Craig Langenfeld, of Rally Software, (Craig has been providing some thought leadership and has been working directly with me on this blog series) just brought me up to date on another leading indicator of agile’s march across the chasm into high assurance development. Last month, Craig attended the first ever GE Agile Conference at the GE Advanced Manufacturing & Software Technology Center in Detroit, Michigan.
The conference was hosted by Carl Shaw, GE Healthcare Global IT Agile Champion (kind of a telling title, eh?) . Craig noted that topics ranged from basic, introductory Agile concepts to advanced examples of using Agile to build medical devices at GE.
Ryan Martens, Rally Founder and CTO, was the Keynote Speaker on the last day of the three-day conference. He spoke on applying Agile concepts in a highly innovative world to get products in the hands of those who can better social wellbeing faster.
Craig also noted that Brian Pate of SoftwareCPR, gave a presentation on “Agile methods for medical device software.” This presentation is available on their website (
It’s a solid presentation with some guidance on IEC62304 (an IEC and ISO international standard for medical device software, one that is harmonized with FDA CFR 820.30. see my post.). It’s a great example of what this series is all about.
Brian notes three common misconceptions that can interfere with the adoption of agile methods in medical devices, including:
1) lack of obvious rigorous treatment of requirements
2) no formal verification and validation in normal agile practice
3) no formal agile mechanisms for dealing with risk assessment hazard, and hazard mitigation.
But he goes on to illustrate how to deal with these misconceptions in a high-assurance development model as well. Refer directly to that presentation for his advice.
I’ll be dealing with these issues as well in the upcoming series. In the next post or two in this series, I’ll suggest an agile lifecycle model that can support rigorously assured software quality and provides recommendations for continuous verification and as-necessary validation practices. Then we’ll get into the meat of specific practices that agile teams can use to develop such software, in an agile, safe and efficacious way.
Note: Special thanks to Craig Langenthal of Rally, Carl Shaw of GE Healthcare and Brian Pate of Software CPR for providing content and permissions for this particular post.