Validating safe and effective use of a neonatal respiratory machine

A medical technology company needed to confirm that a neonatal breathing circuit was ready for use in the US market and in its intended clinical environment. We were asked to manage summative usability testing to validate safe and effective use, including protocol review, participant recruitment, lab setup, and data collection.

We recruited healthcare providers with varying levels of experience and relevant clinical backgrounds. At our Chicago lab facilities, we recreated a realistic care environment using a ventilator, neonatal incubator, and an additional researcher acting as a care team member. Guided by a moderator, participants completed representative tasks with the device as they would in their normal work setting.

Our simulation-based approach allowed us to capture authentic user interactions, identify potential use errors, and assess device usability under realistic conditions. These findings directly supported the client’s regulatory submission.

The client received comprehensive validation data and actionable findings to confirm safe and effective device use, helping ensure readiness for market launch in the intended clinical setting.