Additional peculiarities of medical devices that should be considered in their development process.

Medical devices are peculiar products: their definition varies from country to country, they are used to treat diseases and they are different from pharmaceuticals. In 2012, the authors began to describe the complex and demanding environment of the medical device industry. In this article, the authors' previous research is extended with additional peculiarities of medical devices such as recall, pricing and adoption factors.

Modeling of the medical device development process.

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 (PDP) and the medical device sector is no different. However, one can question which is the most adequate PDP model to follow or what information that model should contain, or even how the information should be represented. Here, the authors review the existing PDP models dedicated to medical devices. The model's 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.

Medical device specificities: opportunities for a dedicated product development methodology.

The medical sector, similarly to other industries such as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression 'medical device', and before entering the market, manufacturers must demonstrate their product's safety and effectiveness. In such a complex and demanding environment, it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, medical device specificities are identified, and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.