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.

• [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.

1. Mike Drues: "If the FDA doesn’t understand your device, it’s not their fault—it’s the manufacturer’s responsibility to communicate effectively."
2. Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection."
3. Mike Drues: "A picture’s worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly."

MedTech Trends

1. Clear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices.
2. Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification.
3. Visual aids, like images and videos, are becoming standard tools to enhance submissions.

Practical Tips

1. Test your description’s efficacy by asking someone unfamiliar with the device to explain it back to you.
2. Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists.
3. Incorporate visuals or videos to clarify complex mechanisms or testing processes.

Future Questions

1. How might advancements in AI reshape the expectations for device descriptions?
2. Could the FDA eventually require interactive or multimedia submissions as standard?
3. What new tools or technologies can help manufacturers streamline the description-writing process?

• 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.

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...

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

Latest Trends in MedTech Standards

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.

Practical Tips for Compliance

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.

Questions to Ponder for the Future

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:

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...

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

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...

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

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 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:

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 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.