Barriers to Adopting Agile Practices When Developing Medical Device Software

Abstract

Agile methodologies such as XP and Scrum are founded upon the four values and twelve principles of agile software development. A software development project is only considered to be truly agile if these values and principles are followed. However, software developed for use in medical devices must be regulatory compliant and this can make the process of following a single agile methodology such as XP difficult to achieve. This paper outlines how we identified the barriers to agile adoption in the medical device software domain through performing a survey. These barriers include: lack of documentation; maintaining traceability; regulatory compliance; lack of up front planning and the process of managing multiple releases. Based on this research recommendations are also made as to how these barriers can be overcome.

Agile – Is it Suitable for Medical Device Software Development?

“…For example, Pair Programming and TDD worked well for Medtronic providing them early feedback and improved quality [23]. A survey of 20 Irish MD software development organisations in 2012 revealed that 50 % of organisations were using the V-Model, 25 % of them were following an agile approach and the "remaining 25 % used other development lifecycles such as the Waterfall, and Iterative & Incremental approaches" [25]. The case studies [9,16,23,26] highlighted that following an agile approach "can resolve problems associated with plan driven software development" [25].…”

Challenges in Flexible Safety-Critical Software Development – An Industrial Qualitative Survey

“…McHugh et al [9] address flexibility from a process perspective, basing their work on an industrial survey, in which they investigated barriers preventing the adoption of agile practices in safety-critical medical device development. They found that the barriers they identified were tightly coupled with current regulatory constraints on medical software, but they emphasized that the barriers were not insurmountable even with todays best practices and standards.…”

Mobile medical app development with a focus on traceability

“…Therefore, eXtreme Programming can be used in conjunction with Scrum . Case studies have emphasized that following an agile approach can overcome the issues associated with plan‐driven software development …”

“…2 Case studies 35,[39][40][41] have emphasized that following an agile approach can overcome the issues associated with plan-driven software development. 42 Participants felt that by integrating agile practices into the V-model development life cycle, it provides the advantage of accommodating changes more easily than the previous 2 approaches.…”