Let's Talk Risk! Podcast

In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on life support. But the story doesn't stop there. We take you inside the analytical process , examining over 2,000 adverse event reports from the FDA’s MAUDE database, and revealing...

Summary “When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.” In this Let’s Talk Risk! conversation , host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples,...

Summary “You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.” In this Let’s Talk Risk! conversation , Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing cl...

FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025: With the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information and othe...

Summary “A major change proposed in the draft of ISO 10993-1 revision is the focus on foreseeable misuse and effect of cumulative device use for biological safety. ” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Priyanka Murawala, an expert in biological evaluation of medical devices. They discuss the latest updates on ISO 10993-1, the differences in regulatory approache...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opp...

Summary “MedTech in India is poised to generate $50 billion in revenues by 2030.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulat...

The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments, Severity Rating has been incorrectly selected for...

Summary “The 2025 conference was held in Amsterdam and it really was an amazing success.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Bijan Elahi, a leading authority in medical device safety risk management. They discuss the recent 2025 International Medical Device Safety Risk Management conference held in Amsterdam, focusing on the evolution of patient-centric safety...

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...