Global Medical Device Podcast powered by Greenlight Guru

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 the device's human context.Human Factors & Usability: Language directly impacts product use. As an R&D or Human Factors professional, align your labeling and instructions with the language that resonates most with your defined user group. Utilizing terms like "care partner" for non-professional support ensures that instructions for use are mutually supportive and not hierarchical.Marketing & Communication: MedTech companies should audit their external communications, including advertisements and white papers. A focus on "customer service" aspects (efficiency, speed, clear communication) can resonate more with the consumer/customer mindset than traditional "patient" messaging, provided it is balanced with clinical integrity.Quality Management Systems (QMS) & Design Input: Use diverse language during design input collection to capture a broader range of needs. Focus groups that employ words like "user experience" and "customer journey" often uncover different, yet equally critical, insights compared to those solely focused on "patient safety" and "treatment protocol." Greenlight Guru's QMS and EDC solutions help capture and manage these diverse inputs effectively, ensuring alignment with both clinical and user needs.Professional Dialogue: Embrace "strong opinions held loosely." MedTech leaders should cultivate internal and external dialogues that challenge existing assumptions about user terminology. A willingness to be corrected is key to identifying blind spots in product development and market strategy.ReferencesDr. Allison Komiyama's LinkedInEtienne Nichols' LinkedIn: Connect with EtienneBlue Stocking Health: A company dedicated to redefining and amplifying the conversation around medical technologies.The Media Bias Chart / Ad Fontes Media (Vanessa Otero): Mentioned in the episode as an example of thoughtful dialogue and understanding different perspectives.MedTech 101 SectionCaregiver vs. Care PartnerIn the MedTech and healthcare world, the distinction between Caregiver and Care Partner is an important example of evolving language.Caregiver: Traditionally, this term suggests a one-way, hierarchical relationship where one person provides care and the other passively receives it. It often implies a professional role or a person solely responsible for the physical needs of another.Care Partner: This term signifies a mutual, collaborative relationship. It acknowledges that the person with the health condition is an active participant in their own care and that their support person (spouse, family member, friend) is working alongside them to manage the condition. It's a key linguistic shift that promotes empowerment and shared decision-making.Analogy: Think of a dance. A Caregiver might be seen as the instructor directing every move, while a Care Partner is an equal on the dance floor, moving together with shared goals and rhythm.Feedback Call-to-ActionWe want to hear from you! Do you prefer to be called a patient, a customer, or a partner in your health journey? Your feedback drives our content and helps us bring the most relevant topics to the MedTech industry. Send your thoughts, episode reviews, and topic suggestions directly to us at podcast@greenlight.guru. We read every email and aim to offer personalized responses.SponsorsThis episode of the Global Medical Device Podcast is brought to you by Greenlight Guru. In a complex and evolving industry, managing your processes efficiently is critical. Greenlight Guru provides the industry's leading suite of solutions: a Medical Device QMS to simplify compliance and accelerate product development, and Clinical Data Solutions (EDC) to streamline and digitize your clinical trials. The ability to embrace a user-centric approach, whether you call them a patient or a customer, requires robust quality and clinical data infrastructure—precisely what Greenlight Guru delivers. Learn how their solutions can power your next-generation medical device innovation.

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 efforts.Quotes"Active review of device submissions, if you already had something in or you were smart enough, you saw the writing on the wall, you got it in on September 30, you’re good to go. Those will still keep going on schedule with and the FDA is going to try to meet their MDUFA goals..." - Michael Nilo"If yours stands out as being something that is easier to handle, makes it easier to process, they can navigate through it better, you have a better chance of getting a quicker, faster, better review process once it’s opened up."TakeawaysRegulatory Strategy & Submission Quality: Use any government shutdown delay to drastically improve the navigability and clarity of your marketing submission (PMA, 510(k)). A well-organized, hyperlinked, and clear application will likely be processed faster by reviewers facing a post-shutdown submission backlog.Financial Risk & Small Business Designation: Small medical device manufacturers should anticipate potential government shutdowns and file their small business designation application well in advance. Failure to process this designation during a lapse can result in paying the full, significantly higher user fee, which dramatically impacts startup runway.Operations & Quality Focus: While regulatory submissions are stalled, pivot R&D and Quality teams to focus on parallel work streams. This includes advancing process validation, completing outstanding quality system activities (e.g., risk management file updates), and solidifying commercialization and reimbursement strategies.IDE Reviews Continue: Companies initiating clinical trials should note that Investigational Device Exemption (IDE) submissions are generally considered essential and will still be reviewed within the MDUFA 30-day timeline. This is one of the few submission types that allows for continued progress during a shutdown.Leverage User Fee Systems: Understand that the FDA's user fee structure (MDUFA) ensures that key pre- and post-market safety functions, as well as active review of existing applications, can be maintained for a period, acting as a crucial shock absorber for the industry.ReferencesMichael Nilo's LinkedInEtienne Nichols' LinkedIn: Connect with EtienneMDUFA (Medical Device User Fee Amendments): The legislation that authorizes the FDA to collect fees from companies that submit certain marketing applications for medical devices, which funds a significant portion of the agency's device-related activities and performance goals.IDE (Investigational Device Exemption): An FDA process that allows a device that is not yet legally marketed to be used in a clinical study to collect safety and effectiveness data. IDE reviews are generally protected during a shutdown.MedTech 101 Section: User Fees and the MDUFA BufferWhen the U.S. government shuts down, it means Congress hasn't passed a budget, and non-essential federal agencies must pause most operations because their taxpayer funding stops. However, the FDA has a financial safety net for its medical device work: User Fees, authorized by the Medical Device User Fee Amendments (MDUFA).Think of MDUFA as a dedicated savings account funded by MedTech companies. When a company submits a major application like a 510(k) or PMA, they pay a fee. This money goes into a separate reserve. When a government shutdown happens, the FDA can tap into this reserve to keep essential, MDUFA-related work going. This includes the salaries of reviewers who are already working on your application, ongoing post-market surveillance, and crucial safety functions. The money acts as a buffer, allowing the FDA to continue its core mission for a limited time, which is why existing reviews aren't immediately halted. New submissions, however, often can't be processed because that intake and processing function is deemed non-essential and is not typically covered by the emergency user fee funding.Feedback Call-to-ActionWe thrive on your input! If this discussion about government shutdowns and MedTech strategy sparked any thoughts, or if you have a topic you'd like us to cover, we want to hear from you. Email us directly at podcast@greenlight.guru. We personally read every email and are committed to providing you with the most relevant and actionable MedTech insights.SponsorsThis episode is brought to you by Greenlight Guru, the only MedTech-specific platform providing end-to-end solutions. Don't let a government shutdown pause your internal quality momentum. Leverage Greenlight Guru's eQMS and EDC solutions to keep your product development, design controls, and clinical data management moving forward, ensuring your systems are inspection-ready and helping you build a submission so flawless it cuts through the FDA's post-shutdown backlog. Visit www.greenlight.guru to learn more.

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 adoption.Use Performance Data as a Motivator: Feedback and benchmarking can tap into a professional’s competitive spirit. Monitor device usage and provide timely, relevant feedback (the "Gold Star" effect) using KPIs that matter to their professional values, not just revenue goals.Make Users Part of the Process: Involve clinicians and end-users in the development cycle early on. Actively listening to their challenges and integrating their feedback ensures the final product is designed to solve their problems and fits seamlessly into their existing workflow.ReferencesDr. Shannon Decker's LinkedInEtienne Nichols' LinkedIn: Connect with EtienneSchema Theory: Discussed as the framework for how adults integrate new information with their existing base of knowledge and experience.MedTech 101 Section: Pedagogy vs. AndragogyPedagogy and Andragogy are two core concepts in education theory that explain how different groups of people learn.Pedagogy (Child Learning): This is the traditional model where the teacher is in charge. Learning is directed, sequential, and structured by an authority figure (e.g., a child must learn A before they learn B). The child relies on the teacher for direction and motivation.Andragogy (Adult Learning): This model recognizes that adults are fundamentally different learners. Adult learning is self-directed, problem-centered, and motivated by relevance. Adults must understand why they need to know something and how it immediately applies to their lives or work. They also leverage their deep existing experience base (their schema) to evaluate new information.Why it matters in MedTech: In a fast-paced field like medical devices, requiring an engineer to passively read 40 procedural documents (a pedagogical approach) is inefficient. Using an andragogical approach—by giving the engineer a project, showing them how the procedure solves a real-world problem, and having them practice the task—results in faster adoption, greater compliance, and better performance.Feedback Call-to-ActionWe want to hear from you! Do you use andragogy principles in your training? Have a question about leveraging intrinsic motivation in your team?Send your feedback, episode reviews, or topic suggestions directly to the Podcast Producer: podcast@greenlight.guru. We read every email and your input helps shape the future of the Global Medical Device Podcast.SponsorsThis episode is brought to you by Greenlight Guru, the only MedTech-specific platform with both a next-generation QMS and an integrated Electronic Data Capture (EDC) solution.In an industry where successful training and adoption rely on integrating quality with practical use, Greenlight Guru helps you eliminate disconnected, clunky systems. By integrating your quality processes (QMS) with your clinical data capture (EDC), you ensure your teams are operating on the same source of truth, making it easier for adult learners—from R&D to clinical investigators—to understand and adopt your technology. Get the purpose-built platform that helps you design and build higher quality devices faster. Learn more at greenlight.guru.

This episode tackles the often-overlooked but critical topic of medical device reimbursement. Host Etienne Nichols speaks with Haley King, co-founder and CEO of Paxos Health, about why this process is just as vital as FDA approval for a device's commercial success. They explore the journey a medical device takes, highlighting the distinction between FDA approval and securing reimbursement from payers.Haley explains the three key pillars of reimbursement: coding, coverage, and payment. She delves into the complexities of CPT codes and the significant difference between a temporary Category 3 code and the gold-standard Category 1. The discussion also covers the immense challenges medical device companies face, including the lengthy timeline—sometimes years—to secure payer coverage, which can be a make-or-break factor for startups. The conversation wraps up with a look at how artificial intelligence is beginning to streamline the cumbersome, manual process of patient access and appeals.Key Timestamps1:45 - The initial challenge of making coverage match medical need.3:30 - The three-part reimbursement pathway: coding, coverage, and payment.5:50 - Navigating CPT codes and the difference between Category 1 and Category 3.10:15 - Common challenges for medical device companies seeking payer coverage.13:20 - The multi-year timeline to achieve Medicare coverage for innovative devices.15:00 - Advice for regulatory and quality professionals on speeding up reimbursement.20:10 - How AI is currently being used in patient access and reimbursement.24:45 - Debating the accuracy of AI and its role in replacing human expertise.Quotes"A lot of times patients are not going to be able to pay out of pocket for expensive medical treatments, and a lot of times providers are not going to be able to write off those treatments on their side. So somebody needs to pay for this. And that's usually the health insurance companies..." — Haley King"I think that for this sort of a use case [AI], you're always going to want some human in the loop... AI has the potential to be super, super powerful in this space, but I think you're always going to want to have human experts involved." — Haley KingTakeawaysIntegrate reimbursement strategy early: Unlike FDA approval, which focuses on safety and efficacy, payers also demand evidence of a device's clinical and economic value. Medical device companies, particularly startups, should integrate reimbursement planning into their pitch decks and product development timelines from the outset.Recognize the two-step process: FDA approval is not a golden ticket to reimbursement. Companies must understand the subsequent and often lengthy process of securing coding, coverage, and payment from payers like CMS and private insurance companies, which can take several years.Enhance clinical trials for payers: Regulatory and quality professionals can speed up the reimbursement process by designing clinical trials that not only meet FDA requirements but also generate robust data to prove a device's clinical and economic value. This may involve including additional endpoints to justify the cost.Harness AI for efficiency, not replacement: AI is a powerful tool for automating the tedious parts of reimbursement, such as sifting through patient records and payer policies. However, it should be viewed as a way to enhance, not replace, the work of human experts who can handle complex edge cases and appeals.Be aware of coding complexities: The distinction between a temporary Category 3 CPT code and a permanent Category 1 code is a major hurdle for innovative devices. Companies must be prepared for a potential multi-year journey to prove their device’s value to the American Medical Association (AMA) and payers.ReferencesPaxos Health: Haley King’s company, which helps patients and physicians navigate insurance barriers for medical care.Current Procedural Terminology (CPT) Codes: The standardized language used by healthcare providers and payers to bill for medical services.Study on Payer Coverage: A 2023 study referenced in the episode, with authors including Josh Macaur and Dr. Erin Saxton, that found a nominal time of 5.7 years for innovative medical devices to achieve Medicare coverage.You can also connect with Global Medical Device Podcast host Etienne Nichols on LinkedIn: https://www.linkedin.com/in/etienne-nichols-824a7114/MedTech 101: The CPT Code BreakdownThink of a CPT (Current Procedural Terminology) Code as a unique ID number for a specific medical procedure or service. When a doctor performs a treatment, they use this code to communicate with an insurance company (payer) what they did so they can get paid.Category 1 Codes are like the established, official ID numbers. They're for widely accepted procedures with proven clinical value and are typically covered by insurance.Category 3 Codes are like temporary ID numbers. They are assigned to newer, innovative procedures that are still being studied. They allow doctors to track the procedure's use, but they don't guarantee that insurance will pay for it. The goal is to collect enough data over time to upgrade to a Category 1 code.Feedback Call-to-ActionYour feedback helps us create content that matters to you. Have a topic suggestion or a question about this episode? Please reach out to us at podcast@greenlight.guru. We read every email and appreciate your insights!SponsorsThis episode is brought to you by Greenlight Guru, the only medical device success platform built specifically for MedTech companies. As discussed in this episode, getting your device to market requires more than just a great product; it needs a robust quality system and a clear path to market adoption. Greenlight Guru's QMS and EDC solutions are designed to streamline your development process from concept to commercialization, helping you secure the data needed for both FDA approval and payer reimbursement. To learn more, visit www.greenlight.guru.

In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies make, like treating security as an afterthought and jumping straight into coding without a solid architectural plan.Mohamad Foustok introduces the concept of "zero trust" and the critical importance of designing for security across the entire product lifecycle, from initial concept to post-market surveillance. The discussion clarifies that cybersecurity is not limited to network-connected devices but applies to any medical device with a software function, regardless of its connectivity. They also touch on the historical context of FDA guidance, noting a significant shift in recent years that has raised the regulatory bar and put a greater emphasis on robust cybersecurity documentation.The guests provide actionable advice for MedTech professionals, stressing the value of a balanced approach that integrates security and functionality from day one. They explain that a well-thought-out process, though seemingly slower at the outset, ultimately saves time and resources by preventing costly and time-consuming redesigns later on. This episode serves as a vital guide for anyone looking to build a secure and compliant medical device in today's evolving regulatory landscape.Key Timestamps[01:50] Common pitfalls in developing SaMD, including overlooking regulatory guidance like IEC 62304.[03:20] The critical mistake of treating cybersecurity as an afterthought in product development.[05:00] Who cybersecurity applies to beyond software, including patients, manufacturers, and supply chains.[06:30] The FDA's stance on cybersecurity for any device with a software function, even if not network-connected.[08:00] A discussion on "reasonable assurance of cybersecurity" and what it means for manufacturers.[10:00] The "zero trust" principle and why you should never assume a network is secure.[14:00] How hospitals and other stakeholders are demanding more rigorous cybersecurity standards.[15:40] The ideal process for a "security-first" development lifecycle.[21:00] Why rushing development without a proper architecture can lead to significant delays and cost overruns.[23:00] A brief history of FDA's cybersecurity guidance and the major shift in 2023.Quotes"Software as a medical device ultimately is a medical device, and so you want to be developing it from the get-go with that mindset." — Jose Bohorquez"Security can't be an afterthought. You have to consider security at the inception of your approach to a product." — Mohamed FustokTakeawaysA "Security-First" Mindset is Essential: Integrate cybersecurity from the initial architectural phase of your project. This proactive approach saves significant time and money by avoiding costly redesigns and delays later in the development process or after an FDA submission.Cybersecurity is for All Software-Driven Devices: Don't assume that only cloud-connected devices need cybersecurity documentation. The FDA requires documentation for any device with a software function, including embedded systems and programmable logic, even if it's not connected to a network.Regulatory Compliance is a Process, Not a Document: The FDA is not just looking for a checklist of documents; they want to see a well-defined and consistently followed process for how you build and secure your software. This includes a "reasonable assurance of cybersecurity" that stands up to scrutiny.Hospitals are Your New Regulators: Beyond FDA compliance, be prepared for hospitals and other buyers to conduct their own rigorous cybersecurity audits. A strong cybersecurity posture is becoming a key differentiator and a prerequisite for market access.ReferencesIEC 62304: The international standard for medical device software life cycle processes. It is a foundational requirement for developing compliant medical software.FDA Guidance Documents: Specific documents from the U.S. Food and Drug Administration that provide detailed requirements for software as a medical device (SaMD) and cybersecurity.Etienne Nichols' LinkedIn: For more insights and connections in the medical device industry, connect with Etienne Nichols. [https://www.linkedin.com/in/etienne-nichols-105151241/]MedTech 101Zero Trust: A cybersecurity principle that means you should never automatically trust anything inside or outside of your network perimeter. Instead, every access request must be verified before granting access. Think of it like a strict security guard who checks everyone's ID, even if they claim to work there. In a hospital setting, this means a medical device should not assume the hospital's Wi-Fi is secure; it should treat every connection as potentially hostile and build in its own protections. This is in contrast to the old model where everything inside the network was trusted by default.Feedback Call-to-ActionWe love to hear from our listeners! Your feedback helps us create content that is most valuable to you. Please send your comments, topic suggestions, and guest recommendations to podcast@greenlight.guru. We read and respond to every email personally.SponsorsThis episode of the Global Medical Device Podcast is brought to you by Greenlight Guru. In a world where regulatory requirements for software are constantly changing, having a robust and agile Quality Management System is non-negotiable. Greenlight Guru's Medical Device QMS & EDC solutions are purpose-built to help you navigate these complexities, from initial design through post-market surveillance, ensuring your SaMD and other medical devices are secure, compliant, and ready for market. Visit their website to learn how their solutions can streamline your entire development process.

This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between applied science and new product development, where teams identify unmet clinical needs and shape a product concept. This conversation offers a clear roadmap for balancing creativity with structure, using the Design Council's Double Diamond model and Stuart’s 10 key insights for observing user behavior.Stuart Grant’s discussion on the front end of innovation highlights the importance of deeply understanding the user and the environment in which a device will be used. He introduces a number of tools and techniques, such as the Pugh Matrix and the NVivo software, to help teams transition from a broad exploration of ideas to a focused, viable product concept. Stuart explains that while the front end may seem "fuzzy," it can be a systematic process that uncovers the true clinical and market needs that will determine a product's success. He emphasizes that the most successful devices aren't just incrementally better, but are born from a deep understanding of customer insights.This episode is an essential guide for anyone involved in MedTech innovation, from academic researchers to seasoned engineers. Stuart's insights challenge the conventional reliance on key opinion leaders and provide a framework for a more holistic, user-centric approach. He outlines how to identify and interpret subtle user behaviors, from workarounds and unconventional uses to unspoken frustrations, all of which are critical for developing a truly impactful and user-friendly medical device. Whether you're at the very beginning of a project or looking to improve your current innovation process, this episode provides actionable strategies to bridge the gap between a great idea and a marketable product.Key Timestamps(2:00) Defining the "Front End": Stuart explains what the front end of innovation is and why its name has evolved from the "fuzzy front end."(8:00) The Double Diamond Model: An explanation of the UK Design Council's Double Diamond, illustrating the divergent and convergent phases of problem-solving.(12:30) Common Pitfalls: Discussing the three critical questions to answer: Is there a market (viability)? Is the technology possible (feasibility)? Do users want it (desirability)?(15:00) Balancing Creativity and Structure: The roles of different team members and how to manage the creative (divergent) and critical (convergent) phases of innovation.(21:00) 10 Ways to Find User Insights: Stuart breaks down the specific techniques and red flags to look for when observing users, including workarounds, affordances, and areas of disjuncture.(26:00) The Problem with KOLs: Why relying solely on key opinion leaders can be a mistake and the importance of observing a wider range of users.(30:00) Triggers of Use: How unconventional uses of a device can reveal new product opportunities.Standout Quotes"A craftsman will build you exactly what you ask for. An artist will build you what you didn't know you need." - Etienne Nichols"You don't just do what the customer says because that could lead to a terrible product." - Stuart GrantTakeawaysObservation is Key: Go beyond interviews. The most valuable insights come from observing users in their natural environment, such as a surgeon in the operating room. Pay attention to "workarounds" or unconventional uses, as these often reveal critical unmet needs.Balance Divergence and Convergence: Use a structured approach like the Design Council's Double Diamond to manage the innovation process. Start with a broad, creative phase to gather information and ideas (divergence), then narrow down and refine them into a concrete solution (convergence).Assemble a Diverse Team: The best innovation teams include a mix of skill sets, from engineers and designers to marketers and clinical representatives. Each function plays a critical role in controlling the process and ensuring the product is viable from multiple perspectives.Look for Disjuncture: Be on the lookout for inconsistencies between what a user says and what they actually do. This "disjuncture" can reveal hidden pain points and lead to profound insights that others might miss.Don't Over-Rely on KOLs: While key opinion leaders offer valuable expertise, their extensive experience can cause them to overlook usability issues that affect the majority of users. Include a diverse range of users in your research to ensure your product is accessible and effective for the broader market.ReferencesDesign Council Double Diamond: A visual representation of the design process, emphasizing phases of divergent and convergent thinking.Donald Norman, "The Design of Everyday Things": A foundational book on human-centered design, which discusses concepts like affordances.Pugh Matrix: A tool used to compare and evaluate multiple design concepts against a set of criteria.Etienne Nichols's LinkedIn ProfileMedTech 101: The Double DiamondImagine you have a new idea for a medical device. Where do you start? The Double Diamond model is a simple but powerful framework to guide you. Think of the first diamond as the "problem space." You start by diverging, or expanding your view, to explore every angle of a problem. This is like brainstorming—you collect a wide range of information about the user, the environment, and the clinical need without judgment. Then, you converge on a single, clear problem statement.The second diamond is the "solution space." You diverge again, this time to come up with many different ideas and concepts to solve the problem you've defined. You're thinking creatively about all the possible solutions. Finally, you converge one last time to select and refine the best solution, turning it into a concrete product concept. This process ensures you're not just solving a surface-level issue but a real, well-defined problem with a well-considered solution.Feedback Call-to-ActionWhat are your thoughts on the "front end" of innovation? Have you experienced any of the user insights Stuart discussed? We'd love to hear your stories and questions. Email us at podcast@greenlight.guru with your feedback or to suggest a topic for a future episode. We read every email and will respond to you personally.SponsorsThis episode is brought to you by Greenlight Guru, the only medical device success platform designed specifically for MedTech companies. Their MedTech Suite, including both QMS & EDC solutions, is built to address the unique challenges of medical device product development and quality management. Just as Stuart Grant highlighted the importance of a structured process to go from an idea to a marketable product, Greenlight Guru helps you manage that entire journey with purpose-built software. To learn how Greenlight Guru can help you navigate the entire product lifecycle, visit www.greenlight.guru.

In this episode, host Etienne Nichols sits down with seasoned MedTech entrepreneur Steve Bell to discuss the critical lessons for starting and scaling a medical device company. With over 30 years of global experience, Steve shares insights from his work with major corporations like Johnson & Johnson and his role in building Europe’s largest MedTech unicorn. He reveals how a conversation with his wife led him to develop an extensive course and a new MedTech AI tool to help founders navigate the complex and often unforgiving startup landscape.Steve emphasizes the importance of moving beyond a great idea to build a viable business. He outlines the foundational mistakes that sink over 75% of startups, from emotional attachment to non-viable concepts to underestimating the time and financial commitment required. He introduces his “greenhouse score” system, an objective, data-driven tool designed to help founders evaluate their business idea against global competition, urging them to "kill their ideas early" if they aren't built for success.The conversation also touches on the unique challenges facing first-time founders, including the critical decision of who should lead the company. Steve advises against a "have-a-go-hero" mentality and highlights the value of bringing in experienced leadership to avoid costly mistakes. He stresses that true success lies in being "needs-based, not product-based," focusing on solving a core problem rather than becoming overly attached to a specific solution. The episode concludes with a warning about protecting intellectual property (IP) and the costly mistake of sharing proprietary information prematurely.Key Timestamps00:02:13 The origin story of Steve's MedTech startup course.00:04:58 The #1 reason MedTech startups fail: A good idea isn't always a good business.00:08:54 The greenhouse score and MedTech AI advisor for objective business idea validation.00:11:09 Why entrepreneurship is a "wide open field" and how to find a path.00:12:00 The importance of "Location, Location, Location" for MedTech startups.00:13:58 The MedTech Survival Guide book and life lessons learned.00:17:02 Should a first-time founder be the CEO?00:18:10 How to find and compensate an experienced CEO.00:20:45 Why you must be needs-based, not product-based.00:22:47 The difference between a business and an orphan or philanthropic project.00:23:53 The risk of destroying your IP before you even get started.Quotes"Every idea is good, but not every idea is a good business... some of them are just really interesting tech that's trying to look for a home." - Steve Bell"Most likely thing for most companies is the idea you go in with is not the idea you come out with... You need to be needs-based, not product-based." - Steve BellTakeawaysValidate Your Idea Objectively: Don't rely on gut feelings. Use data-driven tools to assess your business idea's viability. If your "greenhouse score" is low, don't abandon the need—pivot the solution or fix the weaknesses.Stack the Deck in Your Favor: Simple, logical choices can significantly increase your odds of success. This includes selecting a strategic business location and prioritizing a strong team over a lone "have-a-go-hero" founder.Hire Experienced Leadership: A first-time founder should rarely be the CEO. Bringing in a seasoned professional with C-suite experience can save millions of dollars and years of development, as they bring invaluable scar tissue and a network of investors.Protect Your Intellectual Property: Be mindful of how you share information. Publishing abstracts or presenting data prematurely can destroy your ability to patent your invention. Treat your IP like a "billion-dollar map" and guard it accordingly.Focus on the "Need," Not the "Product": Your passion should be for solving a problem, not for a specific device. Your initial product idea may not be the one that succeeds, but your mission to solve the underlying clinical need should remain constant.ReferencesSteve Bell's MedTech Course: An extensive online course with over 100 videos designed to guide MedTech entrepreneurs from concept to exit.MedTech Advisor AI: An upcoming tool that uses an algorithm to provide an objective "greenhouse score" for MedTech business ideas.Greenlight Guru: Provides both a QMS and an EDC solution to help medical device companies of all sizes manage their product development and quality processes.Etienne Nichols' LinkedIn: https://www.linkedin.com/in/etienne-nichols-10705174/MedTech 101: The Entrepreneur's MindsetIn MedTech, a startup is a new company in its early stages, often focused on a single breakthrough technology. But as Steve Bell explains, a great technical idea isn't enough; you need a great business idea. This means the company must have a clear path to profitability and market sustainability.Think of it this way: a car enthusiast might build a highly advanced, custom race car in their garage (a great technical idea). But if it costs a fortune to build and can only compete in a small, niche racing circuit with no prize money, it's not a viable business. An entrepreneur, on the other hand, would look at a market need—say, a demand for affordable, electric delivery vehicles—and then design a vehicle to meet that need, ensuring there's a clear way to make a profit. The entrepreneur focuses on the market need first, not just the technology.Feedback Call-to-ActionWhat are your biggest challenges as a MedTech entrepreneur? Email us your questions or topic suggestions at podcast@greenlight.guru. We read every message and value your input! Your feedback helps us shape future episodes and provide the most relevant content for the MedTech community.SponsorsThis episode is brought to you by Greenlight Guru. Launching a MedTech startup is a marathon, not a sprint, and managing your quality and clinical data shouldn't slow you down. Greenlight Guru offers a modern, intuitive QMS & EDC solution specifically for medical device professionals. Our software helps you streamline your product development, ensuring you can focus on building a successful business without getting bogged down by compliance issues. Greenlight Guru provides the tools you need to stay on track from concept to market and beyond.

In this episode, host Etienne Nichols sits down with Josh Eckelberry, Principal at Solas BioVentures, for an illuminating conversation about venture capital in the MedTech and life sciences sectors. Josh shares his journey from a medical background to a career in venture capital, driven by a passion for creating "leveraged change" by helping innovative technologies reach a broader patient population. He explains how this approach allows for a greater impact than what's possible in one-on-one clinical care.Josh delves into the unique investment philosophy of Solas BioVentures, which is an operator-led firm that provides hands-on guidance to early-stage startups. He introduces the firm's core "dote, goat, float, and moat" framework, which evaluates a company's therapeutic efficacy, management team, economic viability, and intellectual property. The discussion provides a candid look at how venture capitalists assess risk and make investment decisions, highlighting the importance of building a strong, emotionally intelligent team and demonstrating a clear path to market.The conversation also explores practical strategies for startups to de-risk their investment proposition. Josh offers insights on how companies can use a pre-submission to get crucial feedback from the FDA, and how leveraging the right advisory board can instill confidence in potential investors. He explains the value of bringing in key opinion leaders and how a well-structured clinical trial, with thoughtfully designed inclusion and exclusion criteria, is essential for proving a technology's safety and efficacy.Key Timestamps1:02 - Josh's transition from medicine to venture capital.7:27 - The unique, operator-led investment approach of Solus Bio Ventures.12:47 - The "dote, goat, float, moat" framework for evaluating startups.15:02 - What makes a great management team ("the goat").24:43 - De-risking strategies for early-stage MedTech companies.27:55 - The importance of regulatory discussions with the FDA.30:13 - Building and compensating a strong advisory board.Quotes"I call that leveraged change. I try to change that fulcrum of not just one patient at a time like I felt like in clinical medicine, but advocating and changing the lives of hundreds of people by getting these drugs and devices to market." - Joshua EckelberryTakeawaysFocus on the team: Investors, particularly at the early stage, place significant emphasis on the management team's experience, emotional intelligence, and ability to navigate challenges. Past success and a positive, collaborative culture are key indicators of future performance.De-risk early and strategically: To attract early-stage capital, companies must proactively address key risks. This includes securing strong intellectual property, proving therapeutic efficacy, and engaging with regulatory bodies like the FDA through pre-submissions to gain confidence.Build a knowledgeable advisory board: A well-vetted board of advisors with a strong reputation and deep industry knowledge—particularly in areas like reimbursement and regulatory affairs—can be a major confidence booster for investors.Understand the "Dote, Goat, Float, Moat" framework: Companies should be prepared to address these four pillars: Dote (therapeutic efficacy), Goat (management team), Float (economics/reimbursement), and Moat (intellectual property).Embrace the conversation: Early-stage investors are often more accessible than founders might assume. Reaching out and engaging with firms like Solus Bio Ventures can lead to valuable feedback and potential opportunities.ReferencesSolas BioVentures: The investment firm where guest Josh Eckelberry serves as Principal.Etienne Nichols' LinkedIn: https://www.linkedin.com/in/etiennenichols/Greenlight Guru: A medical device quality management software (QMS) and electronic data capture (EDC) platform for a medical device company's entire product lifecycle.MedTech 101Venture Capital (VC): A form of private equity financing provided by venture capital firms or funds to startups, early-stage, and emerging companies that have been deemed to have high growth potential. VCs invest in exchange for an equity stake in the company.Pre-submission (Pre-Sub): A formal request submitted to the FDA to receive feedback on a medical device before a marketing submission (e.g., 510(k), PMA). This allows a company to de-risk its regulatory pathway by getting clarity and guidance on clinical study design, quality system requirements, and the most appropriate regulatory path.Intellectual Property (IP): Intangible creations of the mind—such as inventions, designs, and patents—that are legally protected from being copied or used by others without permission. In MedTech, this is often a company’s most valuable asset and provides a competitive advantage.Feedback Call-to-ActionWe want to hear from you! If you have a question or a topic you'd like us to cover, please reach out to us at podcast@greenlight.guru. We read every email and respond personally. Your feedback helps us create the content you want to hear.SponsorsThis episode is brought to you by Greenlight Guru, the only medical device success platform that offers both QMS & EDC solutions. Greenlight Guru helps medical device professionals get their devices to market faster and keep them on the market by providing a purpose-built software platform that streamlines the product lifecycle. From design controls to risk management and post-market surveillance, Greenlight Guru is your partner in improving the quality of life.

This episode takes an unexpected journey with Edwin Bills, a lead expert in medical device risk management and a key contributor to the development of ISO 14971. Edwin shares stories from his diverse career, beginning with his time as a submariner and electronics technician in the Navy, where he worked on early GPS technology and helped build missile subs from the ground up. This unique hands-on experience taught him the importance of knowing every component of a system.From there, Edwin transitioned into manufacturing, where he applied his skills in teaching electronics and later, quality management. He was trained by renowned quality gurus like Joseph Juran and learned about concepts like Six Sigma and Kaizen from companies like Motorola and Toyota. These experiences, which focused on process improvement, cost of quality, and efficiency, laid a critical foundation for his future work.Edwin connects these seemingly disparate experiences to his pivotal role in medical device risk management. He explains how issues in manufacturing—such as supplier quality, process capability, and yield—directly impact patient safety and a company's financial bottom line. This holistic view, blending technical expertise, quality principles, and a deep understanding of manufacturing processes, ultimately led him to the committee that developed the ISO 14971 standard.Key Timestamps01:52 - Edwin's military background as a submariner and electronics technician, and how he helped build a missile sub from scratch.04:27 - The transition from military to a career in manufacturing and quality management, including his training under Joseph Juran.10:59 - Edwin’s role in supplier quality and his lessons learned from working with a wide range of suppliers.15:48 - The impact of Kaizen projects and other modern manufacturing techniques on efficiency and quality.18:18 - An incredible story of a supplier with an ownership mindset that maintained delivery schedules after a factory fire.18:59 - Connecting manufacturing experience and quality principles to the fundamentals of risk management.20:46 - The crucial link between quality, patient safety, and a company’s financial success.25:28 - How to apply statistical and manufacturing improvement tools in the medical device industry.27:20 - The value of hands-on experience and a holistic understanding of a product's lifecycle.30:09 - How Edwin’s diverse experiences ultimately led him to a key role in developing ISO 14971.Quotes"If you want to think about cost of quality, it, you know, what is the cost to the company of this? You've got to have safe and effective medical devices." - Edwin Bills"When you get a statistician to help you improve your manufacturing processes, you want an industrial statistician... When you get to the clinical trials, that person's not the right person to have. You want a research statistician." - Edwin BillsTakeawaysManufacturing Quality is Risk Management: The principles of quality improvement, process control, and supplier management—learned in high-volume manufacturing—are directly applicable to mitigating risks in medical devices. A high-quality, reliable process inherently reduces the likelihood of product failures that could harm patients.Prioritize Quality Over Price: As Edwin's experience with the electric motor supplier shows, prioritizing the lowest cost can lead to significant issues, non-conformances, and a higher overall cost of poor quality. A supplier focused on quality and delivery will ultimately save a company money and protect its reputation.Seek Hands-On Experience: Knowing a product "down to the nuts and bolts" provides invaluable insight. This can be achieved through cross-functional training, allowing engineers and managers to understand the practical challenges of manufacturing and assembly, leading to more robust and safer designs.Right Tool, Right Time: The medical device industry can improve by adopting modern statistical and process improvement tools like Kaizen and Six Sigma. However, it's crucial to select the right kind of expert for the specific task at hand, whether it's process improvement or clinical trial design.Holistic Approach to Risk: Effective risk management goes beyond just patient safety. It must consider the full spectrum of risks, including financial and reputational damage, which are often the direct result of a failure to manage quality and safety risks effectively.ReferencesJoseph M. Juran: A 20th-century quality management pioneer. His work on the "Juran Trilogy" (quality planning, quality control, quality improvement) and the concept of the "cost of quality" were foundational to modern quality systems.Six Sigma: A set of techniques and tools for process improvement, originally developed by Motorola. It aims to reduce defects and variation to near-perfect levels.Kaizen: A Japanese term for "change for the better" or "continuous improvement." It is a business philosophy focused on improving all functions and involving all employees.ASQ (American Society for Quality): A global organization dedicated to quality management and improvement.Link to Etienne Nichols' LinkedIn: https://www.linkedin.com/in/etienne-nichols-pmp-csm-a1851b14/MedTech 101CPK (Process Capability Index): CPK is a statistical measure that tells you how well a manufacturing process is performing relative to its design specifications. A higher CPK value means the process is more reliable and consistently produces parts that meet requirements. A CPK of 1.0 means the process is just barely capable of meeting the specs, while a CPK of 2.0 (associated with Six Sigma) means it’s highly capable and produces very few defects.Kaizen: Think of Kaizen like a never-ending team effort to make small, smart improvements. Instead of waiting for a big problem to fix, everyone from the CEO to the factory floor worker looks for tiny ways to make things a little bit better, a little bit faster, or a little bit safer every single day.Feedback Call-to-ActionWe value your insights! What topics would you like us to explore next? Share your feedback, suggest future guests, or leave us a review. You can reach us directly at podcast@greenlight.guru. We read every message and look forward to hearing from you.SponsorsThis episode is brought to you by Greenlight Guru, the only medical device success platform designed specifically for MedTech companies. Their flagship QMS and EDC solutions are helping MedTech professionals get products to market faster, and with less risk. To learn more about how Greenlight Guru's solutions can streamline your quality and data processes, visit www.greenlight.guru.

In this episode, host Etienne Nichols sits down with Lesley Worthington, an executive coach with a background in psychology, law, and over 20 years in quality and regulatory affairs. They explore the critical, yet often overlooked, role of communication in building a robust culture of quality. Lesley explains that while quality professionals possess deep technical knowledge, they often struggle to be heard because they focus on being clear and correct rather than on making others feel understood. This conversation delves into why traditional training methods fall short and how a shift in mindset can lead to better relationships and greater influence.Lesley highlights that true influence and buy-in don’t come from simply explaining things well, but from actively listening and making others feel heard. The discussion touches on common pitfalls, such as using excessive jargon, over-explaining, and failing to understand the listener's perspective. Lesley emphasizes the importance of building trust and psychological safety, which allows for open communication and the ability to ask clarifying questions without fear. She shares practical strategies, like paraphrasing to confirm understanding and moving from a "broadcast" mindset to one of curious listening.The conversation concludes with a look at the limits of traditional training, which often focuses on information over action and fails to address personal habits and emotional intelligence. Lesley describes how her coaching practice provides a personalized space for professionals to think through their specific challenges and discover their own solutions. She advocates for simple, plain language and encourages a shift from fear-based interactions to curiosity-driven ones, underscoring that the core of effective communication is a human-centric approach.Key Timestamps[02:52] - The PR Problem: Lesley addresses why skilled professionals in quality and regulatory roles often struggle to be heard, linking it to their non-direct authority and a tendency to prioritize correctness over relationships.[06:34] - The Buy-in Breakthrough: The difference between being understood and making someone feel understood is explored, revealing that true buy-in hinges on empathy and listening.[09:34] - Communication Blind Spots: This segment uncovers common, subconscious behaviors that undermine communication, such as using too much jargon, over-explaining, and failing to consider the audience's knowledge.[14:17] - The Power of Admitting 'I Don't Know': Etienne and Lesley discuss how acknowledging a lack of understanding can build trust and demonstrate self-awareness, countering the fear of appearing "dumb."[16:42] - Fear vs. Curiosity: Etienne shares his perspective on curiosity as the opposite of fear and a powerful tool for overcoming communication anxieties.[18:12] - Why Training Fails: The limitations of traditional corporate training are examined, highlighting its focus on information rather than the personalized, action-oriented work required for true behavioral change.[25:39] - The Coaching Advantage: Lesley explains how coaching helps professionals solve their own problems and gain clarity by creating a dedicated space for focused thinking and reflection.Quotes"Buy-in isn't about whether people understand; it's about whether people feel understood." — Lesley Worthington"Curiosity... I think the opposite of fear is curiosity." — Etienne NicholsTakeawaysShift from Correctness to Connection: The most effective medical device professionals understand that their influence isn't solely based on being technically correct. Instead, they build strong relationships by focusing on making others feel heard, which ultimately encourages buy-in.Plain Language is a Global Asset: In an increasingly globalized industry, avoiding jargon and using plain language is crucial. This not only enhances clarity for non-specialists but also helps prevent miscommunication across different languages and cultures.Listening as a Strategic Tool: Listening isn't passive; it's an active, strategic skill. By asking clarifying questions and paraphrasing what you've heard, you can build trust and ensure mutual understanding, leading to smoother project execution and a stronger culture of quality.Identify Your Communication Blind Spots: Many professionals have communication habits—like over-explaining or using jargon to prove credibility—that unknowingly undermine their effectiveness. Recognizing and addressing these "hidden things" is the first step toward becoming a more influential leader.Action Over Information: While traditional training provides valuable information, true change comes from putting that knowledge into practice. Personalized coaching and self-reflection are powerful tools for addressing specific, real-world communication challenges that generic courses cannot.ReferencesFDA QMS Regulation (QMSR): The episode references the FDA's new Quality Management System Regulation (QMSR) and its preamble, which includes expectations for a "culture of quality."Etienne Nichols's LinkedIn: For more insights and connections within the medical device industry, you can connect with Etienne Nichols on LinkedIn: https://www.linkedin.com/in/etienne-nichols/.Lesley Worthington's LinkedIn: To learn more about executive coaching and communication, connect with Lesley Worthington on LinkedIn.MedTech 101 SectionCurse of Knowledge: This psychological bias describes the difficulty a person has in thinking about a problem from the perspective of a less-informed person. In the context of the medical device industry, a quality or regulatory professional with a deep understanding of a topic (like a CAPA or a 483) might mistakenly assume that everyone else on the team shares the same level of knowledge. This leads to the use of jargon and a lack of clear explanation, which can confuse others and hinder collaboration. The "curse" is broken by consciously stepping back and using simple, everyday language that is accessible to all.Feedback Call-to-ActionWhat are your biggest communication challenges in MedTech? Share your thoughts and topic suggestions with us. We want to hear from you! Please send your feedback, questions, or ideas directly to us at podcast@greenlight.guru. Your input helps us create the content you need most.SponsorsThis episode is brought to you by Greenlight Guru, the only medical device QMS and EDC platform designed specifically for MedTech professionals. Greenlight Guru's end-to-end solution helps you streamline your quality processes and clinical trials, ensuring compliance and accelerating your time to market. To learn more about how Greenlight Guru's Quality Management Software (QMS) and Electronic Data Capture (EDC) solutions can help your company, visit www.greenlight.guru.