The challenge

A medical device startup developed a next-generation medical wearable device intended for adult patients and caregivers. However, early pilot testing revealed high rates of use errors during device set-up and pairing, potentially leading to incorrect health data transmission.

Our approach

Over the course of six months, Human Factors Insight conducted two iterative rounds of formative usability testing with representative patient and caregiver participants.

All usability studies were conducted in a simulated test environment. During each usability test session, each participant performed representative use scenarios to evaluate the wearable medical device’s usability.

Results

The final human factors (HF) validation study showed a 85% reduction of use errors associated to critical tasks among the target participant user groups. The Human Factors Engineering (HFE) report was submitted to the FDA as part of the 510(k) package, resulting in clearance in under 6 months with zero additional HFE questions from regulatory reviewers.