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!
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Beth Loring
- Apr 7
- 2 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.
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Nadya Ganem
- Apr 12, 2022
- 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...
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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...
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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...
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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...
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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...
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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”...
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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,...
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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.
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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
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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
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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.
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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...
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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...
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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,...
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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...
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