Innovation in Healthcare for IndiaThe 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

Malnutrition

Infectious

Diseases

Life Style Related Diseases

• 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

trained talent

• 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

Few Healthcare Issues: Low innovation

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 spending over $200 billion by 2025

Healthcare Growth Driver: Increasing healthcare spending

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

Opportunity

Healthcare

Innovation

Healthcare Industry

Investor

Inventors

Device Manufacturer

Institutes

Unique opportunity to lead with affordable Med Tech innovation

Capturing Opportunity: Stanford India Biodesign

SIB at AIIMS

*SIB (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: Mission

• 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

Educate Collaborate Innovate

Fellowship Internship

SIB: Process

Where this approach leads to :

Let us have a look at some of the many projects this philosophy gave birth to

Clinical Immersion

456 50 15172 3

Intuitive Screening

Impact, Market, Feasible outcome

PhysicianFeedback

+Research

Team Priority

Need Filtration

Co-Founders: Nish Chasmawala, Amit Sharma, Dr Sandeep Singh

ICUs Wards Nursing Facility Domestic

16M patients affected every year

No affordable device available

Project 1: A novel way to manage fecal incontinence in non-ambulatory patients.

• 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

Moving ahead…• Product refinement

• Executing clinical & Regulatory strategy

• India is the first go-to market

• Robust IP portfolio – national phase

• Angel investment

PediatricNeo-natal

Cardiac ArrestHypotension

GeriatricTraumaShock

ObstetricEmergencies

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

Project 2: A better way to gain intraosseous access in emergency patients.

Team: Jayant Karve, Srinivas Kiran, Dr Sandeep Singh

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

InfuseInsertion Remove GuidePlacement

15MillionRoad Traffic Accidents (RTAs) per annum in India

5.4 MillionIncidence of Lower Limb Injuries in RTAs

Project 3: A better way to temporarily immobilize lower limbs in trauma patients.

Team: Pulin Raje, Dr Darshan Nayak

Cost per unit estimate: Rs 40

A disposable splint manufacturing in Delhi box factory

500,000 babies are born with hearing loss all over the world.

100,000 are born hearing impaired in India.

Congenital hearing loss is one of the most common birth disorder.

Late detection of hearing loss leads to: • Loss of speech for lifetime• Impaired cognitive development• Obstacle to education and employment• Expensive to the entire system

Screening for all

Inst

itutio

nal b

irth

s

Non- In

stitutional births

Project 4: A novel hearing screening device for newborns in resource constrained settings.

Challenges:

Novel features: Unique reusable electrode system, Novel algorithm, Novel noise cancellation

Next Steps

• Product development

• Comparative clinical trials

• IP portfolio

• Funding

Milestones Achieved:

• Working prototype• Safety and efficacy clinical trials• Customer feedback

Team: Nitin Sisodia- Stanford India Biodesign fellow 2010 Pragun Goyal – Computer science engineer, IIT D Mayank Kumar- Electrical engineer, IIT D

Effective resuscitation can save almost all thesebut requires advanced skill and regular training like a pediatrician

2.6 crore annual births

Birth Asphyxia:

2,10,000 babies dieevery year.

15,00,000won’t breathe

at birth

An easy-to-use, low-cost neonatal resuscitation solution that enables primary care staff

Project NeoBreathe

Project 5 NeoBreathe

to resuscitate newborns effectively

Positions neck

automatically

Objective feedback,

better performance

Allows 1 person to give chest

compressions also

Can work as manual

transport ventilator

Built in Timer

Project NeoBreathe

Heart rate counting

Easier, better sealing with 2

hands

In-built suction

No power required

136

Current status:Prototype bench-tested

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

Project 6: A better way to transfer patients in hospitals.

Team:Dr Mansi Aggarwal, Shitij Malhotra

Project 7: A better way to dislodge and remove mucus in patients with COPD.

Team: Gaurav Kulkarni, Dr Sumita Gupta

Difficulties

Collapsed veins Small cross-section of veins 1.5-2 mm

Blind procedure

Need potential

Global Need - 1 of 3 Vein-puncture fails in pediatric patients

www.ncbi.nlm.nih.gov/pubmed

Project 8: A better way to detect blood vessels in pediatric patients.

Team: Vishal Agale, Chandni Kabra, Megha Agrawal, Dr Ramakant Beesetty

Cater to pediatric anatomical variations

Hand LegDorsum of hand

Brighter trans illumination

Light intensity control Easy maintenance

Device

In United States alone 800,000 injuries occur annually due to sharps.Globally it accounts for 3.5 million injuries per year.

Cause for infections like Hepatitis B and C , HIV, etc.

OT’s are the second most common environment for sharps injuries.Accounting for 25% of all sharp injuries.

Project 9: A safe & better way to manage sharps during surgical procedures.

Team: Sonakshi Pandey, Vishal Agale

Product

• Designed for local requirements• Cost effective• Disposable and bio-degradable• Tested and ready to be deployed

Project 10: A better way for the elderly to rise independently from the sitting position.

Team: Chetan A C, Deepali Chandratre, Ekta Sachdev, Rahul Das, Sneha Venkat

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

2Ref: Situation Analysis Of The Elderly in India, June 2011

Rising from chair is a high frequency,effort-intensive activity among all daily activities.

Population > 60 years expected to increase from 605 million – 2 Billion between 2000-2050.1

1WHO

Key features• Uses Natural Energy of Body• Economical• Portable• Camouflaged

Value proposition• No external power is required• Eliminates the need of caregiver• By eliminating peak effort taking activity,

increases mobility of user

Device

Project 11: A way to reduce hospital Acquired Infections that spread through hands of Health Care Workers

Team: Aanan Khurma, Neeraj Jasmathiya, Saurabh Bag, Ripunjay Chachan

Why is hospital Hand Hygiene Low?

• Time• Accessibility• Convenience• Negligence

Key features• Waist mounted • Disposable Cartridges• Easy dispense• Wearable over any attire

Value proposition• Reduced cycle time• Zero contact • Last disinfection time

Device

Patient: 4.8 crores (48M) requiring histological confirmation and staging of suspected viral hepatitis

Physicians choose between:

Safety + Skill (Aspiration) V/s

Ease + Risk (TruCut™)

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

Team: Siraj Bagwan, Jagdish Chaturvedi, Jonathan Pillai, Siddhartha Joshi

Redefining liver biopsy

Next Steps

• Product development

• Clinical trials

• IP portfolio

• Funding

Milestones Achieved:

• Working prototype• Pre-clinical trials• Physician feedback• Business Plan

Competition won

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

Project 13: Emergent management of variceal bleeds

Team: Jonathan Pillai, Siraj Bagwan, Jagdish Chaturvedi, Siddhartha Joshi

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 treatment “.

Novel Features:

Next Steps

• Product development

• Pre-clinical safety trials

• IP portfolio

• Funding

Milestones Achieved:

• Functional prototype• Provisional IP• Physician feedback

Balloon for intuitive device registration

Hermetic seals for lumen collapse

Multi-colored port for intuitive identification

3.6 Crore (36M) patients with ascites from liver failure require chronic care like abdominal

paracentesis.

Project 14: A safe and standardized way to perform abdominal paracentesis

Team: Siddhartha Joshi, Jonathan Pillai, Siraj Bagwan, Jagdish Chaturvedi.

http://www.hopkins-gi.org/GDL_Disease.aspx?CurrentUDV=31&GDL_Cat_ID=AF793A59-B736-42CB-9E1F-E79D2B9FC358&GDL_Disease_ID=E19DBE4A-EE02-4BDE-9FF9-A8371834DE4A

The Problem: No dedicated equipment available for medical professionals to perform abdominal paracentesis

A standardized way for paracentesis

Key Features• 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

entry

Project 15: Extracting impacted nasal foreign bodies

Team: Jagdish Chaturvedi, Siddhartha Joshi, Jonathan Pillai, Siraj Bagwan.

The Problem: No dedicated equipment available for medical professionals to extract nasal foreign bodies

The Need: “An easier way to extract an impacted anterior nasal foreign body in a primary care setting”.

Key Features• Semi-automated hand-held device• Specially designed retractable end

The solution

• 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

The results so far......

• Now : Ask ..

• Later : drpjha@stanford.edu

Questions / Queries ?