Let's Talk Risk! with Dr. Naveen Agarwal

About Let's Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com (https://naveenagarwalphd.substack.com?utm_medium=podcast)

Publisher

Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Category

business · education

Language

en

Explicit

No

First episode

22 Apr 2023

Latest episode

9 Oct 2026

Latest episodes

151 of 189 episodes have a transcript.

1. 

   9 Oct 2026TRANSCRIPT

   Executive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety

   Naveen Agarwal, PhD, explains FDA's rigorous evaluation of toxicological data, emphasizing robust chemical characterization and defensible analytical evidence for biological safety.

2. 

   2 Oct 2026TRANSCRIPT

   LTR 164: Susan Neadle on Combination Device Risk Management

   Host Naveen Agarwal interviews Susan Neadle, Principal Consultant and President of Combination Products Consulting Services, about integrating drug and device risk management for combination products.

3. 

   25 Sept 2026TRANSCRIPT

   Deep Dive: When the Risk Baseline and the QMS Both Break Down

   Host Naveen Agarwal, PhD, analyzes the Pensar Medical FDA warning letter, revealing how a broken risk baseline and failing QMS processes create systemic quality failures.

Inside a recent episode

Executive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety

Published 9 Oct 2026 · Transcript excerpt

[…] Yeah, it really does touch everything. So let's just establish the baseline here. Chemical characterization, or CC, is essentially the gateway to biological safety. It feeds directly into the toxicological risk assessment. The TRA, exactly. Right. We are basically trying to figure out what chemicals might leach out of a device and into a patient. Yeah, that is the core mechanism of the biological risk assessment tree. The FDA's expectation is that you identify and quantify every constituent chemical that could result in human exposure. Every single one. Every single one. But the mechanical difficulty there is that we aren't just looking at the bill of materials, right? […]

Who has been a guest on Let's Talk Risk! with Dr. Naveen Agarwal

Names identified in recent episode analyses. Showing up to five guests.

• Susan Neadle
• Allyson Mullen
• Kerry Flecknoe
• Ankita Mishra
• Bijan Elahi

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

5.0 / 5

2 ratings

Spotify

5.0 / 5

1 ratings

Podcast Authority Score: 60 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

96

Social presence

0

YouTube

0

Engagement

60

Contact Let's Talk Risk! with Dr. Naveen Agarwal

Guest appearances

Books guests

Based on episode analysis; this does not confirm that the show is currently accepting guests.

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