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

MedTech Trends:

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.

Practical Tips for CAPA Implementation:

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.

Future Questions in MedTech:

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...

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.”

Latest MedTech Trends:

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.

Practical Tips for MedTech Innovators:

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.

Questions for Future Development:

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?

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

Latest MedTech Trends:

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.

Practical Tips for MedTech Professionals:

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...

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...

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.

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

MedTech Trends:

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.

Practical Tips for MedTech Professionals:

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.

Questions for Future Developments in MedTech:

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...

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...

In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur."

Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-saving tool used in trauma care, including military and postpartum hemorrhage situations.

The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this episode provides inspiration, practical insights, and a behind-the-scenes look at innovation in healthcare.

Key Timestamps:

• [03:22] – Asha Parekh shares her transition from biomedical engineer to accidental entrepreneur.
• [12:35] – Developing the COBRA-OS and the moment Asha realized the life-saving potential of her product.
• [22:10] – The role of passion in overcoming challenges as a MedTech entrepreneur.
• [35:42] – The importance of securing funding and the challenges of working with quality and regulatory partners.
• [52:20] – How to craft a compelling pitch to secure funding for your MedTech device.
• [01:04:30] – Asha's milestone moments, including the COBRA-OS being used at Formula One race tracks.

Quotes:

• "Passion is what drives you through the tough days. It's what makes the challenges bearable because the impact you're making is worth it." – Asha Parekh
• "Pitching is an art form. Telling a compelling story about your product, especially one that saves lives, can make all the difference." – Asha Parekh
• "You are the expert on your device. Never forget that, even when you're leaning on regulatory experts. Trust your own knowledge of your product." – Asha Parekh
• "The moment I realized that COBRA-OS could save lives, I knew we had to pursue it full-time." – Asha Parekh

Key Takeaways:

Top 3 MedTech Trends:

1. Growing Impact of Trauma Care Devices – Devices like the COBRA-OS are becoming critical in high-risk environments such as military and emergency settings.
2. Regulatory Complexity – Expanding into international markets (e.g., achieving CE mark) requires navigating a web of regulatory requirements.
3. Funding & Innovation – Securing funding is pivotal for early-stage MedTech companies, especially when aiming for large-scale regulatory testing.

Top 3 Practical Tips for MedTech Entrepreneurs:

1. Find a Mission You’re Passionate About – It will sustain you through difficult phases.
2. Master the Art of Pitching – A compelling story can unlock funding opportunities.
3. Be Proactive in Regulatory Knowledge – Don’t rely solely on consultants; know your product’s regulatory pathway inside and out.

References:

• Frontline Medical Technologies – Learn more about COBRA-OS and its use in trauma care at Frontline MedTech.
• Greenlight Guru – For quality and regulatory management solutions, visit Greenlight Guru.
• Rook Quality Systems – Learn more about QMS consulting at Rook Quality Systems.
• Connect with Etienne Nichols on LinkedIn...