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    Gender Inclusivity in User Research
    Nadya Ganem
    • Apr 12
    • 5 min

    Gender Inclusivity in User Research

    Introduction With increasing awareness of the importance of gender inclusivity, the user research community should take time to reflect...
    62 views0 comments
    Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021
    Laurie Reed
    • Dec 14, 2021
    • 4 min

    Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021

    I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...
    106 views0 comments
    FDA Final Rule on the Use of Symbols in Labeling
    Jan Hemmelmann
    • Sep 21, 2021
    • 3 min

    FDA Final Rule on the Use of Symbols in Labeling

    Introduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...
    237 views0 comments
    Telehealth During and After Covid-19
    Jan Hemmelmann
    • Jun 2, 2021
    • 4 min

    Telehealth During and After Covid-19

    Rise in Telehealth during Covid 19 In the last year and a half, state-mandated travel and operating capacity restrictions have caused a...
    36 views0 comments
    Beyond the 5 Why’s
    Nadya Ganem
    • May 10, 2021
    • 5 min

    Beyond the 5 Why’s

    Think of the last time you interviewed someone, and they just responded with “yes” or “no.” We have all experienced an interviewee that...
    134 views0 comments
    4 Examples of How COVID is Accelerating Home Use Devices
    Hannah Cutright
    • Sep 28, 2020
    • 2 min

    4 Examples of How COVID is Accelerating Home Use Devices

    At the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...
    53 views0 comments
    Be Careful What You Ask For: 
Nuances of Phrasing Research Questions
    Carrie McGrath
    • Mar 29, 2020
    • 2 min

    Be Careful What You Ask For: Nuances of Phrasing Research Questions

    We are developing the instructions for use (IFU) for an imaging device used by physicians. The client decided to conduct a small,...
    111 views0 comments
    Beth Loring
    • Apr 24, 2019
    • 3 min

    Updates from the FDA CDRH Human Factors Team 2019

    A few interesting things I learned from the FDA HFPMET at this year's HFES healthcare symposium.
    275 views0 comments
    Worst-Case Scenarios for Usability Testing
    Beth Loring
    • Oct 16, 2018
    • 3 min

    Worst-Case Scenarios for Usability Testing

    Discusses the meaning of "worst case scenarios" and provides guidance on selecting scenarios for usability testing of medical devi
    1,319 views0 comments
    Simulating Stress in Usability Testing
    Beth Loring
    • Jun 1, 2018
    • 4 min

    Simulating Stress in Usability Testing

    This blog discusses the need for realism, types of stress, techniques for simulating stress, limitations of the techniques, and ethical cons
    636 views0 comments
    Update on Hospital Access Challenges
    Beth Loring
    • Jan 22, 2018
    • 1 min

    Update on Hospital Access Challenges

    The good news is that the FDA has published a report on the importance of observational research.
    117 views0 comments
    Seeking Proposals: 2018 HFES Healthcare Symposium in Boston
    Beth Loring
    • Sep 5, 2017
    • 1 min

    Seeking Proposals: 2018 HFES Healthcare Symposium in Boston

    I’m excited to be co-chair of the Medical and Drug-Delivery Devices track for the 2018 International Symposium, to be held March 26-28 in...
    295 views0 comments
    Hospital Access Challenges: Panel Report
    Beth Loring
    • Apr 5, 2017
    • 2 min

    Hospital Access Challenges: Panel Report

    Last month at the 2017 International Symposium on Human Factors and Ergonomics in Health Care I organized a panel discussion to talk...
    172 views0 comments
    Beth Loring
    • Mar 17, 2017
    • 3 min

    FDA/CDER Workshop Highlights

    Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...
    162 views0 comments
    FDA Draft Guidance - Comparative Use HF Studies in an ANDA
    Beth Loring
    • Feb 7, 2017
    • 2 min

    FDA Draft Guidance - Comparative Use HF Studies in an ANDA

    In January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...
    460 views0 comments
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