Code Coverage In The Medical Device Software Industry

Code Coverage In The Medical Device Software Industry

If you develop software in a highly-regulated industry, then you are probably aware of the rules governing software validation, software testing and code coverage. In these industries, testing and validating code is not only a good business practice, but often a basic requirement for being in business. One such industry where this applies is the medical device industry.

The U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA), provides specific guidance for companies involved in developing medical device software or the validation of software used to design, develop, or manufacture medical devices. A complete listing of the General Principles of Software Validation as it relates to the medical device industry can be found online at http://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm.

The Implications of Software Validation and Code Coverage

Per the FDA’s own analysis, “if 3140 medical device recalls conducted between 1992 and 1998 reveals that 242 of them (7.7%) are attributable to software failures. Of those software related recalls, 192 (or 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution.” Although most developers may intuitively recognize the need for validating software and testing methods, the cost of failure related to poorly validated software in the medical devices software space is increased when human lives are potentially on the line.

The FDA goes on to highlight the fact that “software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.”

These benefits are added to those any development team in any industry can gain through a well-tested application — lower total application costs, lower ongoing support costs, and improved ability to reliably modify your code base and implement changes over time.

Over the coming weeks, we will discuss the specific metrics, approaches and best practices that can be used by .NET development organizations to ensure compliance in regulated industries and improve the reliability of your code base.