Feb 28 2025 67 mins 1
Join us in our latest episode of Safe and Effective, where we take a deep (and possibly exasperated) dive into one of the most debated regulatory guidances in the drug-device combination product world — the FDA’s Comparative Analyses and Comparative Use Human Factors Studies Guidance — with none other than our dear friend, industry powerhouse, and regulatory truth-teller, Melissa Lemke.
We’re tackling the big questions head-on:
* What does this guidance actually say (versus what people think it says)?
* Where does it hit the mark?
* And where does it leave us wondering if regulatory agencies and industry are even speaking the same language?
From decoding the intent behind comparative use studies to unpacking why the non-inferiority statistical approach is still a regulatory AND a human factors headache, Melissa and Heidi break down the nuances of this guidance — calling out problem areas, highlighting the biggest misconceptions, and, of course, offering a few unsolicited (but definitely necessary) ideas for improvement.
Whether you’re a regulatory pro navigating drug-device submissions, a human factors engineer caught in the crossfire of comparative studies, or just here for some unfiltered industry banter, this episode is a front-row seat to the real talk you won’t find in official guidance documents.
Expect strong opinions, a little regulatory myth-busting, and plenty of “did they really just say that?” moments.
Because if we have to talk about FDA guidance, we’re at least going to make it worth your time.
- Instagram: Safe and Effective | The Medical Human Factors Podcast
- Instagram: HFUX Research | Medical Human Factors
- Bluesky: @safeeffectivepodcast.com
- Bluesky: @hfuxresearch.com
- Guest: Melissa Lemke
- Safe and Effective | The Medical Human Factors Podcast
- HFUX Research | Medical Human Factors
- Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA
- Host: Heidi Mehrzad
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry
- Applying Human Factors and Usability Engineering to Medical Devices
