SCIENCE FOUNDATION IRELAND:IRELAND COULD assume a leadership position in the development of the next generation of medical devices as a result of the work being undertaken by the Regulated Software Research Group at the Dundalk Institute of Technology.
For most people, medical devices are purely pieces of hardware, but many of the devices implanted in patients these days also have a software component to govern their functionality, while other devices such as blood pressure and heart rate monitors are very much reliant on software.
Recently introduced regulations now define certain software programmes as medical devices in their own rights. This includes the software running on everything from ECG monitors to the PCs analysing medical data.
The difficulty not only for the medical device industry but for device users and patients is how to make sure the software is fit for purpose, does what it is meant to do and, above all, is safe. After all, the performance of this software is critical to human health. It is not as if you are buying a new version of a PC operating system and it has a few bugs that make it crash a few times; that’s irritating but it’s not the end of the world. However, even the most trivial of flaws in medical device software could prove fatal.
And this is where the Dundalk-based team comes in. Led by Dr Fergal McCaffery, the Science Foundation Ireland-funded group is working on the development of the international standards that will govern the development of medical device software in future years. “In the past, regulatory bodies like the US FDA focused on the hardware element and saw the software as part of the device,” McCaffery explains. “Developers were told to follow the generic software lifecycle standard ISO 12207. This is fine for the development of ordinary software but not for safety-critical areas like medical devices.”
This resulted in the standard being worked on for adaptation for use in the medical devices industry and ultimately led to the development of a new standard known as IEC 62304. “This is recognised by all of the regulators for medical products and medical device manufacturers have to have a very good reason for not following it in relation to software. It is, in effect, a seamless way to ensure compliance with all relevant medical software device standards,” says McCaffery.
But the development of the new standard is not a solution in itself. A standard is not merely a set of parameters to which a product must conform. It goes much further than that and includes strict rules for the design and other processes that go into its original creation. It is a question of quality assurance rather than quality control – any product which comes through a fully compliant process should be safe. The problem with IEC 62304, however, is that there is no way of assessing a company against it.
“There is no audit process for it at the moment and that is what we are looking at; developing a process for the assessment of companies against the IEC 62304 model.”
This process is known as Medi SPICE and will provide regulators with a means of determining whether an organisation is capable of meeting the exacting standards of IEC 62304. But it is not just the regulators who will benefit from the work of McCaffery and his team; the Irish medical device industry and indigenous software sector stands to gain as well.
“The automotive sector faced very much the same issue about 10 years ago,” he explains. “The use of software in automotive components was increasing quite rapidly and with it the complexity of the products. The industry wanted to outsource large elements of the software development but needed to be able to assess if the companies chosen were up to the job. They followed the ISO 15502 standard and came up with Automotive SPICE to assess it. We are working with one of the developers of Automotive SPICE in the development of Medi SPICE for this sector.”
And this is where the benefits to Irish industry come in. “If an Irish-based medical device manufacturer wants to outsource software development to a small Irish developer at the moment they would have great difficulty as the developer would have no real way of becoming compliant with all the different regulations.
“Our process will give them a single means of complying with all relevant standards. It will be a complete framework that captures all standards for medical device software. They will also be able to see what they need and don’t need to do for particular applications. It will essentially be a step-by-step guide to compliance for them. This will enable the Irish medical-device sector to engage in more product development and will open up this valuable market to the Irish software sector.”
