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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



 © 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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