An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs

Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software

Developing Health Technology Innovators: A Collaborative Learning Approach

In this paper we present a new initiative to promote collaborative learning through industry partnered, interdisciplinary, student and user centred projects. This was achieved through the development of rehabilitation devices augmented with gamified software. Today development of software systems often requires people from different specialities who can work in multidisciplinary teams to achieve a common objective. A key challenge, therefore, is producing graduates with an understanding of a number of disparate skills across many discipline boundaries. Undergraduates may be knowledgeable in one specific discipline but will not be aware of the issues brought to bear by other relevant disciplines. In an effort to overcome this limitation, a cross-discipline course “Serious Games and Welfare Technology” was developed that allows students from different disciplines to work together to produce innovative, technology- supported health solutions. The course, an EU funded Erasmus+ initiative, was supported by a MOOC and enabled multi- disciplined and multinational teams to produce solutions for leading Health technology companies in the areas of rehabilitation and aging support. Following the first year of offering the course with a cohort of students from 5 countries, we report on the experiences and outcomes achieved from a number of viewpoints