It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
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Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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Matt Deseno is the founder of multiple award winning marketing businesses ranging from a attraction marketing to AI appointment setting to customer user experience. When he’s not working on the businesses he teaches marketing at Pepperdine University and he also teaches other marketing agency owners how they created a software company to triple the profitability for the agency. Our Sponsors: * Check out Kinsta: https://kinsta.com * Check out Mint Mobile: https://mintmobile.com/tmf * Check out Moorings: https://moorings.com * Check out Trust & Will: https://trustandwill.com/TRAVIS * Check out Warby Parker: https://warbyparker.com/travis Advertising Inquiries: https://redcircle.com/brands Privacy & Opt-Out: https://redcircle.com/privacy…
Global Medical Device Podcast powered by Greenlight Guru
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Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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1 Mastering Device Descriptions: The Cornerstone of Medical Device Submissions 50:33
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In this episode of the Global Medical Device Podcast , Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators. Key Timestamps [00:01] Introduction: Why device descriptions are foundational for regulatory submissions. [07:15] Common challenges: Why device descriptions are often poorly written. [14:30] Purpose and impact: How descriptions influence classification, testing, and approval pathways. [25:45] Practical advice: Balancing simplicity with technical detail for diverse audiences. [36:10] Pre-sub meetings: Communicating device descriptions effectively with the FDA. [50:30] Final recommendations: Testing the efficacy of your device description. Memorable Quotes Mike Drues: "If the FDA doesn’t understand your device, it’s not their fault—it’s the manufacturer’s responsibility to communicate effectively." Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection." Mike Drues: "A picture’s worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly." Key Takeaways MedTech Trends Clear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices. Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification. Visual aids, like images and videos, are becoming standard tools to enhance submissions. Practical Tips Test your description’s efficacy by asking someone unfamiliar with the device to explain it back to you. Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists. Incorporate visuals or videos to clarify complex mechanisms or testing processes. Future Questions How might advancements in AI reshape the expectations for device descriptions? Could the FDA eventually require interactive or multimedia submissions as standard? What new tools or technologies can help manufacturers streamline the description-writing process? References & Resources Greenlight Guru: Purpose-built quality management systems for MedTech. Learn more . Stephen Covey: Seven Habits of Highly Effective People —inspiration for improving communication practices. Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now . MedTech 101: Device Descriptions What is a device description? A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes: Anatomy: Components and materials. Physiology: Function and mechanism of action (MOA). Pathology: Risks or potential failures. Why it matters: Guides regulatory classification and testing requirements. Establishes a clear understanding for reviewers, ensuring smooth approval processes. Audience Poll & Call to Action Poll Question: What challenges have you faced in creating a device description? Ambiguity in regulatory expectations Balancing technical detail with simplicity Miscommunication with reviewers Other (email us at podcast@greenlight.guru ) Feedback & Sponsors We value your feedback! Leave a review on iTunes to help others discover the podcast. Send suggestions for future episodes to podcast@greenlight.guru . Sponsor: This episode is brought to you by Greenlight Guru , the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.…
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1 #395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond 42:04
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future. Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices. Key Timestamps [02:30] – Introducing Leo Eisner and his expertise in IEC 60601 and global standards. [06:45] – The complexities of updating IEC 60601 and its 12 working groups. [12:20] – Expected timeline for the fourth edition (2029-2030) and why companies need to plan now. [18:50] – Overview of the most significant upcoming changes, including wireless coexistence and integration of collateral standards. [27:00] – Practical advice for navigating new standards during product development. [36:15] – How to engage in the standards development process and submit comments. [48:30] – Benefits of proactive planning and test preparation for regulatory success. [53:45] – The importance of staying informed and embracing continuous learning in MedTech. Top Quotes from the Episode "The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner "IEC 60601 is often thought of as just an electrical standard, but it’s so much more—it’s about mitigating risks across all aspects of a device." – Leo Eisner "Standards aren’t just rules; they’re lessons learned from history, guiding us to safer, better devices." – Etienne Nichols Key Takeaways Latest Trends in MedTech Standards The modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations. Wireless coexistence and other cutting-edge technologies will soon become international requirements. Consolidating collateral standards improves consistency and reduces redundancies. Practical Tips for Compliance Begin designing for new standards early, even before they are finalized. Stay informed by engaging with industry groups and standards organizations. Use test planning to streamline development and meet regulatory expectations efficiently. Questions to Ponder for the Future How will integrating advanced hazard mitigation strategies impact device innovation? What role will emerging technologies like AI and IoT play in future standards revisions? How can smaller MedTech companies effectively adapt to these significant changes? MedTech 101: Understanding IEC 60601 For new listeners, IEC 60601 is a global standard that ensures the safety and effectiveness of medical electrical equipment. It encompasses requirements for design, labeling, testing, and risk management. With updates spanning usability, wireless technologies, and biocompatibility, it’s essential for any MedTech company working with electrical devices. References and Resources Greenlight Guru – The QMS software designed exclusively for MedTech: Learn more Connect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601: Visit Eisner Safety Consultants Etienne Nichols’ LinkedIn – Connect here Submit comments to standards – Contact your national committee or regulatory body for IEC SC62A involvement. Audience Poll: What aspect of the IEC 60601 update concerns you most—testing, design changes, or regulatory approval? Share your thoughts by emailing us at podcast@greenlight.guru . Sponsor Segment This episode is brought to you by Greenlight Guru , the leading QMS software for the MedTech industry. Simplify compliance and accelerate innovation with tools tailored to your needs. Visit www.greenlight.guru to schedule a demo today and start your journey toward easier compliance! Feedback and Reviews Love the podcast? Leave us a review on iTunes! It helps others find us and improves our content. For feedback or topic suggestions, email us at podcast@greenlight.guru . Stay ahead of MedTech changes by tuning in to the Global Medical Device Podcast. See you next time!…
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1 #394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues 51:18
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities. Key Timestamps: 00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message 03:15 – Introduction to Dr. Mike Drues and his background in PMAs 05:45 – Overview of PMAs and when they should be used 11:30 – Are PMAs the only pathway for Class 3 devices? 16:20 – Types of PMAs: Traditional, Modular, and Streamlined 22:40 – Advantages of PMAs compared to 510(k)s and de novos 27:50 – The strategic use of predicates in the PMA process 33:00 – Clinical data requirements and misconceptions for PMAs 41:10 – Post-market requirements and differences for PMA devices 47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals 54:30 – Final thoughts on overcoming industry resistance to PMAs Standout Quotes: "Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues "Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues 3 Key Takeaways: PMA Isn’t the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden. Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market. Clinical Data Isn’t Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies. References: Previous Greenlight Guru Webinars by Dr. Mike Drues Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 101: PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements. Audience Engagement: Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you anticipate?" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…
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1 #393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko 33:48
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In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man. Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt. Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape. Key Timestamps: 00:00 – Introduction and Greenlight Guru sponsor message 02:45 – Welcoming Justin Bushko; background in MedTech and engineering 07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing 10:45 – Prototyping with a purpose: Ensuring design iterations target risks 16:00 – Balancing innovation, user needs, and cost-effectiveness 20:30 – Defining essential versus “nice-to-have” features in MedTech 26:45 – Strategic pivots in MedTech: When and why to change course 32:50 – The critical role of design freeze and usability studies 39:10 – Lessons from competitive benchmarking and reverse engineering 46:25 – Handling unique challenges in regulated industries like MedTech 52:15 – Opportunities for MedTech innovation and faster regulatory approvals 58:45 – Advice for founders and importance of building the right team Standout Quotes: "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko "MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko 3 Key Takeaways: Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages. Simplicity is Often the Key: Resist the urge to over-engineer; clarify core features and eliminate unnecessary ones to save on costs and improve usability. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration. References: Connect with Justin Bushko on LinkedIn Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 101: Formative vs. Summative Usability Testing – Formative testing occurs early in the design process to gather feedback and iterate quickly, while summative testing is conducted later to validate that the design meets user needs and regulatory requirements. Audience Engagement: Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…
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1 #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell 58:38
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좋아요58:38![icon](https://imagehost.player.fm/icons/general/red-pin.svg)
In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development. Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defining user needs, writing strong design inputs, conducting pre-verification testing, and ensuring that verification protocols provide meaningful evidence. The discussion explores how to avoid common pitfalls, optimize your design reviews, and strategically approach V&V for complex devices, offering listeners a wealth of actionable takeaways for navigating regulatory challenges and accelerating market access. Key Timestamps: 00:01 – Introduction to Greenlight Guru’s QMS capabilities 03:15 – Setting the stage: Why verification and validation matter 08:30 – Differences between verification and validation explained 12:50 – Importance of strong user needs and design inputs 23:45 – Writing effective user needs and identifying users 33:00 – Creating robust design inputs and their sources beyond user needs 40:10 – From design inputs to design outputs: Key considerations 48:20 – Best practices for conducting design reviews and managing revisions 57:15 – Verification strategies: The importance of pre-verification 01:05:40 – Common challenges in V&V, including sample sizes and justifying tests 01:15:10 – Using feedback during testing and leveraging observations 01:23:00 – Final takeaways and practical advice for V&V success Standout Quotes: "Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell "You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell 3 Key Takeaways: Verification and Validation Are Not the Same: Understand that verification ensures your device meets specified design inputs, while validation confirms it meets user needs and functions as intended. Pre-Verification Testing Minimizes Risk: Conducting a "pre-verification" run allows you to refine testing protocols and identify potential design issues before formal verification begins. Define Users Clearly in User Needs: Avoid generic statements; specify which user (e.g., clinician, technician, patient) has which needs to ensure robust validation testing. References: Devon Campbell’s Consulting – Connect with Devon for more insights on product development. Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software MedTech 101: Verification vs. Validation – Verification checks if a product meets specified requirements, while validation ensures it fulfills the needs and expectations of its intended users. Both are critical steps in medical device development, and their successful execution depends on precise, testable requirements. Audience Engagement: Poll Question: "What’s been your biggest challenge in navigating verification and validation for your medical device? Share your experiences below!" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…
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1 #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq 35:58
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a well-designed roadmap serves as a guiding document for market access and investor confidence. The conversation delves into how to navigate complex market regulations, assess classification and compliance needs, and identify opportunities for strategic global market entry. Adnan’s 25+ years of experience provide actionable insights for medtech startups and established companies alike. Key Timestamps: 00:02 – Introduction to Greenlight Guru and Episode Overview 03:10 – Introducing Adnan Ashfaq and his background in medtech 04:45 – Difference between a regulatory strategy and regulatory roadmap 07:00 – What a regulatory roadmap is and why it’s crucial 12:30 – When and why companies need a regulatory roadmap 16:45 – Key elements of a regulatory roadmap: costs, regions, and timelines 23:20 – Importance of classification and its impact on the regulatory path 28:50 – Integrating QMS, clinical investigations, and stakeholder engagement 36:00 – Leveraging a roadmap for strategic market entry and global reach 44:15 – Pitfalls to avoid in creating a regulatory roadmap 54:20 – Using language and intended use statements strategically 01:03:00 – Wrapping Up: Takeaways and Advice for MedTech Professionals Standout Quotes: "A regulatory roadmap is more than just documentation; it’s a strategic guide for accessing markets and securing investor confidence." – Adnan Ashfaq "Understanding whether your device is a medical device, and its classification, can be make-or-break for your entire regulatory strategy." – Adnan Ashfaq 3 Key Takeaways: Regulatory Roadmaps Are Essential: Developing a roadmap early in the process ensures clear regulatory pathways, cost assessments, and market prioritization, helping avoid costly missteps later. Market Entry Strategy Matters: Strategic use of market-specific regulations, such as leveraging faster access opportunities in some regions, can enhance commercialization efforts and post-market success. Language and Classification Are Crucial: Precise language in defining your device's intended use and claims can significantly impact classification, regulatory requirements, and market access speed. References: Simpli Medica – Adnan Ashfaq’s consultancy website. Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software MedTech 101: Regulatory Roadmap – A strategic document that outlines the costs, timelines, market-specific regulatory requirements, and resources necessary for bringing a medical device to market. Different from a regulatory strategy, it focuses on broader market entry planning and serves as a valuable tool for investor engagement and commercial success. Audience Engagement: Poll Question: "Has your company developed a regulatory roadmap to guide market entry? Share your experience and how it impacted your journey!" Feedback: Enjoyed this episode? Have questions or topics you’d like to hear more about? Reach out to us at podcast@greenlight.guru . Don’t forget to leave us a review—it helps us improve and reach more medtech professionals.…
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1 #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli 37:14
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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and conciseness over verbosity. This conversation dives into strategies for optimizing QMS implementation, reducing overhead, and integrating quality culture company-wide. The episode wraps with tactical advice for new medical device founders on setting up their QMS for long-term success. Key Timestamps: 00:02 – Intro to Greenlight Guru and Episode Topic 03:30 – Introducing Ashkon Rasooli and his background 05:15 – Defining the “Non-BS QMS” approach 06:45 – Principle #1: Quality Over Proceduralism 12:00 – Navigating deviations in QMS and avoiding extremes 14:45 – Principle #2: Culture Over Mandate 22:10 – Principle #3: Redundancy Over Duplication 29:30 – Principle #4: Conciseness Over Verbosity 37:00 – The Importance of Designing for Regulatory and Quality from the Start 46:30 – Tactical QMS advice for new medtech founders 57:00 – Wrapping Up and Key Takeaways Standout Quotes: "There is a cost to quality. But quality done right can also be an enormous value-add, not just a regulatory checkbox." – Ashkon Rasooli "A QMS should serve quality and compliance, but it has to be intuitive for every person in your company. Complexity does not mean quality." – Ashkon Rasooli 3 Key Takeaways: Quality Over Proceduralism: Focus on the intent and impact of QMS processes rather than rigid adherence to procedures that may not reflect the realities of your business. Culture Over Mandate: Building a culture of quality involves engaging every employee, not just those in quality roles, to ensure shared responsibility and proactive efforts. Design for Quality Early On: Engaging with quality and regulatory advisors at the architecture and design phase can prevent costly rework and optimize compliance pathways. References: Ashkon Rasooli on LinkedIn Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software: www.greenlight.guru MedTech 101: QMS (Quality Management System) – A structured system of procedures and processes covering all aspects of design, development, manufacturing, and distribution to ensure product safety, effectiveness, and regulatory compliance. Essential for medtech companies seeking to market devices in most global markets. Audience Engagement: Poll Question: "Does your company treat quality as a compliance necessity or a business differentiator? Share your thoughts!" Feedback: Love this episode? Have ideas or topics you want us to cover? Email us at podcast@greenlight.guru and leave a review to help others discover the Global Medical Device Podcast.…
In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes. Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine the benefits and limitations of PCCPs for both AI-driven and physical medical devices and provide practical tips for incorporating this into regulatory and quality management strategies. Key Timestamps: [03:15] Introduction to PCCPs and Change Management [08:40] PCCP’s origin and application for AI-driven devices [14:20] Expansion of PCCPs to all medical devices [25:10] Practical challenges and best uses for PCCPs [34:55] Submitting PCCPs: Considerations and tips [45:30] Potential of PCCPs for non-software devices: 3D-printed knees case [52:40] FDA guidance and limitations for label changes [1:06:20] Final recommendations and quality system implications for PCCPs Memorable Quotes: “PCCPs could allow us to get anticipated changes approved without a new market submission — but that isn’t a blank check. It’s a pre-validation of boundaries.” — Mike Drues Top Takeaways: Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays. Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster. Integrate PCCPs in QMS: Adding PCCP protocols to quality systems may streamline change implementation and regulatory compliance for future device iterations. References: Mike Drues on LinkedIn FDA PCCP Guidance (2023 & 2024) on anticipated changes and market submissions MedTech 101: Predetermined Change Control Plan (PCCP): A regulatory tool from the FDA allowing manufacturers to gain pre-approval for anticipated changes to a medical device, simplifying future modifications. Initially created for AI-driven devices, PCCPs now apply to all device types. Audience Engagement: Have you considered or implemented a PCCP for your device? What changes would you include if you could pre-approve future modifications? Feedback: We’d love your thoughts on the PCCP framework! Email us at podcast@greenlight.guru with your feedback, questions, or ideas for future topics. Sponsors: Special thanks to Greenlight Guru — the industry’s eQMS & EDC platform designed for medical devices. Learn more about how Greenlight Guru can streamline your change management at greenlight.guru .…
In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions that not only ensure compliance but also drive meaningful improvement within medical device companies. With over a decade of experience, Georg brings practical knowledge on avoiding common pitfalls such as "death by CAPA" or failing to recognize high-risk systemic issues. The episode also delves into the importance of verification of effectiveness (VoE) checks, the distinctions between corrective actions and preventive actions, and how to balance a proactive approach with pragmatic solutions. Key Timestamps: [03:15] – Defining CAPA and its critical role in Quality Management Systems [10:45] – Common CAPA triggers: Balancing overuse and underuse [18:20] – Root cause analysis vs. corrective action: A step-by-step approach [25:40] – Containment vs. correction: Key differences in addressing nonconformities [38:10] – Verification of effectiveness: Best practices for ensuring long-term solutions [50:30] – Continuous improvement through CAPA: Avoiding system overload [1:00:05] – Practical tips for balancing CAPA triggers with company priorities Memorable Quotes: “CAPA isn't just about compliance; it's about driving real improvement in your organization." – Georg Digel “The worst thing that can happen is losing oversight on the serious issues because your system is flooded with trivial ones.” – Georg Digel “Root cause analysis isn’t about fixing the symptom, it’s about ensuring the issue never comes back.” – Etienne Nichols Key Takeaways: MedTech Trends: CAPA as a Key to Continuous Improvement – How CAPA systems fuel company growth by addressing both high-risk and systemic issues. Data-Driven CAPA Triggers – Integrating post-market surveillance and production data for more proactive corrective actions. Regulatory Impact on CAPA – The importance of understanding evolving regulations and their influence on product safety and quality management. Practical Tips for CAPA Implementation: Sharpen Your Triggers – Clearly define CAPA triggers to avoid flooding the system with low-risk issues. Effective VoE – Ensure VoE checks are specific to root causes, not just symptoms, for long-term success. Cross-Site CAPA Learning – Use internal audits and external findings from similar companies to prevent systemic failures across sites. Future Questions in MedTech: How will advances in AI and machine learning improve CAPA systems in the future? Can companies move toward more preventive action frameworks, or is CAPA inherently reactive? How will stricter global regulatory updates reshape CAPA strategies in medical device manufacturing? References: FDA 483 and Warning Letters Database – A resource to monitor common CAPA violations and avoid systemic errors. LinkedIn Profile - Georg Digel – Follow Georg Digel for daily insights on improving CAPA systems. Etienne Nichols LinkedIn – Connect with Etienne Nichols for further discussions on CAPA and MedTech trends. MedTech 101: CAPA Systems CAPA stands for Corrective and Preventive Action. It is a crucial part of any Quality Management System (QMS), designed to investigate and address nonconformities (errors or defects) in medical devices. Corrections fix the immediate problem, while corrective actions aim to stop it from happening again. CAPA ensures continuous improvement and regulatory compliance for medical device manufacturers. Audience Poll: Which aspect of CAPA do you find most challenging in your company? Identifying CAPA triggers Conducting root cause analysis Implementing corrective actions Verification of effectiveness Share your thoughts or any questions at podcast@greenlight.guru ! Feedback Call-to-Action: Enjoyed this episode? We’d love to hear your thoughts! Leave a review on iTunes, and feel free to email us at podcast@greenlight.guru with any feedback or suggestions for future topics. Your feedback helps us grow and deliver even better content. Sponsor Mentions: Greenlight Guru – Streamline your quality management with Greenlight Guru's eQMS, a comprehensive system designed for medical device companies. Say goodbye to spreadsheet chaos and hello to efficiency! Check it out at Greenlight Guru . Rook QS – Scaling fast? Rook QS offers quality-as-a-service solutions tailored to growing medical device companies, helping you maintain compliance through every stage. Learn more at rookqs.com .…
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to streamline submissions, accelerate time-to-market, and lower costs for MedTech companies. With a focus on post-market data, off-label use, and pivotal test cases like pediatric devices and robotic surgery, this conversation reveals the immense potential of RWE to improve patient outcomes and advance medical innovation. Simon also touches on the evolution of NEST since its creation under the FDA's MDUFA commitment and provides real-world examples of how RWE has led to FDA clearances, including collaborations with industry giants like Johnson & Johnson and Intuitive Surgical. Key Timestamps: [00:02:05] – Introduction to Simon Mason and NEST's mission. [00:06:30] – The importance of real-world evidence in medical device submissions. [00:10:50] – NEST's relationship with FDA and industry stakeholders. [00:18:25] – Real-world examples: How RWE led to device clearances. [00:25:10] – Challenges in using real-world data for submissions. [00:32:45] – NEST's role in pediatric devices and the potential for off-label approvals. [00:38:30] – The financial and time-saving benefits of using real-world evidence. [00:50:00] – How companies can engage with NEST to accelerate device approvals. Quotes: Simon Mason : “Real-world evidence has the potential to accelerate device approval and save millions in clinical trial costs. It's all about leveraging existing data to support regulatory submissions.” Etienne Nichols : "The opportunity to use off-label real-world data to expand indications opens a whole new world of innovation for MedTech companies." Simon Mason : “Speed is everything in business and in patient care. RWE is all about moving faster while maintaining safety and effectiveness.” Key Takeaways: Latest MedTech Trends: Real-World Evidence (RWE) Revolution : RWE is transforming regulatory pathways by utilizing data already being collected in real-world settings, reducing the need for costly clinical trials. Off-Label Use for Approvals : NEST is helping companies harness off-label data, particularly in pediatric and robotic surgery, to expand product indications. FDA Collaboration : NEST serves as a bridge between the FDA and industry, simplifying the regulatory process for device companies. Practical Tips for MedTech Innovators: Engage Early : Medical device companies should consider engaging with NEST early in their product lifecycle to identify potential RWE opportunities. Data Accessibility : Companies should explore existing registries or datasets that could support their submissions, saving time and resources. Clear Project Goals : When approaching NEST, companies should have a clear understanding of their product claims and the available data to support them. Questions for Future Development: How will the widespread adoption of RWE change the landscape for early-stage MedTech startups? Can RWE become the default pathway for medical device approvals, replacing traditional clinical trials? What role will AI play in streamlining data collection and analysis for real-world evidence? References: MDIC (Medical Device Innovation Consortium) – NEST's parent organization, which coordinates efforts between FDA and industry stakeholders. MDIC Innovators Forum , held April 8-9, 2025 in Washington, D.C. This is the annual event discussing the latest developments in real-world evidence and device approvals. Etienne Nichols' LinkedIn – Connect with Etienne for insights on MedTech innovation. MedTech 101: What is Real-World Evidence (RWE)? Real-world evidence refers to the clinical evidence regarding the usage and potential benefits or risks of a medical device, derived from analysis of real-world data (RWD) gathered outside of traditional clinical trials. RWE is often collected from registries, electronic health records, and off-label device use, and can significantly speed up regulatory processes by leveraging data already in existence. NEST : The National Evaluation System for Health Technology, under MDIC, is a non-profit initiative funded by FDA and MedTech companies to enhance the use of RWE for medical device regulatory submissions. Audience Poll: What do you think is the biggest advantage of using real-world evidence for medical device approval? Faster time-to-market Lower costs More accurate data Email your responses to podcast@greenlight.guru ! Discussion Question: With real-world evidence becoming a critical part of regulatory pathways, how do you see the future of medical device approvals evolving? Will traditional clinical trials become obsolete? Feedback Call-to-Action: We’d love your feedback! Leave us a review on iTunes, or send your thoughts and suggestions to podcast@greenlight.guru . Your input helps us improve and bring more valuable content to the MedTech community. Sponsor Segment: Today's episode is brought to you by Greenlight Guru and Rook Quality Systems . Greenlight Guru is the quality management (QMS) and electronic data capture (EDC) software designed specifically for medical device companies. From design controls to post-market surveillance, Greenlight Guru helps you stay compliant with FDA and ISO standards, ensuring your device reaches the market faster and safer. Visit greenlight.guru to learn how their QMS can help your MedTech innovation thrive. Rook Quality Systems offers customized Quality-as-a-Service solutions for MedTech companies. Whether you need compliance support, process optimization, or help with regulatory submissions, RookQS tailors their services to meet your unique needs. Learn more about how they can elevate your quality management system by visiting rookqs.com . Both Greenlight Guru and RookQS are committed to helping you bring life-changing medical devices to market efficiently and effectively.…
In this episode of the Global Medical Device Podcast , host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these devices, increasingly used by non-healthcare professionals, face unique hurdles such as user training, environmental factors, and technological concerns like cybersecurity and data security. Together, Etienne and Mike also delve into how regulatory frameworks need to adapt for home use, and they highlight potential future issues with devices as AI and robotic assistance grow in prominence. Key Timestamps: [02:20] - Recap of Part 1 & Introduction to Home Use Devices Mike revisits key topics from part 1, focusing on why home use devices matter. [10:45] - Defining the Intended User and Environment Discussion about how labeling must account for who will use the device and where. [15:30] - Technological and Environmental Challenges for Home Use Devices Exploring temperature, humidity, and power inconsistencies affecting performance. [30:05] - Reprocessing and Cleaning Devices at Home The challenges and risks associated with reusing and cleaning devices like CPAPs. [40:15] - Usability Testing & Human Factors Importance of considering non-healthcare users when designing home devices. [55:12] - Cybersecurity Risks in Home Devices The growing significance of data security and strategies for protecting devices in non-clinical settings. [1:05:30] - Post-Market Surveillance and Reporting for Home Devices The complexities of tracking device performance and recalls when used in home environments. Memorable Quotes: "When we talk about intended users, we must shift our thinking from healthcare professionals to patients. Designing for non-clinicians is crucial because usability directly impacts safety." – Mike Drues "If your device has to be recalibrated, why not have a mechanism that disables it when calibration is overdue? That’s a much stronger safeguard than relying on users to remember." – Mike Drues "Cybersecurity is a growing challenge in home devices. It’s not just about protecting personal data—imagine if a critical medical device was hacked." – Etienne Nichols Key Takeaways: Latest MedTech Trends: Increasing Use of Home Medical Devices : Patients are increasingly managing their own health at home, necessitating devices that are user-friendly and adaptable to various home environments. AI & Robotics in Home Devices : With the rise of AI and robotic assistance, the definition of an "intended user" is evolving, requiring future-proof regulatory considerations. Data Security : As more devices become connected, cybersecurity is becoming a top priority, particularly for critical, life-sustaining technologies. Practical Tips for MedTech Professionals: Understand the End-User : When designing devices, consider that patients, not healthcare professionals, will be the primary users. Usability is key. Incorporate Environmental Testing : Take environmental factors like humidity, power outages, and storage conditions into account during the device development phase. Push Updates Automatically : For connected devices, push software updates automatically to mitigate cybersecurity risks, rather than relying on users to pull them. References: FDA Guidance on Home Use Devices : Relevant guidelines shaping the regulatory landscape for home use devices. Philips Respironics CPAP Recall : A case study highlighting the importance of post-market surveillance and recalls. Etienne Nichols’ LinkedIn Profile : Connect with Etienne MedTech 101: Home Use Medical Devices For new listeners, home use medical devices are designed for patient self-administration and management outside of a clinical setting. Examples include CPAP machines, blood glucose monitors, and wearable heart monitors. These devices must meet stringent usability and safety standards, as patients using them often lack formal medical training. Key considerations in the design and regulation of these devices include labeling (clear instructions), user environment (temperature, lighting), and cybersecurity risks. Discussion Question: What technological advancements do you think will have the most significant impact on the future of home healthcare? Let us know by emailing us at podcast@greenlight.guru ! We'd love feedback: Enjoyed the episode? Leave us a review on iTunes—it helps others find us and lets us know how we're doing! Have thoughts or suggestions for future episodes? Reach out to us at podcast@greenlight.guru or connect with Etienne on LinkedIn. Sponsor Message: This episode is brought to you by Greenlight Guru , the only quality management system (QMS) built specifically for medical device companies. Streamline your quality processes and get to market faster with Greenlight Guru’s easy-to-use platform. Visit www.greenlight.guru for a free demo today! This episode is also sponsored by Rook Quality Systems . Documentation is key to a successful quality management system, and Rook Quality Systems helps you create and maintain clear, compliant Standard Operating Procedures (SOPs) and other essential documents. Their team of experts ensures your documentation aligns with regulatory standards, making audits easier and your processes more efficient. Start optimizing your quality management system today at rookqs.com .…
In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction. The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance. This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment. Key Timestamps: [00:01] – Introduction : Etienne introduces the episode and topic of home use medical devices, along with a quick sponsor message. [02:30] – Defining Home Use Devices : Mike Drues explains what qualifies as a home use medical device from a regulatory standpoint. [07:50] – Why Home Use Devices Matter : Discussion on why home use medical devices are a strategic priority for CDRH in 2025 and the safety issues identified by the Emergency Care Research Institute (ECRI). [12:15] – Case Study: Philips Respironics Recall : Mike discusses the technical and regulatory issues behind the Philips Respironics recall and its implications for manufacturers. [25:45] – Post-Market Surveillance and Complaint Handling : The challenges of post-market surveillance and complaint handling for home use devices, and the role of regulatory compliance. [35:30] – The Importance of Intended Use Environment : Exploring how intended use environment should influence design and usability considerations. [45:20] – Teaser for Part 2 : Mike and Etienne preview topics for the next episode, including labeling challenges, human factors, and usability testing for home use medical devices. Key Quotes: “A home use device isn’t just a device that could be used at home; it’s one that’s intended and labeled for use outside traditional clinical settings.” — Mike Drues “When post-market surveillance fails, it’s not just a compliance issue—it’s a safety issue that can put lives at risk.” — Mike Drues “Regulatory logic goes beyond the written rules—it’s about understanding the intent behind them to ensure devices are safe wherever they’re used.” — Mike Drues Key Takeaways: Latest MedTech Trends: Home Use Device Surge: There is a growing trend toward designing devices for non-clinical environments, driven by technological advancements and patient demand for convenience. Regulatory Focus on Safety: Regulatory bodies like the FDA are increasingly prioritizing the safety of home use devices, as seen in CDRH’s 2025 strategic priorities. Impact of High-Profile Recalls: Large-scale recalls, like the Philips Respironics case, highlight the need for robust design controls and post-market surveillance practices for home use devices. Practical Tips: Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures. Emphasize Post-Market Surveillance: Develop strong post-market surveillance and complaint handling processes to catch and address issues early. Communicate Clearly with Users: Create user-friendly labeling and instructions that cater to non-professional users to minimize the risk of misuse. Future Predictions: Regulatory Changes for Home Use Devices: Expect more detailed guidance from the FDA on defining and managing home use devices. Enhanced Usability Testing: Usability and human factors testing will become even more critical as devices move into less controlled environments. Increased Liability Focus: Manufacturers will need to pay closer attention to liability issues as more devices transition to home settings. References: FDA Guidance on Home Use Devices : Design Considerations for Devices Intended for Home Use – This guidance provides detailed recommendations on how to design and label home use medical devices. ECRI’s Top 10 Health Technology Hazards for 2023 and 2024 : An annual report highlighting the safety concerns for home use medical devices. Philips Respironics Recall Case Study : The recall case, which affected over 5.5 million devices, serves as a key example of post-market surveillance failure and design oversight. Connect with Etienne Nichols on LinkedIn . MedTech 101: Home Use Medical Devices For new listeners, home use medical devices are defined as devices intended for use in environments outside of traditional clinical settings, such as homes, schools, and offices. These devices must be designed to accommodate non-professional users, accounting for factors like usability, environmental conditions, and ease of maintenance. Understanding these nuances is essential for developing safe and effective devices for a growing market. Audience Poll: What do you think is the biggest challenge for home use medical devices? A) User error and training B) Environmental factors C) Post-market surveillance and complaint handling D) Device design limitations Share your thoughts with us at podcast@greenlight.guru ! Discussion Question: With the rise of home use medical devices, how do you think the role of post-market surveillance will change over the next five years? Let us know your predictions at podcast@greenlight.guru . Feedback: We'd love to hear your thoughts on this episode and suggestions for future topics! Leave a review on iTunes, and feel free to reach out to us at podcast@greenlight.guru with any feedback. Your insights help us bring you the content that matters most! Sponsor Mentions: Greenlight Guru : Is your QMS holding you back? Greenlight Guru is THE eQMS built for medical device companies to accelerate success and ensure compliance with FDA, ISO, and EU MDR requirements. Streamline your quality processes and focus on innovation. Visit www.greenlight.guru to learn more! Rook Quality Systems : Ready to ensure your QMS is audit-ready? Rook Quality Systems offers comprehensive QMS audits and training tailored to your organization’s needs. From gap analysis to corrective actions, Rook helps you maintain compliance and efficiency. Schedule your audit at www.rookqs.com .…
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1 #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends 44:08
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좋아요44:08![icon](https://imagehost.player.fm/icons/general/red-pin.svg)
In this episode of the Global Medical Device Podcast , host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation. Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony. Key Timestamps: [00:01] – Introduction : Vincent Cafiso’s background as an FDA investigator and transition into industry. [04:15] – Crayo Consulting’s Scope : How Creo Consulting supports MedTech companies from launch strategy to compliance. [12:40] – Bridging R&D and Production : Overcoming challenges when R&D environments don’t align with production standards. [19:50] – Top Trends in Quality Systems : Addressing documentation gaps and missing standards in design history files. [27:10] – Management’s Role in Supporting Quality : The importance of management’s involvement in enforcing quality controls and processes. [38:30] – From FDA to Industry : How Vincent’s FDA background influences his approach to quality and compliance. [54:25] – Skip-Level Meetings and Breaking Silos : Enhancing collaboration and communication within large organizations. [1:06:00] – Final Takeaways and Advice : Building a culture of quality and fostering innovation while staying compliant. Key Quotes: “The regulations are written for tongue depressors and pacemakers—two very different devices. It’s up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso “Documentation shouldn’t just be a checkbox for submission. There’s a lot more innovation happening that doesn’t make it onto paper because companies don’t realize its value.” – Vincent Cafiso Key Takeaways: 1. MedTech Trends: Alignment of R&D and Production : Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework. Regulatory Understanding Across Teams : Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance. Cross-Departmental Collaboration : Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality. 2. Practical Tips for MedTech Professionals: Integrate Quality Early : Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production. Leverage Skip-Level Meetings : Encourage direct communication between upper management and employees for better understanding and faster issue resolution. Document Everything : Don’t treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions. 3. Questions for Future Consideration: How can large organizations maintain the flexibility and collaborative spirit of a startup? What creative approaches can be used to align R&D and production standards in smaller companies? What role will emerging technologies like AI and IoT play in shaping future regulatory landscapes? References: Vincent Cafiso on LinkedIn Etienne Nichols on LinkedIn Creo Consulting : Vincent Cafiso’s current company offering regulatory and quality services to MedTech organizations. FDA Guidance on Design Controls : Essential reading for understanding how to document and verify design history files. Greenlight Guru's EQMS Software : A quality management system built specifically for the MedTech industry, aiding in compliance and product development. Connect with Etienne Nichols on LinkedIn . MedTech 101: What is FDA Inspection Readiness? FDA inspection readiness refers to the ongoing state of compliance and preparedness for an FDA audit or inspection. It involves having robust quality systems, complete documentation, and trained personnel to demonstrate adherence to applicable regulations and standards. This ensures that a company can efficiently respond to any FDA inquiries and avoid costly delays or compliance issues. What are Design Controls? Design controls are a set of quality practices and procedures integrated into the product development process to ensure that medical devices meet user needs, intended uses, and specified requirements. They include stages like design planning, design inputs and outputs, verification, validation, and design transfer. Poll for the Audience: What is the biggest challenge your MedTech company faces when preparing for FDA inspections? a) Documentation and record-keeping b) Cross-departmental communication c) R&D and production alignment d) Understanding complex regulations Share your answer and thoughts by emailing us at podcast@greenlight.guru ! Feedback: Did you enjoy this episode? Leave us a review on iTunes and share your thoughts! Your feedback helps us improve and curate content that matters most to you. Feel free to email us at podcast@greenlight.guru with any suggestions for future topics or guest recommendations. Sponsor Segment: This episode is brought to you by Greenlight Guru , the only quality management software designed by MedTech professionals for MedTech companies. With a robust EQMS platform, Greenlight Guru helps streamline compliance and innovation processes, ensuring faster market access and safer medical devices. Visit greenlight.guru to learn more and schedule a demo today!…
In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They dive deep into IEC 60601, ISO 15223, and the regulatory landscape across global markets. Leo also shares actionable advice on avoiding pitfalls, prioritizing standards, and ensuring compliance to bring safe, effective devices to market without delays. Key Timestamps: [03:20] – Introduction to Leo Eisner and his background in medical device standards [10:15] – Why standards like IEC 60601 are crucial for medical device development [18:45] – Steps for identifying the right standards for your product [27:00] – Common mistakes and the consequences of ignoring standards [38:50] – How to integrate standards into your design process [47:35] – How startups can navigate standards with limited resources [58:00] – Tools for staying updated on changing standards and regulations [1:09:40] – Final advice from Leo on ensuring regulatory success Notable Quotes: "When you really think about it, all this work leads to safer medical devices on the market—that’s crucial." – Leo Eisner "Standards may seem like obstacles, but they’re design inputs that ensure your device will work as intended in every scenario." – Etienne Nichols "If you don’t integrate standards early in the design phase, you bring design risk later into the project, which can be very costly." – Leo Eisner Key Takeaways: MedTech Trends: Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs. Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays. Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts. Practical Tips for MedTech Professionals: Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later. Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated. Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently. Questions for Future Developments in MedTech: Will the move toward "atomic" standards streamline regulatory processes for startups? How will global regulatory bodies harmonize standards across different markets? What emerging standards will impact next-gen MedTech innovations like AI and robotic surgery? References: Greenlight Guru - Quality Management System & Electronic Data Capture solutions built by Medtech professionals for Medtech professionals. Leo Eisner on LinkedIn – Connect with Leo for expert insights on compliance and regulatory standards. IEC Standards – The international standard for the safety of electrical medical equipment. ISO 15223 – Standard for symbols to be used with medical device labeling. MedBoard – A platform for regulatory intelligence, tracking medical device standards. Etienne Nichols on LinkedIn – Connect with the podcast host for ongoing discussions on medical device development. MedTech 101: Consensus Standards – These are standards developed by experts in the field and recognized by regulatory bodies like the FDA. While they are technically voluntary, using them greatly simplifies the regulatory approval process. Audience Poll: What aspect of medical device standards do you find most challenging? Understanding which standards apply Incorporating standards into product design Keeping up with regulatory changes Managing costs associated with compliance Send us your thoughts at podcast@greenlight.guru ! Sponsor Mentions: Greenlight Guru – Today’s episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Built for MedTech professionals by MedTech professionals, Greenlight Guru’s EQMS software helps you manage compliance, quality, and innovation all in one. Learn more at greenlight.guru . Rook Quality Systems – Need quality expertise on demand? Rook Quality Systems provides “quality as a service,” giving you access to their seasoned quality professionals as quickly as you need them. Whether it’s for a project or ongoing support, Rook offers tailored consulting services to help meet your quality and compliance needs. Learn more at rookqs.com . Feedback Call-to-Action: Enjoyed this episode? We’d love your feedback! Please leave us a review on iTunes and let us know what you’d like to hear next. Have questions or suggestions? Email us at podcast@greenlight.guru .…
In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from his extensive career, offering actionable strategies to simplify complex variables, avoid common pitfalls, and ensure a more effective and efficient development process. Key Timestamps : [00:02] – Introduction to Perry Parendo and his background in DOE [05:50] – What is DOE? Perry’s simple, non-technical definition [12:00] – Common problems DOE solves and its application in R&D [22:30] – Risk management and DOE’s role in reducing uncertainty [35:20] – Using DOE in manufacturing processes and real-world examples [48:10] – Common pitfalls and best practices when using DOE Key Quotes : Perry Parendo : “Design of Experiments is a tool to assist in understanding a system. It’s not just a test plan; it’s a way to create structure and strategy in how you approach testing.” Etienne Nichols : “The life of an engineer really happens in that space between input and output—there’s so much to dial in, and that’s where tools like DOE really help.” Takeaways : Key Insights on MedTech Trends : DOE reduces risk : It plays a crucial role in risk management, especially in R&D, where understanding system behaviors early is key to mitigating issues down the line. Structured problem-solving : DOE provides a data-driven, structured way to isolate variables and pinpoint causes, streamlining troubleshooting and optimization in product development. Adaptability of DOE : It can be applied to both small and large-scale problems, from manufacturing issues to high-stakes R&D, making it essential for MedTech innovation. Practical Tips for MedTech Professionals : Start small with DOE : Focus on fewer variables when beginning to ensure you don’t get overwhelmed. Three to seven variables are typically manageable for early experiments. Understand the limits of your tests : Avoid putting all variables into one test; break them down to ensure results are meaningful and actionable. Validate your DOE : Don’t rely solely on DOE results—validate with real-world testing to confirm your findings. References : Perry Parendo : Founder of Perry Solutions, specializing in product development and process optimization through DOE. LinkedIn Connect with Etienne Nichols on LinkedIn . MedTech 101: Explainer on DOE : Design of Experiments (DOE) is a statistical method used to determine how different variables (inputs) affect a process or product outcome (output). It’s widely used in MedTech for optimizing processes and solving manufacturing or product development issues by systematically testing different variables to identify the most influential factors. Questions for the Audience : Poll : How often do you use DOE in your medical device development process? Frequently Occasionally Rarely Never Send your responses to podcast@greenlight.guru . Feedback & Sponsors : Feedback : Loved this episode? Leave a review on iTunes! Your feedback helps us improve and reach more MedTech professionals. Contact us at : podcast@greenlight.guru Sponsor : This episode is brought to you by Greenlight Guru , the only quality management software designed specifically for the medical device industry. Learn how Greenlight Guru can help streamline your product development process at greenlight.guru . Sponsor : Today's episode is sponsored by Rook Quality Systems . Rook offers Quality as a Service solutions to help medical device companies navigate the complexities of regulatory compliance. Their team of experts ensures your quality processes meet the highest industry standards, giving you peace of mind while you focus on innovation. Whether you're preparing for an audit or need ongoing quality support, trust Rook to keep your compliance on track. Learn more at RookQS.com .…
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