Latest / Let's Talk Risk! Podcast
LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
Summary
“The clinical study is actually where your risk analysis is going to meet reality.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory Affairs Specialist at Insulet, about what it really takes to prepare for an IDE and why early-phase risk work is far more than a documentation exercise. Drawing on her experience in diabetes technology, SaMD, and closed-loop systems, Lavanya explains how regulatory, clinical, engineering, and usability thinking must come together long before a device ever reaches a patient.
The conversation also…
The skinny
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