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MedTech Mitra: a facilitation highway for development, validation, authorization and uptake of made-in-India MedTech products

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By: Vinod K Paul

The central government has recently launched an initiative, namely, MedTech Mitra, on 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 an idea of an inventor who demonstrates its proof concept (PoC) in a lab. The inventor then needs a partner to manufacture protypes 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, and market entry.

Innovators and startups may be very good in their technical work, but find it hard to navigate the complex journey from ideation to product ready for use in clinical setting; and often do not get timely and comprehensive guidance and facilitation. 

The difficulties faced by them are related to their lack of understanding of and opportunities for regulatory requirements, testing and validation, industry grade production, animal studies, clinical evaluation/trials, technology assessment imperatives, among others. As a result, a large number of potentially effective medtech products remain stuck at different stages of development pipeline, and do not see the light of the day. Frustration follows, and many innovators may give up. This unacceptable situation suppresses the innovative and entrepreneurial spirit and talent of young people; and undermines nation’s innovative, economic and healthcare interests. 

To address the above problems faced by scientists, innovators and startups, the union government has now created a facilitation and handholding highway to help innovators in their journey of medtech product development and uptake. On 25th December 2023, the Good Governance Day, the Indian Council of Medical Research (ICMR) launched the MedTech Mitra initiative in partnership with NITI Aayog and the Central Drug Standards and Control Organization (CDSCO) of the ministry of health and family welfare. 

A portal has been operationalized on ICMR website coordinated by the Medical Device and Diagnostics Mission Secretariat at ICMR (https://medtechmitra.icmr.org.in/). An applicant innovator / startup fills in online details of the product and stage of its development, and requests guidance. An ICMR-CDSCO team examines the case and identifies area(s) of help required, conduct individualised interactions and handhold individual applicant for specific facilitatory steps. 

Pre-clinical and clinical studies are a big challenge – you need collaborating teams and funds. 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), department of pharmaceuticals, the INTENT network of research institutions and Kalaam Institute of Health Technology, and the two programs 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, authorization 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 handholding system. The potential scope of this system in future is immense.  

MedTech industry is a sunrise sector currently valued at 11 billion USD, and poised to reach 50 billion USD by 2030. India’s innovation ecosystem is shining brighter and brighter. The country has over 1 lakh startups (compared to 500 just a few years ago), with a significant proportion of them focused on medical technologies. 

India 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 must change – not only to cater to nation’s present and future needs, but also to meet 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 medtech sector. Medical devices parks are being developed. National Medical Device Policy has been launched. A National Policy on Research and Development and Innovation in Pharma-MedTech sector was released. A scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme has also been recently initiated for providing a paradigm shift in the pharma- medtech industry –  from the conventional approach of incremental innovation to disruptive innovation. 

MedTech Mitra initiative should be seen as a continuum of the above efforts to galvanise innovation and R&D milieu for the medtech sector embodying Prime Minister’s call of ‘Jai Vigyan, Jai Anushadhan’ and make-in-India. Medtech products would emerge as a major part of our industrial portfolio in the run-up to Viksit Bharat. 

MedTech Mitra is not a portal, but a whole system of expert help, facilitation, technical support and regulatory guidance. Government invites scientists, innovators, startups and established companies to access the MedTech Mitra window. We are committed to continuously learn and improve 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. 

The writer is Member, NITI Aayog. Views are personal.

Courtesy PIB, Srinagar 

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