Polso, End-to-end usability for FDA submission: from risk analysis

End-to-endhuman factors engineering and usability testing for a wearable, multi-sensorwireless wrist monitor.

Polso Connect is a wearable monitoring device that uses a multi-sensor wrist monitor to continuously transmit patient data to clinicians. It tracks multiple vital signs, including blood pressure and EEG, supporting more effective management of chronic conditions outside the clinical setting.

Leveraging our expertise in human factors engineering and user research, Cognit led a comprehensive, end-to-end usability process to ensure the product is safe, effective, and easy to use for a wide range of users.

A central component of this effort was the planning and execution of two full summative studies in the US - each conducted on a different product version. Cognit provided complete end-to-end ownership, from study design and recruitment to execution and FDA-compliant reporting, ensuring the product met regulatory requirements while maintaining a high standard of usability in real-worldconditions.

The process began with a detailed Use-Related Risk Analysis, identifying potential use errors, their root causes, and possible clinical implications. These insights informed three formative studies conducted in Israel with a total of 20 participants, focusing on safety-critical interactions and ease of use in realistic scenarios.

In parallel, we conducted an expert evaluation to identify usability gaps and refine the overall user experience - helping improve both product design and safety.