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PODCAST

Let"s Talk Risk! with Dr. Naveen Agarwal

Casual and informal conversations about practical aspects of medical device risk management.

Every Friday, Dr. Naveen Agarwal leads a Let"s Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a

technology how to

All Episodes

15:57

Case Study: When Clues to a Future Recall Hide in...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/11

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 early warning signals going back five years. Through deep narrative review, we uncover overlooked patterns

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25:53

LTR 118: Off-Label Use with Kristen Petersen

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/08

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, and regulatory considerations surrounding off-label use, as well as the importance of documentation and

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29:53

LTR 117: Queenita Fernandes on Smart Use of AI for...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/08/01

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 clinical literature reviews and signal detection in adverse events. The discussion also highlights the need

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16:31

A Quick Primer on FDA's Final Guidance for...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/28

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 other information, the need for robust cybersecurity controls to ensure medical device safety and

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26:38

LTR 116: Priyanka Murawala on ISO 10993 Update,...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/25

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 approaches between the EU and the US, challenges faced in biological evaluation, significant recalls related to

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1:19

LTR 115: Startup Lessons from EU MedTech Shark Tank

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/18

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“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 opportunities in bringing innovative medical devices…

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31:12

LTR 114: What QA/RA Professionals Need to Know About...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/11

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 regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges

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14:04

Case Study: When Underestimating Risk Leads to a...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/07

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 many assays’ false result failure modes. Additionally, FDA found issues with procedures for CAPA,

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25:02

LTR 113: Highlights from the International Medical...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/07/04

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, the importance of education in the field, and the key themes that emerged from the conference. Bijan

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29:41

LTR 112: Overcoming organizational barriers to risk...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/06/27

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 management, the importance of clear roles and responsibilities, the integration of project management

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29:05

LTR 111: How to sustain and grow a community of...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/06/20

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 a community of practice within organizations, and the challenges and successes associated with fostering

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17:11

Case Study: A Warning Letter Exposes Issues in Risk...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/06/16

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 design (b)(4) will use the severity and occurrence rating scales described in the procedure. However, your

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26:13

LTR 110: Focusing on reliability to build safe...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/06/13

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 of effective communication and leadership in engineering, the challenges faced by startups in balancing

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11:23

Case Study: A Promising Device Fails in the Market...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/06/09

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 Tack implant. All customers should stop using the Tack Endovascular System immediately. Philips will no

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28:28

LTR 109: Focus on risk, not just testing, for...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/06/06

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 distinction between effects and endpoints in biocompatibility. Marina shares insights on common challenges faced in

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27:41

LTR 108: Databases and automation tools for clinical...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/05/30

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 automation tools in streamlining processes, and the importance of proactive monitoring in ensuring device safety and

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27:06

LTR 107: A 3-step approach to developing secure...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/05/23

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 device industry. They explore the importance of mentorship, the challenges faced by startups, and the

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27:04

LTR 106: Critical role of Medical Safety in device...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/05/16

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. Rubinstein's transition from clinical practice to the industry, the importance of integrating medical safety

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26:33

LTR 105: AI-based virtual auditors are coming to MedTech

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/05/09

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 devices, and the innovative use of AI-based virtual auditors. Eckhard shares insights on how AI can enhance

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25:33

LTR 104: Navigating the regulatory landscape for SaMD...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/05/02

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, and the importance of effective communication with regulators. Akram shares insights on change

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147 results

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