Agile in Regulated Environment: Abbott Labs Experience Report

In earlier posts in this series on Agile Development as Applied in High Assurance and Regulated Environments, I mentioned that applying agile development in the context of highly regulated environments is not a new thought, and at least some others have gone down this road before. And while the analysis of CFR 820.30 we did in the last post might indicate a waterfall mentality, the fact is that it doesn’t have to be that way at all.

One real-world example is from Abbott Labs in the development of a nucleic acid purification platform and companion real-time analyzer (whatever that is!) .  Some of the team members gave a presentation at Agile 2009 in Chicago. (I’ve contacted the authors to see if the PPT is still posted on line somewhere. I can’t seem to find it now. If I hear back, I’ll update this post with a link at some point.)

Here’s a few “grabbers” for context:

– “software was developed in iterations (short time-boxed iterations or sprints) and released in increments (collection of iterations, validated etc). –

– it is a myth that you can predict the requirements up-front

– Results: estimated team size and schedule reduction of 20%-30%.  Estimated cost savings of 35%-50%.

– at time of launch, a number of features, once thought to be essential, were not included. Some were deferred for up to three years …nonetheless the product was highly successful and trading off features for three years of sales is an easy choice.”

This surely speaks to the fact that medical device doesn’t have to be developed in a waterfall model, and indeed when it isn’t, typical agile business benefits may well result. The whitepaper on the same topic, Adopting Agile in an FDA Regulated Environment can be purchased here.

In future posts, I’ll be introducing an agile process model for use in high assurance software development that reflects this key fact.

[Nov 10 Update. A reader, Rob Matheson found the deck on line at It actually has deeper  content than the written report.

Thanks Rob!]


7 thoughts on “Agile in Regulated Environment: Abbott Labs Experience Report

  1. I get the validation in a continuous integration environment.

    Will you also be touching on how Continuous Delivery fits into the mix?

    The difference being build (Integration) vs staging/test environments (Delivery)

    • Bernie, Initially, verification (with some automation for traceability) will be the main topic, although I will touch on pre-depolyment validation as well. I’m don’t have much experience to draw on for continuous deployment, outside of non-medical Saas, that is.

      Feel free to chime in with any inputs you have on either topic.


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