A Survey of Software Engineering Techniques in Medical Device Development Raimund L. Feldmann 1) , Forrest Shull 1) , Christian Denger 2) , Martin Höst 3) , Christin Lindholm 3) 1) Fraunhofer Center for Experimental Software Engineering (CESE) 4321 Hartwick Rd - Suite 500 College Park, MD 20742 USA 2) Fraunhofer Institute for Experimental Software Engineering (IESE) Fraunhofer-Platz 1 D-67663 Kaiserslautern Germany 3) Department of Communication Systems Lund University Box 118 221 00 Lund Sweden {rfeldmann, fshull}@fc-md.umd.edu, Christian.Denger@iese.fraunhofer.de, {Martin.Höst, Christin.Lindholm}@telecom.lth.se Abstract 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. 1. Introduction Today, many medical devices could not fulfill their intended use without the software embedded within them, which implements a variety of functions and features. Surveys of trends in the medical device industry (e.g., [1], [2], [3]) indicate that software is one of the most decisive factors for producing innovative products with new capabilities, and predict that the importance of software will only further increase in the future [4]. Studies also predict that the research and development (R&D) investment in software in this market will increase to 33% of the overall budget by 2015 [2]. As the role of software in the medical device domain increases in importance, so do the failures due to software defects. An analysis of medical device recalls by the FDA in 1996 [5] found that software was increasingly responsible for product recalls: In 1996, 10% of product recalls were caused by software-related issues. This was up from 6% in the years 1983–1991. A German survey on medical device recalls in the medical sector indicates that software is the top cause for risks related to construction and design defects of medical device products. This analysis, from June 2006, shows that 21% of the medical device design failures are caused by software defects [6]. This is an increasing trend, since the same figures from November 2005 show software responsible for 17% of construction and design defects. To address such issues, the development of medical device software is regulated by various standards, laws and recommendations (e.g., [7], [8], [9]). In general, these standards describe software life-cycle models that should be implemented by manufacturers. The overall objective is the definition of general process steps and intermediate work-products. Adhering to the regulations and following the specified processes increases an organization’s ability to produce safe, high 0-7695-3081-8/08 $25.00 © 2008 IEEE DOI 10.1109/HCMDSS-MDPnP.2007.4 46 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability 0-7695-3081-8/08 $25.00 © 2008 IEEE DOI 10.1109/HCMDSS-MDPnP.2007.4 46 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability 0-7695-3081-8/08 $25.00 © 2008 IEEE DOI 10.1109/HCMDSS-MDPnP.2007.4 46 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability 0-7695-3081-8/07 $25.00 © 2007 IEEE DOI 10.1109/HCMDSS-MDPnP.2007.4 46