Let's Talk Risk! Podcast

The term compliance is generally viewed as a “necessary evil”, or as a “tax on production”. But it doesn’t have to be this way.

In this episode, Raimund Laqua encourages us to view compliance as an opportunity to consider compliance requirements as part of the overall performance standards generally expected by our stakeholders, including customers and regulators. Compliance can be seen as just doing the minimum required and check the box, but it also offers an opportunity to compare our current level of performance with what we need to achieve market leadership.

About Raimund Laqua

Raimund Laqua is the founder of Lean Compliance, where he focuses on helping companies in highly-regulated, high-risk environment to transform their approach to compliance using lean thinking. As a professional engineer trained in electrical and computer engineering, he started his career building test systems for integrated circuits. Over the next 30 years, he consulted with many companies across different industries to help them achieve business results through lean management, systems thinking, risk management, accountability and responsibility frameworks, and continuous improvement. He founded Lean Compliance Consulting in 2017 where he currently serves as the Chief Compliance Engineer

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.

Sometimes it is a good idea to learn from best practices used in other industries!

In this episode, Andy David shares risk lessons learned while working with hydrogen-powered cars. He shares how design choices are driven by a central idea, which also greatly influences are approach to safety risk management. In the end, safety is an output of our risk mitigation activities. We have to keep the end user in mind and understand their needs for both safety and performance.

We also need to challenge our assumptions to find innovative solutions. As an example, hydrogen is a source of energy, but it does not mean a hydrogen-powered car is inherently more dangerous than a gasoline-powered car.

About Andy David

Andy David is an expert in safety critical embedded software development with many years of experience across different industries. He started his career with an internship at IBM followed by full time roles in heavy equipment, aerospace and automotive industries. He is the MD and Principal Consultant at A2D Consultancy, providing high-integrity software engineering, process and compliance consulting services. One of his current project is a hydrogen-powered car at Riversimple, a UK-based automotive startup.

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 practitioners, including engineers and quality/regulatory experts, mostly focus on device-related risks to ensure safety and effectiveness. Physicians, on the other hand, have to consider the totality of risks, including those arising from the procedure or patient-related factors. Physician’s have to tailor the overall benefit-risk to an individual patient.

In this episode, Dr. Elisha Patel helps us understand a physician’s view on risk.

About Dr. Elisha Patel

Elisha Patel is a qualified dentist with degrees in both biomedical sciences and dentistry. Her clinical experience includes her tenure as a dental surgeon in the National Health Services (NHS) system of healthcare in the United Kingdom. Currently, she is an associate consultant in the medical evidence practice at a leading consulting firm.

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.

The term risk is generally understood as something to be avoided or minimized. In the medical device and pharma industries, risk is generally associated with harm to patients. Regulatory agencies expect the benefits of a medical product to outweigh the risks associated with its use before it can be considered as safe and effective. As a result, the dominant view of risk in the medical device world is that risk needs to be controlled and minimized for patient safety and regulatory compliance. ISO 14971.

But risk also means opportunity. “No risk, no reward”, is a often invoked as a mantra to encourage achievement, especially in business. Sometimes the highest risk maybe the one you did not take when it was worth taking! Risk, therefore, can be perceived both as a negative force to be avoided, or as a positive force to be leveraged.

In this episode, Jayet Moon and Arun Mathew remind us to keep the big picture in mind for risk management. Safety is an important business objective, but not the only one. We need to help our organizations manage all types of risks to achieve business success.

About Jayet Moon

Jayet Moon is the author of Foundations of Quality Risk Management, published by the American Society for Quality (ASQ). He is a chartered quality professional in the UK and holds several certifications from the ASQ. In his current role as a Quality Manager at Terumo Medical Corporation, he is helping to integrate best practices in safe design and development of medical devices through is vast experience in engineering and post-market safety surveillance.

About Arun Mathew

Arun Mathew is currently an associate director of quality systems and risk management at AbbVie. He has over 17 years of diverse industry experience in roles ranging across quality, manufacturing and regulatory functions. His expertise includes medical standards, risk management, computer system validation, process validation, CE marking and FDA submissions.

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 to Let’s Talk Risk!.

Medical device manufacturers operate under a heavy load of audits and inspections. Even the regulatory authorities across the world are recognizing the heavy burden of multiple audits and inspections on manufacturers, which take away resources and time that could otherwise be invested in new product development and continuous improvement activities.

There is a movement in the regulatory compliance world to adopt a least-burdensome approach for regulatory decision making throughout the device lifecycle. In this context, the auditing practices in the industry are moving from an element-based approach to a risk-based approach.

In this episode, Rick Rios explains what risk-based auditing is and shares best practices to conducting a risk-based audit for maximum effectiveness. We also discuss common challenges with the CAPA process in the industry.

About Rick Rios

Rick Rios started his career in the defense industry working as a systems engineer in nuclear programs. Inspired by the Total Quality Management movement, he moved into a Quality and Regulatory role, and later worked in automotive and aerospace industries as an independent auditor. He has been active in the medical device industry as an independent auditor over nearly 15 years. He has successfully developed, integrated, implemented and audited quality systems based on ISO 13485, 21CFR820, MDSAP, EUMDR, DOE QC-1, NQA-1, ISO 9001, ISO 17025, NCSL Z540, and Baldrige Performance Excellence Program.

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.

The medical device regulation in the European Union (EU-MDR) outlines many new requirements for conducting clinical investigations and clinical evaluation throughout the device lifecycle.

The challenge is that the term “clinical risk” is not clearly defined in the EU-MDR. This has created a lot of confusion in the medical device industry about the scope of clinical risks that need to addressed through a clinical evaluation and appropriately integrated with the risk management system.

In this episode, Alexej Agibalow explains how the clinical evaluation process and risk management are interconnected, and recommends a cross-functional, collaborative approach to fully understand various interfaces and synchronize activities between these processes.

About Alexej Agibalow

Alexej Agibalow is a risk management expert at Escentia GmbH and manager of risk and regulatory affairs at Drager.

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 to Let’s Talk Risk!.

Unlike a typical medical device, most in-vitro diagnostics (IVD) “do not touch” a patient. IVD-related risks to patient safety are considered to be indirect risks, because the information generated by an IVD is an intermediate step in the sequence of events. In the IVD world, a trained technician will generally run the assay and provide the information to a clinician. In case of an over the counter (OTC) test, such as a rapid COVID-19 test, the end-user directly receives the test results.

How this information is used to make clinical decisions is generally not in direct control of the IVD manufacturer. The focus of IVD risk management is on minimizing false positive, false negative and invalid results by establishing appropriate performance requirements during design and development phase.

In this episode, we discuss practical challenges practitioners face in designing safe and effective IVDs, and share best practices for IVD risk management.

About Shree Koushik

Shree Koushik has over 25 years of research experience in biochemistry and molecular biology. As a consultant in the medical device industry over the last 10 years, he has successfully helped multiple clients receive FDA approvals for medical devices, combination products, software and IVDs in the microbiology, immunology, personalized medicine, cardiovascular, general surgery and dental specialties. He has also conducted numerous Quality Systems audits, developed Quality Management Systems and represented companies in their response to FDA inspections. Currently, he serves as the managing partner of BRDA consulting offering customer-centric solutions in regulatory affairs, quality assurance and business development.

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.

FMEA is a commonly used technique by engineers in the medical device industry to analyze different failure modes, their causes and effects. When used correctly, it is highly effective in identifying and implementing appropriate control measures to improve product quality and reliability.

However, FMEAs are also overused in the industry; often almost exclusively for risk analysis. The main problem with this approach is that system level hazards and hazardous situations cannot be easily linked to individual failure modes identified in an FMEA. Further, harm can occur even when a medical device is operating in the normal mode.

In this episode, Roger Hill discusses some of the common challenges in using FMEAs and shares best practices based on over 30 years of industry experience.

About Roger Hill

Roger Hill is is a Mechanical Engineer with extensive experience in design, development, manufacturing and ongoing sustainability of medical devices. He started his career in the defense industry and later moved to the medical device industry in the early 1990s. His expertise includes design controls, verification and validation of hardware, manufacturing operations and process validation. He also mentors and teaches classes for biomedical and mechanical engineering students at the University of Texas at Dallas.

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.