Medical Device Software Engineering
Competency Leader
How will Medical Device Software Engineering research impact on the medical device industry?
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 industry is focused upon manufacturing. As mentioned in a report produced by the Expert Group of Future Skills Needs [1], ICT forms a major part of the medical device sector globally, however in Ireland, where a significant ICT sector exists, only a small part of the medical device sector involves ICT. The report also highlighted that Ireland does not have a strong presence in electronics based medical devices (which would include substantial software development). The sector is particularly dependent on the continued use of stents in the treatment of cardiovascular disease. Therefore, either the discovery of an effective drug treatment for vascular plague or the general migration of the manufacture of medical devices to low labour cost locations could negatively affect the future growth of the Irish medical device sector. Our research offers an opportunity to reduce this exposure by supporting the continued development of a software based medical device industry in Ireland through providing a framework that will encourage existing indigenous medical device companies to consider developing software, encourage multi-national medical device companies to consider Ireland as a location for developing software (such companies stated that they would develop software in Ireland if an infrastructure existed that would enable an Irish site to work with their other sites), and to encourage indigenous software companies to consider developing software for the medical device industry.
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.
One of the main obstacles for medical device software development (as opposed to software development for most other sectors) 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. Through this research Dr Mc Caffery aims to assist organisations to overcome this obstacle.
Leadership of the Medical Device Software Engineering Group
Through the development of a medical device software engineering group in Lero we plan to establish Lero as a world leader in medical device software engineering research and Ireland as a premier location for medical device software development. Dr Fergal Mc Caffery will lead this group. Dr Mc Caffery is holder of both Science Foundation Ireland Stokes Lectureship and Principal Investigator awards for medical device software process research and is leader of the Regulated Software Research Group (RSRG) within Dundalk Institute of Technology (DkIT). The medical device software engineering group in Lero will consist of academic members from DkIT, UL, TCD , NUIG and DCU and will complement the work of the RSRG:
- through integrating the research areas of software process, software product lines and formal methods to automatically generate regulatory compliant software development roadmaps for different types of medical device companies developing different medical device products;
- by improving medical device software development environments to facilitate traceability. Traceability is critical for medical device software development. In order to obtain regulatory compliance medical device software development organisations have to demonstrate complete development and maintenance lifecycle traceability.
Dr Mc Caffery has created a strong foundation upon which to build this research. For example, he has recently been invited to join the prestigious SPICE Academy whose membership consists of leading international software process researchers who establish and maintain the international standard for software process assessment (ISO/IEC 15504). This profile has also enabled Dr Mc Caffery to become involved in a number of complementary international projects which will provide the project team access to the ISO standards community, the international software process community and the international medical device community, plus data from the projects. Some of these projects are:
- The development of an international software process assessment standard for the medical device industry (Medi SPICE) – Dr Mc Caffery is the international project leader for this project;
- An EU FP7 Artemis project to develop efficient environments and tools for safety-critical embedded software development – Dr Mc Caffery is leading the medical device domain work within this project.
- Development of a generic process reference model template– the Brazilian government funded a research scientist to work with Dr Fergal Mc Caffery in DkIT for one year.
The group will work closely with world-class international collaborators and Irish based medical device companies and will provide the following significant benefits to the Irish medical device industry:
- Provide convergence between the ICT and BIO research domains. Enable Irish software medical device companies to increase their productivity and develop safer software through adopting automatically generated repeatable software engineering “best practices” that will seamlessly achieve regulatory compliance;
- Encourage large multinational medical device companies to perform software development within Ireland due to the proximity of this research work;
- Build a sustainable research team in this area that will enable Ireland to be recognized as being at the forefront of global medical device software development;
- Graduate PhD students in the area of medical device software development. Transition PhD graduates into the medical device software industry to drive innovation and entrepreneurship;
- Enable the Irish medical device software industry to benefit from collaborating with world-class researchers, this will also ensure that we are leaders in this area and that no research duplication is performed;
- Enable the creation of high-value software development, regulatory affairs (addressing a shortage in this area) and software process jobs in the medical device sector.
[1] Expert Group of Future Skills Needs. 2008. "Future Skills Needs of the Irish Medical Device Sector", http://www.egfsn.ie/publications/2008/title,2514,en.php
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