Medical device- challengesNitesh Kumar Jangir

Co-Founder Coeo labs Pvt. Ltd.

Who am I ?One of you- Electronics Engineer

Worked like you- Three years as Embedded system engineer

Trained in different way-Stanford India Biodesign

Medical Technology consultant

Innovating in a defined way: 7 Patents

Entrepreneur: Co-Founder COEO Labs

Why should we think about innovating medical devices ?

• 70% of the Indian population can’t afford healthcare services.

• 10% to 15% can afford it only with significant financial stress.

• Whereas 60-80% of health care is delivered in the private sector.

• Non-Accessible to non-urban area, 70 % population reside in rural area.

*EY Healthcare report 2014

• Over 75% of the medical devices used in India are imported.

• Often, they are costly and maladapted to low-resource settings.

• Around 60% of the domestic manufacture of medical technology is exported (Industry Analysis).

• We need affordable alternatives.

Why we are still relying on foreign technology after 67

years of independence?

U.S.A., Germany and Japan meeting the 85% of requirement.

What is different in innovating medical device than in other

fields?

Challenges in medical device design?

Its truly interdisciplinary

Cutting edge technology(H/W, S/W, mechanical etc.) for and on human body.

Regulatory

Designing for India is different, why ?

1. Out of pocket expenditure is high.

2. Doctor driven market.

3. Medical system varies with states.

4. Less preventive more treatment oriented.

So many problems,

Why I should innovate medical device.

These challenges can be mitigated !

How?

Why we need a process to design a product ?

Need finding

New Problems

Proof of concept

Market requirement Document

IP strategy

Program Plan

First presentable prototype

Product requirement generation:Standards

Product requirement generation:Literature

Opportunity for an Electronics Engineer

• Entrepreneur

• Technologist

• Technical Consultancy

• Technology management

• Quality control

Funding and Support:

Government: »DBT( Department of Biotechnology)

• BIG(BIRAC IGNITION GRANT)

• SIBRI

• SPARSH

»DST/DSIR

• TePP

• PRISM

• PACE

Others: Private and NGO’s

• BMGF-Bill and Melinda Gates Foundation

• Wellcome trust

• Grand Challenges Canada

• CAMTECH

• ACUMEN

• Aga khan foundation

Case Studies:

Saans

VAPCare

Let’s innovate together for a healthier India.

Stake holder analysis

Regulatory and clinical pathways

• India:

❖ Few classes of medical devices is regulated and require registration, including cardiac stents, heart valves, orthopaedic implants and intraocular lenses etc.

❖ Regulated medical devices imported from outside of India that have obtained prior approval in the U.S., the European Union (EU), Canada, Japan or Australia may legally be sold in India

CE(Europe):

• FDA(USA):

• Device Class and Regulatory Controls

• 1. Class I General Controls

• With Exemptions

• Without Exemptions

• 2. Class II General Controls and Special Controls

• With Exemptions

• Without Exemptions

• 3. Class III General Controls and Premarket Approval

Thank You