Concept Selection in the Development of Medical Devices: the Case of the Smart Stent-graft

During product development, ideas are narrowed down to a single one by the designers in order to satisfy the customers’ needs. This process is called concept selection and is crucial to the development of new products because, from this point onward, the design team is committed to a concept whose modification implies delays and additional costs. Decisions made during the concept selection phase are often difficult due to the uncertainty caused by the lack of objective data. However, it is possible to reduce this uncertainty assessing each concept’s expected costs and benefits. Medical devices, before entering the market, are scrutinized by several agencies around the world to assess their clinicaland cost-effectiveness. In order to reduce the uncertainty associated with concept selection, the parameters evaluated by the multiple agencies should be used to support the idea to pursue. However, as that data is not available yet, in this paper, several parameters are identified to evaluate each concept and, for each metric, the most adequate measurement technique is described. This paper also presents a specific implementation of the design process for a new stent-graft. INTRODUCTION Product development refers to the process of creating products with new or different characteristics to offer fresh or additional features to customers. While some authors describe this process with only 5 steps, others name as many as 25 stages [1]; here, the design process is divided in 8 steps, Figure 1. Normally, the development of a product is triggered by a need or an idea. Then, the design team identifies the specific problems that customers intend to solve purchasing a good or service (customer needs) and generate concepts. From the panoply of concepts, only one is developed and optimized. Following this, prototypes and/or small series are produced. These pre-series are evaluated by a restrict number of clients or by certifier companies. The process ends with the launch of the product in the market. In spite of the design process being commonly represented in a linear fashion (as shown in Figure 1), the development of a product is an iterative process in which different steps can be performed simultaneously (i.e. concurrent engineering [2]). FIGURE 1: DIFFERENT STEPS OF THE PRODUCT DEVELOPMENT PROCESS