Agile development methods are growing in popularity with a recent survey reporting that more than 80% of organizations now following an agile approach. Agile methods were seen initially as best suited to small, co-located teams developing non-critical systems. The first two constraining characteristics (small and co-located teams) have been addressed as research has emerged describing successful agile adoption involving large teams and distributed contexts. However, the applicability of agile methods for developing safety-critical systems in regulated environments has not yet been demonstrated unequivocally, and very little rigorous research exists in this area.