Thursday 27 May 2021

New decade, new blog

 I started a new blog (only in Finnish for the time being). I will post there at least once a decade.

Saturday 1 October 2016

Backlogs vs. requirements: agility meets formality

When we started using Scrum and SAFe, we had to decide what to do with our formal documents. In medical device development, we have to create quite a few documents for each release, ranging from requirements specifications and risk management summaries to test documentation and manufacturing instructions. In FDA parlance, these documents are known as the Design History File (DHF) and Device Master Record (DMR), and they need to be formally approved and properly archived.

Could we have made our documentation more agile? It is possible to interpret your agile artifacts as DHF documents and turn some of your agile practices into formal processes. For instance, we could use our user stories as part of our design input documentation or treat them as change requests. AAMI TIR45:2012 describes ways to combine agility with formality in medical device software development.

We chose a different path: Our backlogs are informal wishlists that can be changed without formal approval. They are used as input for traditional requirements that are then formally verified and validated. Our agile practices are also informal, as we want to be able to experiment with new practices easily. This is not our final stage, as we see many opportunities for streamlining our development processes, but formality is not the best way to get started.

If you use agile development in a regulated environment, how do you manage your formal documents and processes?

Thursday 30 June 2016

Three increments later

We are now in the middle of our fourth program increment, and it is already hard to remember the old way of project planning and tracking. SAFe mission accomplished? No! As I wrote earlier, this is just the beginning of our agile journey. We are still learning how to limit our WIP more effectively, and it will take time and effort to move to truly incremental development. Incremental planning is easier to achieve.

In our business, a verification and validation period for the finished product is a must, but how to make this final V&V more lightweight without compromising product quality and safety? AAMI TIR45 provides some answers for software, but less has been written about agility in system and hardware development for medical devices.

Are we on the right track with SAFe? We have now asked our people three times if they would recommend the new way of working to a friend or colleague. So far, the answers have been more positive after each increment. I’ll let you guess the scale.