Rip and Reapply
I’ve been planning to write something about Agile software development in an FDA regulated environment for several weeks. I worked on a project earlier this year. The CEO was more than an Agile proponent, he was an evangelist of sorts.
I don’t mean that he ranted on and on about the benefits of Agile. He never even used the word. What I mean is that he lived and breathed the methodology. I had considered myself a proponent of lean before I met him and I still do but his direct and tell-me-where-it-says-we-have-to approach took the slack out of any slip back to “because they expect it” rope I allowed myself.
It isn’t often that a visionary, a game changing personality perhaps, affects me as deeply as the few encounters I had with this professional did and I didn’t fully appreciate what I learned from him at the time. Luckily, while I’m not the quickest at realigning thought patterns, I relentlessly engage in continuous improvement and I am closer now than I was then. At least that’s my story.
The phrase “don’t re-invent the wheel” can be either a downer or a breath of fresh air, depending on the project, the passion, and the people involved. My plan this morning was to write something if not seminal at least remarkable. I’d planned to use some Lucid Chart graphics I had put together for this post and though I hadn’t worked out the final delivery, I was confident I’d nail it.
Give me a break, its Monday.
So, I sat down at my current work space (my wife’s dual 24’s are in the far ground), opened up LinkedIn, then searched the topic to see if there was something that would help get the ball rolling. I hadn’t yet changed my default browser to the G team, another learning is included here but I’ll keep it to this mention, and set Yahoo to work using the catchy search string: “agile development regulated FDA.”
The first 10 ya-lections appeared quickly given the number of windows open, the in process cloudown and Pink Floyd vid-stream. I clicked on the first ya-lect scanned it then read it, and decided that I was 53 months late. Dan Oliver’s article is a good read. The second choice, a LinkedIn Slide Share written 12 days later by Michael Walkden and Tavi Scandiff-Pirvu, is good too. I especially like how it started:
- The FDA is not the bad guy
- The FDA is not your customer
- FDA is about ensuring safety and sustaining life
I’m thinking I ought to see what these folks have written lately. The topic I planned to write about today is old news so I played the flexibility game and wrote something else. Yes, I realize the topic is an even older teaching. Sometimes being a master of the obvious has its place.
Today its place was here.
(Wheel media borrowed from Delta Associates)