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.
Safe and Effective
Claim This Podcastby Human Factors Cast
5.0(2 reviews)
13 episodes
Updated Bi-weekly
Accepts GuestsHas SponsorsLocation 🇺🇸
11
Podcast Authority
BetaPoorBased on show quality, social media presence, reviews, charts, and more
Quality11
Social0
YouTube0
Engagement30
Podcast Overview
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.
Language
🇺🇲
Publishing Since
3/24/2023
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Podcast Authority
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Engagement30
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Recent Episodes
February 28, 2025
FDA Regulatory Roundup: CDER Human Factors ANDA Guidance (ft. Melissa Lemke)
<p>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.</p><p>We’re tackling the big questions head-on: </p><p>* What does this guidance actually say (versus what people think it says)? </p><p>* Where does it hit the mark? </p><p>* And where does it leave us wondering if regulatory agencies and industry are even speaking the same language? </p><p>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.</p><p>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.</p><p>Expect strong opinions, a little regulatory myth-busting, and plenty of “did they really just say that?” moments. </p><p>Because if we have to talk about FDA guidance, we’re at least going to make it worth your time.</p><ul><li><a href="https://www.instagram.com/safeeffectivepodcast">Instagram: Safe and Effective | The Medical Human Factors Podcast</a></li><li><a href="https://www.instagram.com/hfuxresearch/">Instagram: HFUX Research | Medical Human Factors </a></li><li><a href="https://bsky.app/profile/safeeffectivepodcast.com">Bluesky: @safeeffectivepodcast.com</a></li><li><a href="https://bsky.app/profile/hfuxresearch.com">Bluesky: @hfuxresearch.com</a></li><li><a href="https://www.linkedin.com/in/melissa-r-lemke-hfe/">Guest: Melissa Lemke </a></li><li><a href="https://www.safeeffectivepodcast.com">Safe and Effective | The Medical Human Factors Podcast</a></li><li><a href="https://www.hfuxresearch.com">HFUX Research | Medical Human Factors</a></li><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and">Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA</a></li><li><a href="https://www.hfuxresearch.com">Host: Heidi Mehrzad</a></li><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination">Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry</a></li><li><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices">Applying Human Factors and Usability Engineering to Medical Devices</a></li></ul><br/>
November 12, 2024
Election Edition: What happened to the Human Factor in Elections and Society?
<p>I can no longer be silent. I really believed better for us. Despite all the division in this country, I believed in the true American spirit. That when we are in crisis, we rally, we come together, we unify, we stand next to each other, and we support each other, and we fight for each other.</p><p>But I guess those times are over. </p><p>Or maybe they were never really achieved. </p><p>Or maybe, just maybe, this is the new beginning we needed all along.</p><p>Maybe we needed an undeniable end.</p><p>Clear cut. No illusion of what happened and why.</p><p>All so we can course correct and start healing.</p><p>Rise from the ashes.</p><p>So we can finally experience a rebirth of something better.</p><p>Maybe even something more beautiful than we could have ever imagined. </p>
October 16, 2024
Starting from Scratch: Integrating Agile Mode into HF/UX Research Operations (ft. Nick Roome)
<p>Join us in our latest episode of Safe and Effective, where we dive headfirst into the wild and wonderful world of integrating agile development methodologies into HF (Human Factors) and UX (User Experience) research operations, with none other than our friend, favorite human, and podcast bestie, Nick Roome.</p><p>We kick things off by tackling age-old questions, such as: how to start HF/UX research operations from scratch? And how to integrate agile development methodologies into it. With a lot of humor and a whole lot of real-world examples, Nick and Heidi walk you through the early stages of setting up HF/UX research operations, as well as how to optimally integrate agile development methodologies into it. Covering the most critical first steps, whilst avoiding some of the more common pitfalls to increase the chances of a “smooth launch,” Nick, a super seasoned expert with a rich background and years of hands-on experience in the field of agile HF and UX research operation functions, shares invaluable insights and tips and tricks not only on how to set up a successful research ops function within an organization, but also how to successfully integrate agile methodologies, such as SCRUM, into it. </p><p>Whether you are part of a startup or an established organization looking to embed HF/UX research into your product development process, this episode is your blueprint. Packed with practical advice, you'll leave feeling equipped to tackle the challenges of integrating agile processes with your research operations.</p><p>Fair warning: when two neurodivergent minds like Nick and Heidi come together, expect a few unexpected "user errors" along the way – because learning can (and should) be fun. So, brace yourself for a delightful mix of laughs and insights, sprinkled in-between those priceless wisdom drops, that only true HF/UX geeks can deliver.</p><p>We promise our usual HF and UX geek-level high entertainment value, plenty of laughs, and insights galore as we explore the world of research ops and agile methods. And while we can only hope for an 80% satisfaction rate (hey, even in HF/UX, perfection’s elusive), we can certainly guarantee you’ll walk away inspired and ready to take your HF/UX research to the next level.</p><p>Instagram: safeeffectivepodcast </p><ul><li><a href="https://www.safeeffectivepodcast.com">Safe and Effective | The Medical Human Factors Podcast</a></li><li><a href="https://www.instagram.com/safeeffectivepodcast?igsh=aDJwZXJkZ2hjN3Vv&utm_source=qr">Instagram: Safe and Effective | The Medical Human Factors Podcast</a></li><li><a href="https://www.linkedin.com/in/manijehmehrzad/">Host: Heidi Mehrzad</a></li><li><a href="https://www.linkedin.com/in/nickroome/">Co-Host: Nick Roome</a></li><li><a href="https://www.hfuxresearch.com">HFUX Research | Medical Human Factors</a></li></ul><br/><p>Mentioned in this episode:</p><p><strong>Human Factors Cast Podcast Network Patreon</strong></p><p>https://www.patreon.com/humanfactorscast</p>
13 total episodes available
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Frequently asked questions
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- What is Safe and Effective?
- How often does this podcast release new episodes?
This podcast updates bi-weekly.
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This podcast is available on 8 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
No, this podcast does not typically feature guests.
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