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Ep.012 Safe and Effective Podcast: FDA Regulatory Roundup: CDER Human Factors ANDA Draft Guidance (ft.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
The Critical Role of Human Factors Task Analysis in Medical Device Development: Bridging Human Factors and Risk Assessment
Task analysis in Human Factors Engineering ensures safe & effective MedDevices by mitigating errors and meeting FDA, IEC and MDR standards.
Jan 306 min read
Ep.010 Safe and Effective Podcast: Starting from Scratch - Integrating Agile Mode into HF/UX Research Operations (ft. Nick Roome)
Podcast about integrating human factors and UX functions within an organization and applying agile development methodologies into it.
Oct 16, 20242 min read
'Safe and Effective' Joins the 'Beers with Engineers' Podcast
Podcast about Engineering with Engineers; in this episode: Human Factors Engineering in Medical Device Development.
Jul 21, 20242 min read
Key Takeaways of FDA and CRCG 2024 DDCP Workshop: When Might "Other Design Differences" Be Justified Without a Comparative Use Human Factors Study (CUHF)?
Key Takeaways of FDA and CRCG 2024 DDCP Workshop: When Might "Other Design Differences" Be Justified Without a Comparative Use Human Factors
Jun 18, 20247 min read
Ep.009 S&E Podcast: AI in Healthcare Human Factors: Ready or Not, Here it Comes, Can We Hide? (ft. Kate Preston and Barry Kirby)
Podcast about developing and using AI in healthcare and medical device and technology development and its human factors challenges.
Jun 7, 20242 min read
HFUX Research Presenting at FDA CDER FY 2024 Generic Drug Science and Research Initiatives Public Workshop
It’s Hip to be Square: Demonstrating Equivalency without Inferiority in Comparative Use Human Factors Studies
May 3, 20242 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.006 Safe and Effective Podcast: The Human (Factor) in the Neurodivergent Experience
Episode 006: In this episode of Safe and Effective we are featuring an excerpt of the previously recorded Human Factors Cast show in...
Dec 26, 20232 min read
Here's a Look Back at the 2023 HFES Aspire 67th International Annual Meeting
What a super awesome week the HFES 67th International Annual Meeting turned out to be.
Oct 31, 20232 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
HFUX joins the The Medical Sales Accelerator Podcast
Heidi reveals the common areas where many innovators fall short & explores how human factors can enhance their efficiency in moving forward.
Oct 19, 20231 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
Ep.001 Safe and Effective Podcast: FDA Human Factors Regulatory Roundup (ft. Janet Creaser)
Ep.001 Safe and Effective Podcast: FDA Human Factors Regulatory Roundup (ft. Janet Creaser)
May 26, 20231 min read
We're Back - HFUX joins the Human Factors Cast and Show: This week 'Road Rage Meets Robo-Cars'
Episode 282: On this episode the human factors cast discover how road rage affects your #driving and the potential impact on #selfdriving...
May 17, 20231 min read
Best Practices for Use-Related Risk Analysis Through Collaboration of Human Factors and Clinical
Introduction Integrating human factors and its user-centered approach and corresponding Human Factors Engineering (HFE) process into risk...
May 15, 20233 min read
Announcing: Safe and Effective | The Medical Human Factors Podcast!
This is the official trailer for Safe and Effective, the Medical Human Factors Podcast.
Mar 25, 20231 min read
On a Roll - HFUX joins the Human Factors Cast and Show: This week 'How the Culture Affects HCI'
Episode 272: On this episode the human factors cast talked about #culture, #cognition, and #humancomputerinteraction. They also answer...
Feb 23, 20231 min read
Back at it again - HFUX joins the Human Factors Cast and Show: This week 'Pilots in Distress'
Episode 266: On this episode the human factors cast talked about the system that keeps #pilots from seeking #mental #healthcare. They...
Dec 7, 20221 min read
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