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.

• [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.

• "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 Nichols

• Shift 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.

• FDA 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.

Curse 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.

What 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 [email protected]. Your input helps us create the content you need most.

This 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.

• 00:02:54 - 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.

• "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 Nichols

• Foster 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.

• ISO 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/

Quality 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.

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 [email protected]. 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.

• 00:02:39 - 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.

"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."

1. Prioritize 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.
2. 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.
3. 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.
4. 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.
5. 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.

• ISO 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/

What 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.

We 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 [email protected]. We read and respond to every email personally.

This 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.

• 01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis
• 03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example
• 06:03 - How a chemistry background informs a deeper understanding of materials
• 08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge
• 11:20 - Discussion on cumulative effects and long-term exposure to materials
• 12:56 - Applying a risk-based approach beyond standard tables
• 15:39 - The difference between extractables and leachables
• 18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance)
• 22:01 - The shift from reactive to proactive biocompatibility approaches
• 23:55 - How to explain complex biocompatibility concepts to non-technical teams

• "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 Daineko

• Go 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.

• Netflix 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.

In 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.

Have 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 [email protected]. We read and respond to every email.

This 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.

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.

• 01:37 - Importance of a Biological Evaluation Plan and in-depth data analysis
• 03:48 - The need for critical thinking in biocompatibility, highlighted by the silver ion example
• 06:03 - How a chemistry background informs a deeper understanding of materials
• 08:06 - Real-world examples of biocompatibility risks from the Netflix documentary, The Bleeding Edge
• 11:20 - Discussion on cumulative effects and long-term exposure to materials
• 12:56 - Applying a risk-based approach beyond standard tables
• 15:39 - The difference between extractables and leachables
• 18:18 - Integrating biocompatibility into the QMS (change management, CAPA, post-market surveillance)
• 22:01 - The shift from reactive to proactive biocompatibility approaches
• 23:55 - How to explain complex biocompatibility concepts to non-technical teams

• "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 Daineko

• Go 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.

• Netflix 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.

In 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.

Have 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 [email protected]. We read and respond to every email.

This 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.

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.

• 03:13 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.

• "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.

1. Prioritize 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.
2. 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.
3. 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.
4. 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.
5. 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.

• Cardiac 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 regulatory and quality standards that an effective MedTech EQMS should be built to handle.
• Etienne Nichols’ LinkedIn: linkedin.com/in/etiennenichols
• Andy Rogantino’s LinkedIn: linkedin.com/in/andyrogantino

• EQMS (Electronic Quality Management System): An electronic system for managing quality processes and documents in a regulated industry. In MedTech, this software helps companies comply with standards like ISO 13485 and FDA regulations by managing design controls, risk, document control, and other quality-related activities.

Poll Question:

• When does your company typically start thinking about a QMS?
• A. Before development even begins.
• B. During the design and prototyping phase.
• C. When we're preparing for our first regulatory submission.
• D. When we receive a regulatory finding or warning letter.

Have thoughts on today's episode or want to suggest a future topic? We want to hear from you. Email us at [email protected]. Your feedback helps us deliver the most relevant and actionable content to the MedTech community.

• Greenlight Guru: The leading purpose-built Electronic Quality Management System (EQMS) for medical device companies. Greenlight Guru's platform is designed to help MedTech innovators bring safer, more effective products to market faster, ensuring compliance and efficiency from day one. To learn more, visit www.greenlight.guru.

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.

• 00:04 – Introduction to common FDA compliance issues
• 02:02 – Discussion on FDA's policy of not naming individuals
• 05:45 – Mike Drues challenges the "pre-market" classification of common issues
• 09:20 – Documentation requirements for different device classes
• 11:35 – Mike’s take on the most common FDA issues (beyond the presented three)
• 15:40 – Root causes of common compliance problems and industry responsibility
• 20:00 – The role of regulation and FDA's responsibility in clarity
• 27:05 – Deep dive into design change and design creep
• 31:40 – Software changes and the "bug fix" mentality
• 35:45 – Marketing beyond authorized intended use with a real-world example
• 41:00 – Key takeaways and proactive compliance strategies

• "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.

• Regulatory 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.

• Etienne Nichols' LinkedIn
• Greenlight Guru

Greenlight Guru is purpose-built for MedTech. See how it can transform your quality system with a personalized walkthrough — get your demo here.

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.

• 00:04 - Introduction to the episode and Matt Stratton
• 02:21 - Matt Stratton’s journey into neurotechnology and passion for acceleration
• 04:30 - Defining neurotech beyond traditional boundaries
• 07:11 - Major challenges preventing acceleration in neurotech
• 10:16 - The internal and external barriers to collaboration
• 13:40 - The "generalist vs. specialist" dilemma in neurotech expertise
• 17:03 - Optimizing existing neurotech and the future of advanced neuroscience
• 19:34 - What neurotech can learn from other medical device verticals
• 22:50 - The complexity of the brain: "What is normal?"
• 24:50 - Ethical considerations of neurotech advancements
• 26:27 - Overcoming competitive intelligence in collaborative communities
• 29:05 - Bridging the language gap between pharma and medical devices in neurotech
• 31:40 - Matt Stratton's call to action for the neurotech community
• 33:10 - Political challenges and maintaining focus on shared goals

• "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 Stratton
• Matt'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 Nichols
• Etienne's profound statement underscores the power of shared purpose and patient-centric goals in transcending political and competitive barriers within the medical device industry.

• Broadening the Neurotech Definition: Neurotech extends beyond neuromodulation and BCIs to include neurodiagnostics, neuromonitoring, neurological drug delivery, and neurosurgical devices. This broader perspective fosters greater collaboration and addresses common regulatory and patient needs.
• Challenges in Acceleration: Key hurdles include complex regulatory environments, the need for increased collaboration among diverse experts (neuroscientists, biologists, engineers), and adapting to emerging technologies like AI.
• The Power of External Collaboration: Bringing together different industry players helps establish a unified voice for regulatory changes, benchmark best practices, and break down barriers to faster progress, especially as neurotech pushes ethical and technological boundaries.
• Learning from Other Verticals: While neurotech faces unique challenges, insights from established fields like orthopedics and CRM, particularly regarding rapid product development (e.g., "Moore's Law" in tech), offer valuable lessons for accelerating innovation.
• Navigating Complexity and Ethics: The brain's inherent complexity and the fluid concept of "normalcy" introduce unique challenges for neurotech. This includes addressing profound ethical considerations, such as the potential for enhanced human capabilities to exacerbate societal inequalities.
• Fostering Open Dialogue: Community platforms that focus on "mundane" structural and regulatory challenges—rather than confidential IP—can successfully foster collaboration among competitors, demonstrating that shared non-competitive problems are abundant and fruitful for discussion.

• Matt Stratton LinkedIn
• Etienne Nichols LinkedIn
• Coalition

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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.

00:02 – Introduction to Julio Martinez-Clark and episode overview

02:10 – What is GCSA and IAOCR certification?

06:00 – Why certification is emerging now: volume, complexity, and patient safety

09:42 – Certification structure: site vs. individual requirements

13:45 – The Colombian model: First mover in Latin America

17:55 – Global harmonization vs. local certification pitfalls

21:30 – Measuring ROI of certified vs. non-certified sites

26:15 – Future of global site certification and Latin America’s role

30:00 – Regional differences: speed vs. patient pool in trial site selection

36:15 – Final thoughts on FDA trends and LATAM’s emerging position

1. GCSA 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.
2. IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.
3. 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.
4. Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.
5. 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.

• Julio Martinez-Clark on LinkedIn
• Bioaccess LATAM
• IAOCR – International Accreditation Organization for Clinical Research
• Etienne Nichols on LinkedIn

Analogy: Think of GCSA like ISO 9001, but for clinical research sites. It standardizes operational quality and ensures consistent patient safety practices across global locations.

Beginner Example: If a sponsor is choosing between two hospitals, and one has a GCSA badge—it’s like choosing a restaurant with a food safety grade. It builds immediate trust.

Poll Question:

What’s your biggest challenge when selecting global clinical trial sites?

• Assessing quality
• Regulatory alignment
• Patient recruitment speed
• Cost
• All of the above

Engagement Prompt:

Have you worked with certified sites or accredited professionals in your clinical trials? Share your experiences or questions with us at [email protected].

Enjoying the Global Medical Device Podcast? Let us know what topics you want to hear next or leave us a review on your podcast platform of choice. We love your feedback—email us at [email protected] for a personalized reply.

This episode is brought to you by Greenlight Guru, the only MedTech Lifecycle Excellence Platform designed to accelerate product development and ensure clinical compliance. Learn more at www.greenlight.guru.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn’t cut it.

Whether you’re a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.

02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups

06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting

10:20 – Why software and compliance tools get left out of early budgets

14:12 – How missing budget detail impacts product quality and time-to-market

19:04 – Red flags investors look for in MedTech startup budgets

23:30 – How to improve budgeting accuracy without a CFO

28:10 – Critical cost categories MedTech founders often overlook

35:55 – Advice for recovering from a budgeting oversight

39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)

45:00 – Final advice: why networking trumps isolation for smarter budgeting

"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.

1. Broad Budget Buckets Signal Inexperience

Lumping 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.

1. Software and Tools Are Not Optional Extras

Founders 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.

1. Budgets Must Reflect Time and Scale Realistically

Flat 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.

1. Outsourcing ≠ All-Inclusive

Many 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.

1. Recovery Is Possible—If You Own It

If 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.

• Jon Bergsteinsson on LinkedIn
• Etienne Nichols on LinkedIn
• Greenlight Guru – QMS and Clinical platform for MedTech companies

Why “One Line for Compliance” Doesn’t Cut It

Think of compliance like building a house. You wouldn’t budget for the entire construction under “tools and materials”—you’d break it out by framing, plumbing, electrical, permits, inspections, and more. In MedTech, the “compliance house” includes QMS platforms, regulatory consulting, ISO standard licenses, clinical software, and ongoing post-market surveillance costs. Each of these is a critical structural element—and each has its own cost profile.

Poll Question:

What budgeting category do you think is most overlooked in early-stage MedTech startups?

• Clinical trial costs
• Regulatory software/tools
• Consultant scope and fees
• Post-market surveillance

Have you ever discovered a major budget blind spot after launching your MedTech project? Tell us what you missed and what you learned—email us at [email protected]. We might feature your story in a future episode.

Enjoying the podcast? We want to hear from you! Share your thoughts, leave a review, or suggest a topic you’d love to hear about next. Reach out at [email protected] for a personalized response from our team.

This episode is brought to you by Greenlight Guru, the MedTech lifecycle platform trusted by medical device companies worldwide. Whether you're budgeting for your first study or scaling to new markets, Greenlight Guru Quality and Clinical helps you move faster while proving safety and effectiveness. Learn more at greenlight.guru.