prof. balram bhargava

8/2/2019 Prof. Balram Bhargava

1/16

Roadmap for MoH support to innovation in

Healthcare at Stanford India Biodesign, AIIMS

Professor Balram BhargavaMD, DM, FRCP (Glasg), FRCP (Edin), FACC, FAHA, FAMS, FNASc

Professor of Cardiology, AIIMS,

Executive Director, Stanford India Biodesign

March 23, 2012

Presentation to Union Secretary ,MoHFW, Govt. of India

MoHFW

Making innovation an integral part of thepublic health system and philosophy


2/16

Why MoH support to SIB is critical

SIB teams are among the very few teams innovating for the

undersevrved

Commercial investments in SIB will have financial motives, will

drive solution away from the poor

MoH support is ideal and essential for successful invention and

implementation of these solutions


3/16

Underserved populationNeeds innovation in Health-care

Social Innovator:Needs non-commercial fundingsource

Needs access to underservedpopulation

MoHFW:Access and resourcesNeeds innovation to serve better

?

Interface required

MoH SIB collaboration will benefit the masses


4/16

Step 1 : Innovation interface

1. Identification Arm

A: To identify and list high priority problem areas - in program functioning, health

situation and healthcare delivery

B: To assess availability of existing solutions and identify need for innovation

2 Implementation Arm

A. Overall management of innovation interface committee

B. Entrusting the appropriate entity with the task of solving of a particular need

C. Rigorous assessment , uptake and deployment in the public health system

There is a need for Identifying a point of contact for innovatorswithin MoH (with 2 arms)


5/16

Step 2 : Setting up processes for uptake: Innovate

1. An empowered body to rigorously assess, prior to uptake for use in public health

2. Innovation Interface committee can perform assessments

3. Product development at SIB will involve continuing assessment by MoH

4. This will ensure desired suitability to program needs

5. Multiple tenderers may not be available for novel products

6. Therefore, novel uptake procedures are required

7. When MoH commissions the innovation of a solution, it is made to order


6/16

Candidate Innovations for MoH support

Instant intra-osseous access device

for emergency patients

Device for safety and comfort during

transport of lower limb trauma patients

Hearing screening device for

newborns in peripheral settingsDevice to enable frontline health workers

to resuscitate newborns effectively

IntraOz Religo

Sohum NeoBreathe


7/16

IntraOz Instant intra-osseous access device for emergency patients

Current status:

Cadaver trials at AIIMS doneFinal product : Ready

MoH acquires license

Mfg by PSU

MoH places bulk order

Contract Mfg and supplyby fellows Pvt. Ltd. Company

MoH funding, New mfg plantset up in Private-Public Partnership ??

Potential next steps


8/16

Relligo Device to immobilize and protect injured lower limb in trauma patients.

Current status:

Clinical trials at JPN Trauma Center, AIIMSSuccessful Final product : Ready

MoH acquires license

Mfg by PSU

MoH places an Advancemarketing commitment




9/16

Sohum Device to screen newborns for hearing loss in resource constrained settings

Current status:

Clinical trials at AIIMS undergoingFinal product : In development phase

Product development

1.5 crore

Mfg by PSU

MoH places bulk order


MoH funding, New mfg plantset up in Private-Public Partnership?



10/16

NeoBreathe Device to enable frontline health workers to resuscitate newborns effectively

Current status: Under development

Trials commencing : Oct 12Final product : Ready for uptake by March 13

Technology assessment byMoH and stipulation of criteria

R&D support

-Access to MCH program expertsfor feedback and immersion

- Access to various sites forgreater need understanding

Next steps and support requested

Partial funding for R&D

INR 1.5 crore

Agreement* to buy ~ 1000 pcsfor pilot deployment(subject to fulfillment of criteria)

Agreement* for bulk order(subject to success of

Pilot usage)


11/16

Setting up MoH SIB collaboration Recurring funding for Innovation for the underserved

SIB team seeks early stage support

Identified NEEDpresented to InnovationInterface committee

IIC expert panel assesses,

Approves phased funding

for R&D

Early productdevelopmentand testing

Pilot programatic use

Uptake into publichealth system

Interimassessment andadvance order for

pilot usage

Final productdevelopment

and testing

Final assessment


12/16

SIB assists MoH in solving healthcare problems

IIC(MoH)identifiesneed

SIB prepares project plan,

presents to IIC

Approves plan and phasedfunding for R&D

Early productdevelopmentand testing

Pilot programmatic use

Uptake into publichealth system

Interimassessment and

advance order forpilot usage

Final productdevelopmentand testing

Final assessment

Approaches SIB

Setting up MoH SIB collaboration


13/16

Deploying innovations through public health system

Need identified

IIC expert panel assesses,

Final product presented to IIC

(Pilot programmatic use)

Uptake into public

health system

Funding formfg,

scaling up

Mfg plant set up

Govt. buys

licensePSU

manufactures

Product development

MoH

Fundsfo

riteration

Approved YES

NO

Setting up MoH SIB collaboration


14/16

15 day elective Biodesign orientation course in MBBS curriculum

1.Awareness and understanding of medical innovation is low among doctors

2. Will make medical community aware of the problem solving power of

innovative thinking

3.Will foster multi-disciplinary collaboration for problem solving in healthcare

4.Will increase national talent pool of medical technology innovators5.SIB can support with curriculum design

To foster innovation in the country: Doctors need to look atproblems as needs for innovation


15/16


16/16

MoH defines area for innovation

Fellows do an immersion, focusing more on rural andprogrammatic needs

MoH becomes strategic partner

MoH funds training at Stanford

Need filtering and need selection done in

collaboration with representatives from MoH

MoH appropriate need Selected

Innovation and product development

(MoH funded)

Active feedback from users in MoH

Final prototype ready

Testing and validation

Company established

with MoH funding

Builds capacity/

contracts

manufacturing /

partnership with PSU

with MoH help

Product safety and efficacy validated

by clinical trials

Detailed assessment of safety, efficacy and

appropriateness of solution by MoH taskforce

Product deemed suitable for MoH

Presentation made to MoH

Product

licensed to

MoH

Manufacturing and

deployment

implemented by MoH

Continued manufacturing

and supply by company

(Govt. Support up till

break-even)

Pre-Marketing

Agreement

with MoH

Company manufactures

and supplies:

MoH Procures

Company established

without MoH funding,

builds capacity,

manufactures and

supplies

Pre-Mktng

Agreement

with MoH

Company

established

with MoH

fundingProduct deployed into

program and reaches

patient in need

1

2

3

4

4 a

bd

Partnership

Initiation

OPTIONS

Strategic partnership: MoH Funds entire fellowship

Focus area partnership: Partnership begins upon return from Stanford, MoH chooses focus area, funds project phase

Selected need presented to MoH

Product development progresses in collaboration with MoH, with continuous feedback and iterationuntil product is ready for deployment

Finished product presented to MoH for Licensing / implementation partnership / Pre-market agreement

OngoingMo

Hfunding,assessment,

feedb

ackanditeration

c

Partnership

Culmination

OPTIONS

Product Licensing

Pre-marketing agreement

and Support to set up manufacturing

Continued MoH support till break even

1

2

3

4

a

b

c

d

b

Pictorial representation of some more proposed modalities of MoH support to SIB

prof. balram bhargava

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