Hardware Podcasts

#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss

Global Medical Device Podcast · 9 Feb 2026 · 45m · Episode 446

What this episode covers

Dr. Kristy Katzenmeyer-Pleuss, President of KP Medical Device Consulting, explains how manufacturers often overlook critical phases of the medical device life cycle, such as transportation, shelf life, and decommissioning, focusing too narrowly on patient use. She highlights the impact of the upcoming ISO 10993-1:2025 standard on biological evaluations and warns that devices approved in the EU may face unexpected FDA deficiencies regarding 'worst-case' testing for reusable or in situ curing devices. Dr. Katzenmeyer-Pleuss advises narrowing material suppliers and reprocessing options in the Instructions for Use (IFU) early to reduce testing burdens and emphasizes integrating quality systems to capture learnings across a company's portfolio.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
KP Medical Device Consulting, FDA, Greenlight Guru
Also
ISO 10993-1:2025

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