Ritu Kamal

STANFORD INDIA BIODESIGNLessons Learned from an Indo-US CollaborationNCIIA Open 2013

Disparity in IndiaMumbai 2013

Disparity in Indian Healthcare

*Biodesign Fellows

Examples of Medical Technology Innovation

*jaipurknee.org, www.worlddiabetesfoundation.org/composite-2731.htm

What is beyond these dated examples?

✤ Healthcare growth drivers are creating opportunities for innovation

✤ Low cost, high-quality medical devices need to be created to address unmet needs in India

Opportunity for Innovation

The Biodesign Process is a systematic approach to medical technology innovation

12 year old innovation program based at Stanford University

The Biodesign Process

concept

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need

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FINALCONCEPT

need

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Identify → Invent → Implement

1.1 Strategic

Focus

1.2 Observation &

Problem Identification

1.3 Need Statement

Development

2.1 Disease State Fundamentals

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 SCREENING

IDE

NT

IFY

INV

EN

TIM

PL

EM

EN

T

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

4.3Reimbursemen

t Basics

Origins of Stanford India BiodesignNew Delhi, 2006

✤ Identify and train potential leaders in the medical technology innovation in India

✤ Develop medical technologies to solve unmet clinical needs in India

✤ Fuel the growth of the Indian medical technology industry

Goals

Collaborators and Supporters

Department of Biotechnology

Ministry of Science and Technology

Stanford UniversityIIT, Delhi

AIIMS, Delhi

Program Offerings✤ Stanford-India Biodesign

Fellowships

✤ India Biodesign Internships at AIIMS/IIT Delhi

✤ Global student and faculty exchanges

✤ Annual Indian MedTech Summit

✤ National SIB Center in Delhi

✤ Management workshops

✤ www.indiabiodesign.org networking community

Stanford India Biodesign Fellows 2007-2013

Fellowship Year

July Dec+Jan June

Understand Live Project

Stanford, CA

AIIMS, New Delhi

Clinical ImmersionTertiary and Secondary Healthcare settings

Clinical ImmersionPrimary and Outreach Healthcare settings

SIB Internship

✤ Delhi Program trains 5-8 interns yearly

✤ Internship lasts 3-4 months

✤ SIB Fellows act as mentors

✤ Interns have produced innovative products

2011 attendance - over 300 including participation by the NIH

Indian Medtech SummitHeld Annually in New Delhi

Indian Medtech Summit2013 Keynote Speaker: State Minister for Higher Education

Launch of National Biodesign CurriculumInnovation Course taught at several engineering colleges

Results

✤ >300 applicants to the fellowship each year; 4 selected

✤ 25 Fellows trained

✤ 28 Interns trained

✤ 20 provisional patents filed

✤ 6 Summits held

✤ 15 devices developed

✤ 1 Venture backed company (Consure)

✤ 3 Licensed products

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

Singh

Closed first round of venture funding in August 2012

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

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

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

Team: Jayant Karve, Srinivas Kiran, Dr Sandeep Singh

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

InfuseInsertion Remove GuidePlacement

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

15 MillionRoad Traffic Accidents (RTAs) per annum in

India

5.4 MillionIncidence of Lower Limb Injuries in RTAs

Team: Pulin Raje, Dr Darshan Nayak• A disposable splint

• Easy to use

• Ultra low cost

• Licensed to Hindustan Latex Limited in Nov 2012

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

100,000 are born hearing impaired in

India each year

Screening for all

Team: Nitin Sisodia, Dr Ramesh Agarwal, Dr Rakesh Lodha

• Low cost hearing screening device

• Unique reusable electrode system

• Novel algorithm

• Novel noise cancellation

Project 4: A novel hearing screening device for newborns

Project 5: An easy to use neonatal resuscitation system

Effective resuscitation can save almost all these

2.6 crore annual births

Birth Asphyxia:

2,10,000 babies

dieevery year

15,00,000

won’t breathe at

birth

• Automatically positions neck• In built suction, no power required• Easier better sealing• Objective feedback• Single operator use• Built in timer and heart rate monitor

Team: Ayesha Chaudhary, Dr Avijit Bansal, Dr Ramesh Agarwal, Dr Rakesh Lodha

India-Biodesign.orgNetworking website with over 800 members

Thank youhttp://biodesign.stanford.edu/bdn/global/