Episode 004: 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 #HumanFactors 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 usability 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 and most optimal and purpose 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.
We wrap up our episode with a little sneak preview of our new 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, and it’s sneak preview, we venture into the often-avoided topic of #Failure as a path to innovation and resilient outcomes and how its perception across cultures and individual thinking play a pivotal role, not just on our device #Design and #Development, but also our personal and professional growth.
Join us as we navigate these intertwined topics, ensuring a comprehensive understanding of both usability and the multifaceted nature of failure.
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Guest: Helene Quie