Off-the-shelf software (OTSS), and particularly commercial OTSS (COTSS), gets quite a bad press as many professionals in the safety-critical industries (public transport, nuclear power, health care, etc) think or suspect that general-purpose software produced by the likes of Microsoft does not meet the quality standards that they expect or require. But is this criticism really justified? We shall try to find out.

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International standard IEC 62304: 2006 (Medical device software - life cycle processes) introduced the term 'software of unknown provenance' (SOUP) to describe generally available software that had not been specifically designed for incorporation into a medical device, or software for which adequate records of the development process are not [publicly] available“. For obvious commercial reasons big companies like Microsoft seldom make their development processes public, but this does not necessarily mean that the software produced is not developed to a high standard.

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It is actually quite attractive for medical device manufacturers to use OTTS components (either proprietary or open source) as the software is generally "tried and tested" and has probably gone through several post-release improvement cycles. However, the medical device manufacturer is legally liable if the software in the device subsequently fails, so it is the developer's responsibility to ensure that OTTS components used are "up to standard". Helpfully, IEC 62304 outlines the checks that need to be done by the manufacturer to provide this assurance.

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Although still in the minority, a few industry observers have recently argued that the apparent distrust of SOUP is misplaced and that, with a few provisos, it actually represents a sound basis for the development of SaMD. There is a discussion of the use of SOUP in the design of medical device software in the book mentioned on the Current Projects page. A brief summary will be added here in due course.

 

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This page last updated: 02 April 2024

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