In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls.

Key Timestamps:

• [01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting
• [05:45] Lisa's transition from the restaurant industry to medical devices
• [10:30] What triggers a medical device report to the FDA?
• [15:25] Role-play on handling complaints and determining reportability
• [25:00] Detailed explanation of the decision tree for reporting
• [35:15] Differentiating between device malfunctions and serious injuries
• [40:10] Real-life examples and clarifying complex reporting scenarios
• [50:30] The repercussions of late reporting and the importance of timing
• [55:20] Wrapping up and resources for deeper understanding

Insightful Quotes:

• "Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803." - Lisa Van Ryn
• "Having a beginner’s mindset but the heart of a teacher is essential in the medical device industry." - Etienne Nichols
• "If you’re not considering the feedback as important, whether it’s reportable or not, you are missing valuable data." - Lisa Van Ryn

Key Takeaways:

1. Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.
2. Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.
3. Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.

References and Resources:

• Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records
• Lisa Van Ryn on LinkedIn
• Etienne Nichols on LinkedIn

Beginner’s Section: MedTech 101

• Medical Device Reporting (MDR): This refers to the regulatory process in which manufacturers are required to report certain types of incidents and malfunctions related to medical devices to the FDA.
• Serious Injury: A serious injury in the context of MDR is defined as an injury that is life-threatening, results in permanent impairment, or necessitates medical or surgical intervention to prevent permanent damage.
• Complaint Handling: The process by which manufacturers receive, review, and respond to customer complaints about the safety and quality of their medical devices.

Questions for the Audience:

• Poll: Do you believe current regulations on medical device reporting are sufficient for ensuring patient safety?

Feedback Request:

We value your thoughts! Please leave us a review on iTunes and share your feedback. Your suggestions help us improve and guide our future topics. Email your thoughts and topic suggestions to podcast@greenlight.guru.

Sponsors:

This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a...

In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.

• [00:02:30] Christine's journey from biochemistry to medical device innovation
• [00:15:00] Insights on starting a medtech startup and the early failures
• [00:30:45] Effective collaboration with regulatory consultants
• [00:45:10] Handling FDA interactions and strategic submissions
• [01:00:20] Advice for medtech startups on navigating regulatory environments

• "You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk
• "Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine Luk

• Engage with local medtech communities and resources, such as accelerators or innovation hubs.
• Early interactions with the FDA can significantly influence your device’s regulatory pathway.
• Thorough documentation and clear communication with consultants are essential for effective project management.

• Texas Medical Center Innovation Institute
• Proxima Clinical Research
• Christine Luk on LinkedIn
• Etienne Nichols on LinkedIn

Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at podcast@greenlight.guru

Don’t forget to leave us a review on iTunes!

This episode is proudly sponsored by Greenlight Guru, a global leader in MedTech-specific software solutions. Whether you're in the clinical trial phase or ensuring compliance with quality standards, Greenlight Guru offers tailored solutions to streamline your processes. Their software is designed specifically for the medical device industry, helping companies accelerate their product development with confidence and compliance. Learn more about how Greenlight Guru can illuminate your path to market success by visiting their website at Greenlight Guru. Equip your team with the tools to simplify quality management and keep your focus on innovation and patient safety.

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and ultimate success in the market. The discussion highlights the importance of perseverance, the impact of regulatory insights, and the significant role of strategic innovation in enhancing patient outcomes.

• [00:45] - Introduction of Dr. Lee Hunter and his medical device journey.
• [05:30] - Challenges and breakthroughs in designing elbow surgery devices.
• [14:20] - The licensing journey and learning from initial failures.
• [22:50] - Insights into the current medical device market and innovations.
• [35:40] - Discussion on the importance of simplicity and efficiency in medical devices.
• [48:15] - Future directions in MedTech and advice for new innovators.

• "Sometimes the simplest solutions are the hardest to find but the most effective once implemented." - Lee Hunter

1. Innovation in MedTech: Dr. Hunter's journey emphasizes that true innovation often stems from a deep understanding of specific medical needs rather than broad technological applications.
2. Challenges and Resilience: Early failures are often stepping stones to success, highlighting the importance of resilience and adaptability in the medical device industry.
3. Future of MedTech: The potential for simpler, more effective devices that streamline medical procedures and improve outcomes is vast, urging current and future innovators to focus on practical and impactful innovations.

In today's episode, terms like "elbow arthroscopy" and "lateral decubitus position" were discussed. Elbow arthroscopy involves a minimally invasive surgical procedure on the elbow using an arthroscope, while lateral decubitus position refers to the patient lying on their side, which is common during such surgeries.

Did this episode on medical device innovation resonate with you? We would love to hear your thoughts and feedback. Leave us a review on iTunes and share your views on the future of MedTech innovations! For suggestions on future topics, please email us at podcast@greenlight.guru

• Hunter Medical Devices
• Dr. Lee hunter on LinkedIn
• Tennessee Orthopedic Alliance
• Etienne Nichols on LinkedIn

This episode is brought to you by Greenlight Guru, a leading company in medical device consulting. Their expertise and services align seamlessly with the needs of the MedTech community, helping bring revolutionary devices to the market efficiently. Check out their special offers for podcast listeners today!