When it comes to medical devices, we generally think about only clinical benefits as we plan our clinical investigations to generate scientific evidence for demonstrating safety and effectiveness.

However, medical devices also provide many other quality-of life-benefits that are often overlooked during benefit-risk evaluation. One reason is that these benefits are often subjectively experienced by patients, and not usually quantified during clinical investigations.

In this LTR conversation, Ronald challenges us to consider quality-of-life benefits in a quantifiable way during clinical investigations. He shares an example of a minimally invasive orthopedic device to support the meniscus without the need for a total knee replacement. In this case the risk of frequent revision surgery is offset by the significant quality-of-life benefits.

That is why it is important to also consider quality-of-life benefits in the overall benefit-risk evaluation. A good practice is to develop a method to quantify quality-of -life benefits important to patients, and generate data to demonstrate measurably significant difference in these benefits using the device.

Ronald also shares some of the emerging expectations of notified bodies for the newly created role of a PRRC. Personal risk and liability for a PRRC is limited, but you must demonstrate training and competence. However, negligence and intentional mistakes on part of PRRC can result in legal liability. A best practice is to assign a dedicated role as PRRC and not serve in a dual capacity as department head and PRRC at the same time.

Listen to this Let’s Talk Risk! conversation with Ronald Boumans which also includes an open discussion with the audience.

About Ronald Baumans

Ronald Baumans is currently the founder and strategic consultant at Boumans Regulatory Consulting B.V, providing consulting and PRRC services to medical device companies across Europe. Previously he served as Senior Global Regulatory Consultant and Program Manager for European Regulatory Affairs at Emergo by UL. His professional experience spans over 30 years across multiple industry-leading organizations. He is also the founder of PRRC Academy, where he provides training about this emerging role in the medtech industry.

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.

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