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.

• [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.

1. "The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner
2. "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
3. "Standards aren’t just rules; they’re lessons learned from history, guiding us to safer, better devices." – Etienne Nichols

1. The modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations.
2. Wireless coexistence and other cutting-edge technologies will soon become international requirements.
3. Consolidating collateral standards improves consistency and reduces redundancies.

1. Begin designing for new standards early, even before they are finalized.
2. Stay informed by engaging with industry groups and standards organizations.
3. Use test planning to streamline development and meet regulatory expectations efficiently.

1. How will integrating advanced hazard mitigation strategies impact device innovation?
2. What role will emerging technologies like AI and IoT play in future standards revisions?
3. How can smaller MedTech companies effectively adapt to these significant changes?

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.

• 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 [email protected].

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!

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 [email protected].

Stay ahead of MedTech changes by tuning in to the Global Medical Device Podcast. See you next time!

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.

• 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

1. "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
2. "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

1. 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.
2. 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.
3. 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.

• Previous Greenlight Guru Webinars by Dr. Mike Drues
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

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.

Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you anticipate?"

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at [email protected] and don’t forget to leave a review to help others find us.

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.

• 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

1. "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko
2. "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

1. Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages.
2. 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.
3. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration.

• Connect with Justin Bushko on LinkedIn
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

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.

Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!"

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at [email protected] and don’t forget to leave a review to help others find us.

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.

• 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

1. "Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell
2. "You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell

1. 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.
2. 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.
3. 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.

• Devon Campbell’s Consulting – Connect with Devon for more insights on product development.
• Etienne Nichols’ LinkedIn
• Greenlight Guru’s QMS Software

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.

Poll Question: "What’s been your biggest challenge in navigating verification and validation for your medical device? Share your experiences below!"

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at [email protected] and don’t forget to leave a review to help others find us.

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.

• 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

1. "A regulatory roadmap is more than just documentation; it’s a strategic guide for accessing markets and securing investor confidence." – Adnan Ashfaq
2. "Understanding whether your device is a medical device, and its classification, can be make-or-break for your entire regulatory strategy." – Adnan Ashfaq

1. 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.
2. 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.
3. 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.

• Simpli Medica – Adnan Ashfaq’s consultancy website.
• Etienne Nichols’ LinkedIn
• Greenlight Guru’s QMS Software

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.

Poll Question: "Has your company developed a regulatory roadmap to guide market entry? Share your experience and how it impacted your journey!"

Enjoyed this episode? Have questions or topics you’d like to hear more about? Reach out to us at [email protected]. Don’t forget to leave us a review—it helps us improve and reach more medtech professionals.

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.

• 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

1. "There is a cost to quality. But quality done right can also be an enormous value-add, not just a regulatory checkbox." – Ashkon Rasooli
2. "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

1. 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.
2. 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.
3. 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.

• Ashkon Rasooli on LinkedIn
• Etienne Nichols’ LinkedIn
• Greenlight Guru’s QMS Software: www.greenlight.guru

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.

Poll Question: "Does your company treat quality as a compliance necessity or a business differentiator? Share your thoughts!"

Love this episode? Have ideas or topics you want us to cover? Email us at [email protected] 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:

1. Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays.
2. Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster.
3. 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 [email protected] 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.

• [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

• “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

1. CAPA as a Key to Continuous Improvement – How CAPA systems fuel company growth by addressing both high-risk and systemic issues.
2. Data-Driven CAPA Triggers – Integrating post-market surveillance and production data for more proactive corrective actions.
3. Regulatory Impact on CAPA – The importance of understanding evolving regulations and their influence on product safety and quality management.

1. Sharpen Your Triggers – Clearly define CAPA triggers to avoid flooding the system with low-risk issues.
2. Effective VoE – Ensure VoE checks are specific to root causes, not just symptoms, for long-term success.
3. Cross-Site CAPA Learning – Use internal audits and external findings from similar companies to prevent systemic failures across sites.

1. How will advances in AI and machine learning improve CAPA systems in the future?
2. Can companies move toward more preventive action frameworks, or is CAPA inherently reactive?
3. How will stricter global regulatory updates reshape CAPA strategies in medical device manufacturing?

1. FDA 483 and Warning Letters Database – A resource to monitor common CAPA violations and avoid systemic errors.
2. LinkedIn Profile - Georg Digel – Follow Georg Digel for daily insights on improving CAPA systems.
3. Etienne Nichols LinkedIn – Connect with Etienne Nichols for further discussions on CAPA and MedTech trends.

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.

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 [email protected]!

Enjoyed this episode? We’d love to hear your thoughts! Leave a review on iTunes, and feel free to email us at [email protected] with any feedback or suggestions for future topics. Your feedback helps us grow and deliver even better content.

1. 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.
2. 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.

• [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.

• 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.”

1. 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.
2. Off-Label Use for Approvals: NEST is helping companies harness off-label data, particularly in pediatric and robotic surgery, to expand product indications.
3. FDA Collaboration: NEST serves as a bridge between the FDA and industry, simplifying the regulatory process for device companies.

1. Engage Early: Medical device companies should consider engaging with NEST early in their product lifecycle to identify potential RWE opportunities.
2. Data Accessibility: Companies should explore existing registries or datasets that could support their submissions, saving time and resources.
3. Clear Project Goals: When approaching NEST, companies should have a clear understanding of their product claims and the available data to support them.

1. How will the widespread adoption of RWE change the landscape for early-stage MedTech startups?
2. Can RWE become the default pathway for medical device approvals, replacing traditional clinical trials?
3. What role will AI play in streamlining data collection and analysis for real-world evidence?

• 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.

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.

What do you think is the biggest advantage of using real-world evidence for medical device approval?

1. Faster time-to-market
2. Lower costs
3. More accurate data

Email your responses to [email protected]!

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?

We’d love your feedback! Leave us a review on iTunes, or send your thoughts and suggestions to [email protected]. Your input helps us improve and bring more valuable content to the MedTech community.

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.

• [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.

• "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

1. 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.
2. 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.
3. Data Security: As more devices become connected, cybersecurity is becoming a top priority, particularly for critical, life-sustaining technologies.

1. Understand the End-User: When designing devices, consider that patients, not healthcare professionals, will be the primary users. Usability is key.
2. Incorporate Environmental Testing: Take environmental factors like humidity, power outages, and storage conditions into account during the device development phase.
3. Push Updates Automatically: For connected devices, push software updates automatically to mitigate cybersecurity risks, rather than relying on users to pull them.

• 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

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.

What technological advancements do you think will have the most significant impact on the future of home healthcare?

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