Global Medical Device Podcast powered by Greenlight Guru

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.

• Simply 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?

Let us know by emailing us at [email protected]!

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 [email protected] or connect with Etienne on LinkedIn.

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.

• [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.

1. “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
2. “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
3. “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

Latest MedTech Trends:

1. 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.
2. 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.
3. 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:

1. Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures.
2. Emphasize Post-Market Surveillance: Develop strong post-market surveillance and complaint handling processes to catch and address issues early.
3. Communicate Clearly with Users: Create user-friendly labeling and instructions that cater to non-professional users to minimize the risk of misuse.

Future Predictions:

1. Regulatory Changes for Home Use Devices: Expect more detailed guidance from the FDA on defining and managing home use devices.
2. Enhanced Usability Testing: Usability and human factors testing will become even more critical as devices move into less controlled environments.
3. Increased Liability Focus: Manufacturers will need to pay closer attention to liability issues as more devices transition to home settings.

1. 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.
2. ECRI’s Top 10 Health Technology Hazards for 2023 and 2024: An annual report highlighting the safety concerns for home use medical devices.
3. 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.

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.

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 [email protected]!

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 [email protected].

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 [email protected] with any feedback. Your insights help us bring you the content that matters most!

• 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.

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.

• [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.

1. “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
2. “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

• 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.

• 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.

• 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?

1. Vincent Cafiso on LinkedIn
2. Etienne Nichols on LinkedIn
3. Creo Consulting: Vincent Cafiso’s current company offering regulatory and quality services to MedTech organizations.
4. FDA Guidance on Design Controls: Essential reading for understanding how to document and verify design history files.
5. 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.

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.

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.

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 [email protected]!

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 [email protected] with any suggestions for future topics or guest recommendations.

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.

• [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

• "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

1. Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs.
2. Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays.
3. Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts.

1. Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later.
2. Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated.
3. Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently.

1. Will the move toward "atomic" standards streamline regulatory processes for startups?
2. How will global regulatory bodies harmonize standards across different markets?
3. What emerging standards will impact next-gen MedTech innovations like AI and robotic surgery?

• 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.

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.

What aspect of medical device standards do you find most challenging?

1. Understanding which standards apply
2. Incorporating standards into product design
3. Keeping up with regulatory changes
4. Managing costs associated with compliance

Send us your thoughts at [email protected]!

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.

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 [email protected].

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.

• [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

• 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.”

Key Insights on MedTech Trends:

1. 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.
2. Structured problem-solving: DOE provides a data-driven, structured way to isolate variables and pinpoint causes, streamlining troubleshooting and optimization in product development.
3. 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:

1. 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.
2. Understand the limits of your tests: Avoid putting all variables into one test; break them down to ensure results are meaningful and actionable.
3. Validate your DOE: Don’t rely solely on DOE results—validate with real-world testing to confirm your findings.

• Perry Parendo: Founder of Perry Solutions, specializing in product development and process optimization through DOE. LinkedIn
• Connect with Etienne Nichols on LinkedIn.

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.

1. Poll: How often do you use DOE in your medical device development process?

• Frequently
• Occasionally
• Rarely
• Never
• Send your responses to [email protected].

• Feedback: Loved this episode? Leave a review on iTunes! Your feedback helps us improve and reach more MedTech professionals.
• Contact us at: [email protected]

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.