Safe and Effective

About Safe and Effective

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.

Publisher

Human Factors Cast

Category

education · health & fitness · science

Language

en

Explicit

No

First episode

24 Mar 2023

Latest episode

28 Feb 2025

Latest episodes

13 episodes in the feed.

1. 

   28 Feb 2025

   FDA Regulatory Roundup: CDER Human Factors ANDA Guidance (ft. Melissa Lemke)

   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 (https://www.instagram.com/safeeffectivepodcast) Instagram: HFUX Research | Medical Human Factors (https://www.instagram.com/hfuxresearch/) Bluesky: @safeeffectivepodcast.com (https://bsky.app/profile/safeeffectivepodcast.com) Bluesky: @hfuxresearch.com (https://bsky.app/profile/hfuxresearch.com) Guest: Melissa Lemke (https://www.linkedin.com/in/melissa-r-lemke-hfe/) Safe and Effective | The Medical Human Factors Podcast (https://www.safeeffectivepodcast.com) HFUX Research | Medical Human Factors (https://www.hfuxresearch.com) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and) Host: Heidi Mehrzad (https://www.hfuxresearch.com) Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination) Applying Human Factors and Usability Engineering to Medical Devices (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices)

2. 

   12 Nov 2024

   Election Edition: What happened to the Human Factor in Elections and Society?

   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. But I guess those times are over. Or maybe they were never really achieved. Or maybe, just maybe, this is the new beginning we needed all along. Maybe we needed an undeniable end. Clear cut. No illusion of what happened and why. All so we can course correct and start healing. Rise from the ashes. So we can finally experience a rebirth of something better. Maybe even something more beautiful than we could have ever imagined.

3. 

   16 Oct 2024

   Starting from Scratch: Integrating Agile Mode into HF/UX Research Operations (ft. Nick Roome)

   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. 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. 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. 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. 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. Instagram: safeeffectivepodcast Safe and Effective | The Medical Human Factors Podcast (https://www.safeeffectivepodcast.com) Instagram: Safe and Effective | The Medical Human Factors Podcast (https://www.instagram.com/safeeffectivepodcast?igsh=aDJwZXJkZ2hjN3Vv&utm_source=qr) Host: Heidi Mehrzad (https://www.linkedin.com/in/manijehmehrzad/) Co-Host: Nick Roome (https://www.linkedin.com/in/nickroome/) HFUX Research | Medical Human Factors (https://www.hfuxresearch.com) Mentioned in this episode: Human Factors Cast Podcast Network Patreon https://www.patreon.com/humanfactorscast

4. 

   31 May 2024

   AI in Healthcare Human Factors: Ready or Not, Here it Comes, Can We Hide? (ft. Kate Preston and Barry Kirby)

   Join us in our latest episode of Safe and Effective, where we welcome our new friend Kate Preston and our Human Factors Cast family member Barry Kirby to have a chat with us about AI in Healthcare and Medical Device and Development and HumanFactors and its current and future challenges, as well as the implications for such. AI in medical device development and healthcare human factors is more and more becoming an area we not just need to explore further and more comprehensively, but also investigate more diligently for its impact on patient and user safety and data privacy, as its most critical input involves vast amounts of confidential patient and user data. After all, AI is (currently) simply an accumulation, synthesis, and analysis of current data. We explore AI's current applications in healthcare, including its human factors challenges, highlighting its advantages and drawbacks, as well as its implications for future AI usage and development. We walk through some of the most critical aspects of the current landscape of AI in healthcare and how future AI developments could be envisioned. And we get into the complexities of how humans in the healthcare professions are not to be replaced by AI, but instead how AI could potentially support their day to day tasks and workflows by aiding in tasks impossible for humans, such as on-the-spot processing of extremely large data sets. Peeling back the layers of data privacy and patient safety, as well as people's comfort with the use of AI, we end our discussion with breaking down crucial considerations to be taken when implementing AI into healthcare and its professions, as well as the development and the use of the medical devices and technologies used within, including its overall system and structures. Instagram: safeeffectivepodcast K SHARP - Innovators in Human Factors (https://www.ksharp.co.uk/) Guest: Barry Kirby (https://www.linkedin.com/in/barrypkirby/) Guest Kate Preston (https://www.linkedin.com/in/kate-preston-691179a3/) Safe and Effective | The Medical Human Factors Podcast (https://www.safeeffectivepodcast.com) Instagram: Safe and Effective | The Medical Human Factors Podcast (https://www.instagram.com/safeeffectivepodcast?igsh=aDJwZXJkZ2hjN3Vv&utm_source=qr) Host: Heidi Mehrzad (https://www.linkedin.com/in/manijehmehrzad/) HFUX Research | Medical Human Factors (https://www.hfuxresearch.com)

5. 

   22 Mar 2024

   Desperately Seeking: MedDev Human Factors Use Error Classification System (ft. Bert Boquet)

   Join us in our latest episode of Safe and Effective, where we welcome back our good friend Dr. Albert Boquet to talk about using an existing framework, such as HFACS, to develop a unified use error classification system and database to add as a tool to the human factors engineering process in the medical device and combination product (development) industry. In our discussion we shed light on the nuances between not only use errors and their identification and classification, but also how such is a data driven system that requires building on. We get into the complexities of how humans are not engineered, but instead bio-psycho-social systems, and how therefore, their behaviors and actions can not be evaluated using methods and thinking originally derived and intended for engineered systems. We end our discussion with exploring the idea of implementing such a use error classification system, where to start, and how ultimately it could enable an elevated capacity of prioritization and mitigation of risks associated with such and increase device safety and effectiveness overall. Additionally, we provide a sneak preview of what all we have in store for you during the upcoming Safe and Effective Instagram Live events streamed directly from the HFES 2024 International Symposium on Human Factors and Ergonomics in Health Care in Chicago, Illinois, from March 24-26th, 2024. Instagram: safeeffectivepodcast The Human Factors Analysis and Classification System (HFACS) Framework (https://www.hfacs.com/hfacs-framework.html) HFES HCS Poster, March 26th, 2024: Determining When and How to Include Multiple Users in Human Factors Testing - Case Study Examples (https://hfeshcs2024.conference-program.com/presentation/?id=POST252&sess=sess128) HFES 2024 International Symposium on Human Factors and Ergonomics in Health Care, March 24 - 27, 2024 at the Hilton Chicago Hotel (https://www.hfes.org/Events/Health-Care-Symposium) Host: Heidi Mehrzad (https://www.linkedin.com/in/manijehmehrzad/) HFUX Research | Medical Human Factors (https://www.hfuxresearch.com) Guest: Albert Boquet (https://www.linkedin.com/in/albert-boquet-97590912/) Applying Human Factors and Usability Engineering to Medical Devices | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination) FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions)

6. 

   18 Jan 2024

   Women in (Med)Tech in HF/UX (ft. Rebecca Grier)

   Join us in our latest ‘Let’s Get Real’ episode of Safe and Effective, where we delve into a nuanced and multi-faceted conversation with Rebecca Grier, a behavioral science expert in human factors and UX in the tech industry, discussing the broader issues of inequities and inequalities faced by women in the workplace, with a focus on behavioral sciences in the Tech and MedDev industries, particularly in the realms of human factors (HF) and user experience (UX). Together, we explore topics such as biases, advantages and disadvantages, the perception of HF and UX, their interrelationship, historical context, and their application across various industries and organizations. Drawing from our professional and personal experiences, we share insights into the challenges encountered by women in our careers, how the science of human factors has evolved and continuously reinvented itself over the past century, and how our mutual love for data and statistics allows us to embrace our inner data geeks and have fun our own ‘scientist-y’ way. In a moment of candid reflection, we address the realities of misogyny and sexism, both subtle and overt, that we have encountered throughout our careers and lives, how we confronted them and prevailed, and how we remain hopeful for a future where the next generation of women can thrive in a genuinely gender-equal society. The 'Pause Life by Dr. Mary Claire Haver - Demystifying Menopause (https://thepauselife.com/?gad_source=1&gclid=Cj0KCQiAtaOtBhCwARIsAN_x-3L7OxjNl-2iFabWCHKd1aUpIPHVa6jwpje999qozsQuDPnOh648GPMaAvf-EALw_wcB) Women are better leaders – and it's backed by science! (https://www.femalefactor.global/post/women-are-better-leaders-and-it-s-backed-by-science) Men or Women: Who’s the Better Leader? | Pew Research Center (https://www.pewresearch.org/social-trends/2008/08/25/men-or-women-whos-the-better-leader/) Research: Women Are Better Leaders During a Crisis (https://hbr.org/2020/12/research-women-are-better-leaders-during-a-crisis) Research: Women Score Higher Than Men in Most Leadership Skills (https://hbr.org/2019/06/research-women-score-higher-than-men-in-most-leadership-skills) New Research: Women More Effective Than Men In All Leadership Measures (https://www.forbes.com/sites/kevinkruse/2023/03/31/new-research-women-more-effective-than-men-in-all-leadership-measures/?sh=60cff444577a) Gestalt Psychology, Gestaltism, or Configurationism (https://en.wikipedia.org/wiki/Gestalt_psychology) Lillian Moller Gilbreth 'Efficiency Engineer' (https://en.wikipedia.org/wiki/Lillian_Moller_Gilbreth) Guest: Rebecca Grier (https://www.linkedin.com/in/rebecca-grier-ux/) Host: Heidi Mehrzad (https://www.linkedin.com/in/manijehmehrzad/) HFUX Research | Medical Human Factors (https://www.hfuxresearch.com)

7. 

   26 Dec 2023

   The Human (Factor) in the Neurodivergent Experience (ft. Nick Roome)

   In today’s episode of Safe and Effective we are featuring an excerpt of the previously recorded Human Factors Cast show in which Nick Roome and our host Heidi Mehrzad shared their personal experiences living with ADHD and AuDHD/ASD and discussed the various ways in which their neurodiversity impacts their lives. From professional to personal relationships to day to day tasks and lives, as well as how they see the world through their neurodivergent eyes. Of course, as ADHDer’s would, they go off on many side tangents discussing ADHD and parenting, AuDHD in social interactions, and even take a sharp left turn and dive into the deeper meaning of unconditional love, how they personally define it, and how they have learned and experienced it throughout their lives. Our vision for today’s episode is simple: sit back, relax, enjoy their chaotic and often times, let’s face it, hilarious conversation about anything and everything, and know that you are not alone in your neurodivergent mind. And please remember, you are worthy of love, you are enough, and your neurodivergent mind does not make you a burden. And for all the neurotypicals listening out there, we hope you enjoy their beautiful zig zag conversation about how their minds work and process the world around them, and maybe, who knows, you learn something today that will allow you to gain a new or changed perspective and enable you to connect deeper with the neurodivergent people in your lives. Enjoy a very typical ADHD-all-over-the-place-wonderfully-and-deeply-amusing-chat on their very own, deeply personal, daily neurodivergent experience in a world made for neurotypicals. HFES Panel, October 27th, 2023: Failure as a Path to Innovation and Resilient Outcomes (https://hfesam2023.conference-program.com/presentation/?id=DP121&sess=sess220) Host: Heidi Mehrzad (https://www.linkedin.com/in/manijehmehrzad/) Co-Host: Nick Roome (https://www.linkedin.com/in/nickroome/) HFUX Research | Medical Human Factors (https://www.hfuxresearch.com) Safe and Effective The Medical Human Factors Podcast (https://www.safeeffectivepodcast.com) Holiday Note from our Host: During this time of year many people struggle, especially the ones in the neurodivergent community. When everyone’s focus is to come together and travel to where we belong during the holidays, it is easy to get lost and feel alone and isolated. It is therefore all the more important that we take care of and show grace to ourselves and the people around us. Be kind to yourself and one another. We know from research that kindness and our mental health are deeply connected. The research shows that kindness is an antidote to isolation and creates a sense of belonging. It helps reduce stress, brings a fresh perspective and deepens friendships and connections. Empathy, grace, gratitude, and kindness aren’t just some fashionable trends to engage in, they can be the reason someone makes it through the most difficult time of year, the reason someone doesn’t lose all hope, the reason someone finds their smile and joy again and is reminded that in fact they are not alone and love is indeed all around us after all. Be that reason for someone. Be someone’s sunshine. Happy Holidays to everyone.

8. 

   18 Oct 2023

   Failure as a Path to Innovation and Resilient Outcomes (ft. Christy Harper)

   Join us in our latest episode of Safe and Effective, in which we launch our newest segment ‘Let’s Get Real’ - where we drop all filters and stop masking and get real about special and sometimes sensitive topics and issues. In our first ever Let’s Get Real segment we talk with Christy Harper, usability expert and co-founder of End-to-End User Research, a usability and research consulting firm in Houston, Texas, about Failure as a Path to Innovation and Resilient Outcomes. Together, we venture into the often avoided topic of failure (and vulnerability) and how its multifaceted definitions and the perception of such across cultures and individual thinking play a crucial role, not just in device innovation, research, and design and development, but also in our personal and professional lives and growth. We dig deep into how our often limited view and definition of failure (and vulnerability) can sneak into our lives very subtly, but then influence every aspect of it full on. From personal relationships to work relationships, from life aspirations to career ambitions, from innovation to product and medical device research and development, failure and how we define it will nearly always dictate our outcomes. For a moment we get real, real uncomfortable - we promise it won’t hurt - talking about failure and how our definitions and thinking around it limits not just innovation, but our entire lives. Guest: Rebecca Grier (https://www.linkedin.com/in/rebecca-grier-ux/) HFES - Human Factors and Ergonomics Society International Annual Meeting October 23rd - 27th, 2023, in Washington DC (https://www.hfes.org/Events/International-Annual-Meeting/About/About#:~:text=Taking%20place%20October%2023%20%2D%2027,impacting%20our%20field%20and%20the) HFES Panel, October 27th, 2023 in the Georgetown West Room: Failure as a Path to Innovation and Resilient Outcomes (https://hfesam2023.conference-program.com/presentation/?id=DP121&sess=sess220) Host: Heidi Mehrzad (https://www.hfuxresearch.com) Mentioned in this episode: Human Factors Minute https://www.humanfactorsminute.com Human Factors Cast Podcast Network Patreon https://www.patreon.com/humanfactorscast Human Factors Cast https://www.humanfactorscast.media

9. 

   29 Sept 2023

   A Collaborative Approach Between Clinical and HF (ft. Helene Quie)

   Join us in our fourth episode of Safe and Effective, where we dive deep with Helene Quie, regulatory and clinical expert, and founder and CEO of Qmed Consulting A/S in Copenhagen, Denmark. Together, we explore the pivotal role of a collaborative approach between clinical and human factors teams in order to align with regulatory requirements as well as provide for more robust device safety and performance data. Helene sheds light on the criticality of controlled testing environments and how invaluable insights from real-world scenarios are not just fed back into device design and development to achieve improved usability, safety and, effectiveness, but instead also play a crucial role in MDR clinical evaluation requirements and reporting of such. Additionally, we touch on the ever-evolving landscape of FDA and European MDR regulation and requirements and their respective adaptations and adjustments to improve clinical, safety, and usability requirements. We conclude our thought-provoking discussion on the topic of an early use-related risk analysis and its integral purpose and most optimal place in the research and development process. Listen in for an enlightening conversation that bridges the gap between theory and practice of applying a more collaborative approach between human factors and clinical teams in the world of medical device development. In this episode we also provide a little sneak preview of our newest segment, 'Let's Get Real' - where we drop all filters and stop masking and get real about special and sometimes sensitive topics and issues. In our inaugural segment, we venture into the often-avoided topic of failure. Join us as we discuss failure as a path to innovation and resilient outcomes and how its multifaceted definitions and the perception of such across cultures and individual thinking play a crucial role, not just in device design and development, but also in our personal and professional lives and growth. Failure as a Path to Innovation and Resilient Outcomes (https://hfesam2023.conference-program.com/presentation/?id=DP121&sess=sess220) Best Practices for Use-Related Risk Analysis Through Collaboration of Human Factors and Clinical (https://journals.sagepub.com/doi/abs/10.1177/2327857923121044) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745) Guest: Helene Quie (https://qmed-consulting.com) Host: Heidi Mehrzad (https://www.hfuxresearch.com) Applying Human Factors and Usability Engineering to Medical Devices | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and)

10. 

    31 Aug 2023

    Quantitative v. Qualitative (ft. Bert Boquet)

    In our third episode of Safe and Effective, we talk to Bert Boquet about the intricacies of the ever-present data debate of qualitative vs. quantitative in the sphere of medical human factors summative (validation) studies. In our discussion we shed light on the complexities of choosing the right data type and formulating an effective experiment design for validation studies, whilst also discussing the nuances of such between medical devices and combination products. Together, we tackle the myriad of challenges human factors researchers confront regarding not just formulating an effective experiment design, but also identifying a potential unified approach for validation data collection between medical device and combination product approaches to ensure cohesive measures and robust data sets for both. Additionally, we provide a sneak preview of our next episode in which we address the integration of a collaborative approach between clinical and human factors teams, and it's necessity due to the evolution of the MDR and its "new" usability requirements within. Guest: Albert Boquet (https://www.linkedin.com/in/albert-boquet-97590912/) Host: Heidi Mehrzad (https://www.hfuxresearch.com) Applying Human Factors and Usability Engineering to Medical Devices | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and) Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry | FDA (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination)

11. 

    13 Jul 2023

    Human Factors in MedDev Design & Engineering (ft. Maggie Reiff)

    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 (https://www.linkedin.com/in/maggie-reiff-mba-04aa3087/) Host: Heidi Mehrzad (https://www.hfuxresearch.com) Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/instructions-use-patient-labeling-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 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/comparative-analyses-and-related-comparative-use-human-factors-studies-drug-device-combination) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/human-factors-studies-and-related-clinical-study-considerations-combination-product-design-and) Applying Human Factors and Usability Engineering to Medical Devices (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices)

12. 

    19 May 2023

    FDA Human Factors Regulatory Roundup (ft. Janet Creaser)

    In the premiere episode of Safe and Effective we bring you an exciting blend of regulatory insights and live interviews from this years HFES Healthcare Symposium in Orlando, Florida. In our first regulatory roundup segment ever we talk to Janet Creaser about the FDA’s newest human factors draft guidance released in December 2022, Content of Human Factors Information in Medical Device Marketing Submissions. We discuss its content, goal, and use, while pointing out some of its advantages, as well as weak spots. Additionally in this episode we share some insights from this year’s HFES International Healthcare Symposium in Orlando, Florida, from our field correspond indent interviewing some of its organizers. Guest: Janet Creaser (https://www.linkedin.com/in/janet-creaser-ph-d-47562b5/) Host: Heidi Mehrzad (https://www.hfuxresearch.com) FDA Draft Guidance (December, 2022): Content of Human Factors Information in Medical Device Marketing Submissions (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions)

13. 

    24 Mar 2023

    Safe and Effective (Show Trailer)

    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. https://www.safeeffectivepodcast.com/ (https://www.safeeffectivepodcast.com/)

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Apple Podcasts (US)

5.0 / 5

2 ratings

Podcast Authority Score: 11 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

11

Social presence

0

YouTube

0

Engagement

30

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