The findings of an independent review into the equity of medical devices are to be welcomed and will help support NHS innovation aims – but only if they become a strong foundation for system-wide action, says InnoScot Health

The final recommendations of the Department of Health and Social Care’s Equity in Medical Devices: Independent Review were published last week after looking into factors leading to unfair biases in the design and use of medical devices.

It confirmed that minority ethnic people, women, and people from deprived communities are at most risk of poorer healthcare because of those potential biases and has urged improvement.

InnoScot Health’s Head of Regulatory Affairs, Elaine Gemmell has welcomed the greater focus on eradicating inequities which she believes will in turn support better innovation, designed from the outset to meet the needs of all.

However, she also wants to see a strong long-term strategy that realises genuine system-wide action and is able to respond flexibly to the growth of artificial intelligence (AI) being integrated into medical device innovation where biases can be unwittingly incorporated into the development process.

She said: “It is encouraging that proactive steps are being taken to resolve what is a concerning issue around inequities in healthcare which can see some of the most marginalised members of society not receiving the right treatment due to basic lack of consideration for their needs. There is no one-size-fits-all approach when it comes to equitable healthcare.

“The final report makes it clear that inequities in the design and use of medical devices can arise – and have arisen – from lack of diversity across the health research workforce, combined with lack of co-production, and an absence of fundamental equity considerations. That is a situation that is not in-keeping with expected standards of inclusivity in healthcare and a fairer NHS.”

The review focused on three types of medical device that could be particularly prone to unfair biases – ‘optical’ medical devices, such as pulse oximeters; devices assisted by AI; and polygenic risk scores (PRS) in genomics.

Elaine continued: “The COVID pandemic raised concerns over the accuracy of pulse oximeters for patients with darker skin tones, and the report found ‘extensive evidence’ of those concerns being founded.

“The report further notes AI’s ‘great potential benefits to medicine but also possible harm through inherent bias against certain groups in the population’.

“This, it rightly concludes, means that existing biases in society could be incorporated throughout the lifecycle of AI-enabled medical devices, and then magnified through further development.

“With AI increasingly coming to the fore in healthcare innovation, this is a vital ethical point. AI’s advancement and integration has been largely positive so far but must be very carefully monitored as its outputs are essentially a product of the data source it is given and that is then perpetuated. The question which must be immediately asked is whether that is the correct data to begin with.

“Gaining regulatory approval can be difficult to navigate even with the right expertise. It’s now going to be more comprehensive and the Medicines and Healthcare products Regulatory Agency (MHRA) will request that applications to approve new medical devices describe how they will address issues of bias.”

The InnoScot Health team offers skilled regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive and Medical Device Regulation.