𝐁𝐂𝐊𝐈𝐂–𝐑𝐈𝐂𝐇 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐓𝐚𝐥𝐤 𝐒𝐞𝐫𝐢𝐞𝐬 2026: Regulatory Pathways & Standards for Medical Devices

As part of the BCKIC-RICH Healthcare Innovation Talk Series 2026, we had the privilege of hosting Mr. Varun Trivedi, Founder of EasyQ Solutions, for an insightful session on Regulatory Pathways & Standards for Medical Devices; a critical topic for innovators seeking to translate their technologies from the laboratory to real-world application.

With over 17 years of experience in the medical device sector, Mr. Trivedi brought a rare blend of technical depth and practical, hands-on insight to the discussion. The session centred on what he termed the “Four Pillars of Medical Device Regulation,” each rooted in two foundational principles: “safety and effectiveness”.
1. Intended Use & Claims
2. Quality Management System (QMS)
3. Clinical Evidence
4. Post-Market Surveillance

A particularly striking insight he shared was that only 0.27% of Indian medical device companies currently contribute to Class II device markets in the US; a gap he attributed largely to weak QMS foundations rather than technological shortcomings.

The session concluded with an engaging Q&A, during which participants; including early-stage founders navigating device classification and biotech-based combination devices received direct, practical guidance tailored to their respective stages of development.

This session reaffirmed a core belief driving the Talk Series: that regulatory literacy is not a barrier to innovation, but a foundation for it, and that building this understanding early can save start-ups significant time, cost, and credibility in the long run.

We extend our sincere gratitude to Mr. Varun Trivedi for generously sharing his expertise and enriching the session with his insights.

🔗 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐧𝐨𝐰 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐭𝐚𝐥𝐤 𝐬𝐞𝐫𝐢𝐞𝐬: https://lnkd.in/gVig2Hh2