Lean/Agile Software Development Methodologies in Regulated Environments – State of the Art

Abstract

Abstract. Choosing the appropriate software development methodology is something which continues to occupy the minds of many IT professionals. The introduction of "Agile" development methodologies such as XP and SCRUM held the promise of improved software quality and reduced delivery times. Combined with a Lean philosophy, there would seem to be potential for much benefit. While evidence does exist to support many of the Lean/Agile claims, we look here at how such methodologies are being adopted in the rigorous environment of safety-critical embedded software development due to its high regulation. Drawing on the results of a systematic literature review we find that evidence is sparse for Lean/Agile adoption in these domains. However, where it has been trialled, "out-of-the-box" Agile practices do not seem to fully suit these environments but rather tailored Agile versions combined with more planbased practices seem to be making inroads.

Agile Method Tailoring in Distributed Enterprises: Product Owner Teams

“…The use of agile methods in highly regulated environments has been investigated in [37]. Again, however there was little specific discussion of the product owner role in [37].…”

Agile – Is it Suitable for Medical Device Software Development?

“…A working group was formed by the Association for the Advancement for Medical Instrumentation (AAMI) and they produced AAMI:TIR 45:2012 [11] which is an internationally accepted technical report outlining that "agile practices can be successfully adopted to develop regulatory compliant software" [12]. Agile software development literature reports "the promise of improved software quality and reduced delivery times" [13]. There are several reported benefits for adopting agile development practices including: delivering working software frequently; getting fast feedback and adjusting and embracing change accordingly; and minimized bureaucracy [14].…”

Regulated Software Development – An Onerous Transformation

“…By means of reflective analysis we examined the effects on the software development and support teams when the SOX regulations came into effect in 2002. With a growing interest in modern software development methodologies (SDMs) such as Agile and Lean, we performed a mapping study of these SDMs within safety-critical regulated domains [2]. The resulting state-of-the-art gave us a solid understanding of the development issues in such domains as Aviation, Automotive, and Medical Devices.…”

“…What this allows for then, is the potential to evolve the development process and look at more efficient approaches. Our research has seen that companies are looking to the advantages that might be gained from agile methodologies such as eXtreme Programming (XP) and Scrum and, consequently, finding the evolution of their SDLC less problematic than anticipated [2].…”