Over the past few years I’ve talked to a number of customers in the embedded software and medical devices industries, and I continue to see a significant number of these organizations either moving to, or planning on moving to agile development processes.
With all of the inherent challenges for agile in these organizations such as standards/regulatory compliance, hardware changes and integration, security issues, etc. I must say that I’m a little shocked that customers are moving away from their current processes towards something like agile. Add to this the fact that the Agile Manifesto specifically states “Working software over comprehensive documentation” and it doesn’t exactly sound like agile is a great fit for embedded systems in general, let alone medical device.
Now, don’t get me wrong, I am a huge proponent of agile, and I certainly realize that there are many pros for moving to agile, and these have been well documented, but I have to wonder just how agile are these specific industries going? I would bet that most (all?) of these organizations are adopting some of the key fundamentals of agile, but to say they are going “all in” would be a bit of a stretch.

Even industries heavy on process (because of regulatory requirements) are taking the leap into agile. How agile are they?
Looking at the manifesto a little closer, some of the principles are fairly generic and feel more like common sense than anything revolutionary, so they probably apply to any industry. There are a few principles however that are fairly easy to imagine in these industries, such as:
- getting all stakeholders involved in defining requirements (Principle #4), or
- embracing more face-to-face conversations (Principle #6), and
- simplicity, or minimizing the amount of work not done (Principle #10).
But do people really think that Principles #1 (early and often delivery of software), and #2 (welcome changing requirements) really apply to the embedded or medical devices industries? Personally I don’t see it.
So what do you think? Are the embedded software or medical devices industries capable of going full out Agile?







