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...