Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device

Medical device development is often understood as a linear process with design stages occurring sequentially. First stages are usually performed in order to specify the future device definition through interviews/meetings of the end-users, researchers and manufacturers. Because the medical device is original, these first stages mainly involve end-users and researcher. However, regulation constraints and economic reality sometimes makes manufacturers hesitant to base the industrial development on this initial basis. Functional analysis, well known by manufacturers, is a method used to accurately define the final functions of a medical device. In this conference, we estimate that the functional analysis can be put to profit in a more efficient way if researchers and end-users get familiar with it prior to the interview/meeting stages. Although the results of such knowledge democratisation is not demonstrated here, we present the function analysis conducted on a lithium monitoring device according to this multidisciplinary approach. We also show that function analysis can be used not only to drive research actions but also to identify regulation requirements.