Usability can make an important difference for user adoption of software that is a medical device (SaMD). Our experts understand design inputs needed to develop safe and easy to use medical software. Check out this publication a “Human Factors Impact on the Development of Software as a Medical Device (SaMD): A Case Study Using the System Usability Scale (SUS)”
Human Factors Impact on the Development of Software as a Medical Device (SaMD): A Case Study Using the System Usability Scale (SUS)
1Otsuka Pharmaceutical Development and Commercialization, Inc., Princeton, New Jersey, United States; 2Innovenn, Inc., Madison, Wisconsin, United States; 3Balanced Experience, LLC, Madison, Wisconsin, United States
Methods: The SUS was used in 4 human factors studies of the APM System. Participants included nephrologists and radiologists who completed test cases using mock data. Participants had no prior experience with the software and received no training on the system. Participants entered clinical information, utilized the automated image measurement to calculate TKV, and generated the automated statistical calculation of predicted growth of TKV, a marker of disease progression. Participants then completed a SUS questionnaire. In each study, a global SUS score was calculated; a total of 79 participants contributed to the global SUS scores: 37 nephrologists, 28 radiologists and 14 nephrologist/radiologist support staff.
Results: APM System received the following SUS scores in studies one through four: 72, 77, 70*, and 80. The SUS score showed an 8 point increase from the first study to the fourth study.
*New functions (e.g. Consultation workflow) introduced.
Conclusion: The SUS results demonstrate the impact of iterative improvements in the design and usability of the APM System. The SUS global scores provide evidence that the perceived usability is above average and comparable to the average SUS score for the top 10 apps across iPhone, Android and tablets.