Episode 4

Published on:

29th Sep 2023

A Collaborative Approach Between Clinical and HF (ft. Helene Quie)

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.

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About the Podcast

Safe and Effective
The Medical Human Factors Podcast
If you're interested in staying informed about the latest developments in medical human factors and user experience, then Safe and Effective is the podcast for you. We bring you lessons learned, case studies, and regulatory updates, through our conversations with experts from industry, academia, and government to share their insights and experiences with you. Join us as we explore the world of human factors and its impact on the medical field. Whether you're an industry expert or a novice looking to learn more, Safe and Effective, The Medical Human Factors Podcast is for you.

About your host

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Heidi M

Heidi is the founder and CEO of the medical human factors and usability consultancy HFUX Research, LLC, which specializes in medical device, technology, and combination product research, design, testing, and development. She has a wide-ranging background as a trained pilot, emergency medical technician, software analyst and human factors and usability expert within the (medical) product development industry. Her motivation for the past 20 years has been directed toward enhancing human-product performance by optimizing user interface design, information architecture and user and product workflow, through the application of human factors science and usability practices. She is an active mentor in the HF/UX community and HFES society. She holds patents in GUI design for medical imaging and surgical navigation software systems, a BS in Aeronautics, and a MS in Human Factors and Systems, both from Embry-Riddle Aeronautical University, as well as technical degrees in IT Mgmt. and Emergency Medical Services, from Sacred Heart University and Daytona State College.