Manufacturing Medical Devices In India
We Balance Between Compliance, Quality And Innovation?
C. Padmakumar - Chairman & Managing Director
Terumo Penpol Limited, Trivandrum
Abstract of Presentation made by Mr. C. Padmakumar
during the 12th National Conference and Technology
Exhibition on Indian Medical Devices & Plastic
Disposables/Implants Industry 2015, Ahmedabad.
It is important to have safe products &
India needs to satisfy the requirement of the
regulator and also needs innovation.
The best way to get consistent quality is to have
standardized processes and have S.O.Ps, but as the,
Doctors and Patients want innovation, this leads to
the need of striking right balance.
Medical devices are quite complex requiring various
disciplines including Plastics, Light engineering,
Chemistry, Bio-chemistry personnel etc. to
collaborate for which a network of organizations is
There are some logical locations for clusters to
exist in our country.
Along with satisfying the regulators, it is
important that the patient safety is not compromised
and new innovations take place.
Low cost innovations are carried out in India by
institutes like Stanford India Biodesign.
European Regulators provide mentoring and hand
holding to SMEs in Medical Device Sector who cannot
afford resources like large companies; hence Indian
regulators should look at the approach by the
European Regulating agencies as well as encouraging
efforts being made by USFDA.
The American and Japanese counterparts have now
realized that the opportunity in India is not just
low cost but also very high power scientific and
engineering talent including design talent looking
very seriously at investing more in India and taking
advantage of the capabilities in India.
Good opportunity to take up medical components
manufacturing in India, and hoping that the
situation will change shortly, making good
components available in India and not being
How do we
balance between Compliance, Quality and Innovation for
Medical Device Manufacturing? It is a complicated business
with prime focus on patient safety.
While it is
very important to have safest products, how do we ensure
access which is directly related to affordability, which
involves costs. Every country has a very strict regulation
for medical devices and India is no exception. We need to
satisfy the requirement of the regulator and we also need
manufacturers the best way to get consistent quality is to
have standardized processes and have S.O.Ps, stick to
those SOPs. However, Doctors and Patients want innovation
which means changing something. It means inherent trade
off here. The trick is to try and strike the right
his personal growth process, Mr. C Padmakumar mentioned
that he started as a young employee in a start up Indian
company at a time when medical device industry was at its
nascent stage. The Company then after growth, tied up with
a major medical device company - a global leader called
Terumo of Japan, as subsidiary and a joint venture
partner. Subsequently, it is now a fully owned subsidiary
of Terumo Cooperation from the last couple of years. Thus,
he has a reasonable level of experience Purely Indian,
Half Indian and now a part of Multinational. It includes
experience in dealing with the multinational medical
devices company and dealing with the Indian market and
Indian hospitals, doctors, patients and with the
growth story further, the Company had started in an
isolated location with very less accessibility.
the nature of Medical Device Industry, he mentioned that
medical devices are quite complex requiring various
disciplines including Plastics, light engineering,
Chemistry, Bio-chemistry personnel and so on have to
collaborate if you want to have a good medical device.
Since, we can not have all these people in the same
organization; we need a network of organizations. This
shows importance of having a cluster of organizations
which exists globally in places like Minnesota, Boston (In
USA) in Dublin, in Japan, in Singapore and also in India.
about the clusters, he mentioned that there are some
logical locations for clusters to exist in our country,
one, unlikely as it may sound is Trivandrum.
as a Potential Cluster Location For Medical Device
gave following supporting facts showing why; Trivandrum
has most of the necessary condition to actually have a
successful medical device industry.
It has 2
reasonable sized medical device companies. One is HLL
Lifecare, which is owned by the government of India,
formally, Hindustan Latex Ltd. A large manufacturer of
condoms and blood bags and other medical devices. The
second is Terumo Penpol.
It has Shri
Chitra Institute of Medical Science and Technology, which
is a unique institution in India and may be in any part of
the world devoted to research in medical devices and it is
a part of a hospital. Half of this institute is actually a
hospital and half of it is R&D set up. The Institute came
up with the blood bags manufacturing technology, which
initially his Company started as “Chitra blood bags”. They
also have developed products like the heart valve. This
source of interaction and information and the R&D center,
is absolutely key factor in helping the industry to grow.
has academia - the Kerala University along with other
engineering colleges as well as the Trivandrum medical
college. All these are necessary for the medical device
I think all
of us will agree that Technology is playing bigger and
bigger role in medical devices, especially Information
Technology. We are using a lot Software which are embedded
in the medical devices these days. We have a very large
Techno-Park in Trivandrum. With companies not just in BPO,
but in softwares and a lot of work is going in Techno
not the least, Trivandrum has a small but growing set of
ancillaries, some of these are being set up by Terumo
Penpol and some of these are set up by HLL Lifecare.