2:00 – 3:30 PM Session 3: Navigating the AI Frontier in MedTech: From SaMD to AI-Driven Drug Development

Session Chair: Sridevi Nagarajan, Founder & Director, AyusArogya Ltd.; DIA Communities Chair for AI in Healthcare

Session Focus: The global MedTech environment for medical AI has reached a decisive turning point. Topics addressed include SaMD classification under the EU AI Act and FDA guidance; AI applications in drug development and MedTech innovation; validation and lifecycle control for adaptive algorithms; cybersecurity obligations; post-market surveillance; and a multi-jurisdictional regulatory strategy spanning the FDA, EMA, MHRA, and CDSCO.

2:00 – 2:15 PM S3.T1: The Regulatory Landscape in 2026 [15 min]
Sridevi Nagarajan (Session Chair)

2:15 – 2:30 PM S3.T2: AI in Drug Development & MedTech Innovation [15 min]
Adarsh Srivastava, Head of IVD Data Insights – Data, Analytics & Research, Roche, India

2:30 – 2:45 PM S3.T3: Validation, Cybersecurity & Lifecycle Control [15 min]
Jaydeep Ruparelia, Founder and CEO, Infopercept
2:45 – 3:30 PM S3.T4: Panel Discussion: Future of AI in MedTech [45 min]
Moderator: Sridevi Nagarajan
Panelists: Speakers with the additional presence of:
3. Aseem Sahu, Deputy Drug Controller (DDC), Medical Device Division, CDSCO (HQ), India
4. Rohit Philip, Senior Program Consultant, KMTC
5. MiRa Jacobs, PhD, Head of Digital Health, MHRA, UK – Virtual
6. Vivek Ahuja, MD, EVP – Global Delivery Excellence, Strategy & Growth, Eversana