Check out Laurie's take-aways from the MassMEDIC Regulatory Roundup Review. A must-read on latest topics for medical device development.

Read about the FDA's new guidance, which details how medical device manufacturers can include pre-planned modifications in their submission.

​ Rebecca Lee ​ At the 2024 HFES (International Human Factors Symposium), Laurie and Jan shared key study design considerations for testing

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!

LHF's summary of Edmond Israelski and William Muto's Risk Management in Human Factors book. Learn how to conduct a uFMEA and FTA!

Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.

Introduction With increasing awareness of the importance of gender inclusivity, the user research community should take time to reflect...

I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...

Introduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...

Rise in Telehealth during Covid 19 In the last year and a half, state-mandated travel and operating capacity restrictions have caused a...

Think of the last time you interviewed someone, and they just responded with “yes” or “no.” We have all experienced an interviewee that...

At the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...

We are developing the instructions for use (IFU) for an imaging device used by physicians. The client decided to conduct a small,...

A few interesting things I learned from the FDA HFPMET at this year's HFES healthcare symposium.

Discusses the meaning of "worst case scenarios" and provides guidance on selecting scenarios for usability testing of medical devi

This blog discusses the need for realism, types of stress, techniques for simulating stress, limitations of the techniques, and ethical cons

The good news is that the FDA has published a report on the importance of observational research.

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...

Last month at the 2017 International Symposium on Human Factors and Ergonomics in Health Care I organized a panel discussion to talk...

Last week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...