Álvarez Camelo, María Andrea

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Characterization of automation systems development in the medical device industry: design of a process model
(2023-12-03) Álvarez Camelo, María Andrea; Medina Áviles, Lourdes; College of Engineering; Velazquez , María; Méndez Piñero, Mayra; Resto Batalla, Pedro; Department of Industrial Engineering; Córdova, Mario
This research presents a comprehensive process model for the implementation of Automation Systems (AS) projects in the medical device industry. To build this model, seven Subject Matter Experts (SMEs) were interviewed aiming to capture their know-how, practices, and lessons learned. The study revealed how AS are implemented from different angles thanks to the diversity of companies and roles of the SMEs. An Agile-Stage-Gate model is incorporated as a contribution of this work. This model was validated with four experts who mentioned activities, roles, deliverables missing in the first version of it. After the first round of validation, all experts agreed on the completeness and readiness of the process model. This graphical tool presents, defines, and organized the process in a simplified way. It represents the consensus among SMEs about how to develop AS. This process model defines phases, steps, activities, deliverables, tools, decisions, and critical tasks inside the project.