Manufacturing Early and Often

Manufacturing Early and Often Risk Reduction in an R&D “Transition”

Aaron Oppenheimer Daktari Diagnos2cs

[email protected]

About Daktari

10/31/11 2 Copyright 2011 Daktari Diagnos2cs Inc.

3

Complex instruments Skilled technicians

Microscopes / Lateral Flow District hospital

Rapid tests / Glucose meters

10/31/11 Copyright 2011 Daktari Diagnos2cs Inc.

Our Approach To Diagnos2cs

One critical blood test is required to deliver effective HIV/AIDS care: CD4 cell count.

• Treatment depends on CD4 test results.

• CD4 tests are performed 2-4x per year for life to monitor treatment effectiveness.

• Poorly designed CD4 testing is the major barrier to effective HIV treatment; only 30% of the total market can be reached by existing technologies.

Test for HIV

Stage with CD4

Treat Monitor with CD4

CD4 cell count assay unavailable

CD4 cell count assay unavailable

HIV drugs available for ~$100 per person-‐year

HIV tes2ng available for $1.50 per test

Copyright 2011 Daktari Diagnos2cs Inc. 10/31/11 4

Example: The CD4 Count Problem

Nurse / Doctor Phlebotomist Lab Technician Lab Supervisor Data Clerk

Staff Required

Time

Reach

Price

Nurse 5 1 2 Days -‐ 2 Weeks 6 Minutes

Product & Se]ng

$ 35,000 Instrument $ 300 $8-‐20/Test + + $8/Test

57 lbs Central Laboratory

Exis2ng technology Needed

5 lbs Backpack / medical bag

30%

100%

10/31/11 Copyright 2011 Daktari Diagnos2cs Inc. 5

Current Technologies Fail To Meet Customer Needs

Housing Cover protects Blister Pack and Sensor Chip, seals the sample entry port, and affords easy, safe handling.

Blister Pack Contains the three reagents required

for the assay. The Instrument depresses the blisters to dispense the fluid and drive it at highly controlled rates.

Sensor Chip Forms the “ceiling” of the Assay

chamber; coated with antibodies to capture CD4 cells and electrodes to measure impedance within the Chamber.

Assay Card Injection-molded card contains the

microfluidic channels for routing sample and reagents, and defines the Assay Chamber.

Lid Seals the microfluidic paths molded

into the bottom of the Assay Card.

Daktari CD4 Cartridge



Daktari CD4 Instrument

Transitioning from Academia to Production


Transi2oning from Academia to Produc2on


Academic Lab Product Development Volume Manufacture

One 100s-1000s 1,000,000+Quantity

Any Standard StandardMaterials

AnyProcesses “Alternate” Standard

$$$Cost $ ¢

“R&D” As Transi2onal Phase


Materials



Materials

A key choice made on day one…

Materials



…will be the basis of other decisions and s2ck around for a long 2me.



Materials

…so it has beher be an informed choice.



Materials

Processes

Risk in the “R&D” Process


•  We need a scalable way to do something

•  How will we want to do it in high volume?

•  How can we do it for the 2 years that will transi2on into the 5-‐year-‐plan?

•  How can we do that today, to get clinical data, raise money…? •  Do it the high-‐volume way (if we can know what it will be) •  Use an alterna2ve material or method with a clear path to high-‐volume •  Just do whatever works – figure it out later

“R&D” Process


•  Do it the high-‐volume way (if we can know what it will be)

•  Use an alterna2ve material or method with a clear path to high-‐volume

•  Just do whatever works – figure it out later

Speed

Slower

Faster

Risk

Lower

Higher

Manufacturing in the “R&D” Process


•  A startup lives and dies on delivering its product

•  Delivering a product relies on manufacturing

•  At Daktari, the design of the manufacturing process started on day 1…

…and we’re s2ll learning

Thanks

Aaron Oppenheimer Daktari Diagnos2cs

[email protected]

Manufacturing Early and Often

Documents

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