Embedded Systems Design Europe - May 2008 - (Page 29)

medical choosing the conﬁguration parameters based on domain knowledge. As a result of this manual analysis, 127 of the 736 warnings reported were found to be of genuine concern; in other words, they either reﬂected poor quality control or had the potential to cause the device to malfunction. These warnings were submitted as part of a report to the CDRH compliance group to take further action as necessary. The total effort expended during the post-market analysis was 210 person-hours. A majority of the effort was expended in conﬁguring the build for the application and manual analysis of the results. While 210 person-hours is still a signiﬁcant amount in terms of the effort required for the analysis, it is considerably less than what would have been required for a purely manual analysis. Additionally, the static analysis method provides for a much more reliable means for tracing errors in the software as opposed to the manual process. PREVENTIVE MEDICINE Static analysis is a valuable tool for postmarket investigation. By reasoning about potential run-time errors in the software, static analysis provides an independent, standardized, and repeatable inspection of a medical device’s software, as part of a broader scientiﬁc analysis of the device. Further, providing the precise location of the failure and a corresponding execution trace enables the investigator to trace the root cause of failure to its origin in the source code. This ability not only helps reduce time and effort involved in post-market investigation, but also leads to a more accurate means for postmarket analysis, as opposed to manual inspection. Most importantly, the use of static analysis allows the post-market investigator to evaluate the product, in this case the software, and not just the processes involved in developing it. Much as static analysis helps the investigator, it can be leveraged to even greater effect by medical-device manufacturers. The manufacturers can use static analysis to help ﬁnd ﬂaws early in the development cycle. Static analysis lends itself readily to veriﬁcation and validation activities and can easily be incorporated as part of the manufacturers’ software-development processes. Doing so facilitates a deeper assessment of the code before releasing it to market and helps establish conformance to good programming practices. On the basis of this experiment, we have reason to believe that static analysis – whether used in pre-deployment analysis by the manufacturer or during postmarket surveillance by an investigator – has the potential to greatly reduce software anomalies and lead to safer, more dependable medical devices. Raoul Jetley (raoul.jetley@fda.hhs.gov) is a researcher at the US FDA, Center for Devices and Radiological Health/Ofﬁce of Science & Engineering Laboratories. Paul Anderson (paul@grammatech.com) is vice president of engineering at GrammaTech, a spin-off of Cornell University that specializes in static analysis. PowerTools are renowned for being a long term investment because of their open and modular architecture. PowerTrace II • 4 GByte of trace memory to record program and data flow • More than 40 processor architectures supported by the trace port USA Lauterbach Inc. www.lauterbach.com Germany Lauterbach GmbH www.lauterbach.de Great Britain Lauterbach Ltd. www.lauterbach.co.uk Italy Lauterbach Srl www.lauterbach.it China Suzhou Lauterbach Technologies Co., Ltd. www.lauterbach.cn Japan Lauterbach Japan Ltd. www.lauterbach.co.jp • Trace port speed up to 550 MHz • Sophisticated analysis methods to perform comprehensive performance analysis and quality assurance tests PowerDebug II • A Gigabit ethernet interface guarantees immediate display and rapid analysis of the trace information. www.embedded.com/europe | embedded systems design europe | MAY 2008 29 http://www.lauterbach.com http://www.lauterbach.de http://www.lauterbach.co.uk http://www.lauterbach.it http://www.lauterbach.cn http://www.lauterbach.co.jp http://www.lauterbach.com http://www.embedded.com/europe

Table of Contents Feed for the Digital Edition of Embedded Systems Design Europe - May 2008

Embedded Systems Design Europe - May 2008 Contents Microsoft Provides Embedded Roadmap Enea Buys Developers Irish Start-Up Raises Funds for Telecom FPGAs Kontron Promotes COM Express Nano Mentor Nucleus Platform Provides UI for Atmel Small Form Factor Boards Head for the SUMIT Proffibus Advances IO-Link Integration Embedded Developers Cautious on Multicore Auto Cooperation Improves Test Altera Launches DO-254 Partner Network Building an ‘Instant-Up’ Real-Time Operating Systems An Architecture for Reusable Embedded Systems Software Free up Bandwidth in PCI Express Evaluating Software in Medical Devices Circuit Sensitivity in Analog Circuits Choosing Flash Memory New Products Advertising Contacts

Embedded Systems Design Europe - May 2008

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