FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers
Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.
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Laurie Reed
Mar 225 min
Conducting an Aseptic Presentation Study
Rebecca Lee
At the 2024 HFES (International Human Factors Symposium), Laurie and Jan shared key study design considerations for testing
Beth Loring
May 8, 20232 min
A Summary of Risk Management Tools for Human Factors
LHF's summary of Edmond Israelski and William Muto's Risk Management in Human Factors book. Learn how to conduct a uFMEA and FTA!
Beth Loring
Apr 7, 20232 min
FYI, Most Medical Devices Are Not Designed For Most People
Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.
Beth Loring
Jun 2, 20214 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...
Beth Loring
May 10, 20215 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...
Beth Loring
Mar 29, 20202 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,...
Beth Loring
Apr 24, 20193 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.
Beth Loring
Oct 16, 20183 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
Beth Loring
Jun 1, 20184 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
Beth Loring
Jan 22, 20181 min
Update on Hospital Access Challenges
The good news is that the FDA has published a report on the importance of observational research.
Beth Loring
Sep 5, 20171 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...
Beth Loring
Apr 5, 20172 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...
Beth Loring
Mar 17, 20173 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,...
Beth Loring
Feb 7, 20172 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...
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