Quantifying Patient Capabilities and Setting the Stage for Future Development: Insights from a Sensor-Augmented Simulated Use Study with Pen Injectors.

Background: While formative and summative usability testing is essential to confirm safe and effective product use, it may not be sufficient to comprehensively understand user capabilities and limitations in device interactions. Therefore, this research aims to quantify user handling forces for different device handling steps of pen injectors through sensor-augmented simulated use studies.

Research Design And Methods: The study involved 46 participants who were divided into two groups: a healthy control group and a group of users with dexterity impairments.

Autoinjectors for large-volume subcutaneous drug delivery: a review of current research and future directions.

Introduction: The growing interest in subcutaneous delivery of larger single-dose volumes using handheld autoinjectors raises questions about the feasible upper limits for injection volume and rate. This review critically evaluates the literature on subcutaneous administration with dose volumes greater than 1.0 mL.

Understanding patient preferences for handheld autoinjectors versus wearable large-volume injectors.

Objective: While interest in the use of wearable large-volume injectors for subcutaneous drug delivery is increasing, it remains unclear whether and under what conditions these emerging dosing options are preferred over more frequent but shorter administration of smaller doses using handheld autoinjectors. Therefore, the objective of this study was to examine the characteristics of patients diagnosed with cancer, diabetes, inflammatory and cardiovascular diseases, and treatment attributes that determine device preferences.

Methods: Based on a cross-sectional online choice experiment, 191 participants expressed their preferences without being physically exposed to the devices or performing injections.

Formative Study on the Wearability and Usability of a Large-Volume Patch Injector.

Background: The subcutaneous self-administration of biologics using a single large-volume bolus dose requires novel large-volume patch injectors. However, the usability and wearability of such on-body devices has rarely been investigated thus far. Therefore, this formative simulated use experiment studies the overall handling and acceptability in terms of the size and weight of a novel 10 mL large-volume patch injector device platform.

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

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.

Hold the device against the skin: the impact of injection duration on user's force for handheld autoinjectors.

: The recent development of high-volume subcutaneous drug delivery using handheld autoinjectors has resulted in longer injection durations. However, the usability of long injections has been neglected. This study aimed to investigate the effects of injection duration on users' ability to apply injections while holding the device against the skin at the injection site.

How to prevent medication errors: a multidimensional scaling study to investigate the distinguishability between self-injection platform device variants.

: The importance of subcutaneous drug delivery using self-injection devices based on common device platforms continues to grow. The resulting broad adoption of potentially look-alike or similar devices, however, raises concerns over limited device distinguishability and ensuing risk of medication errors. The objective of the study is thus to understand whether and how users effectively distinguish between self-injection device variants.

Toward a new age of patient centricity? The application of eye-tracking to the development of connected self-injection systems.

Background: Increasing interest in digitally enhanced drug delivery tools urges both industry and academia to rethink current approaches to product usability testing. This article introduces mobile eye-tracking, generating detailed contextual data about user engagement with connected self-injection systems as a new methodological approach to formative usability assessment.

Methods: A longitudinal case study with a total of 35 injection-naïve participants was conducted.