Validating the Ypsomed SmartPilot

Ypsomed’s latest study, published in the peer-reviewed journal Medical Devices: Evidence and Research, puts this to the test. The human factors validation focused on the SmartPilot, a digital add-on that provides visual and auditory feedback during injection and automatically logs injection data for therapy monitoring. The goal: to determine whether patients, caregivers, and healthcare professionals could use SmartPilot successfully – even without prior training.

Seventy-five participants took part in the study - representing a wide range of intended users: patients with and without dexterity limitations, caregivers, and healthcare professionals, split into distinct user groups conforming with FDA guidelines. Each was asked to use SmartPilot with an autoinjector in a simulated home or clinical environment, following the Instructions for Use.