Validation Methods for Conceptual Modeling: A Study on Medical Devices

摘要

Medical device development (MDD) is an important activity that requires multidisciplinary teams to work together for multiple years. Prior research included the development of a comprehensive model to describe in detail the activities performed throughout this extensive development time. Given the complexity of this model, this work employs various validation methods to verify the correctness, completeness, and implementation of this model. Although there are no guidelines to validate conceptual models, one can establish credibility with the evaluations from subject matter experts (SME) and the exploration of cases. Accordingly, this paper presents a content validation survey performed to review the importance of the concepts, completeness of the model and its intended uses. A case study is also included to complement the content validation, showing a use case of the model for a real MDD scenario. While the content validation justified the model from the perspective of SMEs, the case study validates the model use for inexperienced developers that are also new to medical devices. The perceived usability is measured based on the System Usability Scale, which is a standardized and validated method. A similar approach is used to measure the model use, where a scoring index is proposed.