Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 133-142 |
| Journal | International Journal on Advances in Life Sciences |
| Volume | 8 |
| Issue number | 1-2 |
| Publication status | Published - 2016 |
| MoE publication type | A1 Journal article-refereed |
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Keywords
- agile methods
- agile software development practices
- Mdevspicer
- medical device risks
- medical device software
- medical device software development
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Agile medical device software development : Introducing agile practices into MDevSPICE. / McCaffery, Fergal; Lepmets, Marion; Trektere, Kitija; Özcan-Top, Özden; Pikkarainen, Minna.
In: International Journal on Advances in Life Sciences, Vol. 8, No. 1-2, 2016, p. 133-142.Research output: Contribution to journal › Article › Scientific › peer-review
TY - JOUR
T1 - Agile medical device software development
T2 - Introducing agile practices into MDevSPICE
AU - McCaffery, Fergal
AU - Lepmets, Marion
AU - Trektere, Kitija
AU - Özcan-Top, Özden
AU - Pikkarainen, Minna
PY - 2016
Y1 - 2016
N2 - 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 MDevSPICEr that integrates the regulatory requirements from the relevant medical device software standards. This paper describes how the MDevSPICEr 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 MDevSPICEr in the medical device industry and introduce an agile methodology together with its benefits and challenges. This paper outlines how MDevSPICEr can be extended to include agile practices to enable medical device software development to be performed in a more flexible manner.
AB - 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 MDevSPICEr that integrates the regulatory requirements from the relevant medical device software standards. This paper describes how the MDevSPICEr 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 MDevSPICEr in the medical device industry and introduce an agile methodology together with its benefits and challenges. This paper outlines how MDevSPICEr can be extended to include agile practices to enable medical device software development to be performed in a more flexible manner.
KW - agile methods
KW - agile software development practices
KW - Mdevspicer
KW - medical device risks
KW - medical device software
KW - medical device software development
M3 - Article
VL - 8
SP - 133
EP - 142
JO - International Journal on Advances in Life Sciences
JF - International Journal on Advances in Life Sciences
SN - 1942-2660
IS - 1-2
ER -