The British Standards Institute (BSI) has established a specialised regulatory team aimed at regulating software used as a medical device (SaMD) alongside artificial intelligence (AI) in a bid to stay ahead of the industry boom.
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The new dedicated team has been established to pitch and investigate possible future regulations that would specifically pertain to computer software used in medical devices themselves as well as on PCs as part of a larger medical device suite.
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Effective immediately, the BSI says that the new regulatory team, led by global head of active implantable medical devices and SaMDs Thomas Doerge, will begin to examine methods of creating a new set of standards for the rapidly growing sector in anticipation of a boom in SaMD clients. BSI also claims that resources are drawn into the team based on demand for SaMD work, ensuring efficient resource allocation and short lead times.
Speaking with Medical Device Network, operations delivery director of regulatory services, Haydar Jaafar, detailed how SaMD has taken top priority for the group in the wake of an explosion of medical device software flooding all walks of the industry.
Jaafar said: “We have seen a vast increase in applications when it comes to software, there has been a huge increase in interest. Whenever we see a demand from an operation point of view we need to begin focusing on that demand. Create the team and create the expertise to ensure that we have the right skills in place. At the end of the day, it is all about patient safety, so that we ensure the products are fit for purpose.
“Compliance is important for us. Because we are putting people together, they are looking at standards, examining what is in this field in terms of existing software standards. So, by putting the group together, we will have discussions on best practices and pitfalls. We see ourselves as an extension to the manufacturer of products and placing that product on the market.”
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By GlobalDataDetailing the scope of the new team’s remit, Jaafar explained that the BSI has seen companies investing heavily in AI as a means of futureproofing themselves in the same way that companies were racing in the 90s and 2000s to secure web domains andthe BSI is best positioned to cater to this new activity.
Jaafar added: “Software does malfunction and require updates all the time. With software, developments are more frequent, so you need more agility in terms of response from our side. We want to make sure that we set up a system that allows us to understand how these programs are progressing.” Elsewhere in the rapidly expanding field of SaMD, AiM Medical Robotics has partnered with Harvard Medical School to conduct a study validating its own AI for deep brain stimulation (DBS). At the same time, the UK-based AI company, Brainomix, has seen its 360 e-Lung system granted market clearance from the US Food and Drug Administration (FDA).
