Clinical risk evaluation of medical device software: an axiomatic design-based methodology

¹ Department of Innovation and Information Engineering, Guglielmo Marconi University, Via Plinio 44 - 00193 Rome, Italy
² Institute for Research on Population and Social Policies, National Research Council, Via Palestro, 32 - 00185 Rome, Italy
³ Institute for System Analysis and Computer Science “A. Ruberti”, National Research Council, Via dei Taurini, 19 - 00185 Rome, Italy

^* Corresponding author: f.rolli@unimarconi.it

Abstract

The increasing complexity of medical device (MD) management software requires the adoption of new methodological approaches that pay particular attention to safety issues. The risk analysis is one of the key activities to be carried out by the manufacturer before the development of the software application as it determines the type of documentation to be provided as well as the activities to be performed to place the MD on the market. After the definition of software requirements and their iterative transformation into architectural items and/or units, the manufacturer defines the safety class of each item. The adoption of an axiomatic design approach facilitates this process. This combination of techniques helps to focus the design of medical device software on non-conformities with a clear link to clinical risk. This objective can be achieved by assessing the complexity of the system to be designed, both in terms of its functional size, and as a level of overall clinical risk. In this multi-dimensional perspective, the software effort expressed in function points provides an estimate of the development cost. While the clinical risk analysis allows to quickly identify critical areas, to intervene with the same promptness and to draft a management plan according to the regulations of the various control authorities.