A software analysis technique for quantifying reliability in high-risk medical devices

Embedded micro processors are becoming increasingly important in medical treatments These devices are embedded in CAT scanners radiation therapy devices MRIs and are used in the control of drug production Embedded systems are becoming more sophisticated and the programs that control these system have increasing demands for precision and reliability Recently the FDA has been under increased pressure by Congress to end the paralysis within the agency in granting pre market approval to the so called high risk devices Complaints have been aimed at the FDA s Center for Devices and Radiological Health which has become reluctant to approve devices This fear it is claimed is due to several past controversies including the silicone breast implants and the P zer Inc heart valve As evidence that there really is a slow down in approval in scal approvals were granted in scal approvals were granted and in scal only pre market high risk approvals were granted In this paper we will brie y present a software engineering technique called sensitivity analysis that aims at producing software that is less likely to hide faults When sensitivity analysis indicates that faults are not likely to hide from testing we can more comfortably rely on the results of testing Sensitivity analysis has been automated and preliminary results from the automated analysis suggest that the technique will have signi cant advan tages for the development validation and regulation of medical devices