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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-02-09
- Length: 45m
- Episode: 446
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu
- Listen: https://podcast.greenlight.guru/episode/the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleuss

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=0) Introduction and Guest Background
- [3:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=181) Defining the Medical Device Life Cycle
- [5:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=318) ISO 10993-1:2025 and Regulatory Risks
- [8:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=499) Global Discrepancies and FDA Testing
- [12:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=720) Early Design Decisions and IFU Constraints
- [20:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=1218) Quality System Integration and Traceability
- [32:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu#t=1961) Postmarket Data and Future Strategy

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)

## Most relevant to

early-stage companies

## Mentioned

- KP Medical Device Consulting (company)
- ISO 10993-1:2025 (other)
- FDA (company)
- Greenlight Guru (company)

## Related episodes from other shows

- [025 - “The Frying Pan to the Fire” with Edwin Bills](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-23-025-the-frying-pan-to-the-fire-with-edwin-bills) (Let's Combinate)
- [232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-01-232-medtech-material-selection-cost-compliance-sustainability-and-biocompatibili) (Let's Combinate)
- [148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner](https://hardwarepodcasts.com/podcast/lets-combinate/2024-08-07-148-standards-applicability-assessments-atomic-requirements-documentation-and-ti) (Let's Combinate)
- [202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-20-202-becoming-an-expert-in-the-work-nobody-wants-to-do-design-risk-and-the-messy) (Let's Combinate)
- [093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-09-446-the-hidden-physics-of-the-medtech-life-cycle-with-dr-kristy-katzenmeyer-pleu. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.