  Background: Medical device development projects must follow proper directives
and regulations to be able to market and sell the end-product in their
respective territories. The regulations describe requirements that seem to be
opposite to efficient software development and short time-to-market. As agile
approaches, like DevOps, are becoming more and more popular in software
industry, a discrepancy between these modern methods and traditional regulated
development has been reported. Although examples of successful adoption in this
context exist, the research is sparse. Aims: The objective of this study is
twofold: to review the current state of DevOps adoption in regulated medical
device environment; and to propose a checklist based on that review for
introducing DevOps in that context. Method: A multivocal literature review is
performed and evidence is synthesized from sources published between 2015 to
March of 2020 to capture the opinions of experts and community in this field.
Results: Our findings reveal that adoption of DevOps in a regulated medical
device environment such as ISO 13485 has its challenges, but potential benefits
may outweigh those in areas such as regulatory, compliance, security,
organizational and technical. Conclusion: DevOps for regulated medical device
environments is a highly appealing approach as compared to traditional methods
and could be particularly suited for regulated medical development. However, an
organization must properly anchor a transition to DevOps in top-level
management and be supportive in the initial phase utilizing professional
coaching and space for iterative learning; as such an initiative is a complex
organizational and technical task.
