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Manufacturing Medical Devices In India

How Do We Balance Between Compliance, Quality And Innovation?

Mr. 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 & affordability.

  • 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 required.

  • 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 imported.

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 innovation.

For 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 balance.

Introducing 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 regulators.

Taking the growth story further, the Company had started in an isolated location with very less accessibility.

Introducing 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.

Explaining 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.

Trivandrum – as a Potential Cluster Location For Medical Device Industry.

He further 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.

  • The place 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 industry.

  • 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 Park.

  • Last but 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.

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