Between 2005 and 2010, a reported 4,343 medical devices were recalled in the United States by more than 800 companies across a wide range of therapy categories. Indeed, reports of injuries and deaths resulting from failures of infusion pumps prompted the Food and Drug Administration to launch an “Infusion Pump Improvement Initiative” in 2010 to more tightly regulate manufacturers.
Intel and Wind River have teamed up to explore a solution. The result is a concept reference design that combines Intel processing innovation with Wind River expertise in embedded technologies, tailored specifically to the needs of therapeutic device original equipment manufacturers and software developers. It will enable them to streamline the design and development process and accelerate time-to-market with more reliable and secure products. This paper outlines the challenges that developers and manufacturers face and how the Intel-Wind River therapeutic device concept helps address them.