1. www.artixio.com
2023
ARTIXIO CONSULTING
EXCELLENCE IN LIFESCIENCES,
FROM CONCEPT TO MARKET
Incubators & Accelerators – Opportunities
for Students & Faculties – Early Stage
Entrepreneurs
Session on
Presented by
For
2. Artixio| Incubators & Accelerators – High Level Comparison
INCUBATOR ACCELERATOR
Office Space Yes May be
Mentorship Yes Yes
Networking Opportunities Yes Yes
Funding Sometimes Yes / Connect with Investors Yes / Connect with Investors
Equity Model Usually Fee based / May ask Equity Equity Based
Technical Facilities Yes May be
Type of Engagement Rolling Based Admissions Cohort based
Legal Yes Yes
Regulatory Yes Yes
Marketing Sometimes Yes
Financial Advice Yes Yes
Stage of Development Early Stage – When Product/ Business Model is not defined Growth/ Scaling - Clear Product/MVP, Business Model
Timeline 6-12-24 Months
Long Term Sustainable Growth / Flexible Duration
3-6 Months
Rapid, Efficient Scaling / Fixed Duration
Industry Focus Industry Specific / Often General Industry Specific
3. Artixio| Incubators & Accelerators – How To Chose?
Ideation MVP Investment Validation Launch Growth Maturity Exit
Accelerator
Venture Capital
Incubator
WHERE ARE YOU IN THIS JOURNEY?
4. Artixio| MedTech Incubators & Accelerators – In The MEDTECH Context
Coverts your MedTech Idea
into viable business model
with additional support
relevant to the Industry
Principles of risk based
methodology
QbD- Product Design
Support tech gap areas-
excluding core
competency
Regulatory requirements-
Regulatory Strategy
Adopt to business needs at
an accelerated pace to cope
up with a market which is
continuously evolving
Determining market gaps
for innovation adoption-
Market Strategy
Forming business
partnerships- Customer
acquisition
Funding / Capital Infusion
INCUBATORS ACCELERATORS
5. Artixio| MedTech Incubators & Accelerators – Case Study – 4BaseCare
Founded
Incubated
Accelerator
6 Startups Cohort
Support Provided
$10K Equity-Free Cash
Grant
Technology
Business strategy
Regulatory and clinical
validation
Edison Platform
Sales Team
Accelerator
5 Startups Cohort
Support Provided
Seed investment
Business and scientific
guidance
Access to Illumina’s
sequencing systems
Reagents
Fully operational lab
space for six months
Genomic tests for Cancer Patients'
treatment guidance, A mobile-based
patient-centric EMR.
Won Elevate 2019
INR 50 Lakhs
4baseCare and ACTREC-Tata
Memorial Centre - AI based
clinical interpretation
platform
Grant
Partnership
Partnership
Growth
Partnership
Investment $2M 2021
2018 2019 2020 2021 2022 2023
6. Artixio| MedTech Incubators & Accelerators – What Do They Offer?
Business mentorship and
Technical mentorship for
fostering medical device
entrepreneurship
Information and support in
setting up a business venture
with finance, legal, HR and
regulatory inputs
Professional assistance in risk analysis, regulatory
compliance, quality management system,
technology documentation, product
documentation, ethical clearance
Training on biocompatibility, risk
management, human factors
engineering, packaging and
sterilization, selection of
biomaterials, quality management
systems, regulatory systems and
documentation.
7. Artixio| MedTech Incubators & Accelerators – What Do They Offer?
Office space on rental
Laboratory facility
Wet lab
Laboratory facility
Dry Lab
Clean work space
Specialized Utilities
Chemical, polymer, biochemistry, biotechnology,
ceramic & related projects with reagent racks, fume
hood, facility of laboratory gases, electrical power and
basic equipment such as weighing balance,
refrigerator, heater, stirrer, oven, shaker, air
compressor/vacuum
Electro-mechanical, instrumentation projects with
electrical power (light loads), internet connectivity
Laminar flow work bench) – for final assembly or
manufacturing process and also shareable clean/non
clean work space for cleaning, drying, packaging and
sterilization
Reagent water, ultrasonic component cleaning
equipment, sealers for medical device packing
and ETO/ Steam sterilizers
INFRASTRUCTUE at MEDTECH INCUBATORS MEDTECH FACILITIES
Analytical characterisation facilities
(HPLC, LCMS, GC, TGA, DTA, UV, FTIR,
FT Raman, AFM ...)
Microscopes (TEM, SEM, ESEM,
Confocal, Optical, Projection stereo...)
Mechanical characterisation facilities
(Tensile / Compressive, DMA, Burst,
impact, fatigue ..)
Surface Characterisation facilities
(Roughness, texture, profilometry..)
Coating Characterization facilities
(thickness, adhesion, corrosion …)
Medical device in vitro evaluation
facilities, In silico validation facilities
Design workstations and design
software
Structural Analysis and Computational
Fluid Dynamics software
Metrology and calibration
OTHER SERVICES ACCESS
Testing services on material
characterisation and biological evaluation
Large animal experiments
Consultancy on risk analysis, regulatory
compliance, quality management system,
technology documentation, product
documentation, ethical clearance
IP services, Library and information
Services
Support from clinical community, Clinical
trials coordination
8. Accelerator 'Madhavbaug,' one of India’s largest Ayurveda Cardiac
Care clinics
https://fhealth.in/
D2C, home healthcare,
telemedicine, patient-centric
innovations, medtech and digital
therapeutics
$1.5 million across 8-10 companies
over three batches in FY 23
Acclerator Government of India Biotechnology Industry Research
Assistance Council (BIRAC) and Tata Trust enabled
Social Alpha
https://hiex.ch/innovations.html
Cancer Care, Drone Logisctics, 3D
drug Delivery, UAV
Incubator IIT Kanpur, DST
https://siicincubator.com/programs-nidhi-
accelerator.php
Agritech, Cleantech, Cybertech,
Education, Fintech, Hardware,
Healthcare, Infra, AI/ML/IoT, UAV
100+ Companies, $1B+ Valuation
Accelerator https://actionforindia.org/ Social Healthcare, Remote Health
Monitoring, Diagnostics, Insurance
10+ Healthcare/MedTech startups
Accelerator mPragati – IIT-D / ICMR, DHR
https://www.mpragati.in/
Implants
Surgical Instrumentation
Electronic Instrumentation
Rehabilitation
20+ Startups
Incubator IIT-M Dept of Biotech, MST
https://htic.iitm.ac.in/mti/
Telehealth, Diagnostics, Invasive/
Non Invasive Devices
12+ companies already in market
Grant upto INR 50 Lakhs
Artixio| MedTech Incubators & Accelerators – Examples
9. Incubator Andhra Pradesh MedTech Zone (AMTZ), Medi Valley
Atal Incubation Centre
MedTech Innovations, Woman
Care, Elderly Care, Rehabilitation
10+ startups
Incubator Sree Chitra Tirunal Institute for Medical Sciences and
Technology (SCTIMST), Kerala State Industrial
Development Corporation
Department of Science & Technology, Government of
India
Eye care, diagnostics, Ventilators,
Urinary hospital care, telehealth,
diabetes
Seed funding support
20+ starups
Incubator IIM-A, NIDHI Seed Support, Bharat Inclusion Seed Fund,
Infuse Ventures
Telehealth, IOT, Wearable devices,
Assistive Devices, Predictive
Devices
Upto 50 startups funded per year
Incubator GoI, Govt of Gujrat HealthTech, Diagnostics
Incubator IIMB, NS Raghavan Centre for Entrepreneurial Learning HealthTech, Diagnostics, Genetic
Screening
30+ Stratups
Incubator /
Accelerator
https://startupmission.kerala.gov.in/ Healthtehc, diagnostics, devices 40+ Incubators network
Artixio| MedTech Incubators & Accelerators – Examples
10. Incubator https://entrepreneurs.unltdindia.org/
Shahani Group Initiative
Health Information, Social
Healthtech
5+ healthtech startups
Incubator DA-IICT Centre for Entrepreneurship and Incubation
(DCEI)
http://ceid.daiict.ac.in/index.html#about
HealthTech
Incubator IIM C
https://www.iimcal.ac.in/faculty/centers-of-
excellence/centre-for-entrepreneurship-
innovation/iim-calcutta-innovation-park
HealthTech
Incubator http://www.ndbiindia.org/index.html Mobility, healthTech
Incubator http://www.mutbimanipal.org/our-incubatees Rehabilitation, Diagnostics, Stem
Cell, eLearning
20+ Startups
Incubator /
Acclerator
https://periyartbi.pmu.edu/ Medical Devices, Food Biotech,
Butrition
10+ Stratups
Artixio| MedTech Incubators & Accelerators – Examples
11. Accelerator https://www.edison-accelerator.com/ Digital Transformative Healthcare 10+ Start-ups
Accelerator https://startup.google.com/programs/accelerator/india
/
Google for Startups
Deep Tech, AI/ML HealthTech 10+ Start-ups in India
Incubator /
Accelerator
https://www.ikpknowledgepark.com/incubatees.html Pharma, MedTech, Healthcare,
Biotech, Diagnostics
65+ companies
Artixio| MedTech Incubators & Accelerators – Examples
12. Artixio| MedTech Industry Overview
Medical device industry is
broadly segmented into
devices and diagnostics
Projected to grow around $600
billion in 2025 with
continued CAGR of about 6% till
2030
5
Major Categories of Devices
& Diagnostics
• Consumable & Disposable Devices
• Imaging Diagnostic
• Dental Products
• Orthopaedics & Prosthetics
• Patient Aids
• Software/Digital Products
Semi-Regulated Industry
Ambiguous requirements
depending on technology & country
Wide technology
breadth and
application depth
Varied Innovation Cycle
Across product category
Maturity vs Growth Stage
Key Trends Across Product Categories based on
Innovation Cycle
Wearables | Immersive Tech | 3D Printing |
IoMT | AI | Minimally invasive devices
13. Artixio| MedTech Industry Overview | India Focus
India is the 4th largest market for
medical devices in Asia, among the top
20 markets globally
$11B
Market Size
$50B
By 2030
15%
Market Growth
Rate (expected)
6,000 +
Types of Medical
Devices in India
250 +
MedTech Startups
X 4 by 2030
70% Import
Market
9.37%
Export CAGR
$10B
Export by 2025
Production Linked Incentives: Government has
launched Production Linked Incentive Schemes for
medical devices with financial incentives worth
$400mn to boost domestic production
Development of Medical Devices Parks: New
Medical Devices Parks upcoming in Himachal
Pradesh, Uttar Pradesh, Madhya Pradesh, & Tamil
Nadu to create a robust ecosystem for medical
device manufacturing
Policy Support: Release of National Medical
Devices Policy to enable strong collaborations for
boosting medical devices ecosystem & National
R&D Policy to foster interdisciplinary collaborations
to develop translational skills & start-up ecosystem
Significant
Infrastructure, Policy
and Funding Support
from the Govt. of India
The Drugs and Cosmetics Act, 1940
Sources:
https://www.investindia.gov.in/sector/medical-devices
https://www.ibef.org/industry/medical-devices
14. Artixio| MedTech Product Development Overview
Market Research
and Needs
Assessment
Concept Generation
Feasibility
Assessment
Proof of Concept
Prototype
Development
Design and
Engineering
Functional
Prototypes
Iterative Testing
User Feedback
Regulatory
Considerations
Manufacturability
and Scalability
Pilot Testing
Regulatory
Submissions
Technical
Documentation
Continuous
Improvement
15. Artixio| MedTech Industry – Key Considerations
Global Harmonization
1. Global markets each with its own
regulatory framework.
2. Global harmonization of standards
and regulations is a big
challenge,due to adaptation to
different sets of requirements
Evolution of Regulations
1. Redefine regulations to align with
technological advancements and
patient safety.
2. Ensuring compliance to evolving
regulations is a huge task
Classification and Risk Management
1. Proper classification of medical devices based
on their intended use and potential risks is
crucial.
2. Risk management and all the other associated
requirements is extremely crucial
Pre-Market Approval
1. Pre-market approval before
commercialization
2. Rigorous assessment of clinical
data, safety, and efficacy and
Quality system audit
REGULATORY
INTELLECTUAL
PROPERTY
Patent Protection
Innovation in medical devices is
crucial but the associated patent
protection is crucial, costly and
leads to patent disputes and
challenges
Trade Secrets and Confidentiality
Approach of replication or reverse-
engineering of devices is very high
in medical device industry.
Establishing robust trade secret
protection measures is vital
Licensing and Collaborations
Collaborations and licensing
agreements can complicate
intellectual property ownership
TESTING
Clinical Trials
Substantial equivalence and clinical
studies are required to prove the
safety and efficacy of the device
Post-Market Surveillance
Implementing effective post-market
surveillance systems and promptly
addressing any concerns is a regulatory
obligation
Validation and Verification
Indepth validation and verification
processes is a must for medical devices
to comply to regulatory standards
Labeling and Instructions
Global Labelling requirements are very
complicated and complex for medical
devices. Any non-compliance can cause a
serious impact on the product status in the
market