Hosted by Let · 🇺🇸 US · EN · 170 episodes
Established thought leaders with verified media credentials.
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
Let hosts Let's Talk Risk! Podcast, a education show with 170 episodes published.
Summary “Quality and risk people need to translate safety into business terms.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eric Sugalski about how MedTech professionals can communicate safety,
Summary “AI can be a powerful helper, but it should not be the decision-maker.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with David Grilli about how MedTech teams can use AI responsibly in produc
Summary “Compliance alone does not drive quality” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Mike Cook about the the Voluntary Improvement Program (VIP), and how it can help MedTech leaders go
Summary “FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.” In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about
Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and
Summary “FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?” In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits
Summary “Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.” What happens when a highly regulated medical device depends on a tiny, single-sourced component buried de
Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury. If you a
Summary “AI brings novel risks and addressing them will require a more creative approach to human factors engineering.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned
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
Summary “Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.” Companion diagnostics (CDx) are inherently high-consequence because they can directly sha
Summary “Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.” In this Let’s Talk Risk! conversation, Richard Matt share
Summary “A company can become world class the day the quality team decides.” In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT
Summary “You don’t want to be implementing QMSR while the FDA is waiting in the lobby.” As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion pe
Summary “Risks occur. They happen but they don’t exist… hazards do.” In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer with deep experien
Summary “Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.” In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits down with Jenni
Summary “For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.” In this Let’s
Summary “Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Ashko
Summary “Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.” In this Let’s Talk Risk! conversation, host Naveen Agarwal sits dow
Summary “QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Ste
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Let's Talk Risk! Podcast is hosted by Let. The show is categorised under education (business) and has published 170 episodes.
Let's Talk Risk! Podcast has published 170 episodes.
Let's Talk Risk! Podcast regularly covers education, business, how to. It sits in the education category, with a business focus.
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