulatory

Keisha CFO

Page 16: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

3. Define your product

• Goals:

– Define the Minimal Viable Product that solves

their problem

– Lay out a lifecycle management plan for V2.0

• Choices, choices, choices!

• This will likely be an iterative process with

your previous interviews

Page 17: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

The original iPhone is the ultimate

example of Minimal Viable Product!

Value Proposition

• Wide-screen iPod with on-screen touch controls

• Mobile phone

• Internet communicator

They relied on

OUR DISSATISFACTION for future improvements

Page 18: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

VALTREX: great example of lifecycle

management, “Incremental Blockbuster”

Launch (Year 8)

Improved Dosing vs. Acyclovir

Year 11

“Short Course”

Year 13

Treatment of Cold Sores

Year 16

Transmission Prevention

Page 19: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

4. Design & production:

Verification and Validation

• Verify with customers that product meets

their stated and implicit needs

• Validate via testing that product performs

in expected & repeatable

• Identify manufacturing partner

• Regulatory filing requirements

Page 20: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Our pathway

1. Customer Discovery: Define the problem/issue

2. User Needs Definition: what would the ideal solution look like? The Minimal Viable Product (MVP) solution?

3. Product definition: make choices for MVP, chart a course for lifecycle management

4. Design & production: verification/validation

5. Prepare regulatory dossier

6. Launch

Page 21: Healthcare Innovation: Pathway to Success · Healthcare Innovation: Pathway to Success. Chris West UT: Entrepreneur In Residence ZeroTo510: President cwest@memphisbioworks.org chris@zeroto510.com

Chris West

UT: Entrepreneur In Residence

ZeroTo510: President

[email protected]

[email protected]

901.866.1400 x1382