Global Medical Device Podcast powered by Greenlight Guru

In this episode, host Etienne Nichols speaks directly to professionals in industries like automotive, aerospace, and manufacturing who are looking to transition into MedTech. Drawing from his own experience moving from aerospace to medical devices, Etienne demystifies the industry’s high barriers to entry and explains why your existing skills are more valuable than you might think. The conversation centers on the "three doors" of entry: Quality, Regulatory Affairs, and Product Development. While each path has unique requirements, Etienne emphasizes that foundational skills like project management, root cause analysis, and technical writing are the true drivers of success. He also clarifies the shift in mindset required to work in a highly regulated environment where "move fast and break things" is replaced by rigorous documentation and risk-management protocols. Finally, Etienne provides a five-step roadmap for career switchers, ranging from learning the regulatory language to networking with intention. He concludes with a powerful reminder that technical competence is only the entry fee; long-term career growth in MedTech requires mastering the "layer above"—communication, visibility, and storytelling. Key Timestamps 00:0003:1506:42Door #1: Quality.10:15Door #2: Regulatory Affairs.13:50Door #3: Product Development.17:3022:10doesn't26:4532:15 Quotes Etienne NicholsEtienne NicholsTakeaways Focus on the QMS Foundations:ISO 13485ISO 14971Document Everything:Design ControlsLeverage Cross-Industry Skills:Six Sigma, Root Cause Analysis (RCA), and Process ValidationTarget Mid-Sized Companies:Master "The Layer Above": MedTech 101 Section IQ/OQ/PQ (Process Validation) Think of this like baking a signature cake for a high-stakes competition. IQ (Installation Qualification):OQ (Operational Qualification):PQ (Performance Qualification): References ISO 13485:2016:21 CFR Part 820 / QMSR:RAPS (Regulatory Affairs Professionals Society):Workplace Poker by Dan Rust:Etienne Nichols' LinkedIn:Connect with Etienne here Sponsors This episode is brought to you by Greenlight Guru. If you are transitioning into MedTech, you'll quickly realize that documentation is everything. Greenlight Guru offers the only dedicated Quality Management System (QMS) and Electronic Data Capture (EDC) solutions designed specifically for the medical device industry. Whether you are navigating your first clinical trial or scaling a quality system from scratch, Greenlight Guru helps you move faster while staying compliant. Feedback Call-to-Action We want to hear your story! Are you trying to make the jump into MedTech, or have you recently made the switch? Send your questions, topic suggestions, or feedback to podcast@greenlight.guru. Etienne reads every email and provides personalized responses to help you on your journey. We’d also love for you to leave a review on your favorite podcast platform!

In this deep-dive episode, host Etienne Nichols shifts away from the "inspiring" fluff of entrepreneurship to deliver a gritty, practical masterclass for medical device founders. Drawing from his experience judging at MedTech Innovator and speaking with hundreds of founders, Etienne highlights a sobering reality: success in this industry isn't just about having the best technology. It is about getting the right specialized experts in the room at exactly the right time to avoid the "walls" that sink most startups. The conversation centers on the critical importance of early-stage strategic planning. Etienne argues that the most important first step for any founder isn't building a prototype or filing a patent—it’s establishing a regulatory strategy. By understanding the classification and requirements of a device early on, founders can prevent the catastrophic loss of capital and time that occurs when a design doesn't match the eventual clinical or regulatory data requirements. Finally, the episode walks listeners through the transition from design to commercialization. Etienne emphasizes the "valley of death" that occurs after FDA clearance, where many companies fail because they lacked a reimbursement strategy. This episode serves as the essential recording Etienne wishes he had ten years ago, offering a comprehensive blueprint for navigating the complex MedTech ecosystem in 2026. Key Timestamps 00:01:1700:03:0200:05:3500:08:1100:09:1800:10:3300:14:2800:17:2700:19:0200:20:0700:22:3300:24:07 Quotes Etienne NicholsEtienne NicholsTakeaways Regulatory First:Document from Day One:Leverage CMO Expertise:Plan for Reimbursement Early: References ISO 13485:2016:ISO 14971:ISO 10993:IEC 60601 & 62304:Greenlight Guru:Etienne Nichols' LinkedIn:Connect with Etienne MedTech 101 Section Design Controls Think of design controls like a rigorous "paper trail" for a recipe. If you were baking a cake for a grocery store, you couldn't just throw ingredients in a bowl. You would need to prove what the ingredients were (Inputs), show that the final cake matches the recipe (Verification), and confirm that people actually enjoy eating it (Validation). In MedTech, this process ensures the device you built is exactly what you intended to build and that it actually helps the patient. 510(k) vs. De Novo vs. PMA 510(k) (Cleared):De Novo (Granted):PMA (Approved): Sponsors This episode is brought to you by Greenlight Guru. For founders navigating the design and development stage, Greenlight Guru offers a dedicated Medical Device QMS software that makes documenting design controls and risk management seamless. As you move into clinical testing, their EDC (Electronic Data Capture) solutions ensure your clinical data is high-quality and submission-ready. Align your technology with your regulatory strategy by visiting greenlight.guru. Feedback Call-to-Action We want to hear from you! Whether you have questions about the five stages or suggestions for a deep dive into reimbursement, send your thoughts to podcast@greenlight.guru. Etienne reads every email and provides personalized responses to help you on your founder journey. Did this roadmap help you? Please leave us a review on Apple Podcasts or Spotify—it helps other MedTech founders find the show!

In this episode, Etienne Nichols sits down with Staci Miller, a Human Factors and UX Strategist at GenUX, to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late in development, leading to costly submission delays or rejections when the FDA finds the documentation fails to tell a cohesive safety story. The conversation dives deep into the technical distinctions between a Use-Related Risk Analysis (URRA) and a User Failure Mode and Effects Analysis (uFMEA). Staci provides a framework for deciding which approach fits your product, emphasizing that while large conglomerates with post-market data may lean toward uFMEAs, startups and those with novel devices should prioritize the URRA to effectively map out user interactions without the crutch of existing market data. Finally, Staci addresses one of the most persistent myths in the industry: the idea that clinical trial data can replace human factors validation. She clarifies that while the two can overlap in specific, premeditated circumstances (such as complex implants like aortic valves), they serve entirely different masters—one focused on clinical efficacy and the other on the safety of the user interface across diverse environments. Key Timestamps 04:1206:4510:3013:1518:5022:1025:40 Quotes "The FDA doesn't put things out there just to have a good time... If they've made human factors a requirement and you're treating it as a 'suggestion,' you're giving yourself enough rope to hang yourself." - Staci Miller "People are obsessed with the product themselves—the design outputs. But the FDA wants to see the design inputs. They want to see the blueprints of how you built that house, not just the wallpaper." - Staci Miller Takeaways Premeditation is Key:Map User Groups Early:Environment Matters:HF is Risk Management: References ISO 14971:FDA Human Factors Guidance:Etienne Nichols:LinkedIn Profile MedTech 101: URRA vs. uFMEA Think of a uFMEA (User Failure Mode and Effects Analysis) like a car manufacturer looking at an old model to see why the brakes failed in the past—it relies on known data to fix specific parts. A URRA (Use-Related Risk Analysis) is like teaching someone to drive a brand-new type of vehicle (like a spaceship) for the first time. Since you don't have "crash data" yet, you have to carefully map out every single step the pilot takes and imagine every possible way they could push the wrong button in the heat of the moment. Sponsors Greenlight Guru: This episode is brought to you by Greenlight Guru, the only quality management platform designed specifically for the medical device industry. Whether you need to manage your QMS to stay compliant with ISO 14971 or streamline your clinical data through their EDC solutions, Greenlight Guru helps you move faster with less risk. Feedback Call-to-Action We want to hear from you! Do you have questions about your specific regulatory pathway or a topic you’d like us to cover? We provide personalized responses to every listener who reaches out. Send your thoughts, reviews, or suggestions to podcast@greenlight.guru.

In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should always launch outside the U.S. first, noting that shifting regulatory landscapes—especially in Europe—have made the U.S. a more attractive primary entry point for many. The conversation pivots to the technical and strategic nuances of "same device, different claims." Mike explains that if a device maintains the same design but utilizes different labeling or indications for use across borders, it is technically a different device in the eyes of regulators. This creates significant complexity for Quality Management Systems and post-market surveillance, particularly concerning reporting requirements for Class III (PMA) devices. Finally, the duo explores the "trap of equivalency," where companies mistakenly assume that a CE Mark or other international approval guarantees a smooth path through the FDA. From differing consensus standards to the strategic use of OUS (Outside US) clinical data, the episode provides a roadmap for global players to synchronize their regulatory and reimbursement strategies early in the development lifecycle. Key Timestamps 01:4504:1205:3007:5011:1512:4014:3016:1520:0025:20 Quotes Takeaways Sync Your Standards:Design for the "Lowest Common Denominator":Rethink Clinical Trials:Anticipate "Off-Label" Pressure: References FDA Recognized Consensus Standards DatabaseGreenlight Guru QMS & EDCEtienne Nichols’ LinkedIn MedTech 101: Label Expansion Think of Label Expansion like a smartphone software update. The hardware (the phone) stays the same, but the update allows the phone to do something it couldn't do before—like a new photography mode. In MedTech, if you have a stent approved for use in the leg (the "old label") and you want to use that same stent in the heart, you apply for a "label expansion." You aren't changing the device; you're just proving it’s safe and effective for a new job. Sponsors: Greenlight Guru This episode is brought to you by Greenlight Guru. Navigating international waters requires a robust foundation. Greenlight Guru’s Quality Management Software (QMS) helps you maintain a "single source of truth" for your design history files and labeling, while their Electronic Data Capture (EDC) solution streamlines the collection of the clinical data you'll need to satisfy both the FDA and international regulators. Whether you are managing post-market surveillance for a PMA or running a multi-center global trial, Greenlight Guru has you covered. Feedback Call-to-Action We want to hear from you! Did this episode change your mind about your international launch strategy? Do you have a "culture shock" story from bringing a device to the US? Send your thoughts, reviews, or topic suggestions to podcast@greenlight.guru. We read every email and love providing personalized responses to our listeners.

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:[07:42] Leveraging Data:[10:18] The At-Home Monitoring Shift:[13:45] The "Data Gap":[18:22] Investment Non-Negotiables:[23:10] Diligence and Deception:[27:45] SPV vs. Hedge Fund Models: Quotes Takeaways Regulatory is the Roadmap:Harmonize Your Trials:

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 00:4503:1205:3008:1511:4014:5018:2521:1025:40 Quotes Takeaways Regulatory Flexibility:Collaborative Cost-Sharing:Design for Sensitivity:Workflow Integration: References FDA HDE Program:Greenlight Guru:QMS & EDC solutions

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 01:4504:1205:3009:1513:4017:2221:0525:10 Quotes Takeaways Front-load Risk Assessments:

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 01:4503:1004:22Lifecycle Evaluation:06:5008:15Foreseeable Misuse:12:10Bioequivalence:13:4515:3018:5021:1525:40 Quotes Takeaways Lifecycle is the New Frontier:

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 00:0003:4505:1208:2010:3013:1515:4019:00 Quotes "This is a starting point. This is not a stopping point... Use your own good judgment.""The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use."Takeaways Prioritize the Big Four:Understand Pathway Nuances:Avoid Boilerplate SOPs:

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 Timestamps 01:4504:1206:3008:5012:1515:4019:0022:15 Quotes Takeaways Right-Size Autonomy:Implement Redundancy:

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 Timestamps 00:0001:2804:2305:4508:3010:1414:3918:4220:2525:5728:52 Quotes Takeaways The CEC Framework:Embrace SOS Moments:Human-Centric AI Strategy:Strategic Vulnerability:

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 Rasooli Key Takeaways: 1. Latest MedTech Trends: 2. Practical Tips for MedTech Enthusiasts: 3. Predictions for the Future: References: Ashkon Rasooli on LinkedInashkon@engeniussolutions.comEngenius SolutionsAFDO/RAPS Working GroupEtienne Nichols on LinkedIn Sponsors: 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.guru Share 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: Quotes: MedTech Trends: Practical Tips: References: JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru’s platform for Quality Management & Clinical Investigations Questions for the Audience: Feedback: podcast@greenlight.guru 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 Timestamps 00:0003:4508:1211:5015:35Micro-timestamp: 2026 Predictions.18:22The Holy Trinity of AI:22:1027:4531:15 Quotes Nyquist AITakeaways AI Literacy is a Financial Multiplier:The 80/20 Rule of Automation:The Three-Layer AI Strategy:Value-Based Billing: References Nyquist AI:FDA ELSA:

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][2:00][2:42][3:50]Myth 1 Busted:[5:10][6:30][7:40][8:40]regulatory mapping[10:30]Critical Shift 1:[13:00]Critical Shift 2:[17:00]Critical Shift 3:

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 Timestamps hidden job markettransverse skills Quotes position yourself, how to brand yourself- Elena Kyriastrategy, relationships, [and] the human side- Elena KyriaTakeaways Prioritize AI Literacy:

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 Timestamps 01:4503:5005:05Starting Point: Clause 7.5 (Production and Service Provision)06:20Software of Unknown Provenance (SOUP)08:3511:1012:2013:55Clause 4.2.3 (Medical Device File)SBoM16:3017:3520:1521:30Clause 6.3 & 6.4 (Resource & Work Environment):24:45Clause 7.3.8 (Design Transfer to Production):26:0027:10

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: Quotes: Key Takeaways: Insights into MedTech Trends: Practical Tips for MedTech Enthusiasts: References: Kavetha Ram's LinkedIn ProfileEtienne Nichols' LinkedIn ProfileGreenlight Guru Questions for the Audience: Reach out to us and let us know what you thought of the episode at podcast@greenlight.guru Also, 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: Quotes: Takeaways Insights on MedTech Trends: Practical Tips for Listeners: Questions for Future Developments: 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 Columns

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 Takeaways Reference Links: Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne Nichols' LinkedIn Remember 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!