Regulated Software Research Group

Research Area – Medical Device Software Processes 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. Currently, 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 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.

Through this research Dr Mc Caffery plans to encourage: existing multinational and indigenous medical device companies to increase their medical software development; overseas medical device companies to perform software development in Ireland; indigenous software development organisations (of which there are many) to develop medical device software.

One of the main obstacles for medical device software development is the fact that before a medical device can be marketed the organisation has to obtain regulatory compliance for that device (including its software development processes) within the state in which the medical device will be marketed. If the state is the US, then the device will have to comply with the Food and Drug Administration regulations and associated standards. If the state is Europe, then the device will have to comply with the Medical Device Directives regulations and associated standards.

Core expertise The Regulated Software Research Group (RSRG) was established in 2008 as a result of Dr Mc Caffery receiving Science Foundation Ireland (SFI) Stokes Lectureship funding to develop a software process improvement framework for the medical device industry. The RSRG within the Software Technology Research Centre consists of 5 academics from the Department of Computing and Mathematics in DkIT, Lero (the Irish Software Engineering Research Centre) researchers, and leading international software process improvement collaborators. Over the forthcoming months 2 postdoctoral researchers, 5 PhD students and one visiting scientist will join the group.

Dr Fergal Mc Caffery is the leader of the RSRG. He has recently received SFI Principal Investigator funding to develop a global software development framework for the Irish medical device industry. He also leads the medical device software development package of a European 7th Framework Artemis project to improve software development environments for safety­critical software. Additionally, he has been appointed as the international leader of a project to develop an international standard for medical device software process assessment (Medi SPICE). Recently Dr Mc Caffery was also invited to join the SPICE academy which contains 15 of the world’s leading SPI researchers. He has published over 70 research papers in leading international journals, and peer­ reviewed conferences in the area of SPI. He is also been accepted to represent Ireland in relation to the development and review of international software process standards.

Core objective The main objective of this research is to support the development of the Irish medical device software industry. This research involves the development and integration of research from three different areas: the development of reference and assessment models for 10 foundational medical device software processes; the development of software process assessment methods and software process improvement roadmaps; and the inclusion of the global software development strategies.