An ontology model for the medical device development process in Europe

Abstract

Product development refers to the transformation process of an idea into a product or service. It can be applied to any sector, but special attention must be given to each industry particularities. In the case of medical devices, the development process should consider the multiple definitions of the term medical device, a vast regulatory framework as well as numerous organizations that evaluate the devices safety and effectiveness before entering the market. It should also consider various stakeholders and a variety of requirements regarding risk and quality. Currently, literature regarding product development methodologies applied to medical devices is scarce, and there is no graphical representation of the process addressing the environment in which it occurs. Here such representation, for the European market, is made in order to help to understand how medical devices are developed, evaluated and approved. The development process of medical devices was depicted because it is the most practical, easiest and fastest way to maintain, understand and communicate information. Furthermore, it facilitates the identification of the elements driving the process and reduces the complexity of the reality being represented. As the diagram presented is generic, it can be applied to every segment of the medical device industry. In addition, it can be both used by designers and management to guide the process, implement quality standards, support decision and select tools.