Published on January 23, 2009
© 2006 ReaMetrix, Inc. All rights reserved.
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 2
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 3
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 4
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. © 2006 ReaMetrix, Inc. All rights reserved. Page 5
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 6
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 7
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 8
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 9
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 10
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! © 2006 ReaMetrix, Inc. All rights reserved. Page 11
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 12
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 13
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/)) © 2006 ReaMetrix, Inc. All rights reserved. Page 14
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 © 2006 ReaMetrix, Inc. All rights reserved. Page 15
The first batch © 2006 ReaMetrix, Inc. All rights reserved. Page 16
© 2006 ReaMetrix, Inc. All rights reserved. Page 17
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 ? © 2006 ReaMetrix, Inc. All rights reserved. Page 18
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. Page 19
Thank You © 2006 ReaMetrix, Inc. All rights reserved. Page 20
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