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.

In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.

Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.

The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product's lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US’s stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.

1. 01:45 – The shift from "checkboxing" to a risk-based approach.
2. 03:10 – The rapid timeline of the 2025 revision and the influence of ISO 14971.
3. 04:22 – Lifecycle Evaluation: Assessing safety beyond the "brand new" state.
4. 06:50 – Chronic toxicity vs. acute reactions: Why front-end evaluation matters.
5. 08:15 – Foreseeable Misuse: When doctors use scopes outside their intended anatomy.
6. 12:10 – The concept of Bioequivalence: Using existing data to justify reduced testing.
7. 13:45 – Breakthrough: The removal of material-mediated pyrogenicity testing for known materials.
8. 15:30 – Why the US voted "No" on the current draft: A call for better guidance.
9. 18:50 – Notified Bodies and MDR: The 2025 version as "State of the Art."
10. 21:15 – Practical chemistry tests for aging polymers (DSC, GPC, FTIR).
11. 25:40 – Advice for small vs. large companies on building material databases.

1. Lifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.

The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.

Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.

1. 00:00 - Introduction to QMS requirements and guest Mike Drues.
2. 03:45 - The core sections of a QMS according to the Quality System Regulation.
3. 05:12 - Why the QSR list is a starting point, not a stopping point.
4. 08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.
5. 10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?
6. 13:15 - Understanding the timing and strategy for FDA Establishment Registration.
7. 15:40 - The Triage Approach: Which QMS sections matter most during early development?
8. 19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.

1. Prioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.
2. Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.
3. Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...