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CMMI for development has been successfully applied for process improvement in various product development environments, including aerospace, defense, government, financial, and insurance industry sectors; however, relatively little is known of its adoption in medical device engineering. This article summarizes a comparison performed between CMMI-DEV v1.3 and the regulations and standards that drive software-intensive medical device product development, primarily IEC 62304. It shows what opportunities for performance excellence may be missed when medical device engineering teams chase ISO 13485 and IEC 62304 compliance without using CMMI-DEV to supplement their process management and improvement.
Key words
CMMI, medical device software, process improvement, software process
INTRODUCTION
The Capability Maturity Model Integration® for Development (CMMI® or CMMI-DEV) has been successfully applied for process improvement in various product development environments for more than 10 years (Chrissis 2011), with its predecessor, the Capability Maturity Model for Software (Software CMM), used successfully in the 1990s (Paulk et al. 1995). The Software Engineering Institute has provided reports on the successful use of CMMI in aerospace, defense, government, financial, and insurance industry sectors; however, relatively little is known of its adoption in medical device engineering.
This article summarizes a comparison performed between CMMI-DEV vl.3 and the regulations and standards that drive software-intensive medical device product development. The primary perspective is for medical device software engineering, where the most significant opportunity lies. This article shows what is missed when medical device engineering teams chase ISO 13485 (ISO 2003) and IEC 62304 compliance without using CMMI-DEV to effectively manage processes. A detailed mapping of CMMI-DEV vl.2 to IEC 62304 is provided in an earlier paper (Walker 2009).
SETTING THE CONTEXT
To set a context for process improvement and medical devices, the authors begin with an overview of CMMI-DEV, ISO 62304, and related standards for medical devices.
Capability Maturity Model Integration for Development
CMMI-DEV is a general reference model for process improvement in product development consisting of project management, engineering, support, and process management process requirements (Ghrissis 2011). Although applied across domains, CMMI has most successfully been applied in software engineering. Three constellations of CMMI-for development, acquisition, and services-have been developed; the focus of this analysis is CMMI for development, which is summarized in Table 1.
CMMI-DEV is structured in process areas that are assigned...