Frugal Innovation : India’s most valued resource: The India Biodesign Programme

CEUTEH 2014

Professor Balram Bhargava MD, DM, FRCP (Glasg), FRCP (Edin), FACC,

FAHA, FAMS, FNASc Professor of Cardiology,

Executive Director, Stanford India Biodesign,School of International Biodesign

All India Institute of Medical Sciences, New Delhi, INDIA

“This is what it takes to be India’s best public hospital. The Government-run hospital, with about 2,000 beds, treated 3.5 million people, achieving mortality and infection rates comparable to the best facilities in the developed world – for fees that come to about $1 a day for inpatients”

AIIMS: An Oasis for India’s Poorest

Newsweek International, October 30, 2006

Indian Healthcare Issues: Insurance Markets

• Mostly Self-Pay Market dominated by out-of-pocket spending

• Medical insurance sector is weak and fragmented• Benefits of insurance unavailable to the most vulnerable• Voluntary, contributory and community-based health schemes limited

• New government schemes like NRHM, RSBY for better care• Government has committed to increasing public spending in

healthcare to 3% of GDP by 2017: Universal Health Coverage

Insurance (or lack of it) starting to influence patient and physician choices in consumption of medical technology and healthcare

39 M…Fall back below the poverty line because of health related expenses

• Indian Med Tech industry low on innovation: • Only 1% of sales invested in R&D (vis-à-vis 11% in the west)• 65% of Indian manufacturers focused on low end medical disposables • Very few Class III devices• Trained Talent nonexistent

• Med Tech ecosystem in infancy

Indian Healthcare Issues : Innovation Landscape

80 % FOR 20%• Price of imported technology is a major concern• Limited capital for high-risk ideas• Regulatory and IP changes good but slow• Limited facilities for product testing, validation and accreditation

• A decade of rapid economic growth• Fast rising literacy• More girls in schools• Relentless spread of mobile phones• Economy worth $2 trillion (10th biggest)• Income per person is up• Rural poverty down• Polio has been eradicated• Paved roads becoming more widespread• The country is stable• It is young, big and fast growing

The Economist September 29th, 2012; India in search of a dream: Aim Higher

The Indian Economy: Current status

Healthcare spending over $200 billion by 2025

Healthcare Growth Driver: Increasing healthcare spending

India’s Innovation Hotspots: Geographical View

2,500 miles

Frugal Innovation in India: “More for less for more”

• Abundant culture of ‘jugaad’ or creative improvisation• A huge market with a growing, aspirational middle class

• Indian consumer extremely price-sensitive and willing to experiment• Major gaps in service stimulate demand for low-cost solutions

• New sources of social finance (E.g. grants and small business loans) are lowering the cost of investing in frugal innovations

• National Innovation Council’s inclusive science and innovation policy is prioritising getting ‘more for less for more’

OUR FRUGAL FUTURE: Lessons from India’s innovation system, Nesta 2012

Frugal innovation: A new approach pioneered in the Global South

Frugal ‘Jugaad’ Innovation

The art of overcoming harsh constraints by improvising an effective solution using limited resource

• Gambiarra or jeitinho in Brazil

• Jua Kali in Kenya

• Zhizhu Changxin in China

• DIY in the US

• Systeme D in France

• Bricolage in Australia

Defining Characteristics of Frugal Jugaad Innovation

• Responds to limitations in resources: financial, material or institutional

• Turns constraints into advantages by minimising use of resources in development, production & delivery in new ways

• Successful frugal innovations are not only low cost but outperform the alternative and are available at a large scale

• Often have an explicitly social mission!

Busting Myths about Frugal Innovation

Frugal Innovations

• Low cost does not mean low–tech• Includes services, not just products• Implies re-design, not just de-featuring or simplifying

‘Jugaad’ Innovators: ‘FIRST’

• Frugal and Flexible• Inclusive and Intuitive• Redesign and Recombinant• Socially Sensitive• Talented with Tenacity

Jaipur Knee

• GE ECG machine

• Tata Nano car

• Aakash tablet PC

• 1298 ambulances

• Aravind eye hospitals

• Swach water filter

• Narayana Hriduyalaya

• Bharti Airtel mobile services

• SELCO solar power

• Jaipur prosthetics

Some frugal innovations from India: Six in healthcare

Frugal Innovations: Examples

Embrace™

Jaipur Knee

GE Mac 400 Portable ECG

Fetal Heart Monitor

Impact of Frugal Innovation: Higher Value at Lower Cost

HighOne Hundreth -

MediumOne Tenth -

LowTwo Thirds-

Low Efficient Dramatically Reduced

Relative Decrease in Product Cost

Aravind Eye Care

Jaipur Foot

Reverse engineered Vaccines

Jaipur Knee

NH- Heart SurgeryGE Mac 400

Relative Decrease in Innovation Cost

Adapted from Nesta, “Bound and Thronton, 2012

Generic Competition to drive prices down

ARV : Triple therapy (Lowest prices per patient per year)

• Upwards of 40% of Indians:

• Are unbanked

• Are off the electricity grid

• Have limited access to healthcare and education

• The west can gain by engaging with India

• Frugal, flexible and inclusive innovation can improve lives!

Frugal ‘Jugaad’ Innovation: Indian Mindset!

Opportunity for Frugal Innovation

Healthcare Innovation

Healthcare Industry

Inventors

Device Manufacturer

Investors

AcademicInstitutes

Unique opportunity to lead with affordable Med Tech innovation

Opportunity for Frugal Innovation: Areas

Capturing Opportunity: Stanford India Biodesign

SIB at AIIMS

*SIB (Stanford India Biodesign)

• Only a few program/centers promoting medical device innovation worldwide

• Stanford India Biodesign (SIB) established at AIIMS is first such program in Asia.

SIB

Stanford University, CA

AIIMS, New Delhi

IIT, Delhi

Pushkar Ingale, Product Designer

Nitin Sisodia, Industrial Designer

Ritu Kamal, BioMed Engineer

Geeta Handa, Physician

Darshan Nayak, Physician

Pulin Raje, Product Designer

Asokan T, Mechanical Engineer

Rahul Ribeiro, Material Scientist

Amit Sharma, Industrial Designer

Jayant Karve, Product Designer

Nish Chasmawala, Plastics Engineer

Srinivas Jaggu, Electronics Engineer

Sandeep Singh, Cardiologist

Avijit Bansal, Chest Physician

Mridusmita Choudhary, Elect. Engineer

Ayesha Chaudhary, BioMed Engineer

Chinmay Deodhar, Mechanical Engineer

2008Emergency Medicine

29 Fellows + 49 Interns trained

Jagdish Chaturvedi, ENT Physician

Siddhartha Joshi, Industrial Designer

Jonathan Pillai, BioMed Engineer

Siraj Bagwan, Product Designer

2009Emergency Medicine

2011Pediatric Care

2010Pediatric Care

2012Gastroenterology

The Biodesign Process

1.1 Strategic

Focus

1.2 Observation &

Problem Identification

1.3 Need

Statement Development

2.1 Disease

State Fundamental

s

2.2 Treatment Options

2.3 Stakeholder

Analysis

2.4 Market

Analysis

2.5 Needs Filtering

4.6 Final

Concept Selection

1. NEEDS FINDING

3. CONCEPT GENERATION

5.1IP Strategy

5.3 Clinical Strategy

5.6 Reimbursement

Strategy

5.5 Quality & Process

Management

5.2R&D Strategy

6. INTEGRATION

5.8 Sales &

Distribution Strategy

6.2 Business

Plan Development

6.3 Funding Sources

5.9 Competitive Advantage &

Business Strategy

6.1 Operating

Plan & Financial

Model

2. NEEDS SCREENINGID

EN

TIF

YIN

VE

NT

IMP

LE

ME

NT

3.1Ideation &

Brainstorming

4.5 Prototyping

4.2 Regulatory

Basics

4.4 Business Models

3.2 Concept

Screening

4. CONCEPT SELECTION

5.7 Marketing & Stakeholder

Strategy

6.4 Licensing & Alternate Pathways

5.4Regulatory Strategy

5. DEVELOPMENT STRATEGY & PLANNING

4.1 Intellectual Property Basics

4.3Reimburseme

nt Basics

Clinical Immersion

Community Medicine Immersion

456 50 15172 3

Intuitive Screening

Impact, Market, Feasible outcome

PhysicianFeedback

+Research

Team Priority

Need Filtration

▻Diapers1 and Catheters2 are not effective

▻Painful for the patients and not user

friendly

▻Costs: $10,000/patient

Novel Approach:▻Above the rectal valve

▻No interference in physiologic

functioning

▻Works outside ICU’s

▻For a motivated family member

Visceral Nerves

Somatic Nerves

1. 2.

A novel way to manage fecal incontinence in non-ambulatory patients

A new standard of care for management of fecal incontinence that:

• improves clinical outcomes• reduces operating costs• grows the overall market

Designed for 16M Indian patients Value proposition for 100M Global patients Market: $5 Billion plus global potential

• FIM Safety and Feasibility trial successfully concluded at AIIMS.

• Long-term Efficacy and Functionality study successfully concluded

• Multi-centric RCT in progress

CONSURE Medicals

Technology Platform:

▻Pliable lattice that diverts liquid and formed stool

▻ICU’s, wards, nursing homes, rehab facilities

▻No pain sensation

▻Minimal training required

▻Eventually an OTC product

▻Designed for 16M Indian patients

▻Value proposition for all 100M Global patients

▻Market: $5 Billion plus global potential

Consure: Fecal Incontinence Device: USFDA Approved

PediatricNeo-natal

Cardiac ArrestHypotension

GeriatricTraumaShock

ObstetricEmergencies

“IO infusion should be the first alternative to IV in cardiac arrest patients”

A better way to gain intraosseous access in emergency patients

Key features• Manual operation • Ergonomic design• Sterility maintenance• Needle guidance & visibility

Value proposition• Controlled access• Resource constrained environment • Suitable for both pediatric & adults• Affordable

Device: INTRA -OZ

InfuseInsertion Remove GuidePlacement

15MillionRoad Traffic Accidents (RTAs) per annum in India

5.4 MillionIncidence of Lower Limb Injuries in RTAs

A better way to temporarily immobilize lower limbs in trauma patients

Cost per unit estimate:

Rs 40 (~$0.75)

A disposable splint manufacturing in Delhi box factory: Hi CARE LIMO

Commercial product launched from SIB AIIMS

Birth asphyxia* claims 811,000 lives each year

Effective resuscitation can help prevent these …

A novel integrated solution for Effective newborn resuscitation

at all levels of care

Project NeoBreathe

A better way to resuscitate neonates

NEOBREATHE: Funding and Awards

Supported by: Department of Biotechnology

• Next generation medical bed sheet

• Unique composite polymers for comfort & functionality

• Patient transfer ability when needed

• Salient features – works with different height, gap and alignment

• Globally 200M of surgeries & billion plus market

TRANSFERLIFE: A better way to transfer patients in hospitals

Shifting patients from the stretcher to the bed is a dangerous process for both the patient and the caregiver

Cardio-pulmonary Resuscitation (CPR) Device

Sudden Cardiac Arrest (SCA) is one of the leading causes of death in both developed as well as developing countries.

Estimated annual burden of the SCA is 4-5 million across the world and 0.8-1 million in India.

Annual Incidence – Sudden Cardiac Arrest

World 4-5 million

USA 0.3-0.4 million

Europe 0.6-0.7 million

India 0.6-0.8 million

Prototype Development – Funded by Welcome Trust (UK)

Preliminary Proto Revision-1 Proto Revision-2 Proto Revision-3 Proto

Key Features

Integrated automated resuscitation system usable in resource constrained environment

Novel proprietary technology based on underlining physiology

Automated device with minimal training requirement

Portable device

Accu- feedTM

Bioscoop

Accufeed

The results so far......2007-14

• 29 fellows and 59 interns

• 22 different devices; 5 products in clinical trials

• 24 patents filed; 12 in progress

• 7 technology transfers

• 4 startups

• 7 medical technology summit and workshops

• National curriculum launched

• 1 product launched in MOH; 1 USFDA approval

Better & Affordable Healthcare with Frugal Innovation

Photo Courtesy: National Geographic, Jamkhed, Maharashtra State, India

School of International Biodesign Stanford India Biodesign

(SIB)

AIIMS and IIT, New DelhiBCIL, DBT; Government of India

Stanford University, USA

SIB – Thinking and Philosophy

Never give up:

FIGHT

Frugal Innovation for Global HealthTechnologies

GANDHI

Global Affordable Need-based Development in

Healthcare Innovation

SIB – Goals‘More for less for more’

• To become the epicentre of Frugal Medical Technology

Innovation

• To train People in MedTech Innovation building on the Biodesign

process

• To innovate for the unmet clinical needs with focus on developing

countries

iFellowshipindigenous international innovation Fellowship

indigenous Fellowship in Frugal Medical Technology Innovations (Biodesign)

Experiential learning of multi-disciplinary teams2 Yr long fellowship

• Call for Applications - Sep 2014

• Interviews - Oct / Nov 2014

• Expected no of fellows - 12 ( 8 national + 4 international )

• Fellowship starts - Jan 2015

iFellowship-milestones

Jan 2015 Informational training

Feb, Mar, Apr 2015 Clinical Immersion

May, Jun, Jul 2015 Concept Selection

Aug, Sep, Oct, Nov 2015 Product Development

Dec 2015 Presentation at MedTech Summit

iFellowship - Year 1

2 Months Industry externship

3 to 6 Months Visit to partner institution (tech development / animal testing)

1 to 2 months Clinical Testing / First in man (Ethical clearances)

3 to 5 months B-Plan competitions, Acceleration, Secure Funding, Licensing

Dec 2016 Fellows Graduate at MedTech Summit

iFellowship - Year 2

Innovations in Medicine

• Applicability in different geographies• Ignite more Innovations

• Devices | m-Health | Systems | Processes | Health IT

• Can impact healthcare access & affordability• Often interdisciplinary• Aravind Eye, Sri Chitra Heart, Boat Clinics, Stroke detection

app, Card-board splints

They need a platform !

BMJ Innovations• First International interdisciplinary journal focused on

Innovations • A melting pot of ideas that will fuel more innovations• 1st Global Launch at 8th MedTech Summit ( Dec 2014 )• International Board : US, UK, Singapore, Japan, Australia,

Israel, more…• Everyone’s invited !

Thank You!

Welcome to the 8th Indian Medtech

SummitDec 12, 13, 2014

New Delhi