Agile Intro for Regulated Medical Software

Ideal for those new to Agile who need proven strategies for handling risk management, regulatory documentation, integration with hardware and with usability design. We show you the fundamentals that underlie all the various Agile methodologies, and how Agile practices are inherently safer and easily meet both FDA and EU regulatory requirements.

Agile Next Steps for Regulated Medical Software

Perfect for those with Agile experience or training who need to go deeper into the mechanics of how to achieve regulatory compliance in the areas that make medical device work different from other industries – hardware-software integration, documentation, risk management to name a few.

Back in 2016, I attended the Agile Alliance Technical Conference (since renamed Deliver:Agile, which I think was a HUGE mistake, but that’s for another article) I saw a keynote by Uncle Bob Martin called The Future Of Programming (video of that keynote here). It was powerful, insightful, and not ashamed to point fingers. The other day, I found a video on Youtube of a similar talk by Uncle Bob here, and I felt compelled to spread the word about his message, even more relevant in 2019.

The overarching theme of the talk was the history of computers, from the “beginning” to the present, but also who was designing them and programming them, how that was done, and how all of those changed over time, for better or worse. He also does an interesting approximation of the number of computers and number of developers through the years.

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I’ve been a Software Engineering Manager or Team Lead for a long time, and Agile coaching has been part of all of those jobs. I’m on the Board of Agile New England, and have been for about 10 years. I’ve been supporting the Agile community for about 13 years. Having helped multiple companies with their agility, I also have a feel for what works in specific situations, and a pragmatic approach to what and how implement it.

I enjoy management,  but after speaking to some Agile Coaches I know well, I am looking to for Technical Agile Coaching positions instead. They both focus on something I am passionate about, which is focusing on the effectiveness and happiness of the entire team. They’re just going at it from different angles.Continue reading

I ended up talking about knowledge management quite a bit at Agile Games 2018 and Mob Programming 2018.  I don’t have a lot of formal training in this area, but it’s something that I’ve focused on a lot, and I’ve learned a lot from people who have studied it a great deal.  Rather than respond directly, I decided to add a blog post about it, to benefit more people.  This is an unordered list of these tips.  I would love to hear your additions or feedback on it.

Push vs Pull Communication Channels

There are two different general ways of communicating information: Push and Pull.  Push is when you send information out to recipients and they get notified (email, Twitter, Slack, etc) and Pull is when the recipient seeks out that information that was published earlier (Website, wiki, CMS, documentation).  Using the wrong type can prevent the recipients from having the most recent information in a timely manner.  The main deciding factor is, is it more important that people know about this information as soon as possible (changes to policy, status/availability updates, issues), or that people have the information when they need it (requirements, specifications, resources, environment details).  Many tools can do both, like wikis, which allow people to get notified of updates).  Email doesn’t work nearly as well as you would think at either push or pull, because most people in technical fields get so many emails that they find it hard to both notice and respond to timely emails and categorize those emails so they can find them later.Continue reading