The Floodlight MS smartphone app is an EU MDR-certified medical device that collects objective data on the function of patients with multiple sclerosis between clinic visits with their healthcare provider. The app contains activities that measure cognition, hand function, and walking ability and data can be shared with patients' doctors to have more informed care conversations.
While at Roche, I collaborated with the human factors and design teams to conduct summative studies for the Floodlight program. I also supported the EU MDR gap assessment and audit in the front room as part of the Regulatory team.
Because of COVID-19, I remotely reviewed summative protocols and supported our on-site moderator in conducting 1:1 simulated use testing with a set of 15 representative participants. Then, I transcribed data to create a heat map of the users' performance on tasks to conduct a root cause analysis.
Following analysis of use errors, I contributed toward authoring the summative study reports and usability engineering files to show that the activities within our app were safe and effective for intended users.