UCSF Life Sciences: Week 6 Diagnostics Partners

UCSF Life Science

The Lean LaunchPad

Partners

Version 6/13/12

Who are your Partners and Suppliers?

Key Partners

Who are your Partners and Suppliers?

© 2012 Steve Blank

Partners – who are they?

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• Manufacturing / build / component suppliers

• Technology partners

• Channel (S&M) partners

• Strategic partners

• Co-everything (development, branding, etc.)

Keep asking yourself:

Why do I need this partner? How can we keep it valuable to both sides? How is this going to change with time?

Partners – Key Suppliers

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• Outsource suppliers

• Backoffice, supply chain, manufacturing

• Direct suppliers

• Components, raw materials, etc.

Example: Apple builds the iPhone from multiple suppliers

Partnering with (Big) Companies

Leverage

…is the only way to make it work

Protectable Leverage1. S&M support2. IP (FTO)3. Complementary products

1. Technology / Products2. New customers3. IP

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Molecular Diagnostics

Partner Examples

Chip Manufacturers

Partners

LiquiLume

Hospitals

OEMs

Packaging

Reagents (IDT, Fisher)

Sample Prep (not for RUO)

Shippers (UPS, FedEx)

Distributors (Fisher)

Doctors

Clinical Labs

Dx Test Company

Research Labs

Back End Front End

Back-End Partners

Type Examples Benefit Risk / Need

Chip manufacturer

HTE Labs Make optofluidic chips (key element of technology)

High / Critical

Packaging ? Keep device costs low Low / Essential

OEMs Laser or detector manufacturers

Parts needed to build complete instrument

Low, Med / Essential

Reagents Supplier

IDT, Fisher Provide custom probes and control targets.

Med / Essential

Sample Prep. Instrument

Qiagen Partner for validation of input target samples

Low / Nice

Front-End Partners

Type Examples Benefit Risk / Need

Distributor Fisher Sell chips, reagents Low / Not critical for RUO

Research labs UCSF oncologists, Stanford MDx Lab, UCSF Micro. Lab

Will validate technology; publish; develop assays

Low / Critical during phase I

Dx test company

Genentech;Companion Dx w

pharma and biotechs;Specialty Dx test cos.

Possibly unique test on unique platform, partner

develops assayStrategic alliance

Low / Synergistic

Clinical labs Quest, LabCorp Help develop CLIA-waived application; 510(k); clinical

trials

Med / Crucial during phase II

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Medical Device

Partner Examples

REGULATION

CLINICAL

TRIALS

IP

REIMBURSEMENT

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WEEKS LEFT!

CLINICAL

TRIALS

ONLY TWO

REIMBURSEMENT

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Next week’s lecture

REGULATION

CLINICAL

TRIALS

IPREIMBURSEMENT

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Next week’s slides

As per the syllabus, plus:

1. Your final (validated?) hypotheses: regulation

2. Your final (validated?) hypotheses:reimbursement

3. Preliminary hypotheses: IP needs and clinical trialstructure, size, etc.