Beyond Proof of Concept Beattie, Global Health Operations

Beyond Proof of ConceptPatrick Beattie, Global Health Operations

October 1st, 2011

Diagnostics For All (DFA)

• Founded in 2007

• Located in Cambridge, MA

• Non‐profit organization

• Paper‐microfluidics platform

2Diagnostics For All; All Rights Reserved

Our Development Model


•Work with universities to develop technologies into products for manufacturing• Partner with manufacturers in developing countries to manufacture devices and sell them at low‐cost

DFA and paper microfluidics


pH=6.7bacteria mastitis

Anal. Chem. 2009 81, 7091

Simple‐view of problem solving


1. Identify limitation

2. Develop new technology solution

3. Done

Current State Ideal State

Technological Limitation

More accurate view


Technology Manufacturability Cost Distribution

What do we really want?

• Improved technology vs. improved health


In order to have maximum potential impact, downstream issues should be considered before proof of concept

Manufacturing Regulatory approval

Marketing/Dist.Commerc.

Basic research Applied research Development Validation







Understanding the constraints


Technology Manufacturability Cost Distribution

Costs

• How is cost defined?– Cost of goods

• Are grad students really free?

– Cost to manufacture• How many?

• Wasted material

– Cost to consumer• $2 glucose strips

• Billion dollar doses


vs.

Total Cost

• Total cost = COG + licensing + packaging + manufacturing line (equipment + salaries) + QA/QC + distribution + overhead + …


Example cost calculations

Category Cost/test

Cost of goods $0.50

Packaging and casing

$0.40

Manufacturing $0.20

Total Cost/test $1.10


Assume 10MM tests

Methods to reducing cost


Category Original10MM

Cost of goods $0.50


$0.40

Manufacturing $0.2

Total Cost/test $1.10


Case 15MM

Cost of goods $0.50 $0.20


$0.40 $0.40

Manufacturing $0.2 $0.40

Total Cost/test $1.10 $1.00


Case 15MM

Case 210MM

Cost of goods $0.50 $0.20 $0.50


$0.40 $0.40 $0.08

Manufacturing $0.2 $0.40 $0.2

Total Cost/test $1.10 $1.00 $0.78


Case 15MM

Case 210MM

Case 320MM

Cost of goods $0.50 $0.20 $0.50 $0.50


$0.40 $0.40 $0.08 $0.40

Manufacturing $0.2 $0.40 $0.2 $0.10

Total Cost/test $1.10 $1.00 $0.78 $1.00


Case 15MM

Case 210MM

Case 320MM

Cost of goods $0.50 $0.20 $0.50 $0.50


$0.40 $0.40 $0.08 $0.40

Manufacturing $0.2 $0.40 $0.2 $0.10

Total Cost/test $1.10 $1.00 $0.78 $1.00

•Manufacturing is a key factor to maintaining low total cost•Potential for innovations beyond simply reducing costs

Manufacturing and Cost


vs.

$300 vs. $100,000But on a per device basis… $6E‐6 vs. $0.002

Pre/Post Proof of Concept

• Pre‐PoC– User needs– User specifications– Current constraints

• Post‐PoC– Validation (CVs, Sens/Spec)– Quality Systems– Regulatory approval– User feedback– Manufacturing scale‐up


Validation

• Working once vs. working 99.999% of the time– CVs, Sensitivity, Specificity

• Availability of purified samples– Spiking into blood, serum, etc.

– Aging issues

• Predicate devices?

• Patient populations– If it’s 1 out of 100, then you need >1,000


Validation


United States

5% suffering from liver damage

Quality Systems

• Doing the same thing every time

• Documentation, documentation, documen…

• Fail early, fail often


Quality Systems


Regulatory Concerns

• Where is your market who is your regulatory body– FDA– CE– WHO– Regional

• Patient population– Cost increases and feasibility

• Predicate devices


User feedback/design modifications


Manufacturing and scale‐up

• Graduate students are cheap, manufacturing technicians are not.

• Typical lateral flow lines make 10’s of million of devices/year

• New equipment = new costs = higher costs– Single product problem


Manufacturing and scale up


~100 devices1000’s of devices

Summary

• Defining goals

• Identifying the real costs

• Manufacturing concerns

• Leveraging technological improvements for the appropriate area


Acknowledgements

• GMW group

• The extended Harvard family

• The DFA team

• Beth Israel Deaconess Medical Center

• PATH


www.dfa.org

Documents

Beyond Proof of Concept Beattie, Global Health Operations