Medical devices provide important life-maintenance and life saving functions. This means that faults that interfere with their proper functioning can lead to injury and death of patients and medical staff. This talk will discuss the techniques and work products appropriate for safety analysis and design of embedded medical devices, including hazard analysis, fault tree analysis (FTA), fault means and effect analysis (FMEA) and fault means, effect, and criticality analysis (FMECA). This talk will also discuss a UML profile for creating such analyses and how they can be linked to requirements and design.

Bruce Powel Douglass is the Chief Evangelist for IBM
Bruce has over 30 years experience designing safety-critical real-time applications in a variety of hard real-time environments and has a doctorate in neurocybernetics. Bruce is a well-known writer on these topics, having authored a number of books, including “Real-Time Agility” (Addison-Wesley, 2009), “Real-Time UML Workshop” (Elsevier Press, 2006), “Real-Time UML 3rd Edition: Advances in the UML for Real-Time Systems” (Addison-Wesley, 2004), “Doing Hard Time: Developing Real-Time Systems with UML, Objects, Frameworks and Patterns” (Addison-Wesley, 1999) and “Real-Time Design Patterns: Robust, Scalable Architectures for Real-Time Systems” (Addison-Wesley, 2002). He contributed work on the UML specification (both 1.x and 2.0), the “UML Profile for Schedulability, Performance, and Time”, the “SysML Profile” and the “UML Profile for DoDAF and MoDAF” and is a former cochair for the Real-Time Analysis and Design Working Group in the OMG standards organization. Bruce teaches and consults all over the world in systems engineering and real-time and embedded systems development.