LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
From Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.
March 27, 2026 · 29 min
About this episode
Naveen Agarwal speaks with Lavanya Ramnath about the intersection of risk analysis and patient-centered design in medical device development.
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 goes deeper than process. Lavanya shares the personal connection that drew her into MedTech, how family experiences with diabetes and cardiac disease shaped her career, and why she approaches device development with a simple principle: build as if it were intended for your own family. From significant-risk judgments and feasibility studies to alarm design, human factors, and mentorship, this episode is a thoughtful reminder that good regulatory work is ultimately about real people, real uncertainty, and real consequences. Listen to the full 30-minute podcast or jump to a section of interest…
People in this episode
Host: Naveen Agarwal
Guest: Lavanya Ramnath
Topics covered
- risk analysis
- IDE strategy
- patient-centered design
- regulatory affairs
- clinical development
- MedTech
Keywords
- risk analysis
- IDE
- MedTech
- clinical study
- regulatory affairs
- diabetes technology
- human factors
- device development
Mentioned in this episode
Organizations: Insulet
Products: diabetes technology, SaMD, closed-loop systems
Places: MedTech
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