Is there such a thing as a “good” risk?

According to Naveen Agarwal, absolutely.

And if the phrase makes your Regulatory or Quality brain twitch a little... well, that’s probably a good reason to listen. 😄

In this episode of Bluestock Talk, Allison sits down with Naveen, founder of Let’s Talk Risk, to talk about something we deal with constantly in MedTech but still manage to make really, really complicated: risk.

Naveen started Let’s Talk Risk because he noticed that people weren’t struggling from a lack of standards, webinars, or training. There’s plenty of that. What’s harder is figuring out how to actually use what we know when we have to make a real decision. His answer has been to get people talking, sharing experiences, and getting more comfortable with the judgment that risk management requires.

Because, as Naveen puts it:

“A good risk is never zero risk.”

That launches Allison and Naveen into a conversation about good risk, bad risk, benefit-risk decisions, and why getting everything into the green box on a risk matrix doesn’t necessarily mean you’ve done your job.

They also get into one of Allison’s “red-flag” claims:

“Our device has zero risk!” 😬

Rather than immediately reaching for a standard and explaining why that’s wrong, Naveen suggests something much more human: get curious. Ask why someone believes so strongly in the device. Understand the excitement first. Then help translate it into language that FDA will understand.

A few things to take away:

• Zero risk isn’t the goal. Good judgment is.
• Risk management belongs to all of us, not just QA/RA folks.
• Benefit-risk changes as products, evidence, and alternatives evolve.

CHAPTERS

00:00 Meet Naveen
01:26 Why Let’s Talk Risk exists
05:09 Community, conversation & content
13:59 Why risk isn’t one-size-fits-all
20:03 “Our device has zero risk!”
24:17 Why Naveen isn’t writing a book
30:58 Write for one person
34:53 Unsubscribers, criticism & staying focused
47:35 AI hallucinations, bias & critical thinking
50:11 The MedTech that changed Naveen’s life
53:35 A future benefit-risk episode?

Naveen’s “Let’s Talk Risk!” podcast brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. Check it out on his YouTube channel at https://www.youtube.com/@NaveenAgarwalPhD, on Substack at https://naveenagarwalphd.substack.com/podcast, on Spotify at https://open.spotify.com/show/3lmY8rpFa2snQIJSBUaW0c, or via your other favorite platforms.

💙 Bluestock Talk explores the people, ideas, and medical technologies transforming healthcare.

Want more honest conversations about MedTech, innovation, and the people building it? Tune in to Bluestock Talk as Allison Komiyama, PhD, RAC, explores the people, ideas, and medical technologies transforming healthcare.

Have a guest, medical device, or healthcare topic you’d like Allison to explore? Let us know in the comments.

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