In September 2009, Dr Fergal Mc Caffery from the Department of Computing and Mathematics and the Software Technology Research Centre within Dundalk Institute of Technology (DkIT) commenced a research project that has been funded through Science Foundation Ireland’s Principal Investigator Programme (grant number 08/IN.1/I2030). The title of this research project is “Developing a global software development framework for the medical device industry”. Dr Mc Caffery’s project was one of only 22 projects funded under the highly competitive Science Foundation Ireland (SFI) Principal Investigator Programme through the Autumn 2008 call. This is the first SFI Principal Investigator project to be funded in DkIT and significantly it was the only Principal Investigator project funded from the Institutes of Technology sector. Dr Mc Caffery is also the holder of a Science Foundation Ireland Stokes Lectureship for medical device software process research (grant number 07/SK/I1299). The project involves the integration of 2 different areas which are both critical to the success of the Irish economy – software and medical devices. The medical device domain is a key growth area for the Irish economy. Medical devices with a “Made in Ireland” label are highly desirable throughout the global medical device community. At present the Irish medical device sector is focused upon the manufacture of medical devices. Research and development within this sector is mainly focused upon improving the manufacturing process. At present the Irish medical device software industry is small in comparison to the Irish medical device manufacturing industry. However, upon observing the global medical device industry it is clear that software plays a pivotal role in medical devices and particularly in relation to the more complex electronic medical devices. Ireland is internationally recognised for its software industry and is one of the leading exporters of software, with a particular focus in the areas of telecoms, insurance and finance. Therefore, Ireland has a very strong foundation upon which to grow the Irish medical device industry. Through the development of the global software development (GSD) framework Dr Mc Caffery plans to establish the Regulated Software Research Group in DkIT as a world leader in medical device software process research and Ireland as a premier location for medical device software development. This research is based on the integration of three research areas to develop a GSD framework for the medical device industry. This will assist Irish medical device software companies to achieve regulatory compliance by following a prescribed roadmap of software engineering best practices. The following research areas will be developed and integrated: 1. Development of a medical device process template which will enable software development reference and assessment models to be produced for different processes. The resultant processes will be reviewed by the international Medi SPICE (an international software process assessment standard for the medical device industry that is currently being developed, Dr Fergal Mc Caffery
is the international project leader of this project) team and will be integrated into the Medi SPICE standard. 2. When performing GSD, industry needs to be cognisant of factors which have a significant effect on the efficiency of globally distributed software development. 3. The development of a range of software process roadmaps which will fulfil the needs of different sizes and types of software development organisations, from the small indigenous to the large multinational, from organisations new to developing medical device software to organisations that have delivered medical device software for many years. Dr Mc Caffery is now assembling a very strong team of researchers within the Regulated Software Research Group in DkIT. The group will work closely with Lero researchers (in UL and DCU), worldclass international collaborators and Irish based medical device companies.