DevOps in an ISO 13485 Regulated Environment

Abstract

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.