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A survey of software engineering techniques in medical device development

: Feldmann, R.L.; Shull, F.; Denger, C.; Host, M.; Lindholm, C.


IEEE Computer Society:
Improving patient safety through medical device interoperability and high confidence software. Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability, HCMDSS/MD PnP 2007 : 25 - 27 June 2007, Cambridge, Massachusetts; Proceedings
Piscataway/NJ: IEEE, 2007
ISBN: 0-7695-3081-8
ISBN: 978-0-7695-3081-9
Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) <2007, Cambridge/Mass.>
Workshop on Medical Device Plug-and-Play Interoperability (MD PnP) <2007, Cambridge/Mass.>
Fraunhofer IESE ()

A wide variety of the functions provided by today's medical devices relies heavily on software. Most of these capabilities could not be offered without the underlying integrated software solutions. As a result, the medical device industry has become highly interdisciplinary. Medical device manufacturers are finding an increasing need to incorporate the research ideas and results from traditionally disconnected research areas such as medicine, software and system engineering, and mechanical engineering. In 2006, we conducted a survey with more than 100 companies from Europe and the USA to shine some light on the current status of the integration of software engineering technologies into the medical device domain. The initial results of this survey are presented in this paper. Both software engineers and the medical device industry can use these findings to better understand current challenges and future directions, to achieve a better integration of the fields.