Towards
Indigenously
Developed,


Locally
Relevant,
Affordable
Diagnos<cs



The
Search
for
a
Sustainable
Model



13th
Sep...
Disclosure

  
ReaMetrix
is
a
cross‐disciplinary
group
made
up
of
Biologists,

     Chemists,
Physicists
and

Engineers,
...
Framing
the
Big
Picture


 
DiagnosHcs
is
an
important

 component
in
disease
management.

 DiagnosHcs
is
all
about
“inf...
How
is
the
cost
of
diagnos<cs
influenced
in
different
contexts?


 In
most
developing
countries,
the

  diagnosHc
soluHons
...
Different
priori<es
in
different
environments


  

In
the
developed
countries:

      •  Labor
costs
dominate
the
COGS.

 ...
An
Opportunity
to
Change
the
Paradigm?


 
Re‐Pose
the
problem
in
the
local
context

 
QuanHfy
the
cost
of
generaHng
cli...
Case
Study:
Affordable
CD3/CD4
Diagnos<cs

      
Test
is
used
for
the
measurement
of
immune
system
T‐Cells
–
to
enable
a
...
Anatomy
of
Clinical
Informa<on
Genera<on
in
the
Indian
Context
–
esp.
in
out
reach
centers




  Sample
journey
and
cost
a...
Issues
with
the
Current
Tes<ng
Methodology


 Technical




   
Aged
blood
samples

   
Accuracy
and
reliability
of
    ...
A
Systems
Approach:
Reagents
+
Instrumenta<on
+
Delivery

Reagents

  
Strategy
:
Take
advantage
of
low
labor
cost
in
Ind...
A
Systems
Approach:
Reagents
+
Instrumenta<on
+
Delivery


Reagents
:
Designing
Features
that
are
Locally
Relevant

Concep...
A
Systems
Approach:
Reagents
+
Instrumenta<on
+
Delivery

                                               • 
Ability
to
be
...
A
Systems
Approach:
Reagents
+
Instrumenta<on
+
Delivery


How
does
this
enable
a
new
paradigm
?


• 

The
instrument
as
w...
A
Systems
Approach:
Reagents
+
Instrumenta<on
+
Delivery


Enabling
Local
Economic
Ac<vity
and
Empowerment
of

Health‐work...
Saantwanam

 A
health
screening
project
in
Kerala


  FighHng
life
style
diseases
–
A
novel
project
by
HAP,

   Kutumbash...
The first batch




 © 2006 ReaMetrix, Inc. All rights reserved.         
                                               P...
© 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?

 
H...
In
summary…

   
One
has
to
look
at
“diagnosHc
informaHon

    generaHon”
holisHcally,
not
just
as
a
set
of

    assay
re...
Thank You




© 2006 ReaMetrix, Inc. All rights reserved.                     
                                           ...
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Towards 
Indigenously 
Developed,

 Locally 
Relevant,
Affordable 
Diagnosics


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Towards 
Indigenously 
Developed,

 Locally 
Relevant,
Affordable 
Diagnosics


  1. 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. 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
 © 2006 ReaMetrix, Inc. All rights reserved. Page 2
  3. 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
 © 2006 ReaMetrix, Inc. All rights reserved. Page 3
  4. 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
 © 2006 ReaMetrix, Inc. All rights reserved. Page 4
  5. 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.
 © 2006 ReaMetrix, Inc. All rights reserved. Page 5
  6. 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
 © 2006 ReaMetrix, Inc. All rights reserved. Page 6
  7. 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 © 2006 ReaMetrix, Inc. All rights reserved. Page 7
  8. 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 © 2006 ReaMetrix, Inc. All rights reserved. Page 8
  9. 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

 © 2006 ReaMetrix, Inc. All rights reserved. Page 9
  10. 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

 © 2006 ReaMetrix, Inc. All rights reserved. Page 10
  11. 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!
 © 2006 ReaMetrix, Inc. All rights reserved. Page 11
  12. 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 
 © 2006 ReaMetrix, Inc. All rights reserved. Page 12
  13. 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
 © 2006 ReaMetrix, Inc. All rights reserved. Page 13
  14. 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/))
 © 2006 ReaMetrix, Inc. All rights reserved. Page 14
  15. 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
 © 2006 ReaMetrix, Inc. All rights reserved. Page 15
  16. 16. The first batch © 2006 ReaMetrix, Inc. All rights reserved. Page 16
  17. 17. © 2006 ReaMetrix, Inc. All rights reserved. Page 17
  18. 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
?










 © 2006 ReaMetrix, Inc. All rights reserved. Page 18
  19. 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. Page 19
  20. 20. Thank You © 2006 ReaMetrix, Inc. All rights reserved. Page 20

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