Formative and validative human factors studies for automated insulin dosing app
Assessing task performance for the use of critical safety-related features ahead of clinical trials
Flexible Problem-Solving
Re-wrote protocols and moderators guides on a short deadline to change a formative study to a validation study, redesigning tasks in order to produce data that could be submitted to the FDA
Root Cause Analysis
Rapid scorekeeping and note-taking during sessions, conducting root cause probing and analysis
Project Management
Project management for in-person study including collecting consent forms, organizing mobile devices and insulin pump prototypes for each participant over several days, troubleshooting prototype issues during sessions, and managing recordings and live streams including webcams and screen mirroring
[Report] Writing
Drafting [document name(s)] including descriptions of use errors and close calls, residual risk commentary, risk mitigation efforts already in place, and any changes to the product which would justify additional testing before clinical trials
Impact
Drafted consistent and thorough documentation of risk analysis for submission to the FDA
Recommended design updates to the app for tasks with an unacceptably high number of use errors
Ensured that studies were organized, well-documented, and ran on schedule
