Background In September 2009, Dr Fergal Mc Caffery from the Department of Computing and Mathematics 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 Principal Investigator Programme in 2009. The project involves the integration of 2 different areas which are both critical to the success of the Irish economy – software and medical devices. 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). How will your current 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. 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.
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. 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 fulfill 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. Overall this work will provide the following significant benefits to the Irish medical device industry: 1. 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 repeatable software engineering “best practices� that will seamlessly achieve regulatory compliance; 2. Lead the development of this framework within Ireland and ensure that it is offered to Irish companies before Medi SPICE is released internationally so that they obtain a competitive advantage by becoming the first companies to be certified in Medi SPICE; 3. Encourage large multinational medical device companies to perform software development within Ireland due to the proximity of this research work; 4. 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; 5. Enable academics to perform converging medical device and software engineering research leading to the development of related Health Informatics courses in Dundalk Institute of Technology (DkIT);
6. Graduate 4 PhD students in the area of medical device software development. Transition PhD graduates into the medical device software industry to drive innovation and entrepreneurship; 7. Enable the Irish medical device software industry to benefit from collaborating with worldclass researchers, this will also ensure that we are leaders in this area and that no research duplication is performed; 8. 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; As a result of being a Science Foundation Ireland Stokes lecturer in DkIT and a senior researcher in Lero (the Irish Software Engineering Research Centre) Dr Mc Caffery has been able to create a strong foundation upon which to build this research. For example, he has recently been invited to join the prestigious SPICE academy which contains 15 of the world’s leading software process researchers who establish and maintain the international standard for software process assessment. 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. Two of these projects are: 1.
The development of an international software process assessment standard for the medical device industry – Dr Fergal Mc Caffery is the international project leader for this project.
2. An EU FP7 Artemis project to develop efficient environments and tools for safety-critical embedded software development – Dr Fergal Mc Caffery is leading the medical device domain work within this project. 3. Development of a Telehealth process reference model – the Brazilian government are funding a research scientist to work with Dr Fergal Mc Caffery in DkIT for one year commencing in January 2010 Dr Mc Caffery is now assembling a very strong team of researchers within the Regulated Software Research Group in DkIT to perform this research. The group will work closely with Lero researchers (in UL and DCU), world-class international collaborators and Irish based medical device companies.
Is there sufficient collaboration between medical device companies and academic research centres? I am quite fortunate in that I have a number of medical device companies who are committed to trialling my research. However, it would always be nice to have more companies to work with in terms of trialling the research. Events such as the one (in October 2009) organised jointly by Science Foundation Ireland and the Irish Medical Device Association certainly are a great help in terms of creating awareness of our research within the medical device community – both in terms of medical device companies and other research centres. Such events are therefore very welcome. Additionally, I also feel that the IDA play an important role in transferring details of ongoing research to relevant organizations. For example, Dr PJ Fitzpatrick of the IDA has profiled my research to organizations and set up initial meetings. Is the development of a fourth level graduate education institute specialising in medical devices innovation still a realistic aspiration? The medical device industry is one of the key growth sectors within the Irish economy, even now in times of recession. Therefore, demonstrating the huge potential there is for the Irish medical device industry. Also when you look around at the world-class medical device research projects that are currently taking place in Ireland and the commercialization potential for these projects the sector looks certain to continue to grow. Add the fact that little medical device software development is currently happening within Ireland given the potential that exists to grow this area in Ireland due to the software development expertise that already exists within the country and the proximity of leading medical device organisations (currently focused upon manufacturing activities). Therefore, the development of such an institute is definitely a realistic aspiration given the medical device research expertise that is already in Ireland – the big question is should such an institute be located in a single location or should it be distributed around the country – as expertise in the various medical device areas is distributed around the country. For example, DkIT plans to deliver Health Informatics courses in the future and would also be well placed to participate in such an institute as it possesses strong research foundations in: •
Medical Device Software Process Research (Regulated Software Research Group);
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Ageing in place devices and technology (Netwell Research Centre)
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Smooth Muscle Research
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Nursing
For more details on this please contact Dr Tim McCormac (Head of Research) in DkIT at tim.mccormac@dkit.ie
How do such joint ventures address key issues such as ownership of intellectual property? A strong MOU would have to be put in place between all the participants detailing who was responsible for each component and in particular who the IP belonged to – similar to the MOU that is put in place for EU FP7 projects. Once again Dr Tim McCormac (Head of Research) in DkIT, would have more information on this.
[1] Expert Group of Future Skills Needs. 2008. "Future Skills Needs of the Irish Medical Device Sector", http://www.skillsireland.ie/press/reports/pdf/egfsn080205_medical_devices.pdf