Home // International Journal On Advances in Life Sciences, volume 8, numbers 1 and 2, 2016 // View article

Agile Medical Device Software Development: Introducing Agile Practices into MDevSPICE®

Authors:
Fergal McCaffery
Marion Lepmets
Kitija Trektere
Özden Özcan-Top
Minna Pikkarainen

Keywords: medical device software; MDevSPICE®; medical device risks; medical device software development; agile methods; agile software development practices

Abstract:
Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. In order to develop a working medical device system through integrating its sub-systems, the sub-systems’ requirements have to be derived from the overall medical device system requirements. The system requirements are continuously collected, analysed and built from the needs of different stakeholders such as patients, health professionals and other companies offering relevant devices, interfaces and software related to the medical device system under development. Various regulatory requirements have to be achieved for a medical device to be allowed market access. We have developed and piloted a medical device software process assessment framework called MDevSPICE® that integrates the regulatory requirements from the relevant medical device software standards. This paper describes how the MDevSPICE® framework has been designed to enable medical device software developers to produce software that will be safe and easily integrated with other sub-systems of the overall medical device. We also describe the lessons learned from piloting MDevSPICE® in the medical device industry and introduce an agile methodology together with its benefits and challenges. This paper outlines how MDevSPICE® can be extended to include agile practices to enable medical device software development to be performed in a more flexible manner.

Pages: 133 to 142

Copyright: Copyright (c) to authors, 2016. Used with permission.

Publication date: June 30, 2016

Published in: journal

ISSN: 1942-2660