Building the ecosystem to benefit from medtech

The Centre recently launched an initiative — MedTech Mitra — for handholding innovators for clinical evaluation, regulatory facilitation and uptake of new medtech products.

The journey of a new medtech product (e.g. medical device or diagnostic) starts as the idea of an inventor who demonstrates its proof of concept (PoC) in a lab. The inventor then needs a partner to manufacture prototypes for further testing. The product may require animal studies. Ultimately, human studies are required to be carried out following strict regulatory and ethical guidelines, and employing robust research methods. An approved and licenced product then awaits opportunity for large-scale production.

Innovators and startups may be very good in their technical work, but find it hard to navigate the complex journey from ideation to a ready-to-use product in a clinical setting. The difficulties faced by them are related to their lack of understanding of regulatory requirements, testing and validation, industry-grade production, animal studies, clinical evaluation/trials, and technology assessment imperatives, among others. As a result, a large number of potentially effective medtech products remain stuck at different stages of development and fail to see the light of the day. Frustration follows, and many innovators may give up. This situation suppresses the entrepreneurial spirit and talent of young people.

To address the above problems, the Indian Council of Medical Research (ICMR) launched the MedTech Mitra initiative on December 25 in partnership with NITI Aayog and the Central Drugs Standard Control Organisation (CDSCO) of the ministry of health and family welfare. A portal has been operationalised on the ICMR website coordinated by the Medical Device and Diagnostics Mission Secretariat at ICMR (https://medtechmitra.icmr.org.in/). Pre-clinical and clinical studies are a big challenge in terms of collaborating teams and funds. The MedTech Mitra team will connect the innovators with researchers of the ICMR’s pre-clinical and clinical trials network and other research institutions. Funding would be offered to institutions that conduct pre-clinical and/or clinical studies on novel medical technologies, selected by a scientific review process. Atal Innovation Mission (AIM), the department of pharmaceuticals, the INTENT network of research institutions and the Kalaam Institute of Health Technology, and the two programmes at the department of health research (namely, Health Technology Assessment in India and Centre for Guidelines) are the core partners of this highway for development, validation, authorisation and uptake of made in India medtech products.

In a short time since its launch, over 80 innovators have connected with MedTech Mitra indicating the large unmet need for such a system. The potential scope of this system is immense. The medtech industry is a sunrise sector currently valued at $11 billion and poised to reach $50 billion by 2030. India’s innovation ecosystem has more than 100,000 startups (compared to 500 just a few years ago), with a significant proportion of them focused on medical technologies. India also has a huge demand for medical devices, including diagnostics, but we import 80% of them. The indigenous medtech products are quite often of low-end technology. This has to change: They need to cater not only to the nation’s present and future needs but also to the global demand. It is India’s destiny to be a super hub of medical technologies. For this, our innovation and R&D system has to excel. And, our industry has to transform itself into a supplier of high-end and innovative medtech products worldwide.

The government has recently taken several steps to promote the medtech sector. Medical device parks are being developed and the National Medical Device policy has been launched. A National Policy on Research and Development and Innovation in the pharma-medtech sector was released. A Scheme for the Promotion of Research and Innovation in the Pharma MedTech Sector (PRIP) has also been recently initiated to provide a paradigm shift in the pharma-medtech sector. The MedTech Mitra initiative should be seen as a continuum of the above efforts to galvanise the sector.

MedTech Mitra is not a portal, but a whole system of expert help, facilitation, technical support and regulatory guidance. The government invites scientists, innovators, startups and established companies to access the MedTech Mitra window. We are committed to learning and improving this friend-of-innovators enabler. MedTech Mitra has the potential to be a game-changer for India’s MedTech innovation ecosystem and the Make in India mission. The platform will also strengthen India’s efforts to achieve universal health coverage through affordable, indigenous, high quality medical devices and diagnostics.

Vinod Paul is member, NITI Aayog. The views expressed are personal