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Published on:

19th May 2023

FDA Human Factors Regulatory Roundup (ft. Janet Creaser)

In the premiere episode of Safe and Effective we bring you an exciting blend of regulatory insights and live interviews from this years HFES Healthcare Symposium in Orlando, Florida.

In our first regulatory roundup segment ever we talk to Janet Creaser about the FDA’s newest human factors draft guidance released in December 2022, Content of Human Factors Information in Medical Device Marketing Submissions. We discuss its content, goal, and use, while pointing out some of its advantages, as well as weak spots.

Additionally in this episode we share some insights from this year’s HFES International Healthcare Symposium in Orlando, Florida, from our field correspond indent interviewing some of its organizers.

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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.