Global Medical Device Podcast powered by Greenlight Guru

In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology. They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these hurdles to bring life-changing devices to patients faster.Timestamps00:04 - Introduction to the episode and Matt Stratton02:21 - Matt Stratton’s journey into neurotechnology and passion for acceleration04:30 - Defining neurotech beyond traditional boundaries07:11 - Major challenges preventing acceleration in neurotech10:16 - The internal and external barriers to collaboration13:40 - The "generalist vs. specialist" dilemma in neurotech expertise17:03 - Optimizing existing neurotech and the future of advanced neuroscience19:34 - What neurotech can learn from other medical device verticals22:50 - The complexity of the brain: "What is normal?"24:50 - Ethical considerations of neurotech advancements26:27 - Overcoming competitive intelligence in collaborative communities29:05 - Bridging the language gap between pharma and medical devices in neurotech31:40 - Matt Stratton's call to action for the neurotech community33:10 - Political challenges and maintaining focus on shared goalsStandout Quotes"I think the neurotech space is a bit broader than that because there are so many interrelated areas that are relying and using very similar technologies and ultimately aiming for the same patient groups...and will come across the same regulatory structures." — Matt StrattonMatt's expansive view highlights the interconnectedness of neurotech, emphasizing that a holistic approach to defining the field is crucial for effective collaboration and regulatory navigation."If what ties us together is greater than the soil we stand on, then yeah, we can remain standing together." — Etienne NicholsEtienne's profound statement underscores the power of shared purpose and patient-centric goals in transcending political and competitive barriers within the medical device industry.Top TakeawaysBroadening the Neurotech Definition: Neurotech extends beyond neuromodulation and BCIs to include neurodiagnostics, neuromonitoring, neurological drug delivery, and neurosurgical devices. This broader perspective fosters greater collaboration and addresses common regulatory and patient needs.Challenges in Acceleration: Key hurdles include complex regulatory environments, the need for increased collaboration among diverse experts (neuroscientists, biologists, engineers), and adapting to emerging technologies like AI.The Power of External Collaboration: Bringing together different industry players helps establish a unified voice for regulatory changes, benchmark best practices, and break down barriers to faster progress, especially as neurotech pushes ethical and technological boundaries.Learning from Other Verticals: While neurotech faces unique challenges, insights from established fields like orthopedics and CRM, particularly regarding rapid product development (e.g., "Moore's Law" in tech), offer valuable lessons for accelerating innovation.Navigating Complexity and Ethics: The brain's inherent complexity and the fluid concept of "normalcy" introduce unique challenges for neurotech. This includes addressing profound ethical considerations, such as the potential for enhanced human capabilities to exacerbate societal inequalities.Fostering Open Dialogue: Community platforms that focus on "mundane" structural and regulatory challenges—rather than confidential IP—can successfully foster collaboration among competitors, demonstrating that shared non-competitive problems are abundant and fruitful for discussion.References & LinksMatt Stratton LinkedInEtienne Nichols LinkedInCoalitionCall to ActionGreenlight Guru is purpose-built for MedTech. See how it can transform your quality system with a personalized walkthrough — get your demo here.

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials.Key Timestamps00:02 – Introduction to Julio Martinez-Clark and episode overview02:10 – What is GCSA and IAOCR certification?06:00 – Why certification is emerging now: volume, complexity, and patient safety09:42 – Certification structure: site vs. individual requirements13:45 – The Colombian model: First mover in Latin America17:55 – Global harmonization vs. local certification pitfalls21:30 – Measuring ROI of certified vs. non-certified sites26:15 – Future of global site certification and Latin America’s role30:00 – Regional differences: speed vs. patient pool in trial site selection36:15 – Final thoughts on FDA trends and LATAM’s emerging positionQuotes“It’s appalling that in an industry that deals with lives, there was no global standard to certify site or individual competency—until now.”– Julio Martinez-ClarkWhy it matters: This underscores the critical gap in clinical research infrastructure and the urgent need for standards like GCSA.“You can’t measure quality without a shared framework. Certification levels the playing field globally.”– Julio Martinez-ClarkWhy it matters: This highlights how global certification allows consistent benchmarking across clinical sites, benefitting sponsors and patients alike.Key TakeawaysGCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment.IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification.Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization.ReferencesJulio Martinez-Clark on LinkedInBioaccess LATAMIAOCR – International Accreditation Organization for Clinical ResearchEtienne Nichols on LinkedInMedTech 101: What Is GCSA Certification?Analogy: Think of GCSA like ISO 9001, but for clinical research sites. It standardizes operational quality and ensures consistent patient safety practices across global locations.Beginner Example: If a sponsor is choosing between two hospitals, and one has a GCSA badge—it’s like choosing a restaurant with a food safety grade. It builds immediate trust.Poll Question:What’s your biggest challenge when selecting global clinical trial sites?Assessing qualityRegulatory alignmentPatient recruitment speedCostAll of the aboveEngagement Prompt:Have you worked with certified sites or accredited professionals in your clinical trials? Share your experiences or questions with us at podcast@greenlight.guru.FeedbackEnjoying the Global Medical Device Podcast? Let us know what topics you want to hear next or leave us a review on your podcast platform of choice. We love your feedback—email us at podcast@greenlight.guru for a personalized reply.Sponsor MessageThis episode is brought to you by Greenlight Guru, the only MedTech Lifecycle Excellence Platform designed to accelerate product development and ensure clinical compliance. Learn more at www.greenlight.guru.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn’t cut it. Whether you’re a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.Key Timestamps02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting10:20 – Why software and compliance tools get left out of early budgets14:12 – How missing budget detail impacts product quality and time-to-market19:04 – Red flags investors look for in MedTech startup budgets23:30 – How to improve budgeting accuracy without a CFO28:10 – Critical cost categories MedTech founders often overlook35:55 – Advice for recovering from a budgeting oversight39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)45:00 – Final advice: why networking trumps isolation for smarter budgetingStandout Quotes"Relying on the status quo is never good. There are always ways to do things better."Jon reminds founders and compliance professionals alike that innovation doesn’t stop at the product level—it also applies to budgeting, systems, and team empowerment."Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag."This quote highlights the investor’s perspective on sustainability and long-term thinking—crucial traits in any fundable founder.Key TakeawaysBroad Budget Buckets Signal InexperienceLumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools.Software and Tools Are Not Optional ExtrasFounders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake.Budgets Must Reflect Time and Scale RealisticallyFlat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution.Outsourcing ≠ All-InclusiveMany startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what’s included—and what’s not.Recovery Is Possible—If You Own ItIf your budget’s off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility.ReferencesJon Bergsteinsson on LinkedInEtienne Nichols on LinkedInGreenlight Guru – QMS and Clinical platform for MedTech companiesMedTech 101Why “One Line for Compliance” Doesn’t Cut ItThink of compliance like building a house. You wouldn’t budget for the entire construction under “tools and materials”—you’d break it out by framing, plumbing, electrical, permits, inspections, and more. In MedTech, the “compliance house” includes QMS platforms, regulatory consulting, ISO standard licenses, clinical software, and ongoing post-market surveillance costs. Each of these is a critical structural element—and each has its own cost profile.Poll Question:What budgeting category do you think is most overlooked in early-stage MedTech startups?Clinical trial costsRegulatory software/toolsConsultant scope and feesPost-market surveillanceHave you ever discovered a major budget blind spot after launching your MedTech project? Tell us what you missed and what you learned—email us at podcast@greenlight.guru. We might feature your story in a future episode.FeedbackEnjoying the podcast? We want to hear from you! Share your thoughts, leave a review, or suggest a topic you’d love to hear about next. Reach out at podcast@greenlight.guru for a personalized response from our team.SponsorsThis episode is brought to you by Greenlight Guru, the MedTech lifecycle platform trusted by medical device companies worldwide. Whether you're budgeting for your first study or scaling to new markets, Greenlight Guru Quality and Clinical helps you move faster while proving safety and effectiveness. Learn more at greenlight.guru.

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality.Key Timestamps00:02 – Introduction to Greenlight Guru and medtech process integration01:15 – QMS evolution from startup to commercialization03:00 – Phase-based product development overview (Phases 0–6)06:35 – Why QMS should follow product needs, not just regulatory triggers09:10 – Agile vs. proceduralism in quality systems11:50 – Building a quality culture during the feasibility phase15:25 – When to implement QMS controls and how to prepare for “enforcement points”18:40 – Investor-driven and regulatory QMS triggers21:10 – How early QMS planning saves time and reduces future remediation26:20 – Ashkon’s final advice for startups: start small and stay proactiveStandout Quotes"You’ve got to take the BS—being burdensome—out of QMS."Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development."Start small and do a little bit at a time—it won’t seem like a burden."A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort.Top TakeawaysUse the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next.Don’t Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech’s safety responsibilities, rather than formal procedures.Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost.ReferencesAshkon Rasooli on LinkedInGreenlight Guru – Quality management software for medical devicesEtienne Nichols on LinkedIn – Connect with the hostISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standardsISO 14155 Overview – Relevant for clinical validation proceduresMedTech 101: What Are “Enforcement Points”?In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver’s license checkpoint—you may be cruising just fine, but at that moment, you must prove you’re compliant. The earlier you prep for them, the smoother your journey.Poll Question:Where is your company on the QMS journey?A) Pre-feasibility (Phase 0)B) Early product planning (Phase 1–2)C) Preparing for launch (Phase 4–5)D) Post-market and scaling (Phase 6+)E) Not sure where we standWhat’s one thing you wish you knew earlier about building your QMS? Share your thoughts at podcast@greenlight.guru.Feedback CTAEnjoying the Global Medical Device Podcast? Help us shape future episodes—leave a review on your favorite platform or email us at podcast@greenlight.guru. We read every message and respond personally!Sponsor IntegrationThis episode is powered by Greenlight Guru, the only quality management software designed specifically for medtech. Whether you're defining your quality policy in Phase 1 or preparing for design transfer in Phase 5, Greenlight Guru helps you stay aligned, compliant, and agile.

Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval. From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-based strategies, Adam shares hard-earned insights for avoiding the "second valley of death" post-clearance. Whether you're a domestic startup or an international company entering the U.S., this episode arms you with a tactical understanding of compliance landmines and scalable go-to-market strategies.Key Timestamps00:02 – Intro: The real MedTech “valley of death” after FDA clearance04:45 – Why U.S. state-level registration is misunderstood and overlooked08:15 – State-level definitions of medical devices and why they differ11:20 – Strategic go-to-market options: Distribution vs. Direct17:00 – How regulations vary drastically by state (CA, TX, etc.)21:50 – The real risks of noncompliance: lawsuits, bad PR, and due diligence failures26:15 – Why distribution agreements can stall your growth (and how to avoid it)34:30 – Sales tax & use tax: The hidden compliance trap39:10 – Logistics, warehousing, and long-term liabilities in contracts44:55 – Overlooked pitfalls: Secretary of State filings and income tax in 36+ states51:15 – Software as a Medical Device (SaMD): U.S. compliance still applies55:30 – Selling to the U.S. government vs. private sector buyers59:20 – Veterinary devices and why they still need regulatory controls1:03:10 – What a winning go-to-market strategy actually looks like1:10:25 – Adam’s final advice to MedTech startups (foreign and domestic)Standout Quotes"You're not entering one country—you're entering 50 states and D.C. Each with its own rules, definitions, and tax laws."—Adam Steadman explains why U.S. MedTech entry requires a state-by-state strategy, especially for international companies."None of the strategics want your warehouse management system—they want your product, your sales, and your proof of market fit."—Steadman on why building non-core infrastructure slows down commercialization and valuation.Top 5 TakeawaysFDA Clearance ≠ Market Readiness – State-level registrations, sales tax laws, and pharmacy board definitions often delay or block commercialization.Distribution Isn’t Always a Shortcut – National distributors may have misaligned incentives and can lock you into exclusivity that hinders growth.Sales Tax is a Regulatory Minefield – 46 states require separate sales tax registration, exemptions tracking, and monthly filings—even if you're tax-exempt.Beware of Long-Term Contracts – Logistics and distribution contracts often lock companies into rigid terms that prevent pivots or acquisitions.Speed to Market Is Strategic – Getting to market fast is often the difference between becoming #1 or #3—and #3 often gets nothing.MedTech 101What Is “Nexus” and Why It Matters for Sales Tax?“Nexus” refers to the minimum level of economic activity that triggers tax obligations in a given state. For example, selling $100,000 of devices or 200 transactions may establish nexus, requiring you to register for sales tax. Unlike VAT in Europe, U.S. sales tax laws are state-specific, making this a major compliance hurdle for MedTech companies.References & ResourcesAdam Steadman on LinkedInEtienne Nichols on LinkedInMDD Options – Adam’s CompanyGreenlight Guru Quality PlatformPoll Question:Which part of U.S. market entry do you feel least prepared for?State-level licensingSales tax registrationDistribution strategyLogistics & warehousingAll of the aboveHave you faced unexpected delays due to state-level regulations? Share your story—we may feature it in a future episode.Feedback & ContactEnjoying the podcast or have ideas for future topics? We’d love to hear from you!Send your thoughts to podcast@greenlight.guru – we read every message and often reply personally!Sponsor MessageThis episode is brought to you by Greenlight Guru Quality – a purpose-built QMS platform that keeps you always audit-ready. Organize evidence by requirement, flag gaps, and avoid the scramble before inspections. Don’t get ready—stay ready.

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment. Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who’s responsible, and what industry and regulators can do to fix it.Key Timestamps[02:30] What is the MAUDE database, and why does it matter?[06:10] The critical difference between reportable and non-reportable adverse events[11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons[17:45] Underreporting, late submissions, and missing data: The disturbing stats[25:00] High-profile companies dominating late reporting violations[32:10] Legal consequences: What expert witnesses look for in MAUDE data[38:50] Is it poor systems or lack of regulatory understanding causing failures?[46:00] Recommendations for manufacturers: What responsible reporting looks like[53:20] How FDA could modernize the MAUDE database to better serve patients[1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance[1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill itStandout Quotes"A report in the MAUDE database is just a historical record. It doesn’t say why it happened or who’s at fault—just that it happened."— Mike DruesThis quote underscores the limited utility of MAUDE reports and why interpretation requires caution."If you're not a medical device professional without your tools, then you're not really a medical device professional."— Etienne NicholsA poignant reminder that compliance and quality are human-led, not software-enabled by default.Top TakeawaysLate Reporting is Widespread and RiskyNearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm.MAUDE Is Misused—Despite FDA WarningsManufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it.Three Companies Account for Over Half of Late ReportsLarge, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance.Electronic Tools Help, but Culture Matters MoreSoftware can support MDR timelines, but organizations still need internal processes and urgency to act responsibly.FDA and Industry Both Need to EvolveSuggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition.ReferencesFDA MAUDE Database21 CFR 803.16 – MDR Reporting RequirementsEtienne Nichols on LinkedInMedTech 101: What Is MAUDE and Why Should You Care?Think of the MAUDE database as a public logbook of adverse events involving medical devices in the U.S. Unlike peer-reviewed literature or formal recalls, MAUDE captures both mandatory and voluntary reports—from manufacturers, healthcare professionals, and even patients. However, it's not a perfect dataset. Think of it like Yelp for medical device failures: informative, but filled with inconsistencies, duplicates, and vague reviews.Poll Question:How confident are you in your organization’s ability to report adverse events to the FDA on time and accurately?Have you ever tried to use the MAUDE database for competitive analysis or submission support? Share your experience—was the data helpful, misleading, or incomplete?FeedbackHave a topic suggestion or feedback on today’s episode? We want to hear from you. Email us at podcast@greenlight.guru and get a personal response from our team.SponsorsToday’s episode is brought to you by Greenlight Guru, the only MedTech-specific QMS software that empowers companies to simplify complaint handling, streamline MDR submissions, and improve audit readiness. If you're ready to evolve beyond spreadsheets and silos, visit greenlight.guru.

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research. With real-world analogies, like orchestras and dashboards, Muzio explains how leaders can create alignment, drive faster decisions, and unlock collaborative problem-solving by focusing on the future instead of the past. Whether you're part of a startup or an established MedTech firm, this episode delivers actionable strategies to help your team iterate with purpose.Key Timestamps[00:01] Introduction and sponsor message from Greenlight Guru[01:13] Meet Ed Muzio and the premise of Iterate[03:15] Why most management meetings don’t drive real action[06:40] The “Alice” video case study and how it exemplifies iterative management[11:50] Common objections and barriers to implementing iterative processes[17:00] Using forward-looking data instead of status updates[22:08] MedTech example: anticipating 510(k) review delays[29:15] Making decisions early to gain planning time[34:20] How to get started if you’re a small or early-stage company[37:40] Cultural barriers in iterative team models[41:20] Handling matrixed environments and CEO-level priorities[47:10] Why clarity of decision-makers matters in early teams[51:45] The biggest mistake mature companies make in team meetings[55:05] Final advice: focus on behavior, not buzzwordsStandout Quotes“If you walk into a meeting and it's 26 minutes in and you haven’t made a decision yet—and that’s normal—you’re probably not solving anything.”—Ed Muzio on the inefficiency of status-only meetings in traditional management culture.“We don’t need to forecast history. We need to plan around the future.”—Ed Muzio explaining why forward-looking metrics are the only actionable data in iterative teams.These quotes challenge conventional meeting norms and emphasize a proactive mindset crucial to success in fast-moving MedTech environments.Top TakeawaysBackward-looking metrics kill momentum. Most leadership teams spend meetings reviewing past progress. Instead, focus on forecasting future outcomes and addressing variances before they become problems.Accountability must be systemic, not personal. A team can only normalize issue-raising if the entire culture shifts to expect it—making it safe and standard to surface concerns early.“Succeed or fail together” breaks silos. When departments align to shared goals, cross-functional collaboration becomes natural. Incentives that isolate progress undermine execution speed.Don’t vote—decide. In small teams, designate a clear decision-maker and avoid democratic processes that lead to politicking instead of clarity.Adopt flexible systems over rigid charts. Org charts don’t reflect reality. Iterative management embraces the messiness of matrixed teams and adapts meetings and collaboration structures fluidly.ReferencesIterate by Ed Muzio – Book on accelerating team alignment and decision-makingIterateNow.com – Access free videos and practical management tools from Ed MuzioEtienne Nichols on LinkedIn – Connect with the podcast hostMedTech 101: What Is Iterative Management?Iterative management is like adjusting your GPS route in real time—rather than simply reviewing where you’ve been, you keep making small course corrections to reach the goal faster. In a MedTech context, this means shifting focus from milestone recaps to real-time issue resolution, involving all departments in forward-looking planning. Visual tools like pragmatic dashboards (with projected vs. actual timelines) help clarify where corrections are needed.Poll Question:What’s the biggest obstacle your team faces in solving problems before they escalate?Status-focused meetingsLack of cross-functional alignmentFear of raising issuesUnclear decision-making authorityEngagement Prompt:Have you ever worked in a team where raising early concerns was encouraged—not penalized? Share your experience and tag a team leader who made it work.Feedback & Listener CTAEnjoying the podcast? We'd love to hear your feedback. Email us at podcast@greenlight.guru with your thoughts, questions, or suggestions for future guests. Every email gets a personal response!SponsorsThis episode is brought to you by Greenlight Guru—the only quality management system built specifically for MedTech. Want your design history file audit-ready and effortlessly connected across departments? Learn more at www.greenlight.guru.

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail. From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts.Key Timestamps00:00 – Introduction & Greenlight Guru Sponsor Message01:26 – Live from LSI: Introducing Justin Bushko02:55 – Why Early-Stage Engineering Mistakes Derail Companies04:12 – The Critical Role of DFM and Tolerance Analysis06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices08:10 – Human Factors Oversights & Surgeon Behavior10:25 – What CEOs Should Focus On vs. Engineers12:20 – Economic Buyers, KOLs, and Commercialization Challenges14:05 – Don’t Chase the Exit: Why Founders Should Build for Longevity16:00 – Final Thoughts and TakeawaysStandout Quotes“If your partners can’t explain how and why they did your tolerance analysis, they probably didn’t do it right—and it’ll cost you nine months later.”—Justin Bushko, on the hidden dangers of relying too heavily on outsourced design partners.“Founders aiming for a quick exit send the wrong message. Build something sustainable. Acquisition should be a byproduct—not the goal.”—Justin Bushko, challenging the exit-first mindset common in early-stage MedTech.Top TakeawaysDFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight.Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse.Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don’t wait until post-market feedback.Understand Economic Buyers, Not Just KOLs: A surgeon’s support doesn’t guarantee adoption. You need champions who can advocate to hospital boards and procurement teams.Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest.ReferencesGreenlight Guru – Sponsor and end-to-end MedTech quality management platformJustin Bushko on LinkedInEtienne Nichols on LinkedInMedical Device Fireside Chats – Justin Bushko’s Book (Amazon) (If mentioned/linked on-site)MedTech 101: What is Tolerance Stack-Up Analysis?Imagine building a puzzle where each piece is just slightly off in size—by the time you put it all together, nothing fits. That’s what tolerance stack-up is about. Every part in a device has a manufacturing variation. If those tolerances aren’t analyzed cumulatively, you can end up with a product that doesn’t assemble or fails under stress. Tolerance analysis helps predict and prevent these compounding errors before they happen.Poll Question:What’s the biggest product development risk in early-stage MedTech?Tolerance stack-up issuesIgnoring human factorsEconomic misalignment with buyersRushing to an early exitDiscussion Prompt:Have you ever seen a product fail in the field due to a design assumption? Share your story and how it changed your approach.FeedbackEnjoyed the episode? Want to hear more from product engineers, founders, or regulators? Let us know!Send your feedback, guest ideas, or questions to podcast@greenlight.guru — we read every email and respond personally.Sponsor MentionThis episode is brought to you by Greenlight Guru, the only MedTech-specific quality management platform. Whether you’re an engineer working through DFM or a CEO planning your go-to-market strategy, Greenlight Guru helps you manage compliance, risk, and innovation—all in one place.

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA’s 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/QA professionals, and software teams. He also shares why waiting until the last minute on cybersecurity could cost startups millions—or even kill a project entirely.Whether you're a quality professional trying to build compliant systems or an innovator racing toward FDA submission, this episode lays out exactly what you need to know to stay ahead of cyber threats and within regulatory guardrails.Key Timestamps:00:01 – Intro to guest Christian Espinosa and Blue Goat Cyber06:28 – Why medical device cybersecurity is different from traditional IT security11:49 – Real-world hacking example: acne laser device turned skin-burner13:57 – FDA expectations post-September 2023: what changed17:12 – Secure boot: a microcontroller mistake that derailed a launch20:35 – Common cybersecurity vendor mistake MedTech companies make23:40 – SBOM: Software Bill of Materials and why it's legally critical27:58 – Cyberattacks in hospitals: assuming a hostile network35:44 – AI in medical devices: data bias and cybersecurity challenges41:10 – Developers ≠ cybersecurity experts: the training gap nobody talks about45:20 – What RA/QA professionals need to know now49:30 – Why cybersecurity must be iterative, not a final-phase add-on55:20 – Espinosa's final advice for MedTech professionals57:52 – The story behind “Blue Goat Cyber”Standout Quotes:“Cybersecurity for medical devices isn’t about data breaches—it’s about patient harm. You could paralyze someone or misdiagnose sepsis. This isn’t theoretical.”— Christian Espinosa, on the real risks of insecure devices“Most developers don’t understand cybersecurity. We assume they do—but that’s like expecting an architect to be a locksmith.”— Christian Espinosa, on why so many devices fail security assessmentsTop Takeaways:Cybersecurity isn’t just about data—it's about patient safety. From burning skin to missed sepsis diagnoses, vulnerabilities in devices have real-world harm potential.FDA now requires more than just a basic security plan. Post-September 2023 rules mandate testing (SAST, DAST, fuzzing), SBOMs, and risk assessments tied to patient harm.Start cybersecurity planning during the requirements phase. Hardware like microcontrollers must support secure boot and other protections—retrofits can cripple product plans.Iterate cybersecurity like any core development activity. One-time testing near submission is too late; build security into your pipeline just like QA or usability.Traditional cybersecurity vendors aren’t enough. Many fail to meet FDA’s nuanced expectations for medical devices, causing costly submission rejections.References & Resources:Christian Espinosa on LinkedInBlue Goat CyberEtienne Nichols on LinkedInMedTech 101 – Understanding SBOM (Software Bill of Materials):Think of an SBOM like a nutrition label on food. Just as you want to know if a product contains allergens or preservatives, FDA wants to know what libraries and components are in your software. A clean, complete SBOM identifies both security vulnerabilities and potential licensing conflicts—like borrowing ingredients you’re not legally allowed to use. Want a visual explanation? Consider a flowchart showing third-party libraries linking into your main software repository, flagged with vulnerability scores.Poll Question:Is cybersecurity currently integrated into your product development process—A) From Day 1B) Only near submissionC) We outsource and hope for the bestD) What cybersecurity?What’s your biggest challenge when it comes to building cybersecurity into your product lifecycle? Email us your thoughts at podcast@greenlight.guru.Feedback:If this episode sparked new insights or raised questions, we’d love to hear from you. Send us your feedback or suggest a topic at podcast@greenlight.guru. We personally respond to every email and appreciate your ideas for future guests and discussions.Sponsored by Greenlight Guru:Most companies spend more time preparing for audits than in the audit itself. Greenlight Guru Quality lets you link cybersecurity and quality evidence directly to requirements, making you “always audit-ready.” Learn more at www.greenlight.guru.

In this insightful discussion, regulatory affairs expert Mike Drues shares his expertise on transitioning medical devices from prescription (Rx) to over-the-counter (OTC). He reveals what triggers new submissions and emphasizes the vital role of usability testing for lay users. Drues elaborates on the risk management challenges posed by removing healthcare providers from the process and the implications of real-world evidence for FDA approvals. Listeners gain practical insights into navigating FDA interactions and aligning regulatory strategies with business goals.