India boasts the fourth largest medical device sector in Asia, currently valued at $5.2bn and growing by around 16% every year. With some estimates predicting a rapid growth of the industry to $50bn by 2025, the Indian medical device market offers manufacturers and investors a diverse range of opportunities. This is not only due to its sheer size, but as a result of the regulatory makeover it underwent in 2017.

The Medical Devices Rules 2017, which took effect on the 1 January 2018, have sought to bring the sector in line with global standards and practices. Up until their introduction, outside of a list of just ten device types, medical equipment was not regulated at all in India. Now, they’re all placed into one of four categories based on the intended use of the device and the potential risks that come with its use. The higher risk, the more strenuous the approval process.

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Much like pharmaceuticals, if a medical device is already approved in the EU, US, Australia, Canada or Japan, clinical investigation is not needed for it to be sold in India.

The changing face of Indian medtech

Meril Life Sciences, an Indian medtech company founded in 2006 as part of the healthcare diversification plan of the Bilakhia Group, has felt the impact of the country’s changing medical device industry first-hand. The company specialises in the manufacturing of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endosurgery and ENT products.

Meril Life Sciences vice president Sanjeev Bhat says: “I very distinctly remember that before 2005, the Indian medtech space was not very clearly granulated. The pharma space was very well defined in terms of APIs, more drugs and generic formulations, but the medtech space wasn’t so much.”

In recent years there has been a significant increase in the domestic manufacturing of medical device equipment in India. While imported products still comprise around 80% of total sales, improved awareness among the urban population about the latest advances in medical technology has increased demand in turn, with industry leaders conducting seminars and workshops across the country to spread awareness.

Bhatt says: “In the last ten years or so, the government has very consciously made a very interesting decision growing the healthcare reach within towns, and the hospital sectors grew. So now you would find tertiary care hospitals or even semi-tertiary care hospital in class B and class C towns [the Indian Government’s method of ranking different areas] so that has altered the space very distinctly.”

India’s aging population has also prompted action from the medtech sector. It is estimated that Indian care providers will need to supply as many as 1.75 million additional beds by the year 2025, the public sector’s contribution to which is expected to only be 15% – 20%. This demographic time bomb has prompted many device manufacturers to step into the healthcare delivery space to fill this demand.

Alongside this, medical tourism is actively encouraged by the Indian government, which expanded its e-tourism Visa regime in February 2019 to include medical visas which permit a stay in the country of up to six months. International tourists coming to India specifically for medical treatment demand a high quality of care which has prompted the providers across the country to improve their medical technology infrastructure.

Regulatory and attitude changes

Alongside regulatory and demographic changes, Bhatt notes an attitude change in Indian people’s approach to medical treatment.

Bhatt says: “In an Indian population most of the treatment is usually elective care; unless there is an emergency you don’t need to go to the hospital, that’s a very popular perception. If there is a heart attack, you rush, but if there is a knee pain, don’t rush. And for a 65-year-old, 70-year-old person a knee pain is part of the whole growing old process. That changed right in front of us.

“When we started Meril back in 2006 we were doing about 45,000 knee replacements each year – now we are doing over 200,000 knee replacements annually with more than half a million taking place across the country.”

Meril currently the leading total knee replacement (TKR) company in India, with a 20% share of the market.

What Meril did next

Meril has utilised the Indian device market’s dynamic shifts to the best of its advantage, presenting the results of 14 studies at the June 2019 EuroPCR conference in Paris. It also showcased its VR technology for case-based training on cardiac procedures, exhibiting a brand new dedicated training village with 13 hands-on simulator activities for its latest innovations and 12 master class sessions on coronary, peripheral and structural heart technologies.

Among the trials exhibited were the positive safety and efficacy results of two of the company’s recently CE-approved devices: the MeRes100 bioresorbable scaffold (BRS) for patients with coronary artery disease and the Myval transcatheter heart valve (TVH) for severe symptomatic aortic valve stenosis.

The MeRes100 BRS is an arterial scaffold system which fully reabsorbs naturally in the artery over the course of two to three years, allowing the artery to regain its full form and structure. Its next generation bioresorbable technology with low strut thickness of 100 microns makes it easier to deliver and helps to minimise vascular injury during and after surgery and enables early formation of endothelial tissue.

MeRes100 was able to demonstrate zero scaffold thrombosis and a very low rate major adverse cardiac events of 1.61% – 1.87%.

Bhatt says: “For platforms such as MeRes100, the whole idea is to reinstall and re-establish faith within bio-dissolvable scaffolds. Physicians know that the first generation did not live up to expectations and the challenge was beyond the technological capacity at the time.”

The MyVal TVH is a balloon expandable heart valve made from nickel cobalt alloy. It has a unique honeycomb design with open cells on the upper half to ensure un-jailing of the coronary ostia and closed cells on the lower half for high radical strength. It is equipped with an internal PET sealing cuff for lower profile and puncture resistance and an external PET buffing to minimise paravalvular leaks. Dr Seth also explained that the delivery system of the Myval device is intuitively simple, with an operator friendly rotatory handle that also demonstrates high distal flexion for ease of navigation.

MyVal demonstrated 100% acute procedural success and no device-related mortality up to one year follow-up.

Now the two products have been CE-marked for consumer use, Meril is focused on putting its technology at the heart of cardiovascular care.

Bhatt says: “The next phase of our launch is more to educate and familiarise physicians with our technology and the clinical trials. In the next couple of weeks we will begin the evaluation process where we seek approval and build the registry and clinical trial platforms. This will establish further confidence and allow operators to gain personal experience with our platforms.”