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...

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...

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,...

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...

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...

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...

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...

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...

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...

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...

This episode features host Etienne Nichols and guest Andy Rogantino, who discuss the critical timing and process for evaluating and implementing an Electronic Quality Management System (EQMS). They challenge the common "wait until something breaks" approach, emphasizing that the most effective MedTech teams integrate an EQMS early in the product lifecycle. The conversation covers the strategic and financial benefits of a well-implemented EQMS, the key stakeholders who should be involved in the evaluation process, and the core criteria for selecting the right software. Rogantino highlights the importance of a purpose-built system and shares actionable advice on turning a quality system investment into a powerful tool for collaboration, efficiency, and audit readiness.Key Timestamps03:13 When is the right time to evaluate an EQMS?04:27 How to prioritize an EQMS investment.05:15 The three pillars of a MedTech company: financial, ethical, and legal/regulatory.07:28 The dual benefits of an EQMS: reducing risk and increasing efficiency.11:59 Who should be involved in the evaluation process?17:32 What to look for when evaluating an EQMS.23:13 The importance of a user-friendly interface.26:53 Navigating the sales and demo process.28:49 Defining clear success criteria for a QMS partnership.31:45 What to avoid during the evaluation and purchasing process.36:52 The compounding risk of doing nothing.40:23 The importance of clinical data and its connection to the QMS.Quotes"When your house is already on fire, it's a little late to install some sprinklers." — Andy Rogantino."If you're asking the question, 'should we build a QMS?', you probably should." — Etienne Nichols.TakeawaysPrioritize Quality Early: Delaying an EQMS evaluation until a regulatory event or product issue occurs puts a company at a significant disadvantage. The most successful MedTech teams treat their QMS as the foundation of their business from the earliest stages of development.Include All Stakeholders: An EQMS is not just for the quality department. Involve product development, regulatory, IT, and leadership. A system that breaks down silos and promotes collaboration across the entire organization is key to long-term success.Invest for ROI: An EQMS is an investment, not an expense. It should be evaluated based on its potential to positively impact the financial bottom line by streamlining processes, reducing the risk of recalls or 483s, and accelerating time to market.Seek a Purpose-Built Solution: Avoid generic, overly-customizable QMS platforms. A system built specifically for the MedTech industry, like Greenlight Guru, provides built-in guardrails and best practices that ensure compliance with standards like ISO 13485 and 21 CFR Part 820 from day one.Evaluate for User Experience: The best software is simple and intuitive. During the evaluation process, consider how the system will feel for the people using it daily. A poor user interface can lead to low adoption and workarounds, negating the benefits of the investment.ReferencesCardiac Arrest: Five Years as a CEO on the Feds’ Hit List by Howard Root: A recommended read for MedTech leaders on the importance of robust quality systems and regulatory compliance.21 CFR Part 820, ISO 13485, ISO 14971, and ISO 9001: Key...

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls. This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.Timestamps00:04 – Introduction to common FDA compliance issues02:02 – Discussion on FDA's policy of not naming individuals05:45 – Mike Drues challenges the "pre-market" classification of common issues09:20 – Documentation requirements for different device classes11:35 – Mike’s take on the most common FDA issues (beyond the presented three)15:40 – Root causes of common compliance problems and industry responsibility20:00 – The role of regulation and FDA's responsibility in clarity27:05 – Deep dive into design change and design creep31:40 – Software changes and the "bug fix" mentality35:45 – Marketing beyond authorized intended use with a real-world example41:00 – Key takeaways and proactive compliance strategiesStandout Quotes"If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules."You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.Top TakeawaysRegulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.References & LinksEtienne Nichols' LinkedInGreenlight GuruCall to...

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

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials.Key Timestamps00:02 – Introduction to Julio Martinez-Clark and episode overview02:10 – What is GCSA and IAOCR certification?06:00 – Why certification is emerging now: volume, complexity, and patient safety09:42 – Certification structure: site vs. individual requirements13:45 – The Colombian model: First mover in Latin America17:55 – Global harmonization vs. local certification pitfalls21:30 – Measuring ROI of certified vs. non-certified sites26:15 – Future of global site certification and Latin America’s role30:00 – Regional differences: speed vs. patient pool in trial site selection36:15 – Final thoughts on FDA trends and LATAM’s emerging positionQuotes“It’s appalling that in an industry that deals with lives, there was no global standard to certify site or individual competency—until now.”– Julio Martinez-ClarkWhy it matters: This underscores the critical gap in clinical research infrastructure and the urgent need for standards like GCSA.“You can’t measure quality without a shared framework. Certification levels the playing field globally.”– Julio Martinez-ClarkWhy it matters: This highlights how global certification allows consistent benchmarking across clinical sites, benefitting sponsors and patients alike.Key TakeawaysGCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment.IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification.Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization.ReferencesJulio Martinez-Clark on LinkedInBioaccess LATAMIAOCR – International Accreditation Organization for Clinical ResearchEtienne Nichols on LinkedInMedTech 101: What

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn’t cut it. Whether you’re a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.Key Timestamps02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting10:20 – Why software and compliance tools get left out of early budgets14:12 – How missing budget detail impacts product quality and time-to-market19:04 – Red flags investors look for in MedTech startup budgets23:30 – How to improve budgeting accuracy without a CFO28:10 – Critical cost categories MedTech founders often overlook35:55 – Advice for recovering from a budgeting oversight39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)45:00 – Final advice: why networking trumps isolation for smarter budgetingStandout Quotes"Relying on the status quo is never good. There are always ways to do things better."Jon reminds founders and compliance professionals alike that innovation doesn’t stop at the product level—it also applies to budgeting, systems, and team empowerment."Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag."This quote highlights the investor’s perspective on sustainability and long-term thinking—crucial traits in any fundable founder.Key TakeawaysBroad Budget Buckets Signal InexperienceLumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools.Software and Tools Are Not Optional ExtrasFounders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake.Budgets Must Reflect Time and Scale RealisticallyFlat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution.Outsourcing ≠ All-InclusiveMany startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what’s included—and what’s not.Recovery Is Possible—If You Own ItIf your budget’s off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility.ReferencesJon Bergsteinsson on LinkedInEtienne Nichols on LinkedInGreenlight Guru – QMS and Clinical platform for MedTech companiesMedTech...

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

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

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

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research. With real-world analogies, like orchestras and dashboards, Muzio explains how leaders can create alignment, drive faster decisions, and unlock collaborative problem-solving by focusing on the future instead of the past. Whether you're part of a startup or an established MedTech firm, this episode delivers actionable strategies to help your team iterate with purpose.Key Timestamps[00:01] Introduction and sponsor message from Greenlight Guru[01:13] Meet Ed Muzio and the premise of Iterate[03:15] Why most management meetings don’t drive real action[06:40] The “Alice” video case study and how it exemplifies iterative management[11:50] Common objections and barriers to implementing iterative processes[17:00] Using forward-looking data instead of status updates[22:08] MedTech example: anticipating 510(k) review delays[29:15] Making decisions early to gain planning time[34:20] How to get started if you’re a small or early-stage company[37:40] Cultural barriers in iterative team models[41:20] Handling matrixed environments and CEO-level priorities[47:10] Why clarity of decision-makers matters in early teams[51:45] The biggest mistake mature companies make in team meetings[55:05] Final advice: focus on behavior, not buzzwordsStandout Quotes“If you walk into a meeting and it's 26 minutes in and you haven’t made a decision yet—and that’s normal—you’re probably not solving anything.”—Ed Muzio on the inefficiency of status-only meetings in traditional management culture.“We don’t need to forecast history. We need to plan around the future.”—Ed Muzio explaining why forward-looking metrics are the only actionable data in iterative teams.These quotes challenge conventional meeting norms and emphasize a proactive mindset crucial to success in fast-moving MedTech environments.Top TakeawaysBackward-looking metrics kill momentum. Most leadership teams spend meetings reviewing past progress. Instead, focus on forecasting future outcomes and addressing variances before they become problems.Accountability must be systemic, not personal. A team can only normalize issue-raising if the entire culture shifts to expect it—making it safe and standard to surface concerns early.“Succeed or fail together” breaks silos. When departments align to shared goals, cross-functional collaboration becomes natural. Incentives that isolate progress undermine execution speed.Don’t vote—decide. In small teams, designate a clear decision-maker and avoid democratic processes that lead to politicking instead of clarity.Adopt flexible systems over rigid charts. Org charts don’t reflect reality. Iterative management embraces the messiness of matrixed teams and adapts meetings and collaboration structures fluidly.Referencesa...

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail. From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts.Key Timestamps00:00 – Introduction & Greenlight Guru Sponsor Message01:26 – Live from LSI: Introducing Justin Bushko02:55 – Why Early-Stage Engineering Mistakes Derail Companies04:12 – The Critical Role of DFM and Tolerance Analysis06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices08:10 – Human Factors Oversights & Surgeon Behavior10:25 – What CEOs Should Focus On vs. Engineers12:20 – Economic Buyers, KOLs, and Commercialization Challenges14:05 – Don’t Chase the Exit: Why Founders Should Build for Longevity16:00 – Final Thoughts and TakeawaysStandout Quotes“If your partners can’t explain how and why they did your tolerance analysis, they probably didn’t do it right—and it’ll cost you nine months later.”—Justin Bushko, on the hidden dangers of relying too heavily on outsourced design partners.“Founders aiming for a quick exit send the wrong message. Build something sustainable. Acquisition should be a byproduct—not the goal.”—Justin Bushko, challenging the exit-first mindset common in early-stage MedTech.Top TakeawaysDFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight.Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse.Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don’t wait until post-market feedback.Understand Economic Buyers, Not Just KOLs: A surgeon’s support doesn’t guarantee adoption. You need champions who can advocate to hospital boards and procurement teams.Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest.ReferencesGreenlight Guru – Sponsor and end-to-end MedTech quality management platformJustin Bushko on LinkedInEtienne Nichols on LinkedInMedical Device Fireside Chats – a...