Medical device usability: literature review, current status, and challenges

Abstract

User involvement during medical device (MD) development and usability engineering techniques may help reduce serious adverse events due to human error during MD use. This paper reviews the scientific literature on MD usability and critically analyzes the MD design and development (MDDD) process. We searched 20 international databases for papers on usability and MDs. After applying exclusion criteria and removing duplicates, we analyzed 144 scientific papers regarding usability aspects and evaluated the target audience and study scope. Among hardware (HW), software (SW), and process (PR) evaluation methods, HW was the most evaluated (49% of papers), while the remainder analyzed HW + SW (15.2%), HW + PR (4.2%), and HW + SW + PR (0.7%). Task analysis, scenario simulation, and questionnaires were the most commonly used techniques (31.6%, 18.4%, and 12.8%, respectively). The target audiences were primarily patients/lay users (62%) and medical staff (14%). Gastroenterology (16.7%), nuclear medicine (13%), and nephrology/urology (9.3%) were the most referred specialties. We found that 48% of all papers did not mention any health facility or service analyzed, while 25.3% analyzed homecare services. Considering the usability scope, product evaluation (32%) and verification or validation trials (29%) were the most common. We present a brief review of the MDDD scenario and argue that better selection of usability methodologies in MDDD should be based around three factors: application of current technical standards on usability, usage of health technology assessment literature, consideration of ethics-related specificities of MD design.