LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
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
More episodes of Let's Talk Risk! with Dr. Naveen Agarwal
- LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
- LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences
- Case Study: How Patient Preference Data Rescued a High-Risk Device
- LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
- LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
- LTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development
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