This document discusses developing affordable diagnostics that are locally relevant in developing countries. It describes ReaMetrix, an organization in Bangalore working on this goal. All of ReaMetrix's initial assumptions about how to achieve this vision in India were wrong, forcing them to explore new paradigms. One approach is developing reagents and instrumentation locally at lower costs while maintaining quality. A case study examines creating an affordable CD3/CD4 diagnostic test for managing HIV patients in India. Issues with current testing methods and a new systems-based approach combining locally-made reagents, instrumentation, and delivery are analyzed.

1. Towards Indigenously Developed,
Locally Relevant, Affordable Diagnos<cs
The Search for a Sustainable Model
13th September 2008
© 2006 ReaMetrix, Inc. All rights reserved.

2. Disclosure
 ReaMetrix is a cross‐disciplinary group made up of Biologists,
Chemists, Physicists and Engineers, based out of Bangalore working
towards the vision of affordable diagnosHcs of relevance to the
developing world.
 We would like to honestly admit that all pre‐conceived ideas with
which we started execuHng on our vision in India, turned out to be
totally wrong.
 This has forced us to look at completely new paradigms that can help
build a sustainable economic model to solve the twin issues of
accessibility and affordability
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3. Framing the Big Picture
 DiagnosHcs is an important
component in disease management.
 DiagnosHcs is all about “informaHon”
generaHon: InformaHon is generated
to help the physician (and in some
cases the paHents) make beSer
clinical decisions.
 DiagnosHcs is never about replacing
the doctor or a replacement of the
experience garnered in a local context
by a doctor
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4. How is the cost of diagnos<cs influenced in different contexts?
 In most developing countries, the
diagnosHc soluHons used are parachuted
from resource‐rich countries.
 During development, the cost economics of
these soluHons were highly influenced by
the local macroeconomic environment
prevailing in those countries.
 Design criteria opHmized for one
environment may not be the right soluHon
for another.
CANNOT HAVE A ONE‐SIZE
FITS ALL APPROACH
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5. Different priori<es in different environments
 In the developed countries:
• Labor costs dominate the COGS.
• The emphasis is on reducHon of labor
both in manufacturing and in process.
• Less emphasis on material conservaHon.
 In the resource‐poor countries:
• Material costs dominate the COGS.
• The emphasis has to be on material
recovery – more of the raw material has
to end up in finished goods.
• Labor component has a small contribuHon
to COGS.
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6. An Opportunity to Change the Paradigm?
 Re‐Pose the problem in the local context
 QuanHfy the cost of generaHng clinical informaHon in the local context
 Define “the affordability index” in the context of local macroeconomic
environment – how much will the stakeholder be willing to pay?
 Affordability index drives the appropriate technology that can deliver
the good and services within the affordability index.
PRICE DETERMINES TECHNOLOGY, TECHNOLOGY DOESN’T SET THE PRICE
Pu#ng this Paradigm to Test …..
A Case Study :
An Affordable CD3/CD4 Diagnos@c Test in Managing HIV Pa@ents
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7. Case Study: Affordable CD3/CD4 Diagnos<cs
 Test is used for the measurement of immune system T‐Cells – to enable a
doctor to manage HIV/AIDS paHents
 Disease management is about trends – not decisions based on a single point
CD4 Count
CD4 Count
Rs.500 – Rs.1200 per test
? Cost per test
Time
Time
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8. Anatomy of Clinical Informa<on Genera<on in the Indian Context – esp. in out reach centers
Sample journey and cost accumulaHon
Provide
Acquire
Transport
Process
Run
Results
Collection Centralized
centre
Path Lab
Path Lab
Doctor
Hospital
Layers of
margin
at every
step
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9. Issues with the Current Tes<ng Methodology
Technical
 Aged blood samples
 Accuracy and reliability of Issues with CD3/CD4 Diagnos@cs
results
 Time lag for treatment
decisions
 Traceability of sample
Lack of a Non‐local Non‐Local
mechanism to Manufacture of Manufacture of
Commercial generate clinical Instrumenta?on Reagents :
informa?on o@en with Reliance on
 Encourages too many layers of closer to where features with Imported
margin affecHng affordability its needed minimal Reagents
relevance in the
 Capital costs for imported Indian context
equipments act as big barrier to
entry as well as in adopHon of
closer to customer models
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10. A Systems Approach: Reagents + Instrumenta<on + Delivery
Reagents
 Strategy : Take advantage of low labor cost in India to develop reagents locally
 Focus on process improvements has increased material yield by an average of 400% ‐
higher yield results in lower cost of a test: Rs 100 per test (nearly 5 fold lower)
 Lower cost reagents BUT with the same quality as the more expensive reagents
imported from outside India
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11. A Systems Approach: Reagents + Instrumenta<on + Delivery
Reagents : Designing Features that are Locally Relevant
Concept of Uni<zed Dried Down Reagents
‐ Reagents require no cold‐chain – for transport as well as for storage
‐ Up to 8 day stability of stained‐fixed samples eliminaHng blood stability issues
associated with long periods of transportaHon from collecHon center to central tesHng
facility
‐ Reagents can withstand extreme heat upto 45 C
Dried Reagents are not a significant
need in the western context … but are
a significant boon in the developing
na?on context !
Adv. of defining the problem locally!
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12. A Systems Approach: Reagents + Instrumenta<on + Delivery
• Ability to be run using a car baSery
• UniHzes waste disposal – minimizes chance of
improper waste handling
• Open system – ability to port mulHple tests
onto the system – It is NOT an instrument for
measuring only CD3/CD4 counts
• Designed to withstand harsh environments
• Portable
• Reduced Capital Cost
• Minimal skill level needed to operate
• Requires no field calibraHon
Uni@zed Test Cartridges
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13. A Systems Approach: Reagents + Instrumenta<on + Delivery
How does this enable a new paradigm ?
• The instrument as well as the dried down reagents enable generaHon of
clinical informaHon closer to the doctor‐paHent interacHon context, that is
currently not possible:
‐ GP’s Office
‐ Outreach Centres
‐ ICU’s in Hospitals
‐ Mobile screening vans
‐ Ambulances
* Though the reagents are affordable – there is sHll enough margin to pay for
the cost of the instrument as well, over a 1‐year period
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14. A Systems Approach: Reagents + Instrumenta<on + Delivery
Enabling Local Economic Ac<vity and Empowerment of
Health‐workers by Novel Methods of Delivering Clinical
Informa<on
Case Study : SAANTWANAM
(Work being carried out by HAP (hNp://www.hapindia.org/))
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15. Saantwanam
A health screening project in Kerala
 FighHng life style diseases – A novel project by HAP,
Kutumbashree & State Bank of India.
 ObjecHves ‐ Screening for Diabetes mellitus, obesity,
hypertension and growth retardaHon.
 Referral to physician & health educaHon.
 Strategy – rely on locally recruited and trained young women
with high school educaHon but from poor families and deploy
them to accomplish the objecHve of wellness management
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16. The first batch
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17. © 2006 ReaMetrix, Inc. All rights reserved.
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18. Ques<ons that arise from these case studies ….
 What more can be done using this
model of healthcare delivery?
 How do we combine innovaHons in
reagent design, instrumentaHon
design and delivery to impact public
health especially in the context of
the underserved ?
 How can we extend these
innovaHons to bring about “wellness
management” rather than just
stopping at “illness“ diagnosis ?
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19. In summary…
 One has to look at “diagnosHc informaHon
generaHon” holisHcally, not just as a set of
assay reagents and hardware planorms.
 Addressing “the economics” problem
innovaHvely, will lead to sustainable
soluHons.
 “Import the science” but not the
implementaHon of the science – great to
think globally but sustainable innovaHon is
all local.
 Using this model, one can not only
address the unmet needs in resource‐poor
seongs but change the way diagnosHc
informaHon is delivered globally.
© 2006 ReaMetrix, Inc. All rights reserved.
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20. Thank You
© 2006 ReaMetrix, Inc. All rights reserved.
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