Global Medical Device Podcast powered by Greenlight Guru

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 Timestamps00:45 – 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 LindsayTakeawaysRegulatory 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...

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 Timestamps01:45 – 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-PleussTakeawaysFront-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.Key Timestamps01:45 – 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 RollinsTakeawaysLifecycle 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.Key Timestamps00:00 - 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 NicholsTakeawaysPrioritize 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...

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being factually incorrect, and explores the cascading levels of risk this poses. The discussion moves from simple credibility issues to severe safety concerns when AI-generated data is used in critical clinical decision-making without proper guardrails.The episode concludes with a forward-looking perspective on how validation is shifting. Ashkon argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is no longer sufficient. Instead, a robust quality framework must include continuous post-market surveillance and real-time independent monitoring to ensure device safety and effectiveness over time.Key Timestamps01:45 - Introduction to MD&M West and the "AI Guy for SaMD," Ashkon Rasooli.04:12 - Defining Generative AI: How it differs from traditional machine learning and image recognition.06:30 - Hallucinations: Exploring failure modes where AI creates plausible but false data.08:50 - The Autonomy Scale: Applying standard 34971 to determine the level of human supervision required.12:15 - Regulatory Gaps: Why no generative AI medical devices have been cleared by the FDA yet.15:40 - Safety by Design: Using "independent verification agents" to monitor AI outputs in real-time.19:00 - The Shift to Post-Market Validation: Why 90% validation at launch requires 10% continuous monitoring.22:15 - Comparing AI to Laboratory Developed Tests (LDTs) and the role of the expert user.Quotes"Hallucinations are just a very familiar form of failure modes... where the product creates sample data that doesn't actually align with reality." - Ashkon Rasooli"Your validation plan isn't just going to be a number of activities you do that gate release to market; it is actually going to be those plus a number of activities you do after market release." - Ashkon RasooliTakeawaysRight-Size Autonomy: Match the AI’s level of independence to the risk of the application. High-risk diagnostic tools should have lower autonomy (Level 1-2), while administrative tools can operate more freely.Implement Redundancy: Use a "two is one" approach by employing an independent AI verification agent to check the primary model’s output against safety guidelines before it reaches the user.span...

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how these experiences shaped her mission to help others lead with authenticity.The conversation centers on the concept of "SOS moments," which Dr. Hoffmann defines as those critical points of distress or crisis that occur in both personal lives and product development. By applying her CEC framework—Curiosity, Empathy, and Connection—leaders can transform these high-pressure moments into stories of strength. This approach is particularly vital in MedTech, where the ultimate goal is to serve patients during their own most vulnerable SOS moments.Etienne and Jenny also explore the intersection of human leadership and emerging technology. While AI continues to streamline technical workflows, Dr. Hoffmann argues that human empathy and curiosity remain irreplaceable assets for innovation. The episode concludes with a practical look at the return on investment (ROI) for "opening up," demonstrating how personal connection leads to higher quality products, better team retention, and the resilience needed to survive the "messy middle" of product development.Key Timestamps00:00 - Introduction of Dr. Jenny Hoffmann and her background in MedTech and innovation.01:28 - Motivation for writing Open Up: Scaling impact through vulnerable storytelling.04:23 - The shift from the "perfectly composed" leader to the vulnerable leader.05:45 - Dr. Hoffmann’s personal origin story: Being one of the first IVF babies in the U.S.08:30 - Listening to the "whisper" and the courage required to respond to inner intuition.10:14 - The ROI of Vulnerability: How personal connection drives higher quality and team motivation.14:39 - Defining SOS moments: Turning distress signals into leadership strengths.18:42 - The CEC Method: Breaking down Curiosity, Empathy, and Connection.20:25 - AI in MedTech: Why human empathy is the one thing machines cannot replace.25:57 - Strategic Sharing vs. Oversharing: How to lead by example without losing professional boundaries.28:52 - The power of storytelling for engineers and data-driven professionals.Quotes"The leader is the first one to step out on the bridge that no one’s sure if they want to cross. You paint that vision of the bridge, and then you’re the first one to step out on it." - Dr. Hoffman"If we can put empathy first and think about how we are each a patient first... then we can uncover the real needs to

In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli00:00 - Introduction to AI in MedTech05:15 - Discussing AI's deterministic vs. statistical nature12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology20:45 - Wearable health monitors and patient-driven health data28:10 - The role of AI in medical device operations and manufacturing35:00 - AI at the point of care: Enhancing patient and clinician experience42:15 - Regulatory challenges and the future of AI in healthcareKey Takeaways:1. Latest MedTech Trends:The integration of AI in diagnostics is growing, particularly in radiology, cardiology, and neurology, aiding in more accurate and quicker diagnoses.Wearable health monitors are empowering patients to take control of their health data, leading to personalized healthcare solutions.2. Practical Tips for MedTech Enthusiasts:Stay informed about the latest AI advancements and regulatory guidelines to leverage AI effectively in MedTech.Consider the ethical implications and ensure bias mitigation in AI model training and deployment.3. Predictions for the Future:Increased adoption of AI across various healthcare sectors, including surgery and patient care management.Evolution of regulatory frameworks to better accommodate and oversee AI-driven medical devices.References:Ashkon Rasooli on LinkedInashkon@engeniussolutions.comEngenius SolutionsAFDO/RAPS Working GroupEtienne Nichols on LinkedInSponsors:This episode is brought to you by Greenlight Guru, a comprehensive solution designed to streamline MedTech product development and ensure regulatory compliance. Discover how Greenlight Guru can accelerate your projects at www.greenlight.guruShare your thoughts and questions with us at podcast@greenlight.guru

In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.Key Timestamps:[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.[00:03:30] Jennifer's origin story in quality and regulatory roles.[00:07:15] The pivotal learning moments in quality management and regulatory affairs.[00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.[00:16:30] The significance of human factors in product design and learning from end-user feedback.[00:21:50] Project management skills for quality and regulatory professionals.[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.Quotes:"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-TudorMedTech Trends:An emphasis on proactive quality management to ensure patient safety and product efficacy.The rising importance of human factors and user-centered design in medical device development.The shift towards integrating software and digital solutions in medical devices.Practical Tips:Quality and regulatory professionals should hone their project management skills.Communication and storytelling are key in influencing business decisions and leadership.Always present solutions and alternatives when addressing compliance challenges.References:JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru’s platform for Quality Management & Clinical InvestigationsQuestions for the Audience:Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"Feedback:Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA’s ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity.Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions.Key Timestamps00:00 – Introduction and Michelle Wu’s background in MedTech and AI.03:45 – A founder’s perspective: Michelle’s personal experience in the OR seeing her clients' devices.08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations.11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model.15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role.18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents.22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks.27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals.31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry.Quotes"Knowledge is a commodity now. Previously, regulatory consultants or professionals stood out by their knowledge. Now, with AI leveling the field, the capability lies in those who can ask high-quality questions." - Michelle Wu, Nyquist AITakeawaysAI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%.The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value.The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees").Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output.ReferencesNyquist AI: Michelle Wu’s platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech.FDA ELSA: The...

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).Key Timestamps[0:50] QMSR: The biggest shakeup to US quality requirements since 1996.[2:00] Effective Date: February 2, 2026—the clock is ticking.[2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.[3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).[5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).[6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).[7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).[8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.[10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.[13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.[17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for talent" (many jobs, few candidates) to a market flooded with applicants, often overwhelming internal recruitment teams. This shift, exacerbated by simple application processes like LinkedIn's Easy Apply, makes it challenging for good candidates to cut through the noise and for companies to manage high application volumes.To thrive in this new environment, MedTech professionals, particularly those in Quality Assurance (QA) and Regulatory Affairs (RA), must expand their focus beyond technical competence. Elena stresses the growing importance of transverse skills (the essential human skills like communication, negotiation, and leadership) and, critically, AI literacy. With the pressure on companies to "do more with less," AI is creating an environment where smaller, highly productive teams are favored. This doesn't mean roles will disappear, but professionals must embrace technology to eliminate tedious tasks and focus on high-value, strategic work.Navigating the job market now requires a more intentional and proactive approach, especially to access the hidden job market where the best unadvertised roles reside. Tactics include direct networking with hiring managers and active professional branding. Furthermore, the global regulatory environment's fragmentation—especially between the US (FDA) and EU (MDR/IVDR)—is impacting how companies build their teams, favoring remote work and strategic location choices that factor in the local talent pool and employment laws.Key Timestamps1:50 - The MedTech Talent Shift: From "War for Talent" to a "Reset"4:45 - The impact of high volume and "easy apply" on candidate experience6:15 - Immediate disqualification criteria and "gaming" the application system7:35 - Strategies for accessing the hidden job market (networking and strategy)9:20 - The controversial impact of AI on QA/RA roles and the need for efficiency11:30 - Future-proofing your career: Why leaders and junior professionals must embrace AI13:55 - Understanding transverse skills (soft skills) and business acumen15:40 - The QA/RA role in the age of AI: Focusing on the 30% of high-value expertise17:00 - Tactics for achieving AI literacy: Small wins, experimentation, and habit stacking19:45 - Why the "hidden job market" exists (confidentiality, exclusivity, and pipeline)21:30 - Positioning yourself externally: The power of active contribution on LinkedIn23:45 - The importance of speaking at industry events (e.g., RAPS) to build credibility24:55 - Strategic advice for founders building remote, global teams26:15 - The impact of US vs. EU regulatory fragmentation on talent selectionQuotes“It's not going to be enough to just be good at your job. You're going to need to have a little bit more understanding of how to position yourself, how to brand yourself, how building skills outside of just your technical competency [is important].” - Elena Kyria“This is a massive opportunity... to step up and get started... you can use the technology but then you're focused on strategy, relationships, [and] the human side of it versus the people that are still very manual.” - Elena KyriaTakeawaysPrioritize AI Literacy: MedTech professionals must proactively experiment with AI tools (like note-takers and regulatory intelligence systems) to automate up to 70% of tedious tasks. Waiting for...

This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD). Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how traditional standards intended for physical manufacturing must be creatively interpreted for the virtual world of software development, where apps update weekly and cloud-based systems evolve in real-time. The conversation zeroes in on the often-muddy areas of production and service provision (Clause 7.5), emphasizing that these clauses are far from non-applicable, requiring a "virtual manufacturing space" mindset.A significant focus is placed on the Software of Unknown Provenance (SOUP), treating these building blocks as purchased components that require robust supplier evaluation and validation, bridging Clause 7.5 (production) with Clause 7.4 (purchasing). The discussion extends to crucial concepts like the Software Bill of Materials (SBoM), the complexity of Agile vs. Waterfall approaches within the standard's framework, and the essential role of the new FDA Computer Software Assurance (CSA) guidance in risk assessment.Beyond production, the experts explore the application of resource management (Clause 6), specifically addressing infrastructure, contamination control (malware/ransomware), and the critical need for a well-documented Design Transfer to Production (Clause 7.3.8) evidenced by a complete software release package, including all 62304 requirements. The episode provides actionable insights for quality and compliance professionals struggling to maintain speed and innovation while strictly adhering to regulatory requirements.Key Timestamps01:45 - The changing landscape: Why traditional MedTech rules struggle with modern software updates.03:50 - Historical context of ISO 13485 and its non-distinction between hardware/software.05:05 - Starting Point: Clause 7.5 (Production and Service Provision) and the "Virtual Manufacturing Space" concept.06:20 - Unpacking Software of Unknown Provenance (SOUP) and its link to Clause 7.4 (Purchasing).08:35 - The necessity of validating the development environment (GitHub/GitLab) and building blocks.11:10 - Applying Clause 4.1.6 (Software Validation) to SOUP items and master validation plans.12:20 - Applicable vs. Non-Applicable Clauses: Sterilization/Cleanliness vs. Installation.13:55 - Clause 4.2.3 (Medical Device File) for SaMD: E-labels, UDI, System Architecture, and SBoM.16:30 - Cybersecurity controls and the manufacturer's responsibility for identifying state-of-the-art standards.17:35 - Defining "Production" for continuously updating software and managing significant vs. non-significant changes.20:15 - Clash of Standards: Agile development, ISO 13485, and the missing documentation for version control risk assessment.21:30 - Clause 6.3 & 6.4 (Resource & Work Environment): Looking at data security, access controls, and contamination (malware/ransomware).24:45 - Clause 7.3.8 (Design Transfer to Production): The need for a formal software release package and the importance of the Software Design Trace Matrix.26:00 - The 16 essential documents needed to meet IEC 62304 requirements.27:10 - Production controls when the user influences the outcome (customizable features,...

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram and the episode's focus[00:05:15] Discussion on the challenges and opportunities of new regulations[00:10:40] Insights into the importance of confidence and adaptability in the regulatory field[00:15:20] Kavetha's journey and advice for emerging professionals[00:25:00] The role of innovation and collaboration in MedTech advancements[00:35:10] Strategies for professionals to stay relevant and proactiveQuotes:"Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram"Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols"Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha RamKey Takeaways:Insights into MedTech Trends:Regulatory changes are both a challenge and an opportunity for innovation.Practical Tips for MedTech Enthusiasts:Stay updated with regulatory changes and understand their implications.Engage in continuous learning and skill development.Foster collaboration across disciplines to enhance innovation.References:Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight GuruQuestions for the Audience:"What advice do you have for budding Regulatory Affairs professionals?"Reach out to us and let us know what you thought of the episode at podcast@greenlight.guruAlso, if you enjoyed this episode, please leave us a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.Key Timestamps:00:00:15 - Introduction of Perry Parendo and the episode's focus00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles00:12:20 - Agile methodologies vs. traditional project management in MedTech00:22:35 - The importance of risk management and Monte Carlo simulation in project planning00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities00:45:55 - Strategies for efficient and effective product development processesQuotes:"We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo"There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry ParendoTakeawaysInsights on MedTech Trends:The convergence of agile and traditional methodologies tailored to MedTech's unique demands.The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.A call for innovation that transcends regulatory compliance to genuinely benefit patient care.Practical Tips for Listeners:Adopt a flexible approach to project management by integrating various methodologies based on project needs.Prioritize risk management early in the development process to foresee and mitigate potential challenges.Always align product development objectives with the ultimate goal of improving patient outcomes.Questions for Future Developments:How will evolving regulatory standards shape the next generation of medical devices?What role will patient feedback play in the design and development of future MedTech innovations?Can MedTech sustain its pace of innovation while ensuring safety and compliance?References:Perry Parendo on LinkedInEtienne Nichols on LinkedInBehavioral Grooves podcast with Annie Duke - Thinking in BetsBook - Someday is Today, Ron RichardYoutube video - the Heartbeat of New Product DevelopmentQuality Culture for Product Design SuccessDesign News Columnsa...

In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.Quotes"If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria"Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria"Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena KyriaTakeawaysNetworking is Key: It's not just what you know, but who knows you and what they know you're doing.Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions.Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution.Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team.Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth.Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience.Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career.Adaptability: Be prepared to pivot and adapt to changes within the industry and your career.Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach.Reference Links:Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne Nichols' LinkedInRemember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don’t forget to leave a review on iTunes!*Interested in sponsoring an episode? Use this form and let us know!

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation’s stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.Key Timestamps[02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show’s focus on the China market.[05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.[08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."[11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.[14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.[16:20] Leveraging the Hainan Free Trade Zone (Bo’ao region) for pre-market clinical data collection and urgent needs product access.[18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).[20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.[23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).[25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.[29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.[30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China...

This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality management system (QMS) pathways.Alex and host Etienne Nichols discuss the immense value of having a diverse internal team of consultants to draw from—a collective knowledge base that helps solve complex problems for clients. They emphasize that quality professionals don't need to know "everything" but rather must have the right resources and a "beginner's mindset" to guide companies effectively. The conversation also explores how modern software, like Greenlight Guru's QMS and EDC solutions, eliminates common industry pain points, such as fragmented, error-prone spreadsheet-based design controls by building true, linked traceability directly into the eQMS.Finally, the discussion touches on the philosophical "why" of the medical device industry: the patient. Alex shares a personal story about how orthopedics improved his grandfather's quality of life, underscoring the importance of maintaining a patient-first ethos. They conclude by discussing the upcoming QMSR transition, reassuring listeners that compliance is manageable, especially for those already adhering to ISO 13485.Key Timestamps[01:50] Alex Naber's MedTech Career Path: From Bioengineering to Design Quality and Post-Market Management.[04:30] The Power of Pooled Expertise: Why Greenlight Guru's Consultant Team is a "Sherpa up the mountain."[07:35] The Problem with Spreadsheets: Comparing traditional Design Control methods to modern eQMS traceability.[11:00] Accelerating Compliance: How Greenlight Guru's QMS Templates dramatically cut implementation time.[13:30] The Bloated QMS: Why adopting procedures from large corporations may hinder small-to-midsize companies.[16:00] Design Quality Explained: Marrying R&D/Product Development with QMS compliance.[21:30] The MedTech Ethos: Focusing on the patient and improving quality of life.[27:00] CAPA Management Insights: The critical distinction between Correction and Corrective Action.[30:25] Navigating the QMSR Transition: Reassurance that compliance isn't "that deep" if you are already ISO 13485 compliant.Quotes"It's a rewarding thing to just understand that you don't need to know everything. I think that's a thing that... people should realize and they should reach out to other people that are smarter or more experienced in realms that they don't understand." - Alex Naber"I think what got me into MedTech was more of the ethos behind it... We're creating products to make patients' lives better, to impact our world, our society in a positive manner, to give a better quality of life to individuals." - Alex NaberTakeawaysSeek a Unified Quality Solution: Fragmented quality processes (e.g., design controls in spreadsheets separate from the QMS) introduce significant regulatory risk. Adopting an eQMS, like the Greenlight Guru QMS solution, creates true traceability and dramatically streamlines compliance.Design Quality as a Partner, Not Police: Design Quality Engineers should actively partner with R&D, not...

In this episode, host Etienne Nichols and guest Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, dive into a fascinating dialogue about the language used in healthcare and MedTech, particularly the terms patient, customer, and user. They explore how these words influence the perception of care, service, and the entire medical device development process. The conversation touches on the friction and inefficiencies that arise when the relationship dynamic is unclear, highlighting the different nuances between passively receiving treatment and being an active consumer of health services.The discussion delves into the historical context of the word "patient," which is rooted in the Latin patior, meaning 'to suffer.' Dr. Komiyama shares insights from industry conferences, noting that many individuals prefer to be called a "person" or an "empowered patient" rather than a passive sufferer. This ties directly into the growing movement of individuals seeking to own their health and be active participants in their care, fueled by readily available information and a focus on health span over just disease treatment.Ultimately, the key takeaway for MedTech innovators is the importance of understanding their end-user and tailoring their language—in labeling, clinical studies, and human factors testing—to align with the user's preferred terminology. The shift from "caregiver" to "care partner" is highlighted as a prime example of evolving language that acknowledges a collaborative, mutual relationship, moving away from a hierarchical structure to one of shared purpose.Key Timestamps[0:01:25] - Introduction to Dr. Allison Komiyama and Blue Stocking Health's mission to amplify the good of MedTech.[0:04:14] - Discussion begins: Patient vs. Customer vs. User in MedTech.[0:06:05] - The etymology of "patient" (patior, to suffer) and the push for "person" or "empowered patient."[0:08:22] - Historical context: Passivity of the patient role and the doctor's assumed knowledge.[0:09:50] - The impact of consumerism, AI, and the "health span" movement on patient empowerment.[0:12:35] - The value of seeking multiple opinions and the role of patient priorities in customizing care.[0:15:30] - Shifting terminology: Why "caregiver" is moving toward "care partner."[0:18:22] - How language diversity enriches the conversation and enhances communication.[0:21:00] - Tying diverse language use to MedTech innovation and product development.[0:22:15] - The importance of understanding end-user biases and assumptions in MedTech.[0:24:25] - Impactful personal stories: How specific interactions define a positive care experience.[0:29:10] - Concluding thoughts: Why plurality and qualifiers (e.g., "empowered patient") may be the ideal goal.Quotes"I think there's a lot of folks at FDA even that we're like, we don't want to use the word patient. We want to use the word person. And patient actually comes from the term patior, which means to suffer." - Dr. Allison KomiyamaTakeawaysRegulatory & Clinical Strategy: When defining the target population for your device—in 510k, IDE, or PMA submissions—be mindful of the terminology. Consider using terms like "end-user," "person living with [condition]," or "care partner" alongside "patient" to reflect a modern, inclusive understanding of...

This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration (FDA). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's perspective on which FDA functions halt and which remain active during a funding lapse. He clarifies that while the processing of new, user-fee-supported marketing applications like PMAs and 510(k)s typically stops, essential activities like active review of already-filed submissions, post-market safety surveillance, enforcement of recalls, and Investigational Device Exemption (IDE) reviews continue, drawing on existing user fee reserves.The discussion pivots to the significant slowdowns that occur, notably the suspension of non-MDUFA-goal-tied interactions, such as Q-submissions (Pre-Submissions) and most interactive reviews. For startups and small manufacturers, the halting of the crucial small business designation processing can be particularly detrimental, leading to astronomically higher user fees once the government reopens. Michael emphasizes that the industry should anticipate this political risk and plan submission timelines strategically, positioning a government shutdown as an "uncontrollable natural disaster" that requires proactive risk mitigation.Michael provides actionable advice for MedTech leaders to pivot during a shutdown. He recommends using the enforced delay to significantly improve the quality of submissions—making them easier to navigate and review once the FDA is fully operational—to gain a crucial advantage over the backlog of queued submissions. Furthermore, companies should utilize the time to focus on parallel activities such as process validation, refining quality systems, and strengthening commercial and reimbursement strategies. Michael stresses the importance of remembering the core mission: getting life-improving technologies to patients, and using any delay as an opportunity to emerge stronger and more prepared for commercial launch.Key Timestamps1:45 - The initial effects of a shutdown: What truly stops at the FDA (new submissions) versus what keeps running (existing reviews, IDEs, post-market surveillance).3:50 - Why active review of filed submissions continues—the role of the user fee "reserve."5:58 - Critical functions that stop or slow down: Pre-submissions (Q-subs), interactive reviews, new policy guidance, and routine inspections.7:25 - The major impact of halting the small business designation process on user fees for new manufacturers.8:36 - MDUFA (Medical Device User Fee Amendments) explained: How user fees fund the FDA and maintain operations during a lapse.11:51 - Direct effects on a MedTech company's runway and the loss of interactive review.13:17 - Actionable advice: Improving submission quality for easier review to mitigate the post-shutdown backlog.15:00 - Strategic pivot: Focusing on parallel work like process validation and quality system refinement.16:03 - Communicating with investors and partners: Positioning the shutdown as an uncontrollable event and shortening the commercial launch gap.18:50 - Looking ahead: Planning submissions around budget resolution deadlines to anticipate shutdown risk.20:53 - Final advice: Keeping the patient-focused mission in mind and maximizing internal...

This episode of the Global Medical Device Podcast, hosted by Etienne Nichols with guest Shannon Decker, CEO of VBC1 and an expert in healthcare transformation, dives deep into the science of how adults learn, contrasting pedagogy (child-centered learning) with andragogy (adult-centered learning). The discussion reveals why traditional training methods, like handing new hires 40 SOPs to read, are often ineffective for experienced professionals in the MedTech industry.Shannon explains the core principles of andragogy: adults are self-directed, problem-centered, and bring a vast reservoir of experience to the table (schema theory). They are less motivated by sequential, externally guided learning and more by what is relevant, timely, and what is in it for them. This self-directed approach means successful training in MedTech requires catering to intrinsic motivation and providing tactile, real-world practice rather than just videos or documentation.The conversation pivots to practical applications across the medical device lifecycle. Shannon shares compelling examples, like improving physician adoption of a medical device by shifting the focus from extrinsic financial rewards and regulatory compliance to the intrinsic motivation of improving patient health outcomes. By making users part of the development process and using performance feedback to tap into a professional's competitive spirit, organizations can achieve significantly higher engagement and successful adoption of new technologies.Key Timestamps[03:20] What is Andragogy? How adults learn differently than children.[04:45] The role of schema theory and existing experience in adult learning.[05:40] Why the traditional "drop 40 SOPs" on a new hire’s desk fails adults.[07:15] Case Study: The challenge of low medical device adoption and the missing education piece.[08:50] The power of tactile practice and addressing user confidence (e.g., misusing the device).[11:00] Contrasting Andragogy (self-directed) vs. Pedagogy (directed/sequential).[14:10] Applying adult learning to device development: solving the user's problem.[16:45] How to boost adoption: Intrinsic motivation and making users part of the process.[18:20] The key physician motivator: Desire to help people over money or administrative requirements.[21:10] Behavior science: Focusing on influential champions and mid/top performers for diffusion.[22:45] The "Gold Star" effect: Using competitive spirit and relevant KPIs for motivation.Quotes"The way we come to learning with adults is different... The best way that they learn is coming up with things that are relevant to them, things that are timely, things that they need. They want to be interested." - Shannon Decker"I don't talk about the money that they're going to make... What I talk to them about is by paying attention and doing these screening exams, you're going to have an impact on the overall health of your patient." - Shannon DeckerTakeawaysStop Relying on Documentation for Training: Adult learners need tactile input and practice. Replace or supplement large volumes of SOP reading with project team involvement, practical exercises, and hands-on use to build confidence and retention.Focus on the "What's In It For Me" (WIIFM): When designing a medical device or a training program, identify the user’s intrinsic motivations. For clinicians, this is often the desire to improve patient outcomes—lead with this message rather than revenue or regulatory burden.Build Champions, Not Just Compliance: Instead of solely focusing energy on low performers or the loudest voices, identify respected, influential leaders (champions) to pilot and advocate for new technology. Their positive experience drives the Law of Respect and encourages wider...