“Our organisation has become a software company. The problem is that our engineers haven’t realised that yet!” This is how the VP Research of a major semiconductor manufacturing company, traditionally seen as the classic hardware company, characterised the context in which software solutions were replacing hardware in delivering their products. This organisation knew precisely the threshold of reuse level for their hardware components before designing for reuse became cost-effective. However, no such sophistication was present in their software processes. Another example of software scaling in importance occurs in the medical device domain. Traditionally medical devices were primarily hardware with perhaps some embedded software. However, a 2010 EU Medical Device Directive classifies stand-alone software applications as active medical devices. Countless other scenarios are emerging, and it is difficult to find a market domain in which the innovation does not depend on software. Thus, we have a context where software, traditionally seen as secondary and a means to an end in many sectors, moves centre-stage. The implications of this global shift are frequently underestimated.
 MDD 93/42/EEC (Medical Device Directive)