In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often overlook critical phases of a product’s journey, such as transportation, shelf life, and the decommissioning phase, focusing instead solely on the point of patient use.

Dr. Katzenmeyer-Pleuss highlights the significance of the upcoming ISO 10993-1:2025 standard and its renewed emphasis on life cycle-based risk assessments. She explains how the transition between global markets—particularly between the EU and the US—can lead to unexpected FDA deficiencies when manufacturers rely on justifications that worked for notified bodies but do not meet more stringent FDA testing expectations for reusable or in situ curing devices.

The discussion concludes with actionable advice on early design decisions, such as narrowing down material suppliers and reprocessing options to reduce testing burdens. They also explore the critical need for cross-functional communication and quality system integration to ensure that learnings from one project or regulatory interaction are captured and applied across a company’s entire portfolio.

1. 01:45 – Introduction of Dr. Kristy Katzenmeyer-Pleuss and the mission of KP Medical Device Consulting.
2. 04:12 – Defining the Medical Device Life Cycle: Concept to decommissioning and the "hidden" phases in between.
3. 05:30 – ISO 10993-1:2025: The impact of the new biological evaluation standard on risk-based approaches.
4. 09:15 – Global Regulatory Discrepancies: Why a device approved in Europe might face hurdles at the FDA regarding "worst-case" testing.
5. 13:40 – Reusable Devices & Reprocessing: Managing the "permutation explosion" of cleaning agents and sterilization cycles.
6. 17:22 – Early Design Decisions: How limiting options in the IFU can significantly decrease your regulatory testing burden.
7. 21:05 – In Situ Curing Devices: The unique testing challenges of materials that change states during use.
8. 25:10 – Quality System Integration: Strategies for linking regulatory deficiencies and materials across multiple projects.

1. Front-load Risk Assessments: Don’t wait for FDA deficiencies to consider how shelf life or reprocessing affects device safety; integrate these into the biological evaluation plan from day one.