Vídeo laringoscópio anatômico confeccionado por manufatura aditiva: revisão de escopo, prospecção tecnológica e validação de um protótipo

Abstract

The development of medical devices necessitates a thorough consideration of usability and user experience (UX) factors. Utilizing three-dimensional (3D) printing through additive manufacturing, a Videolaryngoscope (VLP) was designed to facilitate indirect visualization of the larynx on a mobile device or television screen via a camera integrated with proprietary software. This study aims to systematically review the existing body of literature, conduct a technological prospecting analysis in patent databases regarding the development of VLPs using additive manufacturing technology, explore validation methodologies for healthcare technologies, and assess usability aspects related to the prototype. Usability assessment will be conducted in accordance with ABNT IEC NBR 62366-1 and ABNT IEC NBR 62366-2 standards, in conjunction with the System Usability Scale (SUS) questionnaire. The study comprises three phases: (1) systematic review and technological prospecting of the device, (2) systematic review of usability assessment methodologies for medical equipment, and (3) usability evaluation of a Videolaryngoscope fabricated via additive manufacturing. The data will be tabulated and subjected to statistical analysis, considering a statistical power of 95% and a significance level of 5%. The analyses will be conducted using the PSPP Data Editor software (2024), Shapiro-Wilk test, Kruskal-Wallis test, logistic regression, and meta-analysis (RevMan 5.4). The risk of bias will be assessed using ROBINS-I and GRADE. The project will be submitted to the Research Ethics Committee of the Catholic University of Pelotas (4.780.560/CAAE 47947921.3.0000.5339). The study demonstrated that the 3D-print video laryngoscope is promising but still requires adjustments for clinical optimization. Thus, development process proved essential for its effectiveness and acceptance. Considering these factors from the early design stages significantly contributes to the feasibility and success of the device in clinical practice, highlighting the importance of a user-centered approach in the creation of new medical technologies.