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

• Published in: Patient preference and adherence Vol. 15; pp. 159 - 168
• Main Authors: Schneider, Andreas, Richard, Philipp, Mueller, Philippe, Jordi, Christoph, Yovanoff, Mary, Lange, Jakob
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2021; Taylor & Francis Ltd; Dove; Dove Medical Press
• Subjects: Age; autoinjector cap removal; Caregivers; Chronic illnesses; Design and construction; Disease; Drug administration; drug delivery; Drug delivery devices; Drug delivery systems; Drug dosages; Influence; Mechanical properties; Multiple sclerosis; Original Research; Patients; Perceptions; Psoriasis; Questionnaires; Rheumatoid arthritis; self-injection; subcutaneous injection; user-centric device development; United States; United States > US; self-injection; drug delivery; subcutaneous injection; autoinjector-cap removal; user-centric device development
• ISSN: 1177-889X; 1177-889X
• DOI: 10.2147/PPA.S298725

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. 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. 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. 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.