In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challenges facing the pediatric medical device market. Following a personal experience in a neonatal ward, Edwin highlights the stark reality that many pediatric treatments rely on adult devices adapted off-label, often leading to safety risks and clinical inefficiencies.

The conversation delves into the "mismatch" of the pediatric market: these devices require the same rigorous regulatory and quality standards as adult products but offer significantly lower financial upside due to smaller patient populations. This creates a barrier for investors and manufacturers, leaving clinicians and nurses to "work miracles" with tools that aren't always fit for purpose.

Despite these hurdles, Edwin shares an optimistic vision for the future. He discusses his initiative to build a collaborative network of experts—including regulatory consultants, testing houses, and grant writers—willing to provide pro-bono or at-cost support for pediatric startups. The goal is to create a streamlined regulatory roadmap that prioritizes patient safety without the prohibitive costs that currently stall innovation.

1. 00:45 – The "Pediatric Gap": Why pediatric devices have adult-level requirements but lower ROI.
2. 03:12 – Personal Insight: Edwin’s experience in the hospital and the "Guinness philosophy" of giving back.
3. 05:30 – The danger of adhesives and adapting adult materials for newborn skin.
4. 08:15 – Building a pediatric volunteer network: Testing houses and consultancies stepping up.
5. 11:40 – Regulatory Roadmaps: Navigating the age variability from premature infants to adolescents.
6. 14:50 – Off-label usage risks and the "mindset shift" required for manufacturers.
7. 18:25 – Micro-timestamp: The FDA’s Humanitarian Device Exemption (HDE) and P-Sub programs.
8. 21:10 – Real-world clinical friction: Alarm fatigue and sensor sensitivity in NICU settings.
9. 25:40 – The hidden costs: Manufacturing complexity, multiple SKUs, and low-volume production.

1. Regulatory Flexibility: Utilize specific FDA pathways like the Humanitarian Device Exemption (HDE) and the Pediatric Submissions (P-Sub) program to gain early feedback and specialized guidance.
2. Collaborative Cost-Sharing: Seek out "altruistic" partners; many testing houses and manufacturers are willing to work at-cost or under different financial models for pediatric-specific innovations.
3. Design for Sensitivity: Pediatric innovation isn't just about miniaturizing adult tech—it requires solving unique issues like alarm fatigue and skin sensitivity (e.g., non-damaging adhesives).
4. Workflow Integration: Engage the "head nurse" early in R&D to ensure the device fits into the high-stress environment of a pediatric ward without adding to clinical fatigue.

1. FDA HDE Program: A regulatory pathway for devices intended for diseases or conditions that affect small populations.
2. Greenlight Guru: The industry-leading platform for QMS & EDC solutions, helping MedTech companies maintain...

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