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-...
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Medical device- challengesNitesh Kumar Jangir
Co-Founder Coeo labs Pvt. Ltd.
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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
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Why should we think about innovating medical devices ?
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• 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
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• 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.
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Why we are still relying on foreign technology after 67
years of independence?
U.S.A., Germany and Japan meeting the 85% of requirement.
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What is different in innovating medical device than in other
fields?
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Challenges in medical device design?
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Its truly interdisciplinary
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Cutting edge technology(H/W, S/W, mechanical etc.) for and on human body.
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Regulatory
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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.
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So many problems,
Why I should innovate medical device.
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These challenges can be mitigated !
How?
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Why we need a process to design a product ?
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Need finding
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New Problems
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Proof of concept
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Market requirement Document
IP strategy
Program Plan
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First presentable prototype
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Product requirement generation:Standards
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Product requirement generation:Literature
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Opportunity for an Electronics Engineer
• Entrepreneur
• Technologist
• Technical Consultancy
• Technology management
• Quality control
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Funding and Support:
Government: »DBT( Department of Biotechnology)
• BIG(BIRAC IGNITION GRANT)
• SIBRI
• SPARSH
»DST/DSIR
• TePP
• PRISM
• PACE
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Others: Private and NGO’s
• BMGF-Bill and Melinda Gates Foundation
• Wellcome trust
• Grand Challenges Canada
• CAMTECH
• ACUMEN
• Aga khan foundation
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Case Studies:
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Saans
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VAPCare
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Let’s innovate together for a healthier India.
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Stake holder analysis
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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
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CE(Europe):
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• 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
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Thank You