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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry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