An Ontology Model for the Medical Device Product Development Process and Environment

Abstract

The development of medical devices is a complex problem from initial conception to final implementation and monitoring. The development process is critical, and attesting to this, the completeness of the process and the experience of the developers are identified as important factors for commercializing medical devices. Meanwhile, regulations, standards, and patents should also be considered in the development process. The Food and Drug Administration (FDA) has been reported as the primary factor affecting companies’ ability to develop new medical technology. The use of standards is voluntary; however, multiple benefits are attributed to their use. Patents are also necessary to protect the inventions employed in novel medical devices from being used/further developed by competitors. This paper addresses the complex nature of the medical device development process and its environment through development of an ontology model. The model describes the components of medical device development and their relationships, including the testing and approval environment that impacts this process. The final ontology model is the result from a document analysis (DA), completed in multiple iterations, and the verifications of source credibility, completeness, terminology, and redundancy. The comprehensiveness of the presented model should aid inexperienced designers understand and implement the development process more effectively.