Medical device- challenges - EFY CONFERENCES...One of you- Electronics Engineer Worked like you-...
Transcript of Medical device- challenges - EFY CONFERENCES...One of you- Electronics Engineer Worked like you-...
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