Modeling of the medical device development process

Abstract

Models are abstract representations of reality that are built, analyzed and manipulated to augment the understanding of that reality. They can either be mental or codified but, in both cases, they contribute to good decision-making by ensuring that the right people use the right information at the right time. In order to reduce time to market, companies commonly adopt product development processes and the medical device sector is no different. However, one can question which is the most adequate product development process model to follow or what information that model should contain or even how the information should be represented. Here, we review the existing product development process models dedicated to medical devices. The models representation and usability are also debated in order to assist developers to select the most suitable model and adapt it to their needs and reality.