Using New Model-Based Techniques for the User Interface Design of Medical Devices and Systems

Background

The overall risk for manufacturers of risk-sensitive products (e.g. in aeronautics, nuclear engineering, medical technology and pharmaceuticals) has increased in recent years. Expensive products can only be lucrative if they are distributed to a large number of customers worldwide. This increases not only the cumulative potential damage, but also the potential consequences. Especially in the medical field of diagnostic and therapeutic systems undetected remaining failures or residual risks, which occur in the development process, often cannot be tolerated. Bringing defective and erroneous products to the market means a high potential of severe consequences for the manufacturers. Apart from ethical considerations, related costs can endanger the livelihood of enterprises. It ranges from warranty and goodwill costs to product recalls as well as liability for consequential damages.

The medical branch is, similar to almost all manufacturing industries, under a high cost and time pressure, which is characterised by globalisation and dynamic markets, innovation and shorter product life cycles. The increase of the complexity of products and production processes is another factor determining the situation of the risk (Doubt, 2000). The necessity to respond to the risks, is also reflected by the fact that the introduction of systematic risk management processes including the early application of an usability engineering process in accordance with established national and international standards (EN ISO 14971, IEC 62366, MDD (Medical Device Directive), FDA (Food and Drug Administration)) are obligatory for medical device manufacturers.