Risk Management, Innovation and Safety in Medical Devices: Evolving from Compliance to Excellence

The Factor, a Trusted Podcast for the Life Sciences Industry

Today we discuss the current developments and trends surrounding risk management in the medical device industry. Our guests are Edwin Bills and Shannon Hoste, and they touch upon the challenge of consolidating numerous standards and documents while ensuring the consideration of overall residual risk, encompassing aspects like AI, cybersecurity, and biocompatibility.

The conversation explores the need for manufacturers to embrace comprehensive risk management, focusing not only on individual risk analysis but also on evaluating the overall risk of complex systems. We also review ISO 14971, the expansion of guidance documents, and the importance of putting patient safety at the forefront of the risk management process.

Join us as we uncover the intricacies and advancements in medical device risk management.

Today's episode is hosted by Denise Wagner, Senior Director of Human Factors Engineering and Usability Engineering at Agilis Consulting Group. Today's guests are Shannon Hoste, President of Agilis by Kymanox, and Edwin Bills, who teaches the AAMI Risk Management course and is involved in the standards development for ISO 14971.

About the Factor:

The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.

About Kymanox:

Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.

The Factor is edited and produced by Earfluence.