I read this article at MEDS Magazine about Strkyer’s software development process. Stryker is a large and very successful company, so I was a bit surprised to learn that they have had success with the V-Model in software development. In my humble opinion, the V-Model is simply a glorified waterfall model approach, and we’ve seen time and again that the waterfall model is not a good method to attempt.
I don’t believe that most medical device software can thrive in an XP or purely light weight Agile environment either. I believe that we need Agile/Scrum methodologies with some rules and more heavily weighted up-front requirements and design. I’d like to see those of us in the software medical device community come up with our own Scrum, and this may be something that a number of people are eager to collaborate on.
We need to recognize that fixed requirements scope is simply not a reality, in medical devices or otherwise. In the book Agile Software Requirements, Dean Leffingwell points out:
This “fixed requirements scope” assumption has indeed been found to be a root cause of problem failure. For example, one key study of 1,027 IT projects in the Unit Kingdom [Thomas 2001] reported this: “Scope management related to attempting waterfall practices was the single larged contributing factor for failure.”
(i.e., There is no such thing as a fixed requirements scope!) Need we further reason to abandon the waterfall model? Leffingwell offers even more. According to an “oft-cited Standish Group’s Chaos report survey [Standish, 1994]:
- 31% of software projects [using waterfall approach] will be canceled before they are completed.
- 53% of the projects will cost more than 189% of their estimates.
- Only 16% of projects were completed on time and on budget.
- For the largest companies, completed projects delivered only 42% of the original features and functions.
I’ve never observed a true waterfall in practice. I’ve only seen it attempted. Inevitably, there are modifications to the process, as the team and management realizes that there is a need to revisit requirements and design. I don’t care how much time is spend (wasted) on up-front design… It will never be enough, and there WILL be a need to revisit those stages that the waterfall model insists should have been locked down.