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The Center recently launched an initiative, MedTech Mitra, to help innovators conduct clinical evaluations, facilitate regulation and adopt new medical technology products.
The journey of a new medical technology product (for example, a medical or diagnostic device) begins with the idea of an inventor demonstrating his proof of concept (PoC) in a laboratory. The inventor then needs a partner to make prototypes for further testing. The product may require animal studies. Ultimately, human studies must be conducted following strict regulatory and ethical guidelines and employing sound research methods. An approved and licensed product then awaits the opportunity to be produced on a large scale.
Innovators and startups may be very good at their technical work, but they find it difficult to navigate the complex journey from idea to a product ready to use in a clinical setting. The difficulties they face are related to their lack of understanding of regulatory requirements, testing and validation, industrial-grade production, animal studies, clinical evaluations/trials, and technology assessment imperatives, among others. As a result, a large number of potentially effective medical technology products remain stuck in different stages of development and fail to see the light of day. Frustration follows and many innovators may give up. This situation suppresses the entrepreneurial spirit and talent of young people.
To address the above issues, the Indian Council of Medical Research (ICMR) launched the MedTech Mitra initiative on December 25 in association with NITI Aayog and the Central Drugs Standard Control Organization (CDSCO) of the Ministry of Health and Family Welfare. A portal has been made operational on the ICMR website coordinated by the ICMR Diagnostics and Medical Devices Mission Secretariat (preclinical and clinical studies are a big challenge in terms of equipment and collaboration funds. The MedTech Mitra team will connect innovators with researchers from ICMR’s preclinical and clinical trials network and other research institutions. Funding would be offered to institutions conducting preclinical and/or clinical studies on novel medical technologies, selected through 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 programs of the Department of Health Research (viz. Health Technology Assessment in India and the Center of Guidelines) are the main partners of this highway for the development, validation, authorization and adoption of medical technology products made in India.
In a short time since its launch, more than 80 innovators have connected with MedTech Mitra, indicating the huge unmet need for such a system. The potential reach of this system is immense. The medtech industry is an emerging sector currently valued at $11 billion and set to reach $50 billion by 2030. India’s innovation ecosystem has over 100,000 startups (up from 500 a year ago). just a few years), and a significant proportion of them focus on medical technologies. . India also has a huge demand for medical devices, including diagnostic devices, but we import 80% of them. Indigenous medical technology products are usually low-end technology. This has to change: they must address not only the present and future needs of the nation, but also global demand. India’s destiny is to be a super center of medical technologies. To achieve this, our innovation and R&D system has to stand out. And our industry has to transform into a provider of innovative and high-end medical technology products around the world.
Recently, the government has taken several measures to promote the medical technology sector. Medical device parks are being developed and the national medical device policy has been launched. A National Policy for Research, Development and Innovation in the pharmaceutical-medtech sector was published. A Plan for the Promotion of Research and Innovation in the Pharma MedTech Sector (PRIP) has also recently been initiated to provide a paradigm shift in the pharma-medtech sector. The MedTech Mitra initiative should be seen as a continuation of previous efforts to galvanize the sector.
MedTech Mitra is not a portal but a complete 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 innovator-friendly facilitator. 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 and high-quality medical devices and diagnostics.
Vinod Paul is a member of NITI Aayog. The opinions expressed are personal.