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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

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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27:36

LTR 103: Start treating human factors as a science,...

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

2025/04/25

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 research. Charles shares insights from his extensive experience, emphasizing the significance of designing for

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1:42

LTR 102: Collaboration that drives innovation, not...

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

2025/04/18

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“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…

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33:38

Subatack Live: Navigating the chaos at FDA

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

2025/04/17

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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28:54

LTR 101: Power up your career with mentoring

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

2025/04/11

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 importance of believing in oneself and being prepared to invest in the mentor-mentee relationship. They explore

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27:52

Substack Live: Let’s talk about cyber risk in MedTech!

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

2025/04/09

Hi everyoneHere 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 consumers in ensuring the security of medical devices and highlighted the evolving nature of cyber threats,

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32:26

LTR 100: What we will need to lead in the age of AI

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

2025/04/04

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 for authenticity in leadership. Dr. Daccach shares insights from his recent Harvard Business Leadership

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29:25

LTR 99: An exciting growth opportunity for MedTech in...

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

2025/03/28

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 the importance of quality standards, particularly ISO 13485, and how these standards are essential for both

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22:22

Substack Live: How will tariffs affect pharma and med...

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

2025/03/25

Hi everyoneHere 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 imports into the US could face up to 25% in tariffs. * Tariffs on pharma and med device imports could be

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