Smarter Guidance, greater confidence
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.
Users in focus, results that speak
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.
The results were striking. Across more than 1,200 use tasks, participants achieved a 99.7% success rate, with 100% delivering a full injection. Knowledge-based tasks scored even higher at 99.9%. Observed errors were isolated and linked to inattention rather than unclear instructions or design flaws. All participants reported feeling confident using SmartPilot once they had read the instructions.
Access the full study design details and results, along with important safety information including indications and risks, here.
Why it matters
As stated in the publication, this study shows that SmartPilot can be used successfully by a broad range of user groups – including those with physical impairments or those with age-related limitations. But beyond usability, the findings point to something broader: how connected guidance can help overcome barriers to adherence.
SmartPilot not only supports users during each injection, it also captures objective data that can feed into digital therapy management systems. For healthcare teams, that means clearer visibility into patient adherence. For patients, it means greater reassurance and fewer worries about doing something wrong.
Looking ahead
While this validation focused on first-time use, the implications extend further. SmartPilot could simplify onboarding for new patients, enhance support, and enable data-driven insights in real-world settings and decentralized clinical trials.
As digital health continues to evolve, studies like this help establish trust – showing that innovation and safety can go hand in hand.
Author
Carolina Canapè
Carolina Canapè, PhD, MBA, is a commercial leader with over 15 years of experience in MedTech and digital health. She specializes in developing and executing global go-to-market strategies, integrating digital solutions, and driving innovation across clinical and commercial environments. Dr. Canapè currently serves as Business Development Lead for Digital Health at Ypsomed AG, where she is responsible for advancing strategic partnerships and commercial initiatives focused on connected devices. She previously held senior roles at IQVIA, GenomSys SA, and Bracco Imaging, where she drove global business development efforts in digital health. She holds a PhD in Molecular Imaging and an MBA. Her combined scientific and commercial expertise positions her at the forefront of digital transformation in healthcare and clinical research.
