Understanding Usability: Guidance For Gathering Complete, Unbiased Data From Wearables

Usability is critical to wearable-enabled clinical trials. While device characteristics, such as the need for frequent charging, affect usability, they are only part of the equation. The scalability, ease of use, and integrations of the platform are equally important. Sponsors need to get each element right to generate the complete, unbiased data that is essential to success. The FDA has put usability at the center of new draft guidance on digital health technologies.¹ The guidance requires sponsors to describe how the device is worn, operated, and charged, and to include details of how data is collected, stored, transmitted, and archived.

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