Rationale for Using Agile Development in a Regulated Environment

What is regulators view on Agile development? The regulators have realised that many organisation in the regulated industry will be looking to adopt an agile framework for development. The regulators have therefore considered how they look at this and therefore e.g. FDA in January 2013 endorsed the standard “AAMI TIR45: 2012; Technical Information Report; Guidance on the use of AGILE practices in the development of medical device software” [1] as an acceptable approach for using agile in the regulated industry.
This standard describe how the artefacts created in Scrum can be used to create evidence for proper validation during product development that satisfy the regulators requirements to the development process and how the concept of a “Done” product can add the “missing link” to agile to ensure the needed evidence of compliance can be demonstrated during an inspection. The standard also provide guidance on how to align regulators/inspectors expectations to the agile framework.
A few examples on how it can be done! These authority examples are taken from FDA’s ”General Principles of Software Validation; Final Guidance for Industry and FDA Staff”, which is current as of 15-MAY-2019 according to FDA homepage, and can be downloaded from this web-address

FDA states in General Principles of Software Validation Small batches and compliance evidence gathered in a tool like Azure DevOps*
Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied. During planning use critical thinking to identify the tasks needed to create a solution to the User Story and to mitigate possible risks that the solution will not be fit for intended use. Create these tasks in Azure DevOps and use the discussion track to capture considerations and decisions made during development. This will directly fulfil this expectation from authorities.
While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle. The tasks created during Iteration planning plus tasks added during development to address problems/risks identified during development plus the comments in the discussion tracks is the direct evidence for this.
The final conclusion that the software is validated should be based on evidence collected from planned efforts conducted throughout the software lifecycle. Using the discussion tracks in the User Story and task to discuss development considerations and review findings instead of e-mails, etc. will ensure that all needed evidence for making the conclusion about compliance can be retrieved automatically from Azure DevOps during an inspection if needed.

*) other tools like Jira can also be used.
What is the most popular Agile development framework? Scrum is most popular Agile framework today [2], [3] and is particularly good for managing complex software projects and product development.
The benefits include:

  • Cut the validation documentation by 60-70 %.
  • Reduce the technical documentation 30-50 %.
  • Faster delivery of solutions.
  • Offers better transparency to progress and rapid feedback.
  • Increasing the quality of the deliverables.
  • Reduce project risk and cost.
  • Increased productivity.
  • Increase likelihood of shipping something useful for the customer at the scheduled time.
  • Higher flexibility towards an ever changing world.

The framework was described for the first time by Hirotaka Takeuchi and Ikujiro Nonaka in the context of product development in their 1986 Harvard Business Review article “New New Product Development Game” [4].  Scrum is a term borrowed from rugby where it is a method of restarting the  play with all team players gathered closely together with their heads down and attempting to gain possession of the ball. Hirotaka Takeuchi and Ikujiro Nonaka introduced the term scrum in the framework to underline the team aspect of getting in control.

Later this framework was refined by Sutherland and Schwaber jointly and presented at the Object-Oriented Programming, Systems, Languages & Applications conference in 1995 (OOPSLA ’95) in Austin, Texas. Over the following years they developed it further into what became known as Scrum[5].
How do Scrum scale? Scrum in itself focus on a single development team, the Scrum Team, which is typically from 3 to 9 persons. This set a limit to the size of project that can be handled.
There is therefore evolved a number of frameworks based on Scrum that allow to scale and have more Scrum Teams work in parallel. The best know of these frameworks is Scaled Agile Framework, SAFe.
References: [1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=30575;

[2] Forbes: https://www.forbes.com/sites/stevedenning/2015/07/23/the-worlds-most-popular-innovation-engine/#763e41137c76

[3] https://www.qagile.pl/wp-content/uploads/2017/05/versionone-11th-annual-state-of-agile-report.pdf

[4] Original Article: “New New Product Development Game”;Takeuchi, Hirotaka; Nonaka, Ikujiro; HBR January 1, 1986.

[5] The Definitive Guide to Scrum: The Rules of the Game; November 2017; https://www.scrumguides.org/docs/scrumguide/v2017/2017-Scrum-Guide-US.pdf