What can the medical device industry teach us about safety?

The automotive industry is keen to introduce more advanced x-by-wire systems. Many of these will be both complex and safety critical. The industry will need to deal with the issue of designing such systems, and may benefit from experience in other industries. While some lessons can be learnt from aerospace, the completely different cost drivers and manufacturing volumes will lead to different solutions. The medical device industry is arguably the first industry that has needed to develop complex safety critical systems with high software content. In this article we examine which lessons can be learnt. Particularly in Europe, through the regulatory framework the medical device industry has developed common safety standards for specific types of devices. Approaches to risk management have changed from the single-fault hypothesis to the risk-based. Many of the design drivers in medical devices apply equally to automotive systems. This will in turn lead to similar approaches to the design architecture being taken.