Global Medical Device Podcast powered by 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.

In this episode, host Etienne Nichols sits down with MedTech quality expert Beth Waring to explore the often-overlooked but crucial relationship between project managers and quality professionals. They tackle the common friction points and misunderstandings that arise when these two roles intersect, and discuss why this relationship is so vital for building a successful and compliant quality management system (QMS).Beth highlights that the key to a strong partnership is open communication and mutual respect, moving away from the "quality as a police force" mentality. She emphasizes that quality is not just a department but a company-wide mindset—a concept she calls "small Q quality." The discussion provides practical insights on how project managers and quality professionals can work together effectively, ensuring that processes are flexible yet compliant.They also explore how language and tools can either help or hinder this collaboration. By reframing conversations to focus on shared goals like risk mitigation and efficiency, and by adopting user-friendly QMS solutions like Greenlight Guru's, teams can achieve better engagement and compliance. Beth shares a personal anecdote about turning a skeptic into a quality champion by simply explaining the "why" behind a procedure, underscoring the power of education and trust in fostering a culture of quality.Key Timestamps00:02:54 - Defining a culture of quality and the friction points in implementation.00:03:21 - The problem with "big Q" and "small Q" quality and why language matters.00:07:05 - The ideal relationship between a project manager and a quality professional.00:10:34 - The analogy of quality as a safety guardrail for the company.00:11:14 - Expanding the scope of risk management beyond patient harm.00:14:53 - Strategies for overcoming resistance and low adoption of new quality tools.00:17:43 - The importance of involving quality professionals early in the proof-of-concept phase.00:19:30 - Tailoring communication to different departments to enhance engagement.00:21:21 - Beth's story about converting a skeptic into a quality champion by explaining the "why."00:24:42 - The critical role of digital solutions in streamlining change orders and design controls.Quotes"Quality is doing the right thing when nobody's watching." "Quality can be a police force or they can be a partner. We want to make sure they're a partner." - Etienne NicholsTakeawaysFoster a Culture of Collaboration: Shift the mindset from quality as a policing function to a collaborative partnership. Open communication and trust between project managers and quality professionals are essential for success and compliance.Explain the "Why": Rather than dictating procedures, take the time to explain the purpose and regulatory justification behind quality processes. When people understand the "why," they are more likely to adopt and champion the system.Flexibility is Key: A rigid QMS can lead to frustration and workarounds. Build flexibility and risk-based decision-making into your processes from the start, allowing for deviations when justified without compromising safety or compliance.Involve Quality Early: Bringing quality professionals into the R&D and proof-of-concept phases ensures that early-stage documentation is robust and controlled. This streamlined approach prevents issues and rework later in the development cycle.Leverage Modern Tools: Modern Electronic Quality Management Systems (EQMS) like Greenlight Guru's QMS and EDC solutions can transform tedious manual tasks—such as managing change orders and design controls—into an efficient, traceable process, saving time and reducing errors for the entire team.ReferencesISO 13485: The international standard for quality management systems specific to medical devices.21 CFR Part 820: The FDA's Quality System Regulation for medical devices.ISO 14971: The international standard for applying risk management to medical devices.IEC 62304: The standard for the software life cycle process for medical device software.Etienne Nichols's LinkedIn: https://www.linkedin.com/in/etiennenichols/MedTech 101Quality Management System (QMS): A QMS is a structured set of processes and procedures that a medical device company uses to ensure their products meet regulatory requirements and customer expectations. Think of it as the company's "operating manual" for quality. It outlines everything from design controls and risk management to manufacturing, change orders, and post-market surveillance. While historically paper-based, modern companies are moving toward electronic QMS (EQMS) solutions for greater efficiency and traceability.We Want Your Feedback!Thank you for tuning in to the Global Medical Device Podcast. We hope this episode provided valuable insights into the crucial collaboration between project management and quality.Have a topic you'd like us to cover? Your feedback helps us create content that is relevant and useful to you. Please send your suggestions, comments, and questions to our team at podcast@greenlight.guru. We read every message and look forward to hearing from you.

In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not planning for future needs beyond a single study. She emphasizes the importance of looking for a solution that can scale with a company's growth, from pilot studies to pivotal trials, and warns against hidden costs and inadequate post-sales support.The conversation delves into what truly matters in an EDC platform, such as intuitive design, speed of implementation, and the ability to handle repeatable processes. Christine shares that while some vendors may offer "bells and whistles," the core value lies in a lean, efficient system tailored to medical device trials. They also touch on the importance of involving all stakeholders, including site users like clinicians and healthcare professionals, to ensure system adoption and maintain data integrity.Finally, the discussion explores how an EDC system can help CROs win more business. Christine explains that having a scalable, pre-validated solution and a vendor that actively supports business development can be a significant advantage. They also cover the essential compliance features for global trials, such as FDA 21 CFR Part 11 and ISO 14155, and the growing role of hybrid and decentralized trials. Christine's final advice to CROs is to "do your due diligence" and select a solution that's a true partner for long-term success.Key Timestamps00:02:39 - Biggest mistakes CROs make when choosing an EDC.00:03:00 - The importance of future planning and scalability.00:04:40 - The value of post-sales support and avoiding hidden fees.00:05:31 - Essential features versus "vendor noise" and unnecessary bells and whistles.00:08:11 - The analogy of a "battleship" vs. a "ninja" in problem-solving.00:09:13 - Identifying key stakeholders for successful EDC implementation.00:11:17 - Challenges and strategies for engaging healthcare professionals.00:13:31 - When to start looking for an EDC solution and the typical timeline.00:15:44 - The onboarding process and what successful companies do in the first few months.00:18:39 - How CROs can use an EDC solution to win more business.00:20:52 - Global compliance considerations (FDA, EU MDR) for EDC platforms.00:23:36 - Features CROs think they need but don't (e.g., QMS integration).00:26:03 - Adapting to hybrid and decentralized trials.00:27:22 - The key takeaway: do your due diligence and seek a true partner.Quotes"I would say the biggest issue is lack of due diligence... they're not necessarily thinking down the line, 'how is this going to scale with this specific company that they're working with?'""The bitterness of poor quality remains long after the sweetness of low price is forgotten."TakeawaysPrioritize Scalability and Long-Term Planning: Don't choose an EDC solution just for a single pilot study. Evaluate whether the platform can handle the complexity and size of pivotal and post-market studies to avoid costly transitions in the future.Look for True Partnership, Not Just a Vendor: A successful relationship with an EDC provider goes beyond the initial sale. Seek a vendor with strong post-sales support and a willingness to collaborate on business development initiatives to help you win more sponsor business.Ensure a User-Friendly Design for All Stakeholders: An EDC system is only as good as the data entered into it. Selecting an intuitive, easy-to-use platform is crucial for ensuring adoption by clinical operations teams, data managers, and, most importantly, site users like clinicians and healthcare professionals.Confirm Global Compliance and Validation Capabilities: For CROs supporting a variety of trials, it is essential to select an EDC platform that is pre-validated and compliant with global regulations like FDA 21 CFR Part 11 and ISO 14155 for EU MDR.Focus on Core Functionalities Over "Bells and Whistles": Many platforms offer features that look good but are rarely used. A lean, purpose-built solution with essential functionalities like remote data entry, ePRO (electronic Patient Reported Outcomes), and efficient reporting is often more valuable than a system overloaded with unnecessary features.ReferencesISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. This standard is referenced as a key compliance framework for medical device clinical trials, particularly in the European Union.FDA 21 CFR Part 11 - The part of the Code of Federal Regulations that sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.Etienne Nichols's LinkedIn - https://www.linkedin.com/in/etiennenichols/MedTech 101What is a Clinical Research Organization (CRO)?A Clinical Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. Think of a CRO as a specialist that a medical device company hires to manage a clinical trial. They handle everything from designing the study and recruiting participants to collecting and analyzing data, allowing the device company to focus on its core business.What is an Electronic Data Capture (EDC) system?An Electronic Data Capture (EDC) system is a software platform used in clinical trials to collect, manage, and report patient data. Instead of using paper forms, researchers enter data directly into a secure electronic database. This makes the data easier to share, reduces errors, and speeds up the entire clinical trial process. It’s like moving from a paper filing system to a digital spreadsheet, but with built-in security and compliance features specifically for clinical research.Feedback Call-to-ActionWe want to hear from you! What topics would you like us to cover on future episodes of the Global Medical Device Podcast? Your feedback helps us create content that is most valuable to you. Send your suggestions, feedback, and questions to podcast@greenlight.guru. We read and respond to every email personally.SponsorsThis episode is brought to you by Greenlight Guru, the only MedTech-specific QMS & EDC solution. Greenlight Guru helps medical device companies and CROs streamline their entire product lifecycle and clinical trial processes. By providing a modern, purpose-built platform for both Quality Management Systems (QMS) and Electronic Data Capture (EDC), Greenlight Guru ensures you have the tools to manage your clinical data and maintain compliance from a single source of truth. To learn how Greenlight Guru can accelerate your journey, visit www.greenlight.guru.

This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and delve into the nuances of raw data analysis, material composition, and manufacturing processes to uncover potential risks.Marina emphasizes that biocompatibility is not an isolated task but must be fully integrated into a company's quality management system (QMS). She explores the connection between biological safety and key QMS processes such as change management, post-market surveillance, and CAPA. The conversation also touches on the shift from a reactive to a proactive mindset in the industry, driven by new regulations like the latest revision of ISO 10993-1.Using real-world examples, Marina illustrates the importance of considering long-term patient exposure and cumulative effects. She provides clear explanations of complex concepts like the difference between extractables and leachables. Her advice to MedTech professionals is to always be curious, ask questions, and prioritize communication across all teams to ensure the safety and efficacy of medical devices.Key Timestamps01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example06:03 - How a chemistry background informs a deeper understanding of materials08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge11:20 - Discussion on cumulative effects and long-term exposure to materials12:56 - Applying a risk-based approach beyond standard tables15:39 - The difference between extractables and leachables18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance)22:01 - The shift from reactive to proactive biocompatibility approaches23:55 - How to explain complex biocompatibility concepts to non-technical teamsQuotes"Biocompatibility is not a bubble. It must be integrated into the quality management system." - Marina Daineko"Don’t be shy and ask the questions. Stay curious... and communicate." - Marina DainekoTakeawaysGo Beyond the Checklist: A biological evaluation plan and critical thinking are essential. Don't rely solely on standard pass/fail tests; analyze raw data and question unexpected results, as seen in the silver ion example.Assess Cumulative Risk: For long-term or implanted devices, consider the cumulative effect of chemicals that may leach from the device over time. Proactive risk management should account for this long-term exposure.Integrate Biocompatibility into the QMS: Biocompatibility should not be treated as a standalone task. It must be integrated with core QMS processes like change management, CAPA, and post-market surveillance to ensure continuous device safety throughout its lifecycle.Communicate Across Teams: Effective communication is paramount. Technical biocompatibility information must be translated for different teams—from regulatory and quality to marketing and sales—by highlighting the impact on deadlines, compliance, and patient safety.ReferencesNetflix Documentary, The Bleeding Edge: A documentary that exposes systemic flaws and risks within the medical device industry, featuring the case of the Essure device.ISO 10993-1: The international standard for the biological evaluation of medical devices, which is undergoing revisions to emphasize a lifecycle-based approach to safety.Etienne Nichols' LinkedIn: For more insights on MedTech and quality management, connect with Etienne at https://www.linkedin.com/in/etienne-nichols.MedTech 101: Extractables & LeachablesIn simple terms, extractables are all the potential chemicals that could leak out of a medical device under harsh lab conditions, like high temperatures or strong solvents. Think of it as a comprehensive stress test to find every single chemical component.Leachables, on the other hand, are the chemicals that actually leak out under normal, clinically relevant conditions. This is what a patient's body might be exposed to during the device's actual use.Regulatory bodies like the FDA often require both types of analysis to ensure a comprehensive understanding of a device's chemical profile.Feedback Call-to-ActionHave thoughts on today's episode or a topic you'd like us to cover? Your feedback is invaluable. Email your comments and suggestions directly to us at podcast@greenlight.guru. We read and respond to every email.SponsorsThis episode is brought to you by Greenlight Guru, the only medical device success platform designed specifically for MedTech companies. Their all-in-one platform includes both a QMS and a Clinical Data Management System (EDC), providing a single source of truth for all your product development and clinical data. By streamlining your processes, Greenlight Guru helps you get safer, higher-quality medical devices to market faster and with less risk.Greenlight Guru's platform aligns perfectly with today's discussion on integrating biocompatibility into the QMS. By providing a centralized, risk-based system, it helps teams proactively manage design controls and post-market surveillance, ensuring biological safety is considered throughout the entire device lifecycle. To learn more, visit www.greenlight.guru.