Ep.002 Safe and Effective Podcast: Human Factors in MedDev Design & Engineering (ft. Maggie Reiff)

Episode 002: In this episode our host, Heidi Mehrzad, talked with Maggie Reiff. Together they bring you a multifaceted conversation about #HumanFactors in #MedicalDeviceDevelopment from the unique perspective of a #DeviceEngineer. Maggie talks about her experience with integrating human factors into the #MedicalDevice engineering process and some lessons she has learned along the way. They also discuss the intricacies of making a case for 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.

Listen to the podcast here or on your favorite podcast platform.

#safeandeffectivepodcast #meddev #humanfactors #hfe #usability

#meddevice #podcast #pharma #medicaldevices #medtech #fda #humanfactorsengineering #medical #devicedesign #deciveengineering #medicaldevicedevelopment

Research Links for this episode:

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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry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

• Host: Heidi Mehrzad, ceo and founder, HFUX Research

• Guest: Maggie Reiff, head of research and development, GENIXUS