Is the Software Medical Device World Ready for Agile?

To begin with, I don’t see any real reason why software medical device manufacturers should fear Agile. I do, however, see some stipulations that need to be made. Here is a rather dated article on the subject (from 2007) : Agile Development in an FDA Regulated Setting.

The author of the blog post concludes:

It seems to me that Agile methodologies have a long way to go before we see them commonly used in medical device software development. I’ve searched around and have found nothing to make me think that there is even a trend in this direction. Maybe it’s that Agile processes are just too new. They seem popular as a presentation topic (I’ve been to several), but I wonder how prevalent Agile is even in mainstream software development?

Since the article was written (4 years ago), Agile has clearly gained a solid foothold in mainstream software development. With companies bound by medical device FDA guidelines, however (or even IEEE, ISO 9001, ISO 13484), there may be some understandable fear on new approaches. What seems to happen is that the known process becomes the only trusted process, and adoption of anything knew leads to so many questions that it is simply pushed aside (regardless of the potential benefit to the company).

The “twelve principles” of the Agile Manifesto include:

  • Customer satisfaction by rapid delivery of useful software
  • Welcome changing requirements, even late in development
  • Working software is delivered frequently (weeks rather than months)
  • Working software is the principal measure of progress
  • Sustainable development, able to maintain a constant pace
  • Close, daily co-operation between business people and developers
  • Face-to-face conversation is the best form of communication (co-location)
  • Projects are built around motivated individuals, who should be trusted
  • Continuous attention to technical excellence and good design
  • Simplicity
  • Self-organizing teams
  • Regular adaptation to changing circumstances

Uh oh. A few of these principles are very likely to send upper management, at least those that are used to their traditional waterfall SOPs, running for the door. But who says we can’t make modifications where we need to?

I suspect that much of the resistance to Agile methodologies is closely tied to a fear of change. Upper management trusts that which they know, despite some of the obvious shortfalls.

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