Global Medical Device Podcast powered by Greenlight Guru

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Global Medical Device Podcast powered by Greenlight Guru

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.

  1. 6 DAYS AGO

    #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

    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 Overview03:10 – Introducing Adnan Ashfaq and his background in medtech04:45 – Difference between a regulatory strategy and regulatory roadmap07:00 – What a regulatory roadmap is and why it’s crucial12:30 – When and why companies need a regulatory roadmap16:45 – Key elements of a regulatory roadmap: costs, regions, and timelines23:20 – Importance of classification and its impact on the regulatory path28:50 – Integrating QMS, clinical investigations, and stakeholder engagement36:00 – Leveraging a roadmap for strategic market entry and global reach44:15 – Pitfalls to avoid in creating a regulatory roadmap54:20 – Using language and intended use statements strategically01:03:00 – 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:Simply Medica – Adnan Ashfaq’s consultancy website.Etienne Nichols’ LinkedInGreenlight 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...

    36 min

  2. NOV 7

    #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

    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 Topic03:30 – Introducing Ashkon Rasooli and his background05:15 – Defining the “Non-BS QMS” approach06:45 – Principle #1: Quality Over Proceduralism12:00 – Navigating deviations in QMS and avoiding extremes14:45 – Principle #2: Culture Over Mandate22:10 – Principle #3: Redundancy Over Duplication29:30 – Principle #4: Conciseness Over Verbosity37:00 – The Importance of Designing for Regulatory and Quality from the Start46:30 – Tactical QMS advice for new medtech founders57:00 – 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 LinkedInEtienne Nichols’ LinkedInGreenlight 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.

    37 min

  3. OCT 31

    #389: Pre-determined Change Control Plans

    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 LinkedInFDA 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.

    44 min

  4. OCT 24

    #388: Elements of an Effective CAPA Program

    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...

    39 min

  5. OCT 17

    #387: The case for Real World Evidence Studies

    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:a...

    29 min

  6. OCT 10

    #386: The Danger of In-Home Use Medical Devices, Pt. 2

    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 DevicesMike revisits key topics from part 1, focusing on why home use devices matter.[10:45] - Defining the Intended User and EnvironmentDiscussion about how labeling must account for who will use the device and where.[15:30] - Technological and Environmental Challenges for Home Use DevicesExploring temperature, humidity, and power inconsistencies affecting performance.[30:05] - Reprocessing and Cleaning Devices at HomeThe challenges and risks associated with reusing and cleaning devices like CPAPs.[40:15] - Usability Testing & Human FactorsImportance of considering non-healthcare users when designing home devices.[55:12] - Cybersecurity Risks in Home DevicesThe growing significance of data security and strategies for protecting devices in non-clinical settings.[1:05:30] - Post-Market Surveillance and Reporting for Home DevicesThe 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...

    53 min

  7. OCT 4

    #385: The Trouble with Home-Use Devices, Pt. 1

    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...

    36 min

  8. SEP 26

    #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

    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...

    44 min
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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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