Towards  Indigenously  Developed,   Locally  Relevant, Affordable  Diagnosics 

Towards Indigenously Developed,  
Locally Relevant, Aﬀordable Diagnos<cs  

The Search for a Sustainable Model  

13th September 2008 

© 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 


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 


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. 


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 

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


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


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  


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  

Page 10


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! 


•  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
 
Page 12


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 

Page 13


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/)) 

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 


The first batch

Page 16

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 ?           

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. 

Page 19

Thank You

Page 20

Towards  Indigenously  Developed,   Locally  Relevant, Affordable  Diagnosics

Recomendados

Recomendados

Más contenido relacionado

Similar a Towards  Indigenously  Developed,   Locally  Relevant, Affordable  Diagnosics

Similar a Towards  Indigenously  Developed,   Locally  Relevant, Affordable  Diagnosics  (20)

Más de zmanian

Más de zmanian (7)

Último

Último (20)