COVER FEATURE High-Confidence Medical Device Software and Systems

The United States spends about 16 percent of its gross domestic product on healthcare, twice the average of most European nations. Given the shortage of caregivers and the growth of an aging US population, the future of US healthcare quality does not look promising and definitely does not look cheaper. Advances in health information systems and healthcare technology offer a tremendous opportunity for improving the quality of our healthcare while reducing healthcare costs. Advances in computing, networking, sensing, and medical device technology are enabling the dramatic proliferation of diagnostic and therapeutic devices. These devices range from advanced imaging machines to minimally invasive surgical techniques, from camera pills to doctor-on-a-chip, from computerized insulin pumps to implantable heart devices. Although advances in stand-alone diagnostic and treatment systems have been accelerating steadily, the lack of proper integration and interoperation of those systems produces systemic inefficiencies in healthcare delivery. This inflates costs and contributes to avoidable medical errors that degrade patient care. The use of software that controls medical devices to overcome these problems is inevitable and will help to ensure safe advances in healthcare delivery. A critical concern, however, is the cost-effective development and production of reliable and safe medical device software and systems.