Let's Talk Risk! Podcast

<p>Summary</p><p>“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”</p><p>In this episode of the Let’s Talk Risk Podcast, host...

<p>Summary</p><p>“Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.”</p><p>What happens when a highly regulated medical device depends on a tiny, single-sourced...

<p>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...

<p>Summary</p><p>“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”</p><p>In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan...

<p>Summary</p><p>“The clinical study is actually where your risk analysis is going to meet reality.”</p><p>In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory...

<p>Summary</p><p>“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”</p><p>Companion diagnostics (CDx) are inherently high-consequence because they...

<p>Summary</p><p>“Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.”</p><p>In this Let’s Talk Risk! conversation...

<p>Summary</p><p>“A company can become world class the day the quality team decides.”</p><p>In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical...

<p>Summary</p><p>“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”</p><p>As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation...

<p>Summary</p><p>“Risks occur. They happen but they don’t exist… hazards do.”</p><p>In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer...

<p>Summary</p><p>“Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.”</p><p>In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits...

<p>Summary</p><p>“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...

<p>Summary</p><p>“Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.”</p><p>In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal...

<p>Summary</p><p>“Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.”</p><p>In this Let’s Talk Risk! conversation, host Naveen...

<p>Summary</p><p>“QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.”</p><p>In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal...