Let's Talk Risk! Podcast

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...

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...

Summary “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 valid and sufficiently complete to answer t...

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 Managem...

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...

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

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 HIP...

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

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

“If you frame something in a certain way, you can influence the perception of its cause and the solution. ” In this Let’s Talk Risk! conversation , Jack Garvey cautions against starting a CAPA with a problem statement first. Rather, he recommends the analysis to initially begin from a factual review of both technical and situational context leading up to a CAPA, and then defining a specific proble...

“Many of the AI/ML devices are going through De Novo and (in these) human factors considerations are specifically being called out as special controls.” In this Let’s Talk Risk! conversation , Shannon Hoste highlights some of the new concerns emerging for human factor considerations for AI/ML devices in MedTech. She explains how we could consider the level of automation as we think about new hazar...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “Manufacturers that want to go to the European market, thinking about AI devices, it’s really important that you don’t look only at the MDR. You really have to look at the AI Act as well.” In this episode of the Let's Talk Risk Podcast , Florian Tolkmitt discusses the rapidly evolving regulatory lan...

Summary “We are all at some point, either patients or loved ones of patients. So, one way or another, we are all touched by the medical technology we create ourselves. In this episode of the Let's Talk Risk Podcast , Bijan Elahi helps us appreciate the most important aspect of our work as risk practitioners, engineers and quality/regulatory affairs professionals in the medical device industry. Tha...

“There is a clear case to put the money into the design of the product, and control that, than relying on the human factor.” In this Let’s Talk Risk! conversation , Alex Saegert highlights the importance of focusing on risk reduction through safety by design, rather than relying on information for safety to users. He recommends risk practitioners to apply best practices from systems safety to buil...

“Overconfidence in the performance of AI models in the development phase is a common problem.” In this Let’s Talk Risk! conversation , David Giese highlights the growing need for a rigorous, disciplined development process with the goal of meeting regulatory requirements for marketing authorization. He shares how AI developers are often over-confident in the performance of their models, but disapp...

Summary “Medical devices are now increasingly connected in a hospital network. Or even if they are not, they are vulnerable to cyber attacks”. In this episode of the Let's Talk Risk Podcast, Eric Henry highlights the growing concern about security and cybersecurity of medical devices. As technology evolves and medical devices increasingly operate in an i… This is a public episode. If you'd like to...

“Software more than any other type of device, has integrations with other systems and devices. You have to consider a complex network of dependencies and infrastructure when analyzing risks.” In this Let’s Talk Risk! conversation , Megan Kane highlights the growing role of software, including artificial intelligence, in in-vitro diagnostic devices, including in next generation sequencing applicati...