User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector-Cap Removal Forces.

Abstract

Purpose: The subcutaneous delivery of biologics using pre-filled autoinjector devices continues to attract broad scholarly interests. However, research still lacks a detailed understanding of user perceptions as the basis for specifying the clinically relevant technical attributes of a device, such as the cap-removal force. Therefore, this article studies the ability of users to remove the autoinjector cap, as well as the effects of the cap-removal force and user characteristics on the perceived ease of decapping.

Patients and methods: Forty-two participants among patients, caregivers, and healthcare professionals removed the protective cap using non-functional devices with different target cap-removal forces between 25 N and 55 N. Data were collected on the ability of the users to effectively decap the device and their perceived ease of decapping. Linear regression was then applied to quantify the impact of the decapping force and patient characteristics on the perceived ease of decapping.

Results: The participants of the study effectively decapped all autoinjector devices irrespective of age, sex, and dexterity impairments. Moreover, the study reveals that the perceived ease of decapping decreases significantly with increasing decapping force and participants' dexterity impairments.

Conclusion: The study provides initial empirical evidence on the ability of users to decap autoinjector devices and shows how increasing the cap-removal force and dexterity impairments reduce the perceived ease of decapping.