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Ep.012 Safe and Effective Podcast: FDA Regulatory Roundup: CDER Human Factors ANDA Draft Guidance (ft. Melissa Lemke)
Podcast on FDA Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product in an ANDA.
Mar 42 min read


Breaking into Medical Human Factors: A Guide for Aspiring Human Factors Engineers
Breaking into Medical Human Factors: A Guide for Aspiring Human Factors Engineers
Feb 277 min read


Determining When and How to Include Multiple Users in Human Factors Testing: Case Study Examples.
Examples of #UsabilityTesting for products in which multiple users may be involved in managing a #MedicalDevice for its #IntendedUse.
Apr 22, 20242 min read


Ep.008 Safe and Effective Podcast: Desperately Seeking: MedDev Human Factors Use Error Classification System (ft. Albert Boquet)
Podcast about using existing frameworks HFACS to develop a public use error classification system and database for human factors in MedDev.
Mar 22, 20242 min read


Ep.007 Safe and Effective Podcast: Women in (Med)Tech in HF/UX
Discussion on inequities / inequalities faced by women in the workplace, focusing on behavioral sciences, human factors and UX in (Med)Tech.
Jan 18, 20242 min read


Ep.005 Safe and Effective Podcast: Failure as a Path to Innovation & Resilient Outcomes
Failure and how our definitions and individual thinking around it limits not just innovation, but our entire personal and professional lives
Oct 23, 20232 min read


Ep.004 Safe and Effective Podcast: Collaborative Approach Between Clinical and HF (ft. Helene Quie)
Join us in our fourth episode where we dive deep with Helene Quie on the topic of collaborative approach between clinical and HF.
Oct 10, 20232 min read


Ep.003 Safe and Effective Podcast: Quantitative vs. Qualitative Data (ft. Dr. Bert Boquet)
In our 3rd episode of Safe and Effective, we discuss the ever-present debate: qualitative vs. quantitative data with Dr. Bert Boquet.
Sep 7, 20231 min read


Ep.002 Safe and Effective Podcast: Human Factors in MedDev Design & Engineering (ft. Maggie Reiff)
Safe and Effective, The Medical Human Factors Podcast. Latest developments in medical human factors and UX, including regulatory.
Jul 18, 20231 min read
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