Safe and Effective

In our second episode of Safe and Effective, we bring you multi-faceted conversation about human factors in medical device development from the unique perspective of a device engineer, Maggie Reiff. We talk to Maggie about her experience with integrating human factors into the device engineering process and what her lessons learned along the way were. We talk about the intricacies of making a case for proper implementation of human factors into the device design and engineering process and how to keep ahead of the game when leadership pushes back on usability test results they don't agree with.

Additionally, we provide a sneak preview of our next episode in which we address the everlasting debate of quantitative vs. qualitative data in human factors research, and how it is manifested in the medical device development industry, including guidances and regulations.

• Guest: Maggie Reiff
• Host: Heidi Mehrzad
• Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format
• Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry
• Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
• Applying Human Factors and Usability Engineering to Medical Devices

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In our first regulatory roundup segment ever we talk to Janet Creaser about the FDA’s newest human factors draft guidance released in December 2022, Content of Human Factors Information in Medical Device Marketing Submissions.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.

• Guest: Janet Creaser
• Host: Heidi Mehrzad
• FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions

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.

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