In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.

Key Timestamps

• 00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.
• 00:05:22 - Discussing the first leg of risk management: managing residual risks in product safety.
• 00:17:50 - Exploring the second leg: the procedural risks in clinical protocols.
• 00:28:30 - Challenges of enrollment and protocol design.
• 00:35:45 - The impact of regulatory changes on clinical investigations.
• 00:49:10 - Addressing the integration of artificial intelligence in medical devices.
• 01:03:15 - Closing thoughts and call to action from Helene Quie.

Provocative Quotes

• "It's not just about managing risks; it's about ensuring that the benefits are powerful enough to justify those risks." - Helene Quie
• "Every clinical investigation introduces its own set of risks, not just from the product but from the study protocol itself." - Helene Quie
• "We must not only wear different glasses to see through the regulatory and practical aspects but also validate our views with the actual stakeholders involved." - Helene Quie

Key Takeaways

1. Insights on MedTech Trends:

• The increasing importance of data in justifying product safety and efficacy.
• The shift from intuition-based to evidence-based risk assessment.
• Regulatory bodies are placing greater emphasis on comprehensive clinical evaluations.

2. Practical Tips for MedTech Professionals:

• Ensure that risk assessments are detailed and backed by solid data.
• Consider the practical aspects of clinical trial protocols from multiple perspectives.
• Stay updated on regulatory changes to adapt protocols and product development effectively.

3. Future Predictions in MedTech:

• Enhanced scrutiny and requirements for clinical investigations.
• Greater integration of AI and digital tools in medical devices.
• Potential regulatory adaptations to accommodate innovations.

References

• Helene Quie on LinkedIn
• Etienne Nichols on LinkedIn
• QMED Consulting
• Questions to ask for Clinical Preparation
• EUMDR and MDD Comparisons: Insights into how regulatory frameworks have evolved and their impact on medical device development.

MedTech 101

For new listeners, this episode touches upon fundamental concepts like residual risk, clinical protocol, and risk-benefit assessment in the context of medical device clinical investigations. Understanding these terms is crucial for grasping the detailed discussions of the episode.

Audience Engagement

• Discussion Question: "What are your expectations for the future of healthcare with advancements in MedTech?"
• Feedback Request: Listeners are encouraged to leave a review on iTunes and suggest topics for future episodes by emailing [email protected]

Sponsors

This episode is proudly sponsored by Greenlight Guru, a leading provider of MedTech quality management & electronic data capture software. Greenlight Guru's platform is specifically designed to help medical device companies enhance the efficacy and safety of their products, ensuring they meet the stringent standards of regulatory bodies worldwide. Check out their exclusive offer for podcast listeners to streamline your quality management & data capture process.