Medical devices are universally used in our software savvy world and are often taken for granted. These devices are regularly used for measuring and monitoring data in combination with display or representation of the data on a mobile computing device, typically a smart-phone or a tablet. Medical devices such as pacemakers have greatly improved the quality of life for millions of people and most have them fi tted and think no more about it. However, many of these devices are underpinned by complex software.
MDevSpice® is a soon to be spin-out based at DkIT. The cofounders are Dr Fergal McCaff rey, Dr Paul Clarke and Dr Marion Lepmets. They have developed a framework which has been designed to enable best practice adoption and assessment in medical device software development. It integrates accumulated practices from generic software engineering with medical device software standards into one single framework. Until recently both SME’s and multi-nationals had to wade through masses of different rules, regulations and standards before they could proceed with a product development. Once launched MDevSpice®’s new service will make life a lot easier for manufacturers to develop new products.
Dr Paul Clarke explains that “We have been conducting research in this area for many years and often take the lead in the development of new international standards through our work with the International Organisation for Standardisation and the International Electrotechnical Commission,” Clarke says. “In recent years over 20 per cent of medical device recalls in the US were related to software, and this number is growing. Our innovative framework centralises all of the software-centric knowledge in a one-stop shop. It facilitates manufacturers striving for best practice and in turn this will increase the safety of devices while also reducing the risk of potentially embarrassing and costly product recalls. Through our engagement with industrial groups it became apparent that although excellent standards and guidance documents exist to assist manufacturers, when it came to software development, these sources were of varied origin and focus. With the proportion of medicaldevice recalls attributable to software errors on the rise [10 per cent in the early 1990s to 20-25 per cent today] there was a real need for standards consolidation. Apart from the cost of a recall, medical-device manufacturers can also struggle to recover from the damage it can cause to their brand.”
MDevSpice® has received fi nancial support from Science Foundation Ireland and Enterprise Ireland along with some EU funding which has allowed it to become commercially ready to launch its service. It has taken about fi ve years to get to this point and now only fi nal details remain before the service is available. MDevSpice® will employ the founders but will also create new jobs and may, in the future, look for a Chief Executive to look after the dayto- day running of the company. For now MDevSpice® is delighted that the future is so promising with customers already eagerly waiting for the service to become available.