Summative Usability Test of Wearable Seizure monitoring Device (2016)
Motivation
Client A (NDA binding), a startup company that was developing a groundbreaking portable seizure monitoring device, needed help negotiating Food and Drug Administration (FDA) requirements for premarket approval.
Process
The User-View team conducted summative usability tests of the seizure monitoring device on real-life seizure patients in accordance with good manufacturing practices set forth in the Code of Federal Regulations - Title 21 - Chapter I - Subchapter H – Part 820. On Day 1, seizure patients and a designated caregiver came to the testing site and received training on the use of the seizure monitoring device. The next day, patients returned with their caregivers and performed tasks using the device. We identified user errors, determined their causes, assessed the potential user risk posed by these errors, and recommended measures for their mitigation.
Outcome
Client A applied the recommended mitigations and the device was cleared for the next phase of the premarket approval process.
