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PODCAST

Let"s Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

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All Episodes

1:42

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

Let"s Talk Risk! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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! Podcast ·

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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26:20

LTR 98: Critical role of medical safety officer in...

Let"s Talk Risk! Podcast ·

2025/03/21

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 Naveen Agarwal engages with Bettina Brant, Senior Director of Medical Safety at Medtronic, to discuss the

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1:24

LTR 97: Surviving chaos and uncertainty at the FDA

Let"s Talk Risk! Podcast ·

2025/03/19

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“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 implications for regulatory affairs professionals, t…

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32:06

LTR 96: A patient-centric approach to medical device R&D

Let"s Talk Risk! Podcast ·

2025/03/14

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 Peter Braido, VP of R&D at MediView XR, about his extensive experience in the medical device industry. They

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31:09

LTR 95: The case for software risk management in...

Let"s Talk Risk! Podcast ·

2025/03/07

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 software risk management. Software failure will occur, but we need to understand the sequence of events leading to

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0:59

LTR 94: The road ahead for PCCPs and AI/ML amidst...

Let"s Talk Risk! Podcast ·

2025/03/05

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“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 Podcast, Naveen Agarwal and Yu Zhao discuss the P…

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32:56

LTR 93: AI use cases in MedTech regulatory applications

Let"s Talk Risk! Podcast ·

2025/02/28

Summary“To AI or not to AI is no longer a question.”In this Let’s Talk Risk! conversation, Naveen Agarwal and Michelle Wu discuss the transformative role of AI in the regulatory space, particularly in healthcare and life sciences. They explore key trends observed at the JP Morgan Healthcare Conference, share real-world use cases of AI applications, and address concerns about trust, job security, and privacy in the context of AI adoption. Michelle emphasizes that AI is an enabler rather than a

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1:31

LTR 92: Understanding the notified body perspective...

Let"s Talk Risk! Podcast ·

2025/02/26

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“When the notified body goes back and asks you (the manufacturer) for more information, they aren’t necessarily saying that whatever you have done is wrong.” Clinical evaluation is a major requirement for medical devices under the EU regulation, and notified bodies must determine whether the evidence provided by the manufacturer is scientifically…

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30:50

LTR 91: International conference on medical device...

Let"s Talk Risk! Podcast ·

2025/02/21

Summary“People who were passionate about this subject (safety risk management) and were enthusiastic about it, we got together and said ‘let’s just create a conference for MedTech’, and we did.”In this Let’s Talk Risk! conversation, Naveen Agarwal interviews Bijan Elahi, a leading authority in safety risk management of medical devices. They discuss the upcoming International Safety Risk Management Conference in Amsterdam, focusing on its significance, key speakers, and topics such as AI,

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34:16

LTR 90: Lead with empathy to grow your Quality career

Let"s Talk Risk! Podcast ·

2025/02/14

Summary“As a Quality leader, you need to be empathetic to other departments that are impacted by whatever change(s) you are making.”In this Let’s Talk Risk! conversation, Naveen Agarwal and Amit Tyagi explore the intersection of quality management and career growth. Amit shares insights from his extensive experience in quality engineering, emphasizing the importance of innovative thinking, risk management, and effective CAPA processes. They discuss the challenges of navigating change in quality

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1:52

LTR 89: Navigating uncertain times at the FDA

Let"s Talk Risk! Podcast ·

2025/02/12

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“For the foreseeable future, core FDA practices such a reviewing submissions and post-market oversight are going to continue. Smart Money says FDA in 6 months or an year from now, as to these core responsibilities, is operating similarly to FDA of mid-2024.” Yes, there is a lot of uncertainty due to the current political environment in the USA, a…

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34:27

LTR 88: Decoding Privacy Laws in Clinical Research

Let"s Talk Risk! Podcast ·

2025/02/07

Summary“The root cause of most privacy missteps is a lack of education, training and understanding of what the privacy rule actually is.”In this Let’s Talk Risk! conversation, Naveen Agarwal and Edye Edens delve into the critical intersection of privacy laws and clinical trials. They explore the significance of privacy regulations like HIPAA and GDPR, the implications of proposed changes to HIPAA, and the role of AI in enhancing compliance and efficiency in clinical research. Edye shares real-world

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1:06

LTR 87: A Strategic Approach to Regulatory Success...

Let"s Talk Risk! Podcast ·

2025/02/05

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“You can definitely use (GenAI) as your core algorithm, but you need to enforce that it can only do one specific thing or at least a very clarified labeling. ” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal engages with Dr. Yujan Shrestha to explore the rapid advancements of AI and ML in the medical device industry. They dis…

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1:02

LTR 86: Managing Post-Market Design Changes

Let"s Talk Risk! Podcast ·

2025/01/31

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Mismatched design controls can feel like driving through two feet of mud. You will eventually get to your destination, but it will take a lot more time and effort than it really should. ” In this episode of the Let's Talk Risk Podcast, Naveen Agarwal and Aaron Joseph discuss the ongoing challenges of design controls in medical devices, particula…

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