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Go to Market Strategies
for Medical Device Start-ups and Entrepreneurs in India
Example 3 – Orthopaedic Implants
– If you are planning to manufacture/develop high-end
products, then you have to make sure that team has
desired competence, a mix of biomedical and engineering
staff; in addition to the technical staff. An
understanding of raw materials, their source and
applicable test standards like ISO 7206-10:2018
(Implants for surgery) is imperative because this will
help you understand the design requirements at the very
beginning of your product development stage.
Business Overview for a Medical
Device Startups / Entrepreneurs
“Turtle Diagram” is a great tool for
visualizing process characteristics. Processes are made
up of inputs, outputs, criteria, etc. Figure 2 allow you
to look at the entire process, as well as the
communication. Figure 2 can help you , better understand
the process and what minimum requirements you must be
considered by you, when you are planning to setup a
manufacturing unit or want to act as a service provider
for the medical device industry.
Case Study
Scope – To setup a medical device
manufacturing unit with about 35-50 people working in
the premises.
You have to consider these costs: -
a) Understanding the Land cost in the
area where you want to setup the unit
b) Building construction if you are setting up a
Greenfield project
c) Water Charges – Connection and ongoing
d) Electricity Supply – Connection and ongoing
e) Air Handling Unit for sterile products
f) Factory Premises (As per WHO: GMP and/or Schedule
M-III)
g) Competent Technical Staff i.e., Manufacturing Chemist
and Analytical Chemist
h) Machinery and Lab Equipment
Choice of products
You have a basket of over 3000+ products
to choose from and manufacture in India.
Minimum Licences Required:
a) Company Registration (in case
proprietorship you may skip this process)
b) Manufacturing License
c) Goods and Service Tax Number
Competent Technical Staff:
Medical Devices manufacturing shall be
conducted under supervision of whole-time technical
staff which is very important to ensure product quality.
Labelling of Medical Devices:
Medical Devices should be labelled as
per requirements prescribed in Drug and Cosmetic Act and
Rules along with Indian Standards Specifications laid
down from time to time by the Bureau of Indian
Standards. For all international markets, there are
country/region specific requirements which you need to
understand before planning to approach customers. In
international market, labels may also be required in
different languages and disclosures.
Conclusion
The Indian Government has identified the
medical devices as a priority sector for the flagship
'Make in India' program and is committed to strengthen
the manufacturing ecosystem. India is the fourth largest
medical devices market in Asia. Currently, the Indian
market has high reliance on imports but in recent times
the exports have seen a surged. The Production Linked
Incentive Scheme (PLI) and Promotion of Medical Devices
Parks Scheme, are a testimony to this. These schemes
have been cogently constructed to incentivize
large-scale manufacturing and to build required
infrastructure for developing manufacturing clusters
within India.
As a Start-ups / Entrepreneur, its very
important to understand that Medical Devices is a highly
regulated product and you have to plan very carefully
when you are entering into this market. Though the
investment may look small, as compared to returns; but
it is also the fact that if you are ill- prepared or
under-prepared,
you will not be able to sustain. Also, as the world is
talking about waste management and green energy, you
must try to make Green Building at the start phase
itself. This will make your product even more cost
effective and greener for the supply chains.
Lastly, an eagles’ eye on the compliance
requirements is also beneficial as this will help you to
stay focussed on the target that you set for yourself.
Your project will not sway with the slight push of the
compliance needs. Hence a proper plan will help you take
benefit of one of the fastest growing market, with good
growth potential and a wide customer base.
Bibliography
http://seip.urban-industrial.in http://healthworld.com
https://pharmafranchisehelp.com
https://health.economictimes.indiatimes.com/healthfiles/future-growth-of-medical-device-market-
in-india-ascompared-to-the-global-market/628
https://www.investindia.gov.in/sector/medical-devices
https://www2.deloitte.com/content/dam/Deloitte/in/Documents/life-sciences-health-care/in-lshc-
medical-devices-making-inindia-noexp.pdf
https://16949store.com/articles/how-to-use-turtle-diagrams/ |
