Design Development of the SMARTCLIC^®/CLICWISE^® Injection Device for Self-Administered Subcutaneous Therapies: Findings from Usability and Human Factor Studies.

ABSTRACT:

Introduction

An easy-to-use, multiuse, single-patient, electromechanical autoinjector, the SMARTCLIC^®/CLICWISE^® injection device, was recently developed to improve the self-administration options available to patients with chronic inflammatory disease treated with biologic agents. An extensive series of studies were conducted to guide the design and development of this device and to ensure its safety and effectiveness.

Methods

Participants in two user preference studies and three formative human factor (HF) studies evaluated evolving iterations of the autoinjector device, dose dispenser cartridge, graphical user interface, and informational materials; participants in a summative HF test subsequently assessed the final proposed commercially representativ

SUBMITTER: Berman K 

PROVIDER: S-EPMC10272234 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature