Medical Device Prediction Problems

By John McCormick  |  Posted 2004-03-08 Print this article Print

The medical-device software market is becoming a particular area of concern. The FDA says about half of the 10,000 medical devices on the U.S. market are software-driven-everything from pacemakers to infusion pumps to radiation-therapy machines. FDA watchers say many of the companies developing medical-device software are small. Because of the amount of research-and-development money that goes into medical devices, companies are under pressure to get products out the door.

"We will see more problems" in the medical-device field, says Alan Kusinitz, managing partner of SoftwareCPR, a consulting company that specializes in medical-device software. One of his biggest worries is the ever-increasing number of networked medical devices. Independently, software might function normally, but when connected to code in other machines, it may act unpredictably.

"Its the abnormal stuff that always shows up later in weird circumstances," Kusinitz says. "Thats most often where safety problems occur."

There are defense and industrial efforts underway by organizations such as the Sustainable Computing Consortium (SCC) and the Software Engineering Institute, both located at Carnegie Mellon University, to foster programs and standards to reduce software defects. There are also organizations in the healthcare industry, such as the Association for the Advancement of Medical Instrumentation, that are trying to establish standards for software used in medical devices.

In addition, new testing tools and services, such as Software Development Technologies ReviewPro, which examine not just the code but the methodology behind the code, are starting to offer software professionals assistance in vetting their output, as they create it. Also, code-writing practices such as "agile programming" emphasize breaking big projects into small pieces-and getting early and repeated input from users before proceeding.

Such efforts, though, are too late to help Victor Garcia or the physicists at the cancer institute in Panama who were trying to use imported software to save patients, not make them suffer.

Next Page: The role of a medical physicist.


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