Medtronic Inc., a global medical technology company provides therapies for the world's 20 most challenging diseases which include Parkinson's, cardiovascular disorders, spine injuries, diabetes and neurological problems. Milind Shah, managing director, heads Medtronic's Indian operations. He is responsible for the entire sales/marketing operations and expansion projects in South Asia. Armed with an MBA from IIM, Kolkata and B.Tech from IIT, Delhi, Shah served Henkel Group, as managing director prior to the present posting and worked in executive positions at 3M, Electro & Telecom group and NOCIL.

In an interview with Nandita Vijay of Chronicle Pharmabiz, Milind Shah provides an overview of the sector and says that regulatory approval for medical devices has to be made mandatory in India. Excerpts:

The Union government has notified 10 medical devices including cardiac and drug eluting stents as drugs that require central clearance prior to import, manufacture or marketing in the country. In your opinion what would be the impact of this new rule?

The notification will allow market to grow and help patients access the best available to diagnosis, monitor and recover at a faster pace. There is a need for regulation in India as globally all medical devices undergo stringent quality norms.

What would be the efforts by Medtronic's to seek approval from the Government of India for marketing its whole range of medical devices because these include not only cardiac stents, drug eluting stents, but catheters, intra ocular lenses, IV Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements?

Medtronic already has approvals from US FDA and Europe CE and all its products are marketed in India. The American Chamber of Commerce, medical devices sector, Europe's UCOMED and the Confederation of Indian Industry and National Committee for Medical Equipment are in talks with the Government of India's ministry of health and family welfare to provide a list of the medical devices that require Central clearance prior to import, manufacture and marketing in the country. These dialogues would also ensure framing of guidelines for medical devices accreditation, in addition to establishment of required infrastructure to undertake product testing in India, certification and quality standard evaluation. The efforts to appoint a regulatory authority will fuel the growth of the sector.

What is the size of the medical devices that Medtronic Inc and Medtronic India are targeting globally and nationally respectively?

The medical devices market is showing a double-digit growth. The cardiac devices alone are growing at 20 per cent. In India, the growth of the market is estimated to be between 10-15 per cent. There is a clear indication that the penetration levels are higher in the country. This is because of affordability by patients, increased awareness on health care, improved hospital infrastructure and the increased disease patterns.

What are the key drivers of this market? Is it innovative technology, simple to use techniques or pricing?

For Medtronic's the key driver for growth is innovation. Annually the company also pumps in 10 per cent of its annual turnover into research and development. It employs 33,000 personnel of which 9,000 are into product development and research. From an Indian context, the company believes that constant training and awareness programmes are crucial factors to increase sales.

What is the competition faced by the company and its ranking globally and in India for stents and medical devices?

We have a diversified product offering and therefore, there is competition at different levels. In cardiac devices we compete with Johnson & Johnson, Boston Scientific and St. Jude Medicals. Under spinal disorders, Johnson & Johnson and Synthes are the competitors. In neurology, we are the pioneers for devices to treat and control Parkinson disease. In India, we have around 6 installations, which includes National Institute of Mental Health and Neuro Sciences (NIMHANS) and All India Institute of Medical Sciences (AIIMS).

Currently, what is the manpower strength at Medtronic India and any hiring on the anvil, how many and by when?

Hiring is on and we are scouting for biomedical engineers. We also allocate resources for training, which is a comprehensive education programme. We also have doctors on our rolls and this is because they are familiar with medical sciences and devices are an extension of their specialisations.

What are the current trends in the medical devices sector?

The current trend is the convergence of biotechnology, information technology and medical technology. In addition to diagnosis and monitoring, the company has linked information technology and communications to launch Care Link, which is a connection between the patient and doctors miles away on a remote basis. Around 600 hospitals in the US, which have been linked to this service.

Another trend is that health care providers are now convinced that investment in medical devices would bring down cost of treatment for patients because accurate diagnosis can simplify procedures, reduce hospitalisation, decrease discomfort and promote faster recovery.

What are the future prospects for the medical devices sector?

The future holds immense potential for this sector. Companies like Medtronic's India are looking providing the patients affordable healthcare with a range of medical devices. The focus is to grow the market, which is a challenge.