Limited manufacturing for clinical trials was performed at a box factory in New Delhi; estimated cost of manufacture is 8 cents (checking on this figure)
Mechanical Curette specifically designed to “go behind” FBN and extract
SIB Medical Technology Innovation Portfolio
Innovation in Healthcare for India
The Stanford India Biodesign Programme
Few Healthcare Issues: General
• Increasing middle age population
• Poverty and poor nutrition
• Pollution and water sanitation
• Lack of proper roads and electricity
• IMR 58; China 28; Bangladesh 54
• Out of pocket expenditure: Driving into poverty
• Fragmented system - unregulated private sector
Few Healthcare Issues: Low innovation
• 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
Talent nonexistent – vicious cycle of opportunities and dearth of
Med Tech ecosystem in infancy
No money for high-risk ideas – small venture capital
Regulatory and IP changes good but slow
No facilities for product testing, validation and accreditation
Situation Changing: India’s decade of innovation 2010-20
“The country must develop an innovation ecosystem to stimulate innovations.
Innovators must be challenged to produce solutions our society needs. And
innovative solutions with potential must be nurtured and rapidly applied”
Prime Minister, Manmohan Singh
Healthcare Growth Driver: Growing economy
Indian economy expected to grow above 7%
Healthcare Growth Driver: Increasing healthcare spending
Healthcare spending over $200 billion by 2025
Healthcare Growth Driver: Government and talent
Government spending on healthcare is increasing
New schemes like NRHM; RSBY for better care
National Innovation Council creating new policies
Grants and small business loans available and more coming
Collaborations with leading world partners
Adundant talent of doctors, engineers, designers, entrepreneurs
Unique opportunity to lead with affordable Med Tech innovation
Capturing Opportunity: Stanford India Biodesign
• Only fifteen 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)
• To develop leaders in biomedical technology
innovation in India
• To identify unmet healthcare needs and develop
solutions in India
• To help develop low cost, high quality devices for
the “common man”
• To help ignite the Indian MedTech Industry
Project 1: A novel way to manage fecal incontinence in non-ambulatory patients.
Nish Chasmawala, Amit Sharma, Dr Sandeep Singh
16M patients affected every year
No affordable device available
• Developed for all stool types and sphincter tones
• Easy and hygienic to use (profile and placement)
• Reduces nursing time (leakage and dislodgement)
• Minimal training required
• Product refinement
• Executing clinical & Regulatory strategy
• India is the first go-to market
• Robust IP portfolio – national phase
• Angel investment
Team: Jayant Karve, Srinivas Kiran, Dr Sandeep Singh
Project 2: A better way to gain intraosseous access in emergency patients.
“IO infusion should be the first alternative to IV in cardiac arrest patients”
Team: Pulin Raje, Dr Darshan Nayak
Project 3: A better way to temporarily immobilize lower limbs in trauma patients.
Road Traffic Accidents (RTAs) per annum in India
Incidence of Lower Limb Injuries in RTAs
A disposable splint manufacturing in Delhi box factory
Cost per unit estimate: Rs 40
Project 4: A novel hearing screening device for newborns in resource constrained settings.
Late detection of hearing loss leads to:
Non- Institutional births
Screening for all
Loss of speech for lifetime
Impaired cognitive development
Obstacle to education and employment
Expensive to the entire system
100,000 are born hearing impaired in India.
500,000 babies are born with hearing loss all over the world.
Congenital hearing loss is one of the most common birth disorder.
Unique reusable electrode system, Novel algorithm, Novel noise cancellation
Safety and efficacy clinical trials
Nitin Sisodia- Stanford India Biodesign fellow 2010
Pragun Goyal – Computer science engineer, IIT D
Mayank Kumar- Electrical engineer, IIT D
Comparative clinical trials
Project 5 NeoBreathe
Effective resuscitation can save almost all these
but requires advanced skill and regular training like a pediatrician
An easy-to-use, low-cost neonatal resuscitation
solution that enables primary care staff
to resuscitate newborns effectively
sealing with 2
Can work as
Team:Dr Mansi Aggarwal, Shitij Malhotra
Project 6: A better way to transfer patients in hospitals.
About the device:
• 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
Team: Gaurav Kulkarni, Dr Sumita Gupta
Project 7: A better way to dislodge and remove mucus in patients with COPD.
Team: Vishal Agale, Chandni Kabra, Megha Agrawal, Dr Ramakant Beesetty
Project 8: A better way to detect blood vessels in pediatric patients.
Global Need - 1 of 3 Vein-puncture fails in pediatric patients
Small crosssection of veins
Team: Sonakshi Pandey, Vishal Agale
Project 9: A safe & better way to manage sharps during surgical procedures.
In United States alone 800,000 injuries occur annually due to sharps.
Globally it accounts for 3.5 million injuries per year.
OT’s are the second most common environment for sharps injuries.
Accounting for 25% of all sharp injuries.
Cause for infections like Hepatitis B and C , HIV, etc.
Designed for local requirements
Disposable and bio-degradable
Tested and ready to be deployed
Team: Chetan A C, Deepali Chandratre, Ekta Sachdev, Rahul Das, Sneha Venkat
Project 10: A better way for the elderly to rise independently from the sitting position.
Population > 60 years expected to increase from 605 million – 2
Billion between 2000-2050.1
In India, 63.7 Lakhs (6.3M) elderly are confined to their home.
Out of which, 14.34 lakhs ( 1.4M) are confined to bed.2
Rising from chair is a high frequency,
effort-intensive activity among all daily activities.
Situation Analysis Of The Elderly in India, June 2011
• Uses Natural Energy of Body
• No external power is required
• Eliminates the need of caregiver
• By eliminating peak effort taking
activity, increases mobility of user
Team: Aanan Khurma, Neeraj Jasmathiya, Saurabh Bag, Ripunjay Chachan
Project 11: A way to reduce hospital Acquired Infections that spread
through hands of Health Care Workers
Why is hospital Hand Hygiene Low?
Wearable over any attire
Reduced cycle time
Last disinfection time
Team: Siraj Bagwan, Jagdish Chaturvedi, Jonathan Pillai, Siddhartha Joshi
Project 12: Percutaneous Aspiration Needle Biopsy
Need: A safer and easier way to perform percutaneous aspiration
liver biopsy in order to reduce variation in tissue sample
Physicians choose between:
Safety + Skill (Aspiration)
Ease + Risk (TruCut™)
4.8 crores (48M)
requiring histological confirmation
and staging of suspected viral hepatitis
Redefining liver biopsy
Team: Jonathan Pillai, Siraj Bagwan, Jagdish Chaturvedi, Siddhartha Joshi
Project 13: Emergent management of variceal bleeds
Need: “A better way to
temporarily stabilize patients
presenting with an emergent
upper GI variceal bleed in
order to reduce mortality and
morbidity before definitive
1.8 Crore (18M) patients with internal hemorrhaging
from to liver failure (portal hypertension)
Most can be saved if they are stabilized prior to endoscopy
Balloon for intuitive
Hermetic seals for
Multi-colored port for
Pre-clinical safety trials
Team: Siddhartha Joshi, Jonathan Pillai, Siraj Bagwan, Jagdish Chaturvedi.
Project 14: A safe and standardized way to perform abdominal paracentesis
3.6 Crore (36M) patients with ascites from liver failure
require chronic care like abdominal paracentesis.
No dedicated equipment available
for medical professionals to perform
A standardized way for paracentesis
• Cannula like insertion ensures safety of internal organs
• Integrated adhesive with the stabilizing members ensures
that the product stays in place
• Unique one way valve to control flow, yet allow needle
Team: Jagdish Chaturvedi, Siddhartha Joshi, Jonathan Pillai, Siraj Bagwan.
Project 15: Extracting impacted nasal foreign bodies
No dedicated equipment available for
medical professionals to extract nasal
“An easier way to extract an impacted anterior nasal
foreign body in a primary care setting”.
• Semi-automated hand-held device
• Specially designed retractable end
The results so far......
• 21 different devices
• 32 provisional patents
• 5 PCT applications
• 7 products in clinical trials
• 25 fellows and 52 interns
• 6 medical technology summits
• Five startups
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