Regulatory policy

Policy Transformations, Public and Private Participation to Support MedTech Enterprises in India: Report

Wadhwani Foundation, Cyient and Vikaasa of Xynteo release report titled “Accelerating SME Innovation and Scaling in Medtech

The Wadhwani Foundation, Cyient and Vikaasa of Xynteo published a report titled “Accelerating Innovation and Scaling of SMEs in Medtech”. The report highlights two distinct strands of analysis: first, understanding the challenges and opportunities; second, a proposal for recommendations and the way forward to accelerate the adoption of MedTech innovations in public health. The paper aims to capture the need of SMEs for collaborative platforms and policy transformations to improve domestic manufacturing of medical devices and reduce reliance on imports.

The paper highlights the impact of unclear regulations as one of the major impediments to the success of the medical technology industry in India and identifies critical gaps as articulated by various stakeholders around regulations and standards, expanding scale and adopting innovations; and developing talent. Interestingly, the study revealed that only 37 types of medical equipment are regulated in India. At the same time, the market remains flooded with low-priced imports with very high trade margins and long credit periods. Impact on the Indian market, thereby reducing the competitiveness of Indian medical device companies and increasing instances of counterfeiting.

The article highlights the need for Indian medtech companies to generate enough clinical evidence on their products coupled with peer-reviewed journals, without which hospitals are unlikely to source the same for use in their facilities. Indian companies need to invest more in training their employees – in sales, marketing, demonstrations, clinical support, hardware repairs, software troubleshooting, regulatory pathways, etc. Initiatives like the International Biomedical Skills Consortium help Indian companies improve the skills of their employees. coupled with government support through the Health Sector Skills Development Council which can help Indian companies improve the skills of their employees.