Let's Talk Risk! Podcast

At first glance, risk management of diagnostic devices, including in-vitro devices (IVD), is not overly complex. After all, you mostly have to consider the effects of false negative results, false positive results, and invalid or delayed results.

However, it can be challenging to correctly assign the severity of harm(s) resulting from inaccurate and/or delayed results if we don’t fully understand the clinical context of the intended use of a diagnostic device.

In this episode, Joshua Levin advises risk practitioners to clearly define severity levels of potential harms directly in the risk management plan. This is especially valuable in a small company environment focused on developing a single device. He recommends a simple, more pragmatic approach to risk management for IVDs, driven by a solid understanding of the clinical context.

About Joshua Levin

Joshua Levin is a regulatory consultant, currently advising early-stage and mid-size companies in developing effective regulatory strategies and building efficient quality management systems, With 30 years of experience in the Quality/Regulatory space, including nearly 10 years at the US FDA, Josh has a deep understanding of both technical and regulatory aspects of IVD commercialization.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

We often think of the post-market surveillance (PMS) process as a regulatory requirement for medical devices, especially because of the revised EU-MDR (and IVDR) regulations now in effect in the European Union.

But it is more than compliance. According to Per Maegaard, PMS is not just an exercise in meeting regulatory requirements, but intelligence gathering that can help other functions including Marketing. We should think of the PMS process as a value-adding business process, which can provide insights about the real-world clinical experience with our medical device.

About Per Maegaard

Per Maegaard is currently Director and Lead Auditor at MQC, providing quality consulting, process optimization and auditing services to clients in the medical industry. He has 20+ years of professional experience in Quality and Post-Market Safety and Surveillance at leading multi-national companies such as Stryker, Smith & Nephew and Coloplast. As Director of Post Market Safety at Stryker’s Trauma/Extremity division in Europe, he was responsible for establishing a post-market surveillance program to comply with EU-MDR.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

Why - you may ask - should risk practitioners care about empathy? After all, risk management is about managing uncertainty as objectively as possible. How does exercising the empathy muscle help risk practitioners do a better job than, let us say, focusing more on data analysis and regulatory requirements?

In this episode, Christie Johnson reminds us that risk management is a team sport. When working in a cross-functional team, we have to pay attention to every individual’s unique perspective. Instead of pushing our own way to achieve quick results, we need to first allow different perspectives to be shared openly without judgment.

This is the essence of empathy. To listen carefully so we can truly understand the other person’s viewpoint. We don’t have to agree or disagree. But it is very important to make sure we enroll everyone so they are able to contribute fully, and we arrive at the best outcome as a team.

About Christie Johnson

Christie Johnson is currently a partner at Prodct, a boutique advisory firm to support early-stage biotech, medical device, diagnostic and therapeutic companies throughout product development and commercialization activities. Guided by a solid knowledge of ISO 14971 risk management, she helps create effective strategies for quality, regulatory and manufacturing, while also providing direct execution support including resource augmentation when necessary.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

Risk management involves making decisions based on incomplete information at any given time. One area where risk practitioners struggle a lot is in managing risk associated with reasonably foreseeable misuse. We struggle to figure out what type of misuse might be reasonable, and what might be foreseeable, because human behavior often is neither reasonable nor predictable!

That is why Rene Drost advises risk practitioners to focus on building team diversity. When we include diverse viewpoints and life experiences in our analysis, we benefit from our collective insights. A diverse team helps us consider a much broader range of foreseeable circumstances than a team of individuals with very similar background.

About Rene Drost

Rene Drost is currently the senior executive at NAMCO Healthcare Technology, a globally operating knowledge company specialized in maintenance and operations in the healthcare sector. He started his career as a technical officer in the Netherlands AirForce, and later moved to KLM as the head of their maintenance unit. He also manages FSCA.com for vigilance and post market surveillance activities and serves as the PRRC and ISO 13485/27001 lead auditor.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

There is a lot of hype around artificial intelligence (AI) and machine learning (ML) these days. That is why Michael Bocchinfuso encourages Quality/Regulatory professionals in this episode to go beyond the hype and understand these rapidly emerging technologies at a deeper level.

These rapidly evolving technologies offer unique opportunities in the medical device space. To succeed, QA/RA professionals should clearly articulate and emphasize the clinical benefit, anticipate regulatory questions about model bias, and carefully consider risks arising from the use environment.

His advice is to collaborate and facilitate an informed conversation across different functions to help optimize for both safety and effectiveness.

About Michael Bocchinfuso

Michael Bocchinfuso is currently the Director of Regulatory Compliance and Quality at Koios Medical. He is an electrical and software engineer by training. Early in his engineering career, he worked in avionics designing PCBs, and testing and improving reliability of these systems. He then moved into a Quality Engineer role in the medical device industry helping to ensure high quality standards and compliance during product development and beyond. In his current role, he closely collaborates with the product development teams working on AI/ML enabled medical devices in radiology applications, while maintaining an effective and compliant QMS, and coordinating regulatory activities related to various submissions in different countries across the world.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

In this episode, Becki Hiebert recommends taking a strategic approach to building and implementing a Quality Management System (QMS) in a startup.

Unlike a mature, established organization, a startup operates in a fast-paced and rapidly changing environment. That is why you have to think about both speed to support the near term goals, and scalability to support rapid growth in the future.

Her advice - focus on building the right mindset about Quality, use a risk-based approach to create a flexible system and nurture a collaborative work culture.

About Becki Hiebert

Becki Hiebert is currently the QA/RA lead at PulseMedica in Canada, where she is helping the development and commercialization of 3D imaging and laser targeting systems for precise retinal surgery. In her 10+ years of professional experience across both pharmaceutical and medical device industries, she has developed a hands-on expertise in regulatory requirements for current good manufacturing practices. She has served in a variety of roles in quality planning, process improvement, internal audits, quality system training and supplier/purchasing programs.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

Boston marathon is one of the most prestigious running events in the world. It takes a lot of planning to preparation to even qualify to enter the race.

In this episode, Christopher Gehring shares his experience preparing for his first Boston marathon and emphasizes the need for good planning in all our projects, including risk management. We have to be both agile and detailed in our approach, and plan for different contingencies. Even then, we have to be prepared to handle surprises along the way.

It is challenging to strike the right balance, but by trusting our teams and building a culture of collaboration we can achieve success.

About Christopher Gehring

Christopher Gehring is currently a Principal Design Quality Assurance Engineer at Insulet Corporation. He has over 15 years of industry experience with core expertise in design controls, risk management, system engineering, quality management systems and continuous improvement. He holds B.S, and M.S. degrees in Mechanical Engineering, a Professional Certificate in System Architecture and Engineering, and a Graduate Certificate in Business Administration. He is also an ASQ Certified Quality Engineer, Certified Quality Auditor and Six Sigma Green Belt. In his spare time, he enjoys running, sailing and music.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this podcast, consider becoming a free or paid subscriber.

There is a new scrutiny on clinical evaluations in the European Union.

At the same time, medical device manufacturers are challenged to satisfy the new regulatory requirements under EU-MDR because they are no longer able to claim “equivalence” to an existing device under revised criteria.

In this episode, Florian Tolkmitt emphasizes the need to consider clinical evaluation as an important process, not simply a document for compliance. The key point here is that we have to start focusing on planning and project management in addition to having a solid understanding of regulatory requirements. There should be connectivity in operations of different departments so everyone is following the same benchmarks and acceptance criteria.

About Florian Tolkmitt

Florian Tolkmitt is the founder and owner of PRO-LIANCE GLOBAL SOLUTIONS GmbH providing consulting services in all aspects of clinical evaluation, regulatory affairs, risk and quality management. He is an expert in clinical evaluation, post-market clinical follow up and post-market reporting compliance. As a co-founder and board member of RAPS Deutshcland e.V., he is very active in the regulatory community sharing his expertise and mentoring industry colleagues.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

Risk management is a team sport.

In this episode, Hugo Felix reminds us that takes expertise from different functions to fully understand the nature of risk and identify appropriate risk control options. It is not just engineering or manufacturing or quality or clinical; it is all functions working together.

This is more important now than ever as technology is rapidly advancing and medical devices are becoming more complex.

About Hugo Felix

Hugo Felix has 25 plus years of industry experience in devices, in-vitro diagnostics, pharmaceuticals and combination products, where he has helped build compliant patient-centric solutions by impacting quality cultures through strategy, cross-functional collaboration and organizational design. He has served in leadership roles in both early start-ups and large organizations. Currently, he is a Director of medical device and combination products quality assurance at Pfizer.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.

In this episode, Adam Saltman reminds us to not consider risk as an absolute concept; rather think about it in the context of the end user or the patient who is being asked to take the risk in return for a benefit to their health.

There is a disconnect in the medical device industry between patients, manufacturers and regulators. By considering the question “who is taking the risk?”, we can stay focused on the end user or patients as we build and launch medical devices.

About Dr. Adam Saltman

Dr. Adam Saltman started his career as a clinician practicing heart surgery for about 20 years. Later he joined the US FDA as a medical officer where he developed policy frameworks on post-market benefit-risk considerations and patient perspectives. Most recently he served as the Chief Medical and Regulatory Officer in the medical device industry. Currently, he is a Principal Strategy Consultant at NAMSA, the industry leader in offering coordinated medical device product development consulting activities under one roof to achieve accelerated outcomes. He has published more than 100 peer-reviewed articles, served on editorial boards, conducted competitively funded research projects, completed advanced training in Health Informatics from the University of Illinois at Chicago, and is certified as a Quality Improvement Associate by the American Society for Quality.

About Let’s Talk Risk! with Dr. Naveen Agarwal

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

If you enjoyed this episode, consider becoming a free or paid subscriber.