1. Frugal Innovation : India’s most valued
resource: The India Biodesign Programme
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
CEUTEH 2014

2. AIIMS: An Oasis for India’s Poorest
“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”
Newsweek International, October 30, 2006

3. 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

4. Fall back below the poverty line because
of health related expenses

5. Indian Healthcare Issues : Innovation Landscape
• 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

6. • 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

7. The Indian Economy: Current status
• 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

8. Healthcare Growth Driver: Increasing healthcare spending
Healthcare spending over $200 billion by 2025

9. India’s Innovation Hotspots: Geographical View
2,500 miles

10. 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

11. Frugal innovation: A new approach pioneered in the Global South

12. 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

13. 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!

14. 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

15. Some frugal innovations from India: Six in healthcare
• 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

16. Frugal Innovations: Examples
Embrace™
Jaipur Knee
Fetal Heart Monitor
GE Mac 400
Portable ECG

17. Impact of Frugal Innovation: Higher Value at Lower Cost
High
One Hundreth -
Medium
One Tenth -
Low
Two Thirds-
Low Efficient Dramatically
Reduced
Relative
Decrease
in
Product
Cost
Aravind
Eye Care
Jaipur Foot
Reverse
engineered
Vaccines
Jaipur Knee
NH- Heart Surgery
GE Mac 400
Relative Decrease in Innovation Cost
Adapted from Nesta, “Bound and Thronton, 2012

18. Generic Competition to drive prices down
ARV : Triple therapy (Lowest prices per patient per year)

19. Frugal ‘Jugaad’ Innovation: Indian Mindset!
• 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!

20. Opportunity for Frugal Innovation
Healthcare
Industry
Healthcare
Innovation
Inventors
Device
Manufacturer
Academic
Institutes
Investors
Unique opportunity to lead with affordable Med Tech innovation

21. Opportunity for Frugal Innovation: Areas

22. Capturing Opportunity: 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 at AIIMS
*SIB (Stanford India Biodesign)

23. SIB
Stanford University, CA
AIIMS, New Delhi
IIT, Delhi

24. 29 Fellows + 49 Interns trained
Pushkar Ingale, Product Designer
Ritu Kamal, BioMed Engineer
Nitin Sisodia, Industrial Designer
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
Sandeep Singh, Cardiologist
Srinivas Jaggu, Electronics Engineer
Avijit Bansal, Chest Physician
Ayesha Chaudhary, BioMed Engineer
Mridusmita Choudhary, Elect. Engineer
Chinmay Deodhar,Mechanical Engineer
2008
Emergency Medicine
Jagdish Chaturvedi, ENT Physician
Jonathan Pillai, BioMed Engineer
Siddhartha Joshi, Industrial Designer
Siraj Bagwan, Product Designer
2009
Emergency Medicine
2011
Pediatric Care
2010
Pediatric Care
2012
Gastroenterology

25. The Biodesign Process
1.1
Strategic
Focus
1.2
Observation &
Problem
Identification
1.3
Need
Statement
Development
2. NEEDS SCREENING
2.1
Disease
State
Fundamenta
ls
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. DEVELOPMENT STRATEGY & PLANNING
5.1
IP Strategy
5.3
Clinical Strategy
5.5 Quality &
Process
Management
5.6
Reimbursement
Strategy
5.2
R&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
IMPLEMENT INVENT IDENTIFY
3.1
Ideation &
Brainstormin
g
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
5.4
Regulatory
Strategy
4.1
Intellectual
Property
Basics
4.3
Reimburseme
nt Basics

26. Clinical Immersion

27. Community Medicine Immersion

28. 456 172 50 15 3
Intuitive
Screening
Impact,
Market,
Feasible
outcome
Physician
Feedback
+
Research
Team
Priority
Need Filtration

29. A novel way to manage fecal incontinence in non-ambulatory patients
▻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
1. 2.
Visceral
Nerves
Somatic
Nerves

30. 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
CONSURE Medicals
• FIM Safety and Feasibility trial successfully concluded at AIIMS.
• Long-term Efficacy and Functionality study successfully concluded
• Multi-centric RCT in progress

31. Consure: Fecal Incontinence Device: USFDA Approved
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

32. A better way to gain intraosseous access in emergency patients
Pediatric
Neo-natal
Cardiac Arrest
Hypotension
Trauma Geriatric
Shock
Obstetric
Emergencies
“IO infusion should be the first alternative to IV in cardiac arrest patients”

33. 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
Placement Insertion Remove Guide Infuse

34. A better way to temporarily immobilize lower limbs in trauma patients
15Million
Road Traffic Accidents (RTAs) per annum in India
5.4 Million
Incidence of Lower Limb Injuries in RTAs

35. A disposable splint manufacturing in Delhi box factory: Hi CARE LIMO
Cost per unit estimate:
Rs 40 (~$0.75)
Commercial product launched from SIB AIIMS

36. Birth asphyxia* claims
811,000 lives each year
Effective resuscitation can
help prevent these …
Project NeoBreathe
A novel integrated solution for
Effective newborn resuscitation
at all levels of care
A better way to resuscitate neonates

37. NEOBREATHE: Funding and Awards
Supported by: Department of Biotechnology

38. 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
• 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

39. 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

40. Prototype Development – Funded by Welcome Trust (UK)
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
Preliminary Proto Revision-1 Proto Revision-2 Proto Revision-3 Proto

41. Bioscoop
TM
Accu- feed
Accufeed

42. 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

43. Better & Affordable Healthcare with Frugal Innovation
Photo Courtesy: National Geographic, Jamkhed, Maharashtra State, India

44. School of International Biodesign
Stanford India Biodesign
(SIB)
AIIMS and IIT, New Delhi
BCIL, DBT; Government of India
Stanford University, USA

45. SIB – Thinking and Philosophy
Never give up:
FIGHT
Frugal Innovation for Global HealthTechnologies
GANDHI
Global Affordable Need-based Development in
Healthcare Innovation

46. 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

47. iFellowship
indigenous international innovation Fellowship
indigenous Fellowship in Frugal Medical Technology
Innovations (Biodesign)
Experiential learning of multi-disciplinary teams
2 Yr long fellowship

48. iFellowship-milestones
• Call for Applications - Sep 2014
• Interviews - Oct / Nov 2014
• Expected no of fellows - 12 ( 8 national + 4 international )
• Fellowship starts - Jan 2015

49. iFellowship - Year 1
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

50. iFellowship - Year 2
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

51. 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 !

52. 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 !

53. Welcome to the 8th
Indian Medtech
Summit
Dec 12, 13, 2014
New Delhi
Thank You!