The medical device industry is finally catching up to other industries in terms of software safety standards, but at what cost?
The medical device industry has lagged other industries in the adoption of safety standards for software design. The situation has improved with the introduction of IEC 62304, and medical device software reliability has improved. But there may be a cost to innovation.
Recent quality concerns are driving many industries to start looking seriously at ways to improve the quality of software development. Not surprisingly, there are marked differences in the quality of software in the different sectors. The automotive industry, for instance, does a good job of listing all software requirements in a database and was the original of the MISRA software coding standards. The railway and process industries have long had standards governing the entire development cycle of electrical, electronic and programmable electronic systems, including the need to track all requirements. The automotive sector, though, has only recently introduced a standard for a similarly broad-based approach.
By contrast, medical software guidelines are typically more in line with low-risk applications, even when a software failure could result in serious physical injury or death. Despite this apparent disparity between medical software and other safety critical standards, the case for software, which has been proven to be reliable through standards compliance and requirements traceable process, is becoming ever more compelling.
But there is a downside. Medical device software is frequently developed by very small startup companies, perhaps more so than any other safety-critical sector. In the other sectors, the overheads associated with standards such as these are mostly carried by large organizations. As the overhead involved with the transition from prototype to production can be daunting, the standards can create a significant barrier for small companies to overcome.
How many potentially life-saving devices will never see the light of day as a result?