Oisín Cawley

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

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 plan-based practices seem to be making inroads.

An agile v-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

Through the use of semi structured interviews with medical device software organizations it emerged that medica device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC) particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software.

Lean Software Development – What Exactly Are We Talking About?

As the Software Engineering landscape continues to evolve and new paradigms are introduced, there can be a tendency for both industry and academia to enthusiastically embrace new approaches and march forward under whatever banner conventional wisdom has decided to adopt. One such banner is Lean Software Development, a paradigm that continues to see a growth in interest driven by the need for cost reductions within industry. The term lean attracts the attention of business, but precisely how it applies within software development is still being debated. In addition, its relationship to the better understood agile methodologies is also a topic for debate. Having been drawn into this research area ourselves, we present here a review of Lean Software Development and try to distil out for the reader some understanding of this somewhat undefined topic. We conclude with some thoughts on where this subject might go to from here.

Medical Device Software Development - A Perspective from a Lean Manufacturing Plant

Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.

A conceptual framework for lean regulated software development

A growing number of companies are discovering that their software development processes must be in compliance with some form of regulation. This is particularly so when it comes to safety-critical or business-critical systems such as Automotive Software, Robotics, Medical Devices or Finan- cial Management systems. These regulations aect the soft- ware development process itself in various forms. Further- more, much attention is being given to ways of improving the eciency of businesses, for example, by adopting lean principles. This raises the question for how to adopt lean principles for software development within a regulated envi- ronment? This poster presents the results of our empirical research into lean and regulated software development. Built from a combination of data sources, we have developed a conceptual framework comprising ve primary components. In addition the relationships they have with both the central focus of the framework (the situated software development practices) and with each other are indicated.

Regulated Software Development – An Onerous Transformation

Software development within regulated settings is becoming more and more common place. Compliance typically involves saying what you do and doing what you say. However, in some domains, especially safety-critical ones, it needs to be more than simply following the rules, and should be something which everybody in the organisation supports in their daily tasks. This can be difficult to achieve and requires an organisational transformation, but once begun, sets the foundation on which the software development process can evolve.

Trials and Tribulations of the Global Software Engineering Process: Evolving with Your Organisation

This chapter will provide the reader with a firsthand account of the trials and tribulations of working in and managing a Global Software Engineering (GSE) function. By describing the move from a distributed collection of self-sufficient manufacturing plants with locally managed software engineering resources, to a GSE function as a shared service, the focus will be on how the management of that group had to fundamentally change in order to satisfy the complex projects and customer base which resulted. In parallel it will discuss the effect of regulation on the software engineering management process. Tracing the introduction of financial systems regulations, it will discuss the issues this brought to the GSE process and how they were successfully overcomed. These topics will be augmented by research that the author has carried out into regulated software development.