An aneurysm is a localized blood-filled dilatation of an artery whose consequences can be deadly. One of its current treatments is endovascular aneurysm repair (EVAR), a minimally invasive procedure in which an endoprosthesis, called a stentgraft, is placed transluminally to prevent wall rupture.
2Early stent-grafts were custom designed for the patient through the assembling of off-the-shelf components by the operating surgeon. However, nowadays, stentgrafts have become a commercial product. The existing endoprostheses differ in several aspects, such as shape design and materials, but they have in common a metallic scaffold with a polymeric covering membrane. This paper aims to gather relevant information for those who wish to understand the principles of stent-grafts and even to develop new devices. Hence, a stent-graft classification based on different characteristics is presented, and the significant features of an ideal device are pointed out. Additionally, the materials currently in use to fabricate this type of prosthesis are reviewed and new materials are suggested.
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.
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.
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