beyond proof of concept beattie, global health operations
Post on 11-Mar-2022
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Diagnostics For All (DFA)
• Founded in 2007
• Located in Cambridge, MA
• Non‐profit organization
• Paper‐microfluidics platform
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Our Development Model
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•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
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pH=6.7bacteria mastitis
Anal. Chem. 2009 81, 7091
Simple‐view of problem solving
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1. Identify limitation
2. Develop new technology solution
3. Done
Current State Ideal State
Technological Limitation
More accurate view
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Technology Manufacturability Cost Distribution
What do we really want?
• Improved technology vs. improved health
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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
Manufacturing Regulatory approval
Marketing/Dist.Commerc.
Basic research Applied research Development Validation
Manufacturing Regulatory approval
Marketing/Dist.Commerc.
Basic research Applied research Development Validation
Understanding the constraints
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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
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vs.
Total Cost
• Total cost = COG + licensing + packaging + manufacturing line (equipment + salaries) + QA/QC + distribution + overhead + …
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Example cost calculations
Category Cost/test
Cost of goods $0.50
Packaging and casing
$0.40
Manufacturing $0.20
Total Cost/test $1.10
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Assume 10MM tests
Methods to reducing cost
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Category Original10MM
Cost of goods $0.50
Packaging and casing
$0.40
Manufacturing $0.2
Total Cost/test $1.10
Category Original10MM
Case 15MM
Cost of goods $0.50 $0.20
Packaging and casing
$0.40 $0.40
Manufacturing $0.2 $0.40
Total Cost/test $1.10 $1.00
Category Original10MM
Case 15MM
Case 210MM
Cost of goods $0.50 $0.20 $0.50
Packaging and casing
$0.40 $0.40 $0.08
Manufacturing $0.2 $0.40 $0.2
Total Cost/test $1.10 $1.00 $0.78
Category Original10MM
Case 15MM
Case 210MM
Case 320MM
Cost of goods $0.50 $0.20 $0.50 $0.50
Packaging and casing
$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
Category Original10MM
Case 15MM
Case 210MM
Case 320MM
Cost of goods $0.50 $0.20 $0.50 $0.50
Packaging and casing
$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
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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
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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
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Quality Systems
• Doing the same thing every time
• Documentation, documentation, documen…
• Fail early, fail often
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Regulatory Concerns
• Where is your market who is your regulatory body– FDA– CE– WHO– Regional
• Patient population– Cost increases and feasibility
• Predicate devices
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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
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Summary
• Defining goals
• Identifying the real costs
• Manufacturing concerns
• Leveraging technological improvements for the appropriate area
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Acknowledgements
• GMW group
• The extended Harvard family
• The DFA team
• Beth Israel Deaconess Medical Center
• PATH
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