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13 th September 2008 Towards Indigenously Developed, Locally Relevant, Affordable Diagnos<cs The Search for a Sustainable Model

Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

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Page 1: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

© 2006 ReaMetrix, Inc. All rights reserved.

13thSeptember2008

TowardsIndigenouslyDeveloped,LocallyRelevant,AffordableDiagnos<cs

TheSearchforaSustainableModel

Page 2: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 2 © 2006 ReaMetrix, Inc. All rights reserved.

Disclosure

 ReaMetrixisacross‐disciplinarygroupmadeupofBiologists,Chemists,PhysicistsandEngineers,basedoutofBangaloreworkingtowardsthevisionofaffordablediagnosHcsofrelevancetothedevelopingworld.

 Wewouldliketohonestlyadmitthatallpre‐conceivedideaswithwhichwestartedexecuHngonourvisioninIndia,turnedouttobetotallywrong.

 Thishasforcedustolookatcompletelynewparadigmsthatcanhelpbuildasustainableeconomicmodeltosolvethetwinissuesofaccessibilityandaffordability

Page 3: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 3 © 2006 ReaMetrix, Inc. All rights reserved.

FramingtheBigPicture

 DiagnosHcsisanimportantcomponentindiseasemanagement.

 DiagnosHcsisallabout“informaHon”generaHon:InformaHonisgeneratedtohelpthephysician(andinsomecasesthepaHents)makebeSerclinicaldecisions.

 DiagnosHcsisneveraboutreplacingthedoctororareplacementoftheexperiencegarneredinalocalcontextbyadoctor

Page 4: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 4 © 2006 ReaMetrix, Inc. All rights reserved.

Howisthecostofdiagnos<csinfluencedindifferentcontexts?

 Inmostdevelopingcountries,thediagnosHcsoluHonsusedareparachutedfromresource‐richcountries.

 Duringdevelopment,thecosteconomicsofthesesoluHonswerehighlyinfluencedbythelocalmacroeconomicenvironmentprevailinginthosecountries.

 DesigncriteriaopHmizedforoneenvironmentmaynotbetherightsoluHonforanother.

CANNOTHAVEAONE‐SIZE

FITSALLAPPROACH

Page 5: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 5 © 2006 ReaMetrix, Inc. All rights reserved.

Differentpriori<esindifferentenvironments

 Inthedevelopedcountries:•  LaborcostsdominatetheCOGS.

•  TheemphasisisonreducHonoflaborbothinmanufacturingandinprocess.

•  LessemphasisonmaterialconservaHon. Intheresource‐poorcountries:

•  MaterialcostsdominatetheCOGS.

•  Theemphasishastobeonmaterialrecovery–moreoftherawmaterialhastoendupinfinishedgoods.

•  LaborcomponenthasasmallcontribuHontoCOGS.

Page 6: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 6 © 2006 ReaMetrix, Inc. All rights reserved.

AnOpportunitytoChangetheParadigm?

 Re‐Posetheprobleminthelocalcontext

 QuanHfythecostofgeneraHngclinicalinformaHoninthelocalcontext

 Define“theaffordabilityindex”inthecontextoflocalmacroeconomicenvironment–howmuchwillthestakeholderbewillingtopay?

 Affordabilityindexdrivestheappropriatetechnologythatcandeliverthegoodandserviceswithintheaffordabilityindex.

Pu#ngthisParadigmtoTest…..ACaseStudy:AnAffordableCD3/CD4Diagnos@cTestinManagingHIVPa@ents

PRICEDETERMINESTECHNOLOGY,TECHNOLOGYDOESN’TSETTHEPRICE

Page 7: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 7 © 2006 ReaMetrix, Inc. All rights reserved.

CaseStudy:AffordableCD3/CD4Diagnos<cs

 TestisusedforthemeasurementofimmunesystemT‐Cells–toenableadoctortomanageHIV/AIDSpaHents

 Diseasemanagementisabouttrends–notdecisionsbasedonasinglepoint

CD

4 C

ount

Time

CD

4 C

ount

Time

Rs.500 – Rs.1200 per test ? Cost per test

Page 8: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 8 © 2006 ReaMetrix, Inc. All rights reserved.

AnatomyofClinicalInforma<onGenera<onintheIndianContext–esp.inoutreachcenters

SamplejourneyandcostaccumulaHon

Acquire Process Run Provide Results Transport

Collection centre

Path Lab Doctor

Hospital

Centralized Path Lab

Layers of margin at every step

Page 9: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

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

IssueswiththeCurrentTes<ngMethodology

Technical  Agedbloodsamples  Accuracyandreliabilityofresults

  Timelagfortreatmentdecisions

  Traceabilityofsample

Commercial  EncouragestoomanylayersofmarginaffecHngaffordability

  CapitalcostsforimportedequipmentsactasbigbarriertoentryaswellasinadopHonofclosertocustomermodels

IssueswithCD3/CD4Diagnos@cs

Non‐LocalManufactureof

Reagents:RelianceonImportedReagents

Lackofamechanismtogenerateclinicalinforma?on

closertowhereitsneeded

Non‐localManufactureofInstrumenta?on

o@enwithfeatureswith

minimalrelevanceintheIndiancontext

Page 10: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

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

ASystemsApproach:Reagents+Instrumenta<on+DeliveryReagents

 Strategy:TakeadvantageoflowlaborcostinIndiatodevelopreagentslocally

 Focusonprocessimprovementshasincreasedmaterialyieldbyanaverageof400%‐higheryieldresultsinlowercostofatest:Rs100pertest(nearly5foldlower)

 LowercostreagentsBUTwiththesamequalityasthemoreexpensivereagentsimportedfromoutsideIndia

Page 11: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 11 © 2006 ReaMetrix, Inc. All rights reserved.

ASystemsApproach:Reagents+Instrumenta<on+Delivery

Reagents:DesigningFeaturesthatareLocallyRelevant

ConceptofUni<zedDriedDownReagents

‐ Reagentsrequirenocold‐chain–fortransportaswellasforstorage‐ Upto8daystabilityofstained‐fixedsampleseliminaHngbloodstabilityissuesassociatedwithlongperiodsoftransportaHonfromcollecHoncentertocentraltesHngfacility‐ Reagentscanwithstandextremeheatupto45C

DriedReagentsarenotasignificantneedinthewesterncontext…butareasignificantbooninthedevelopingna?oncontext!Adv.ofdefiningtheproblemlocally!

Page 12: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 12 © 2006 ReaMetrix, Inc. All rights reserved.

ASystemsApproach:Reagents+Instrumenta<on+Delivery

Uni@zedTestCartridges

• AbilitytoberunusingacarbaSery

• UniHzeswastedisposal–minimizeschanceofimproperwastehandling

• Opensystem–abilitytoportmulHpletestsontothesystem–ItisNOTaninstrumentformeasuringonlyCD3/CD4counts

• Designedtowithstandharshenvironments

• Portable

• ReducedCapitalCost

• Minimalskilllevelneededtooperate

• RequiresnofieldcalibraHon

Page 13: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 13 © 2006 ReaMetrix, Inc. All rights reserved.

ASystemsApproach:Reagents+Instrumenta<on+Delivery

Howdoesthisenableanewparadigm?

• TheinstrumentaswellasthedrieddownreagentsenablegeneraHonofclinicalinformaHonclosertothedoctor‐paHentinteracHoncontext,thatiscurrentlynotpossible:

‐GP’sOffice‐OutreachCentres‐ICU’sinHospitals‐Mobilescreeningvans‐Ambulances

*Thoughthereagentsareaffordable–thereissHllenoughmargintopayforthecostoftheinstrumentaswell,overa1‐yearperiod

Page 14: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 14 © 2006 ReaMetrix, Inc. All rights reserved.

ASystemsApproach:Reagents+Instrumenta<on+Delivery

EnablingLocalEconomicAc<vityandEmpowermentofHealth‐workersbyNovelMethodsofDeliveringClinicalInforma<on

CaseStudy:SAANTWANAM

(WorkbeingcarriedoutbyHAP(hNp://www.hapindia.org/))

Page 15: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 15 © 2006 ReaMetrix, Inc. All rights reserved.

SaantwanamAhealthscreeningprojectinKerala

  FighHnglifestylediseases–AnovelprojectbyHAP,Kutumbashree&StateBankofIndia.

  ObjecHves‐ScreeningforDiabetesmellitus,obesity,hypertensionandgrowthretardaHon.

  Referraltophysician&healtheducaHon.

  Strategy–relyonlocallyrecruitedandtrainedyoungwomenwithhighschooleducaHonbutfrompoorfamiliesanddeploythemtoaccomplishtheobjecHveofwellnessmanagement

Page 16: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 16 © 2006 ReaMetrix, Inc. All rights reserved.

The first batch

Page 17: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 17 © 2006 ReaMetrix, Inc. All rights reserved.

Page 18: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 18 © 2006 ReaMetrix, Inc. All rights reserved.

Ques<onsthatarisefromthesecasestudies….

 Whatmorecanbedoneusingthismodelofhealthcaredelivery?

 HowdowecombineinnovaHonsinreagentdesign,instrumentaHondesignanddeliverytoimpactpublichealthespeciallyinthecontextoftheunderserved?

 HowcanweextendtheseinnovaHonstobringabout“wellnessmanagement”ratherthanjuststoppingat“illness“diagnosis?

Page 19: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 19 © 2006 ReaMetrix, Inc. All rights reserved.

Insummary…

 Onehastolookat“diagnosHcinformaHongeneraHon”holisHcally,notjustasasetofassayreagentsandhardwareplanorms.

 Addressing“theeconomics”probleminnovaHvely,willleadtosustainablesoluHons.

 “Importthescience”butnottheimplementaHonofthescience–greattothinkgloballybutsustainableinnovaHonisalllocal.

 Usingthismodel,onecannotonlyaddresstheunmetneedsinresource‐poorseongsbutchangethewaydiagnosHcinformaHonisdeliveredglobally.

Page 20: Towards Indigenously Developed, Locally Relevant,Affordable Diagnosics

Page 20 © 2006 ReaMetrix, Inc. All rights reserved.

Thank You