Successful Collaborative Software Projects for Medical Devices in an FDA Regulated Environment: Myth or Reality?

The significance of executing a successful collaborative distributed software project in a regulated medical device industry is often recognized but such projects are never perfectly achieved. There expectations of standard software being delivered ´bug-free, on time and on budget´. In addition, FDA regulations impose a high standard on such medical device software by mandating the adherence to strict processes on software development. These processes include verification and validation of the software to assure the safety and effectiveness of the medical device. In such a regulated global software development environment, questions regarding mis- communication and lack of appropriate knowledge transfer are often raised, discussed and projected as being the main reason why collaborative projects either fail or are delayed. The requirements hold not only for the software that becomes part of the product but also for software used in its development. In this paper we analyze the nature of the global software development collaborative environment and identify several challenges in such projects for internally used software. These challenges include the burden of providing to the FDA a set of traceable documentation as evidence of following a specific process from software conception to software validation. We also discuss the human motivations that, when faced with these challenges, can affect success. We present two case studies of such globally distributed software development projects with entirely different focuses and study the underlying challenges and success factors. Finally we also discuss the driving factors for successful collaborative efforts and draw upon the incentives from our individual experiences in a real-world FDA regulated global medical device industry environment.