Takeaways from the MassMEDIC Regulatory Roundup Review
Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.
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Laurie Reed
Sep 115 min read
FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers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.
Laurie Reed
Mar 225 min read
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
Jun 27, 20235 min read
FDA Guidance on the Q-Submission Program
Check out LHF's analysis of the new FDA guidance on the Q-Submission Program! A must-read for anyone interested in interacting with the FDA!
Beth Loring
May 7, 20232 min read
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 6, 20232 min read
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
Apr 12, 20225 min read
Gender Inclusivity in User Research
Introduction With increasing awareness of the importance of gender inclusivity, the user research community should take time to reflect...
Beth Loring
Dec 14, 20214 min read
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...
Beth Loring
Sep 21, 20213 min read
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...
Beth Loring
Jun 2, 20214 min read
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 read
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
Sep 28, 20202 min read
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”...
Beth Loring
Mar 29, 20202 min read
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 read
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 read
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 read
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 read
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 read
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 read
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 read
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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