Medical Devices Development: The Bottom-Up or The Top-Down Approach?

Abstract

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints related to their use in clinical situations in terms of usability by non-trained people, automation and integration.