Software can serve as a source of innovation and a key differentiator for medical devices, especially given the adaptability of software and the speed at which software changes can be prototyped and implemented. The reality is that the complexity and pace of change for embedded software is rapidly outpacing the ability of organizations to address these issues with manual processes and disconnected point tools.

Regulatory pressures and increasing complexity, coupled with the increasing globalization of the market, creates an environment where quality, reliability and safety compete with the business needs to reduce time-to-market and increase product development efficiency.

This paper reviews some of the key challenges facing the medical device industry, and examines the role that a comprehensive and coherent Software System Lifecycle Management (SSLM) platform, that manages all assets and processes in software-containing product development, can play in meeting these challenges.