Pinch Force Endurance and Usability Considerations for Pre-filled Syringe Designs Used by Chronic Obstructive Pulmonary Disease Patients.

Abstract

Background Prefilled syringes (PFS) are commonly used for self-administered injectable drugs, particularly for chronic conditions. A critical design factor is the injection force needed to depress the plunger, which varies by drug viscosity and syringe mechanics. This is especially important for patients with potential strength limitations. Human factors studies help evaluate these physical demands to ensure PFS can be used safely and effectively across diverse users. Assessing both maximum force capabilities and endurance provides key insights for optimizing syringe design and minimizing patient discomfort.Objectives This study evaluated Chronic Obstructive Pulmonary Disease (COPD) patients' experience with PFS samples of varying injectability (injection force and duration) and measured pinch force endurance-an indicator for PFS physical demand. Those insights aimed to guide PFS design for users with strength limitations.Methods 42 COPD patients performed simulated injections using three PFS samples (28N, 38N, 47N force) and rated perceived demand. They also gripped a surrogate PFS device at 28N and maximum force to measure endurance. Data predicted the 5th percentile pinch force endurance for COPD patients.Results The estimated COPD patients' 5th percentile pinch force endurance at 28N was 16 seconds, while their maximum pinch force endurance was around 4.4 seconds. Males pinched and held 28N longer than females, but no gender difference was observed at the maximum force. Endurance decreased as required force approached maximum capacity (consistent with Rohmert's Curve).Conclusions PFS usage can be challenging for users with strength limitations. A 28N force was sustainable for 16 seconds for 95% of COPD patients. Developers should minimize injection force where possible and accommodate varied injection styles-lower forces improve endurance, aiding users with reduced strength. These findings support designing accessible PFS for diverse populations.