Let's Talk Risk! Podcast

Summary “We still see companies having difficulty in accepting risk management as a tool for better decision making. Risk is often seen as a blocker rather than an enabler.” In this Let’s Talk Risk! conversation , host Naveen Agarwal and Brett Travaglio discuss the challenges and opportunities in risk management within the medical device industry. Key themes include cultural resistance to risk man...

Summary “Communities of practice are more than just knowledge sharing platforms. They serve as engines for standardization and cross-functional alignment across various business units.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Ronak Dunung, a rising star in medical device risk management. They discuss Ronak's journey into risk management, the importance of creating...

The EYE-SYNC(R) device uses a modified virtual reality headset, connected to a tablet, to track eye movement in response to visual stimuli for assessment of a concussion. In a recent warning letter, FDA cited the following issue with software risk analysis: Your Risk Management Procedure, SOP-10011, Rev 002, states that the level of risk is determined by Risk Priority Numbers(RPN) and that the des...

Summary “If your device fails 1 out of 100 times, you might think it is good. But if that one time is in the middle of surgery, or when the parent is using it for their children, you are bringing harm.” In this episode of the Let's Talk Risk Podcast , Naveen Agarwal and Mitra Soltani delve into the critical relationship between reliability and safety in medical devices. They discuss the importance...

In March, 2025, FDA announced the Class I recall of the Tack Endovascular System (TES) , indicated for treating dissection of the blood vessels after they are widened using a balloon or stent (angioplasty): Philips is recalling Tack Endovascular Systems due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tac...

Summary “Know your device, prepare your biological evaluation plan and apply a risk-based approach.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with biocompatibility expert Marina Daineko to discuss the intricacies of biocompatibility assessments for medical devices. They explore the upcoming updates to ISO 10993-1, the importance of a risk-based approach, and the distinct...

Summary “It is essential to monitor (literature) and stay ahead of the curve so you are not surprised.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Veronika Valdova to discuss the complexities of clinical evaluation and documentation requirements under the EU MDR. They explore the challenges faced by manufacturers in compiling necessary documents, the role of automatio...

Summary “Cybersecurity is not something you want to try to just throw in at the last minute. Apply a security-by-design approach to incorporate security thinking and process from the earliest stages.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Jose Bohorquez to discuss the critical intersection of software development, cybersecurity, and risk management in the medical...

Summary “Understanding how a device operates in the clinical environment is critical for managing patient safety risks, especially for diagnostic devices.” In this Let’s Talk Risk! conversation , Naveen Agarwal engages with Dr. Marc Rubinstein, head of medical safety at GRAIL, discussing the critical aspects of medical safety and risk management in the medical device industry. They explore Dr. Rub...

Summary “What fascinates me about the AI auditor is that it is very strict on one hand, and very complete on the other hand.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Eckhard Jokisch, a lead auditor with extensive experience in ISO 13485 and ISO 9001. They discuss the importance of building trust in the auditing process, the challenges of risk management in medical d...

Summary “When you over-collaborate, you confuse the word inclusion with something else. That’s when collaboration becomes ineffective.” In this episode of the Let's Talk Risk Podcast , Naveen Agarwal and Dr. Ahmet Tezel discuss the critical role of collaboration in the medical device industry. They explore the balance between effective collaboration and o… This is a public episode. If you'd like t...

Summary “The learning for us is that we have to make the regulator’s job easier (in India).” In this Let’s Talk Risk! conversation , Naveen Agarwal engages with Akram Sheikh, an industry leader in the Indian medical device sector. They discuss the rapid growth of the medical device industry in India, the challenges posed by new regulatory frameworks, particularly for software-based medical devices...

Summary “Many devices that pass the FDA human factors engineering review simply are not acceptable when they reach the marketplace.” In this Let’s Talk Risk! conversation , Naveen Agarwal engages with Charles Mauro, a pioneer in human factors engineering. They discuss the importance of usability in medical devices, the challenges faced in the industry, and the need for rigorous human factors resea...

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Summary “If you ready to take that step, be prepared to do the work. Mentoring is a two-way street.” In this Let’s Talk Risk! conversation , Naveen Agarwal and Angelina Lisandrelli discuss the significance of mentoring in career development, emphasizing the personal and professional growth that comes from these relationships. Angelina shares her own journey with mentorship, highlighting the import...

Hi everyone Here is the recording of our second Substack Live session. We talked about cybersecurity for medical devices with Nidhi Gani . Our discussion covered the recent Silk Typhoon cyber espionage incident, the implications of cyber attacks on patient safety, and the frameworks for managing cybersecurity risks in healthcare. Nidhi emphasized the shared responsibility of manufacturers and cons...

Summary “If you are not in it, you are already late.” In this episode of the Let's Talk Risk Podcast , Naveen Agarwal and Dr. Juan Daccach discuss the evolving landscape of leadership in the age of AI, particularly within the medical device industry. They explore the challenges of transitioning from clinical practice to corporate leadership, the importance of emotional intelligence, and the need f...

Summary “85% of the medical devices in India are imported. There is now a strong focus on developing internally but also make healthcare more accessible to the masses.” In this Let’s Talk Risk! conversation , Naveen Agarwal engages with Rajesh Kathuria, a seasoned quality executive, to discuss the rapid growth of the MedTech industry in India and the accompanying regulatory changes. They explore t...

Hi everyone Here is the recording of our first Substack Live session. We did have some technical glitches, but it was a lot of fun to talk about the potential impact of tariffs on pharma and medical device supply chains. My guest was Marco who writes about risk and resilience On the Edge of Resilience on his Substack. Please go check it out and subscribe. Here are some of the key points: * Pharma...

Summary “Our true end goal is to be proactive in safety versus reactive. Bring in your medical safety early and often.” How do we figure out why our medical device(s) are failing to perform as intended in the real-world clinical environment? This is where Medical Safety Officers can help us truly understand the root cause(s) during a CAPA investigation. In this Let’s Talk Risk! conversation , host...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “More importantly than ever, a good product development and risk-based approach is going to be critical.” In this episode of the Let's Talk Risk Podcast , Naveen Agarwal and Michael Nilo discuss the current state of the FDA amidst significant staff cuts and organizational chaos. They explore the imp...

Summary “Is it good enough for myself as well as my family and the community at large?” How do we keep the patient front and center when making design decisions for a medical device? How can we balance functionality with safety without over-engineering a device that becomes difficult to use and cost-prohibitive? In this Let’s Talk Risk! conversation , Naveen Agarwal explores these questions with P...

Summary “If there is a risk in your design for a device used in a hospital setting, you have qualified people there. But at home, there is no more safety net. So (AI) software risk becomes even more important.” In this Let’s Talk Risk! conversation , Erhan Ilhan shares how software is increasingly being used as a medical device in our industry. As a result, we have to pay more attention to softwar...

Summary “Clinicians need to to trust the (AI) algorithm, and knowing how it works helps them understand where it might fail, or where extra attention might be needed.” In this episode of the Let's Talk Risk Podcast , Dr. Jay Vaishnav discusses the rapid growth of artificial intelligence (AI) in the medical technology (MedTech) field, particularly in Radiology. She shares insights from her extensiv...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “The Digital Health Center of Excellence was hit pretty heavy, and also AI researchers at OSEL. I am not too worried about PCCP but the impact could be on how quickly FDA can finalize the other draft guidance with larger scope applied to all medical devices.” In this episode of the Let's Talk Risk P...