Scrum for Medical Device Software

It was a failed Scrum-but implementation in exactly this industry that encouraged me to become a Scrum Master in 2004.

At the time I was a developer working on a new patient monitoring device (ECG, blood oxygenation, brainwave). We had a technical lead who held daily standups sitting around a table. We had no backlog and no Sprint Planning sessions. If there were Reviews or Retrospectives, developers such as myself were certainly not invited.

We had no Product Owner apart from a senior executive who was notionally responsible for project outcomes. Weak product ownership impeded delivery as there was no scope management or expression of pull. We wrote our own requirements.

It was explained to me that the market for these devices was cyclical, in that hospitals only had budgets for such purchases every 4 years or so. Releases were arranged to this cadence and subject matter experts were lost to the engineering firm over the two or three years of project slack. By the time I was there it had fallen well below the critical mass needed to facilitate production. There were simply not enough stakeholders of the right caliber to own backlogs, to populate and order them, or to explain product scope.

I walked the death march for a year before quitting. A week after I left I attended one of Ken's Scrum Master training courses, which I happily paid for out of my own pocket. I felt that justice had not being done to the framework and that I should find out more about its correct application.

I have been working for a Medtronic competitor as product manager for a monitoring system of cardiac rhythm management devices.
In those years, I never heard the words "Agile" or "Scrum", however in this environment the Agile Manifesto and Scrum values were lived more intensively than in any other environment I have experienced so far. We used Feature Driven Development, and the employees somehow just knew how to generate business value in short iterations. I highly doubt it is possible to sell them Scrum or an Agile Coach. Most things a Coach would say, they would just answer: Yes of course, how could anyone think differently? Why should we pay someone to tell us trivial facts?
If you are new in such an environment, you adapt to it and it is a harsh shock when you come into a new environment as described by Ian.

I agree with "Ludwig”. Earlier, we haven’t heard the word "Agile" or "Scrum", but now they become the most important in the environment. Scrum is simply a management framework, generally formalized for software development projects and helps in building customer collaboration. It really offers shift in the way medical device manufacturing processes are conducted. Now better products are developed, which directly improve healthcare and save thousands of lives.