MoHFW

Roadmap for MoH support to innovation in Healthcare at Stanford India Biodesign, AIIMS
Making innovation an integral part of the public health system and philosophy

Professor Balram Bhargava

MD, 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

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

MoH SIB collaboration will benefit the masses

Underserved population Needs innovation in Health-care

Interface required

MoHFW: Access and resources Needs innovation to serve better Social Innovator: Needs non-commercial funding source Needs access to underserved population

Step 1 : Innovation interface There is a need for Identifying a point of contact for innovators within MoH (with 2 arms)
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

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

Candidate Innovations for MoH support

IntraOz Religo

Instant intra-osseous access device for emergency patients

Device for safety and comfort during transport of lower limb trauma patients

Sohum

NeoBreathe

Hearing screening device for newborns in peripheral settings

Device to enable frontline health workers to resuscitate newborns effectively

IntraOz

Instant intra-osseous access device for emergency patients

Current status: Cadaver trials at AIIMS done Final product : Ready

Potential next steps

MoH acquires license

MoH places bulk order

Mfg by PSU

Contract Mfg and supply by fellows Pvt. Ltd. Company MoH funding, New mfg plant set up in Private-Public Partnership ??

Relligo
Current status:

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

Clinical trials at JPN Trauma Center, AIIMS Successful Final product : Ready

Potential next steps

MoH acquires license

MoH places an Advance marketing commitment

Mfg by PSU

Contract Mfg and supply by fellows Pvt. Ltd. Company

Sohum
Current status:

Device to screen newborns for hearing loss in resource constrained settings

Clinical trials at AIIMS undergoing Final product : In development phase

Potential next steps

Product development 1.5 crore

MoH places bulk order

Mfg by PSU

Contract Mfg and supply by fellows Pvt. Ltd. Company MoH funding, New mfg plant set up in Private-Public Partnership?

NeoBreathe

Device to enable frontline health workers to resuscitate newborns effectively

Current status: Under development Trials commencing : Oct 12 Final product : Ready for uptake by March 13

Next steps and support requested

Technology assessment by MoH and stipulation of criteria

Partial funding for R&D INR 1.5 crore

R&D support -Access to MCH program experts for feedback and immersion

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

- Access to various sites for greater need understanding

Agreement* for bulk order (subject to success of Pilot usage)

Setting up MoH SIB collaboration

Recurring funding for Innovation for the underserved

SIB team seeks early stage support

Identified NEED presented to Innovation Interface committee

Uptake into public health system

IIC expert panel assesses,

Pilot programatic use

Approves phased funding for R&D

Final assessment Interim assessment and advance order for pilot usage

Early product development and testing

Final product development and testing

Setting up MoH SIB collaboration

SIB assists MoH in solving healthcare problems

IIC(MoH) identifies need Approaches SIB SIB prepares project plan, presents to IIC

Uptake into public health system

Pilot programmatic use

Approves plan and phased funding for R&D

Interim assessment and advance order for pilot usage

Final assessment

Early product development and testing

Final product development and testing

Setting up MoH SIB collaboration

Deploying innovations through public health system

Need identified MoH Funds for iteration

Product development

Govt. buys license

PSU manufactures

Final product presented to IIC

NO

IIC expert panel assesses, (Pilot programmatic use)

Approved

YES

Uptake into public health system

Funding for mfg, scaling up

Mfg plant set up

15 day elective Biodesign orientation course in MBBS curriculum

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

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 innovators

5.SIB can support with curriculum design

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

1
MoH becomes strategic partner MoH funds training at Stanford MoH defines area for innovation Fellows do an immersion, focusing more on rural and programmatic needs 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 Product safety and efficacy validated by clinical trials Presentation made to MoH 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 iteration until product is ready for deployment Finished product presented to MoH for Licensing / implementation partnership / Pre-market agreement

1 2 3 4

Partnership Culmination

OPTIONS Product Licensing Pre-marketing agreement

Ongoing MoH funding, assessment, feedback and iteration

a b c d

b and Support to set up manufacturing

Continued MoH support till break even

a b c

Detailed assessment of safety, efficacy and appropriateness of solution by MoH taskforce

Product deemed suitable for MoH

Product licensed to MoH

4
Pre-Marketing Agreement with MoH

Manufacturing and deployment implemented by MoH

Company established without MoH funding, builds capacity, manufactures and supplies

Company manufactures and supplies: MoH Procures

Pre-Mktng Agreement with MoH Company established with MoH funding

Company established with MoH funding Builds capacity/ contracts manufacturing / partnership with PSU with MoH help

Continued manufacturing and supply by company (Govt. Support up till break-even)

Product deployed into program and reaches patient in need