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.

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As a Software Engineer and as a geek, I face many tempations.  One of them is “I can add this really cool feature while I’m in the code, and it will take hardly any extra time.  It won’t impact any of my other work at all”.  There are some very good reasons why you shouldn’t do it though, and why it’s an Agile anti-pattern.Continue reading

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Agile methodologies, like most flexible yet powerful systems, rely on knowing exactly where things stand.  You may not know exactly what’s coming in the future, but you know what you’ve already got, and roughly how close work in process is to done.  This is one of the many reasons short iterations are a good idea.  Not only do you know on a frequent basis (the end of each iteration) where you stand, but if what was done is acceptable to the stakeholders (and QA) and can really be considered done.  The product backlog tells you what needs to be done in the future (based on current knowledge, which may change, and that’s OK) and the iteration backlog tells you what’s done and what needs to be done now.  The burndown chart shows how things are going inside the iteration.

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In my last post, I talked about tools for tracking Agile projects.  Whatever too you use, you have to know what to do with the information.  It’s not just about the project being ahead or behind schedule, it’s about using the information to improve the software development process and its implementation.  One optimization which has been part of many Agile schools from the beginning, back to the Toyota days, is minimizing work in process.  In fact, it’s the major focus of Kanban.

Work In Process isn’t just code sitting in your editor.  It’s any task that’s not done, done, done.  In other words, if it hasn’t made it all the way through your software process, it’s still work in process.

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I admit it, I’m a bit of a geek.  OK, I am an Alpha Geek.  And yes, I sometimes go with the slightly more computerized solution that others might.  I just don’t get Agile’s fascination with sticking hundreds of pieces of paper on the wall, though.  Agile teams need a mechanism to share knowledge about stories and tasks.  They often do this by using whiteboards with sticky notes (so they can be moved) or cork boards with push pins and index cards.  There are columns for the stages (waiting, in process, in QA, done done done) and rows for each story.  This article shows an example of one.

I talked about it with an Agile coach friend of mine, Nancy Van Schooenderwoert of Lean Agile Partners, and she made a good point that the paper system makes the whole process easier to learn.  She also pointed out that all software has limitations, and it’s important to start out with the index cards or sticky notes so you don’t get the impression that any limitations in the software are a limitation in the Agile practices.  I get that.  But once the team is passed that point, it’s time to use software-based collaborative tools.  Why?

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Last week I started my new job as a Principal Software Engineer at Workscape.  I’m back in another Agile position, working on Java (and starting work on Flex, too), which are the two things I was looking for.  I would have settled for a position at a company that wasn’t Agile, but it would have been hard, knowing the benefits of it. I was waiting to post this until I got my first paycheck or did my first commit of fixed issues, whichever came first. Thursday and Friday I fixed three issues, so now it’s official.

Workscape offers HR services to other companies and their employees.

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