A pen device for injection of recombinant human growth hormone: a European usability engineering study

Abstract

ABSTRACT Objective The Aluetta™ reusable pen device and instructions for use (IFU) for growth hormone (r-hGH; Saizen®, Merck KGaA, Darmstadt, Germany) administration were tested for Human-Factors Usability, to ensure it could be used safely and effectively by the intended users in the intended use environment. Research design and methods Usability testing was conducted under simulated conditions in three groups of participants: pediatric or adult patients with growth hormone deficiency (GHD), participants without GHD, and healthcare professionals (HCPs). The testing comprised a 45-minute training session, a 2-hour testing session, and a participant-feedback session. Results Twenty-six participants completed the training session and performed all critical tasks related to the pen use across three scenarios. The most difficult tasks were related to the preparation, checking, and maintenance of the device; only 8% of use errors occurred during tasks related to the injection process. Eighty-five percent considered the pen safe and effective to use without further modifications and the training to be clear and effective. Conclusions The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective.