Join us in our fourth episode of Safe and Effective, where we dive deep with Helene Quie, regulatory and clinical expert, and founder and CEO of Qmed Consulting A/S in Copenhagen, Denmark.

Together, we explore the pivotal role of a collaborative approach between clinical and human factors teams in order to align with regulatory requirements as well as provide for more robust device safety and performance data. Helene sheds light on the criticality of controlled testing environments and how invaluable insights from real-world scenarios are not just fed back into device design and development to achieve improved usability, safety and, effectiveness, but instead also play a crucial role in MDR clinical evaluation requirements and reporting of such. Additionally, we touch on the ever-evolving landscape of FDA and European MDR regulation and requirements and their respective adaptations and adjustments to improve clinical, safety, and usability requirements. We conclude our thought-provoking discussion on the topic of an early use-related risk analysis and its integral purpose and most optimal place in the research and development process. Listen in for an enlightening conversation that bridges the gap between theory and practice of applying a more collaborative approach between human factors and clinical teams in the world of medical device development.

In this episode we also provide a little sneak preview of our newest segment, 'Let's Get Real' - where we drop all filters and stop masking and get real about special and sometimes sensitive topics and issues. In our inaugural segment, we venture into the often-avoided topic of failure. Join us as we discuss failure as a path to innovation and resilient outcomes and how its multifaceted definitions and the perception of such across cultures and individual thinking play a crucial role, not just in device design and development, but also in our personal and professional lives and growth.

• Failure as a Path to Innovation and Resilient Outcomes
• Best Practices for Use-Related Risk Analysis Through Collaboration of Human Factors and Clinical
• REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
• Guest: Helene Quie
• Host: Heidi Mehrzad
• Applying Human Factors and Usability Engineering to Medical Devices | FDA
• Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA