Global Medical Device Podcast powered by Greenlight Guru

This episode features Ivanny Franklin, Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes.
Etienne and Ivanny explore the critical intersection of global regulatory bodies—such as the NMPA in China and the FDA in the US—and the necessity of a cohesive clinical evidence strategy. Ivanny emphasizes that for startups, understanding market-specific data requirements is not just a regulatory hurdle but a fundamental component of commercialization and investor conviction.
The discussion also dives into the "patient empowerment" movement, fueled by the convergence of wearables, AI, and at-home monitoring. Ivanny shares her bullish outlook on technologies that give patients control over their data, while acknowledging the tension this creates for physicians and the ongoing need for rigorous regulatory oversight to ensure safety and effectiveness.
Key Timestamps
[03:15] Global Regulatory Strategy: Insights into the NMPA (formerly CFDA) and why China requires in-country clinical evidence.
[07:42] Leveraging Data: How to run a single clinical trial to satisfy multiple global regulatory bodies.
[10:18] The At-Home Monitoring Shift: The rise of wearables and OTC testing in the wake of COVID-19.
[13:45] The "Data Gap": Addressing the friction between patient-gathered data and physician adoption.
[18:22] Investment Non-Negotiables: Why revenue-generating companies and clear regulatory classifications are key for MedSight Capital.
[23:10] Diligence and Deception: The importance of honesty regarding reimbursement codes and 510(k) vs. PMA paths.
[27:45] SPV vs. Hedge Fund Models: A breakdown of how Special Purpose Vehicles allow family offices to be nimble in MedTech.

Quotes
"FDA and NMPA, for example, are quite strict in clinical evidence coming from in-country... as a startup, you really need to understand can we run a single trial with multiple global sites to achieve clearance cohesively." - Ivanny Franklin"I’m an advocate for [at-home monitoring]. I do think that’s the future. However, there is concern around what types of information should patients be receiving and how are they going to act on that information?" - Ivanny FranklinTakeaways
Regulatory is the Roadmap: An investment is often "de-risked" based on the clarity of the regulatory path. If a founder cannot distinguish between a 510(k) and a PMA, it is a major red flag for investors.
Harmonize Your Trials: To achieve "economies of scale" in clinical evidence, work with consultants to design trials that meet the stringent requirements of both the FDA and international bodies like the NMPA early on.
Commercial Scalability over Hype: For revenue-generating companies, investors are less concerned with the "idea" and more focused on physician retention, training, and the cost of scaling the sales team.
Honesty in Reimbursement: Never "make up" or guess CPT codes. Investors utilize experts (like ex-FDA personnel) to pressure-test your reimbursement strategy during diligence.

References
NMPA (National Medical Products Administration): The primary regulatory body for China (formerly the CFDA).
NAMSA: A world-leading Medical Device CRO mentioned as Ivanny’s former professional home.
LSI (Life Science Intelligence): The upcoming conference mentioned where Etienne and Ivanny will speak on a panel.
Greenlight Guru: The preferred platform for QMS & EDC solutions to manage medical device quality and clinical data.
Etienne Nichols: Connect on LinkedIn.

MedTech 101: SPV (Special Purpose Vehicle)
Think of a Special Purpose Vehicle (SPV) like a "carpool" for investors. Instead of a massive bus (a Hedge Fund) that picks up everyone's money and decides where to go over several years, an SPV is a single car created for one specific trip—in this case, one specific company.
Investors put their money into the SPV, and the SPV makes one investment in one startup. This allows smaller investors or family offices to pool their resources together to act as one large "passenger" on a company's cap table.
Sponsors
This episode is brought to you by Greenlight Guru. Moving from a "service-based" model to an "outcome-based" model requires impeccable data and quality management. Greenlight Guru offers both QMS (Quality Management System) and EDC (Electronic Data Capture) solutions designed specifically for the medical device industry. Whether you are gathering clinical evidence for an NMPA submission or scaling a revenue-generating product, Greenlight Guru helps you stay compliant and efficient.
Feedback Call-to-Action
We want to hear from you! Did this breakdown of investment vehicles help you? Do you have suggestions for future MedTech topics? We provide personalized responses to every listener who reaches out. Send your thoughts, reviews, and questions to [email protected].

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

Quotes
"We need to give clinicians the correct tools to work their miracles. They don't want to use products off-label; they want devices actually designed for the children they are saving." - Edwin Lindsay"If you have a pediatric project, there is a community behind you. We are breaking down the barriers of risk and cost because these babies deserve a chance." - Edwin LindsayTakeaways
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.
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.
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).
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.

References
FDA HDE Program: A regulatory pathway for devices intended for diseases or conditions that affect small populations.
Greenlight Guru: The industry-leading platform for QMS & EDC solutions, helping MedTech companies maintain compliance while accelerating pediatric product development.
Etienne Nichols on LinkedIn: Connect with Etienne for more MedTech insights.

MedTech 101: Off-Label Use
In the medical device world, "Off-Label" means using a device for a purpose, or on a patient population (like infants), that the FDA has not officially cleared.
Think of it like this: Imagine you have a high-tech hiking boot designed for a grown man, but you have to put it on a toddler because no one makes toddler-sized hiking boots. You might be able to make it stay on with extra socks and tape, but it won't support the child’s foot correctly and might cause them to trip. In pediatrics, doctors often have to "tape the boot" because specialized devices simply don't exist.
Feedback Call-to-Action
We want to hear from you! Are you working on a pediatric breakthrough, or have you faced challenges in this niche market? Whether you have a topic suggestion or a question for Edwin, send us an email at [email protected]. We read every message and pride ourselves on providing personalized responses to our community.
Sponsors
This episode is brought to you by Greenlight Guru. Navigating the complex regulatory landscape of pediatric devices requires a robust foundation. Greenlight Guru’s QMS (Quality Management System) and EDC (Electronic Data Capture) solutions are specifically designed to help MedTech innovators manage risk and clinical data with precision. Whether you are a one-person startup or a global entity, Greenlight Guru helps you get safe, effective technology to patients faster.

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

Quotes
"The life cycle is really the concept of the medical device from when it’s a concept all the way through to the end where you are disposing or decommissioning... shelf life and transport are steps that usually don’t get a lot of focus, but they are very important." - Dr. Katzenmeyer-Pleuss"You might have one device where literally they don’t ask these questions at all, and then other times they’re very, very picky... the longer you go in that process, the harder it is to pivot without spending a lot of time and money." - Dr. Katzenmeyer-PleussTakeaways
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.
The "Worst-Case" Strategy: When designing testing protocols for reusable devices, aim for a "worst-case" scenario that covers future iterations or additional suppliers to avoid redundant, expensive re-testing.
Standardize Your IFU Early: Providing users with infinite cleaning or sterilization options creates an exponential increase in testing requirements; narrow these down to the essentials to streamline market entry.
Break the Silos: Use your QMS to link specific material risks or regulatory feedback across different project teams so that knowledge isn't lost when personnel leave.

References
ISO 10993-1:2025: The updated international standard for the biological evaluation of medical devices within a risk management process.
Etienne Nichols on LinkedIn: Connect with the host for more MedTech insights.

MedTech 101: In Situ Curing
In this episode, Dr. Katzenmeyer-Pleuss mentions In Situ Curing. Think of this like a medical-grade "liquid bandage" or dental filling. The device starts as a liquid or gel and is applied to the body, where it then hardens into a solid "in the spot" (in situ).
From a regulatory standpoint, this is complex because you aren't just testing one device; you have to test the safety of the liquid, the safety of the solid, and any chemicals released during the hardening process. It is essentially three devices in one when it comes to testing.
Sponsors
This episode is brought to you by Greenlight Guru. When navigating the complex life cycle of a medical device—from the initial risk assessments discussed today to post-market surveillance—you need a unified system. Greenlight Guru’s QMS (Quality Management System) and EDC (Electronic Data Capture) solutions work together to ensure your data is linked, your testing is documented, and your clinical trials are seamless. By connecting your quality and clinical data, you can avoid the "disjointed" project management pitfalls Etienne and Kristy discussed.
Feedback Call-to-Action
What are your biggest hurdles in managing the full medical device life cycle? We want to hear from you. Whether it's a specific regulatory challenge or a topic suggestion for a future guest, send your thoughts to [email protected]. We read every email and pride ourselves on giving personalized responses to our MedTech community.

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

Quotes
"The testing that we developed back in the 50s and 60s actually doesn't really work the best with some of these complex devices... we've been moving the standard away from what we call checkboxing." - Thor Rollins"I only say that expensive tests always impact innovation. We don't want to over-test, but we want to do the right tests." - Thor RollinsTakeaways
Lifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that may degrade after hundreds of cleaning cycles.
Foreseeable Misuse is a Regulatory Reality: If it is likely a clinician will use your device off-label (e.g., a pulmonary scope used in vascular applications), you must account for that biological risk in your assessment.
Leverage Bioequivalence: Stop testing the same stainless steel or titanium repeatedly. Use existing data and internal databases to justify "no testing" for known materials and processes.
Partner with Expertise: Because the standard is less prescriptive and more risk-based, the quality of your Biological Evaluation Plan (BEP) depends entirely on the expertise of the person writing it.
Chemistry over Animals: Whenever possible, use chemistry (Extractables & Leachables) and in vitro methods to replace legacy animal tests, as the 2025 revision officially begins to phase out certain animal-based requirements.

References
ISO 10993-1:2025: The primary global standard for the biological evaluation of medical devices.
ISO 14971: The standard for the application of risk management to medical devices, now heavily integrated into 10993-1.
Nelson Labs: The laboratory where Thor Rollins leads biocompatibility strategy.
Etienne Nichols: Connect with Etienne on LinkedIn.

MedTech 101: Bioequivalence
Think of bioequivalence like buying a generic medication versus a brand-name one. If you know the ingredients (materials) and the way they are manufactured (processes) are identical to a device that has already been proven safe on the market, you shouldn't have to re-run expensive, time-consuming tests. In MedTech, this means showing that your "New Device B" is biologically the same as your "Proven Device A" because they use the same grade of titanium and the same sterilization method.
Sponsors
This episode is brought to you by Greenlight Guru. As the industry shifts toward a risk-based approach as seen in ISO 10993-1:2025, having a centralized source of truth is vital. Greenlight Guru's QMS (Quality Management System) allows you to integrate risk management directly into your design process, while their EDC (Electronic Data Capture) solution helps you gather the clinical evidence needed to prove long-term safety. When your risk assessments and clinical data live in the same ecosystem, "state of the art" compliance becomes a standard, not a struggle.
Feedback Call-to-Action
We want to hear from you! How is your team preparing for the 2025 revision of ISO 10993-1? Are you concerned about the lifecycle evaluation requirements? Send your thoughts, questions, or topic suggestions to [email protected]. We read every email and love providing personalized responses to our community.

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

Quotes
"This is a starting point. This is not a stopping point... Use your own good judgment." — Mike Drues"The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use." — Etienne NicholsTakeaways
Prioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.
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.
Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in your QMS is a significant red flag for FDA inspectors.
Strategic Registration: Register your establishment 60–90 days before your planned commercial launch to manage costs and stay off the FDA inspection radar until necessary.
The Preamble is Key: Read the preamble of the QSR to understand the "why" behind the regulations, which allows for better justification of your quality decisions during an audit.

References
FDA Design Control Guidance (1997): A foundational document for medical device engineering and documentation.
FDA Establishment Registration: Guidance on the timing and requirements for small business fee waivers.
Etienne Nichols LinkedIn: https://www.linkedin.com/in/etiennenichols/

MedTech 101 Section
Concept: The Quality Management System (QMS) Think of a QMS like a pilot’s pre-flight checklist. You don't just "wing it" when you get into a cockpit; you have a documented process to ensure the engine is working, the fuel is full, and the wings are clear. For a small plane (a low-risk Class I device), your checklist is shorter and simpler. For a commercial jumbo jet (a high-risk Class III device), the checklist is massive and detailed. However, the goal for both is identical: ensuring the passengers (the patients) arrive safely at their destination through a repeatable, controlled process.
Sponsors
This episode is brought to you by Greenlight Guru. The subject of right-sizing your quality system is exactly why Greenlight Guru offers both QMS and EDC solutions. Their Ultralight eQMS is designed specifically for fast-moving, product-led teams who need a flexible, compliant system without the overhead of a "museum of SOPs." Whether you are in early-stage R&D or preparing for a global launch, Greenlight Guru provides the tools to keep your quality and clinical data connected and audit-ready.
Feedback Call-to-Action
We want to hear from you! What are the biggest hurdles your team faces when scaling your quality system? Send your feedback, reviews, and topic suggestions to [email protected]. We read every email and pride ourselves on providing personalized responses to our listeners.