Nadya GanemApr 125 minGender Inclusivity in User ResearchIntroduction With increasing awareness of the importance of gender inclusivity, the user research community should take time to reflect...
Laurie ReedDec 14, 20214 minSummary of MedTech Intelligence’s Webinar from Nov 30th, 2021I recently attended a webinar hosted by MedTech Intelligence called “EU MDR Lessons Learned.” The webinar content was presented by three...
Jan HemmelmannSep 21, 20213 minFDA Final Rule on the Use of Symbols in LabelingIntroduction The use of “stand-alone symbols” or symbols without corresponding explanatory text in medical device instructions offers...
Jan HemmelmannJun 2, 20214 minTelehealth 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...
Nadya GanemMay 10, 20215 minBeyond the 5 Why’sThink of the last time you interviewed someone, and they just responded with “yes” or “no.” We have all experienced an interviewee that...
Hannah CutrightSep 28, 20202 min4 Examples of How COVID is Accelerating Home Use DevicesAt the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...
Carrie McGrathMar 29, 20202 minBe Careful What You Ask For: Nuances of Phrasing Research QuestionsWe are developing the instructions for use (IFU) for an imaging device used by physicians. The client decided to conduct a small,...
Beth LoringApr 24, 20193 minUpdates from the FDA CDRH Human Factors Team 2019A few interesting things I learned from the FDA HFPMET at this year's HFES healthcare symposium.
Beth LoringOct 16, 20183 minWorst-Case Scenarios for Usability TestingDiscusses the meaning of "worst case scenarios" and provides guidance on selecting scenarios for usability testing of medical devi
Beth LoringJun 1, 20184 minSimulating Stress in Usability TestingThis blog discusses the need for realism, types of stress, techniques for simulating stress, limitations of the techniques, and ethical cons
Beth LoringJan 22, 20181 minUpdate on Hospital Access ChallengesThe good news is that the FDA has published a report on the importance of observational research.
Beth LoringSep 5, 20171 minSeeking Proposals: 2018 HFES Healthcare Symposium in BostonI’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 LoringApr 5, 20172 minHospital Access Challenges: Panel ReportLast month at the 2017 International Symposium on Human Factors and Ergonomics in Health Care I organized a panel discussion to talk...
Beth LoringMar 17, 20173 minFDA/CDER Workshop HighlightsLast week I attended the sixth annual HFES International Symposium on Human Factors and Ergonomics in Health Care in New Orleans, LA,...
Beth LoringFeb 7, 20172 minFDA Draft Guidance - Comparative Use HF Studies in an ANDAIn January, 2017 the US FDA published a draft guidance, Comparative Analyses and Related Comparative Use Human Factors Studies for a...