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A DEDICATED MED TECH POLICY CENTRE
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
VISION OF KIHT
▪ Focused research on Critical Components
▪ Transfer of Technical knowledge for product development
▪ Bringing strategic and coherent synergy in Scientific Infrastructure
▪ Enabling Rapid Technology Transfer from research to industry
KIHT lives to bring increased access to affordable health products to citizens and a thriving
medical devices manufacturing sector in India.
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
▪DRDO: helicopters
and hovercrafts
▪ISRO: SLV III
▪Agni Prithvi
▪Pokhran II
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
PILLARS OF KIHT
CELL FOR RESEARCH AND DEVELOPMENT
CELL FOR TECHNOLOGY TRANSFER
CELL FOR MARKET INTELLIGENCE AND TRADE
CELL FOR INNOVATION AND MARKET ACCESS
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CRD – CELL FOR RESEARCH & DEVELOPMENT
Formative	Industry	leaders	Research	institutes	Start-up	
Partners	Technology	Meet (FIRST)
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CRD – CELL FOR RESEARCH & DEVELOPMENT
Industry-Academia Collaboration For Accelerating Early Development For Biopharmaceuticals - “Innovate in India
(13) Empowering biotech entrepreneurs and accelerating inclusive innovation”
Implementing Agency:
Biotechnology Industry Research Assistance Council (BIRAC)
(A Government of India Enterprise)
Co-funded through World Bank Loan Assistance
★ Biotherapeutics
• RFP 1: RFP for Biosimilar - Product Development
• RFP 2: Process Development Laboratory
• RFP 3: Chemistry, Manufacturing, Control Units
• RFP 4: cGLP validation facility for Bio therapeutics
• Cell line Repository
★ Vaccines
• RFP 1: Novel Vaccine candidates for HPV, Dengue and Pneumococcal
• RFP 2: Novel and complex vaccine candidates for other diseases of
high burden and priority in India
★ Medical Devices and Diagnostics
http://www.birac.nic.in/desc_new.php?id=295
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CRD – CELL FOR RESEARCH & DEVELOPMENT
Industry-Academia Collaboration For Accelerating Early Development For Biopharmaceuticals - “Innovate in India
(13) Empowering biotech entrepreneurs and accelerating inclusive innovation”
★ Medical Devices and Diagnostics
http://www.birac.nic.in/desc_new.php?id=295
108 Critical
Technologies
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CRD – CELL FOR RESEARCH & DEVELOPMENT
★ Legal Eligible Proponents
• Solely by Indian Company or jointly by an Indian Company and National
R&D Org and Institutions
• By a consortium of Indian Companies along with National Research
Organisations etc.
• Solely by an Academia or Research institution or in collaboration with
other Academia or research institutions
★ Deadline for proposal: 15 December 2017
★ Log on to BIRAC ( http://www.birac.nic.in)
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CTT - CELL FOR TECHNOLOGY TRANSFER
Research Institutes Industry
Startups/Innovators Government Departments
Auction of Technologies on Exclusive & Non-Exclusive basis
MedTech ready to be
Transferred
eAuction
DBT/BIRC Innovations
CTT
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CTT - CELL FOR TECHNOLOGY TRANSFER
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CMT – CELL FOR MARKET INTELLIGENCE & TRADE
Duty Structure Corrections for DIPP
HS Code analysis for better glimpse
IAN (India Angel Network, co-investment for
critical products)
With 3 IITs; 2 BITS; 4 CGIs in 3 months
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
CIM – CELL FOR INNOVATION AND MARKET ACCESS
Policy Papers
▪Safety of Technologies
▪Health Technology
Assessments
▪Practices governing re-use
▪Rapid Certifications
▪Start-up support for critical
components sourcing
▪
Benefits
▪Rapid market access
▪Programmatic evolution
▪Contribution to body of knowledge
base for Medical
▪Generating early alert system for
testing strengths & capabilities
▪
• Burden of Disease in the Indian Diaspora
• Policy Reports
Reprocessing of Endoscopes
Refurbished/Preowned Medical Devices(Imports)
Green and Brown Field Investments (R&D, LLP)
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
Import-
Export
Promotion
Regulatory
Office
Exhibition
Halls
Convention
Centres
Banks
Auditoriums
Technical,
HR&
Financial
Support
Warehouse
Transport&
Support
Services
AMTZ
Centrefor
Component
/PCB
Testing&
Centrefor
Gamma
Irradiation
Facility
Biomater
ial
Testing
Centrefor
MedTech
Innovation
&Rapid
Centrefor
Sterilizatio
n&
EMI/EMC
Centrefor
Radiation
Testing
KIHT
CRDCTTCMTCIM
MedTech Startup Ecosystem
ENABLING MEDTECH STARTUP ECOSYSTEM
Indian Angel
NetworkKIHT - IAN Debt/Equity Pool Finance
upto 400k USD
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
KALAM INSTITUTE OF HEALTH TECHNOLOGY
P7
P1
PN-2
KIHT Pool Money (20%)(X)
Indian Angel Network(IAN) – Alternative Investment Fund(AIF) funded by multiple Angel
Investors (80%)(Y)
Debt refund
in 4Years
KIHT – Kalam Institute of Health Technology
CRD – Cell for Research & Development(KIHT)
P – Project
C – Technology/Product/Project Commercialization
ML – Milestone
e-Auction via
Exclusive/Non-
Exclusive
Manufacturing
setup and
Preferential
Market Access
ML2ML1 ML3
ML1 – Proof of Concept/Prototype development
ML2 – Lab Validated Prototype
ML3 – Field Validated Prototype
ML4 – Regulatory Clearance(CDSCO)
ML5 – Commercialization of Project
P1 P1P1
CRD review team
IAN review Team
Initial
10% Funding
from X and Y
CRD review team
IAN review Team
CRD review team
IAN review Team
CRD review team
IAN review Team
On success of
ML3 20%
Funding from
X and Y
P1
ML5
SelectionBoard
(KIHT,IAN)
Revenue
Generation
PN-1
PN
P1
P2
P3
Dotted lines indicate Equity
Dotted lines indicate Debt Refund
On success of
ML2 30%
Funding from
X and Y
On success of
ML1 40%
Funding from
X and Y
CML4
ENABLING MEDTECH STARTUP ECOSYSTEM
© KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17
Thank you

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DESIGN OF MEDICAL DEVICES CONFERENCE, CHINA 2017

  • 1. A DEDICATED MED TECH POLICY CENTRE
  • 2. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 VISION OF KIHT ▪ Focused research on Critical Components ▪ Transfer of Technical knowledge for product development ▪ Bringing strategic and coherent synergy in Scientific Infrastructure ▪ Enabling Rapid Technology Transfer from research to industry KIHT lives to bring increased access to affordable health products to citizens and a thriving medical devices manufacturing sector in India.
  • 3. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 ▪DRDO: helicopters and hovercrafts ▪ISRO: SLV III ▪Agni Prithvi ▪Pokhran II
  • 4. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 PILLARS OF KIHT CELL FOR RESEARCH AND DEVELOPMENT CELL FOR TECHNOLOGY TRANSFER CELL FOR MARKET INTELLIGENCE AND TRADE CELL FOR INNOVATION AND MARKET ACCESS
  • 5. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CRD – CELL FOR RESEARCH & DEVELOPMENT Formative Industry leaders Research institutes Start-up Partners Technology Meet (FIRST)
  • 6. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CRD – CELL FOR RESEARCH & DEVELOPMENT Industry-Academia Collaboration For Accelerating Early Development For Biopharmaceuticals - “Innovate in India (13) Empowering biotech entrepreneurs and accelerating inclusive innovation” Implementing Agency: Biotechnology Industry Research Assistance Council (BIRAC) (A Government of India Enterprise) Co-funded through World Bank Loan Assistance ★ Biotherapeutics • RFP 1: RFP for Biosimilar - Product Development • RFP 2: Process Development Laboratory • RFP 3: Chemistry, Manufacturing, Control Units • RFP 4: cGLP validation facility for Bio therapeutics • Cell line Repository ★ Vaccines • RFP 1: Novel Vaccine candidates for HPV, Dengue and Pneumococcal • RFP 2: Novel and complex vaccine candidates for other diseases of high burden and priority in India ★ Medical Devices and Diagnostics http://www.birac.nic.in/desc_new.php?id=295
  • 7. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CRD – CELL FOR RESEARCH & DEVELOPMENT Industry-Academia Collaboration For Accelerating Early Development For Biopharmaceuticals - “Innovate in India (13) Empowering biotech entrepreneurs and accelerating inclusive innovation” ★ Medical Devices and Diagnostics http://www.birac.nic.in/desc_new.php?id=295 108 Critical Technologies
  • 8. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CRD – CELL FOR RESEARCH & DEVELOPMENT ★ Legal Eligible Proponents • Solely by Indian Company or jointly by an Indian Company and National R&D Org and Institutions • By a consortium of Indian Companies along with National Research Organisations etc. • Solely by an Academia or Research institution or in collaboration with other Academia or research institutions ★ Deadline for proposal: 15 December 2017 ★ Log on to BIRAC ( http://www.birac.nic.in)
  • 9. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CTT - CELL FOR TECHNOLOGY TRANSFER Research Institutes Industry Startups/Innovators Government Departments Auction of Technologies on Exclusive & Non-Exclusive basis MedTech ready to be Transferred eAuction DBT/BIRC Innovations CTT
  • 10. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CTT - CELL FOR TECHNOLOGY TRANSFER
  • 11. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CMT – CELL FOR MARKET INTELLIGENCE & TRADE Duty Structure Corrections for DIPP HS Code analysis for better glimpse IAN (India Angel Network, co-investment for critical products) With 3 IITs; 2 BITS; 4 CGIs in 3 months
  • 12. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 CIM – CELL FOR INNOVATION AND MARKET ACCESS Policy Papers ▪Safety of Technologies ▪Health Technology Assessments ▪Practices governing re-use ▪Rapid Certifications ▪Start-up support for critical components sourcing ▪ Benefits ▪Rapid market access ▪Programmatic evolution ▪Contribution to body of knowledge base for Medical ▪Generating early alert system for testing strengths & capabilities ▪ • Burden of Disease in the Indian Diaspora • Policy Reports Reprocessing of Endoscopes Refurbished/Preowned Medical Devices(Imports) Green and Brown Field Investments (R&D, LLP)
  • 13. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 Import- Export Promotion Regulatory Office Exhibition Halls Convention Centres Banks Auditoriums Technical, HR& Financial Support Warehouse Transport& Support Services AMTZ Centrefor Component /PCB Testing& Centrefor Gamma Irradiation Facility Biomater ial Testing Centrefor MedTech Innovation &Rapid Centrefor Sterilizatio n& EMI/EMC Centrefor Radiation Testing KIHT CRDCTTCMTCIM MedTech Startup Ecosystem ENABLING MEDTECH STARTUP ECOSYSTEM Indian Angel NetworkKIHT - IAN Debt/Equity Pool Finance upto 400k USD
  • 14. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 KALAM INSTITUTE OF HEALTH TECHNOLOGY P7 P1 PN-2 KIHT Pool Money (20%)(X) Indian Angel Network(IAN) – Alternative Investment Fund(AIF) funded by multiple Angel Investors (80%)(Y) Debt refund in 4Years KIHT – Kalam Institute of Health Technology CRD – Cell for Research & Development(KIHT) P – Project C – Technology/Product/Project Commercialization ML – Milestone e-Auction via Exclusive/Non- Exclusive Manufacturing setup and Preferential Market Access ML2ML1 ML3 ML1 – Proof of Concept/Prototype development ML2 – Lab Validated Prototype ML3 – Field Validated Prototype ML4 – Regulatory Clearance(CDSCO) ML5 – Commercialization of Project P1 P1P1 CRD review team IAN review Team Initial 10% Funding from X and Y CRD review team IAN review Team CRD review team IAN review Team CRD review team IAN review Team On success of ML3 20% Funding from X and Y P1 ML5 SelectionBoard (KIHT,IAN) Revenue Generation PN-1 PN P1 P2 P3 Dotted lines indicate Equity Dotted lines indicate Debt Refund On success of ML2 30% Funding from X and Y On success of ML1 40% Funding from X and Y CML4 ENABLING MEDTECH STARTUP ECOSYSTEM
  • 15. © KALAM INSTITUTE OF HEALTH TECHNOLOGY09/11/17 Thank you