Regulatory
Barriers to entry The phrase ‘there’s an app for that’ might be a cliché now – but it could soon become the case in
modern medicine just as it currently is for consumer devices. That is, at least, if the companies behind so- called ‘Software as a Medical Device’ (SaMD) products manage to surmount the regulatory mountains they’ve traditionally faced. Andrea Valentino speaks to experts across the field to explore the historical challenges of SaMD regulation, how flexibility on both sides of the Atlantic is changing the situation at speed – and some of the hurdles companies may still need to overcome.
odern medical devices would be impossible without regulation. From pacemakers to syringes, officials are vital to ensuring that products function as intended. If nothing else, the importance of this work is reflected in how much funding bodies receive, with 2022’s FDA budget hitting the $6bn mark. Examine the bewildering variety of the regulator’s in-tray, and this munificence makes sense: last year, after all, the FDA approved dozens of distinct medical products, galloping everywhere from bone growth stimulators to cochlear implants. It goes without saying that their British and European counterparts are just as busy – hardly surprising when the global medical devices market is expected to reach $718bn in 2029. Yet in a world where regulators are crucial middlemen in a device’s journey from factory to
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clinic – and critical, of course, in keeping patients safe – recent years have seen officials face a new phenomenon: SaMD.
Short for ‘Software as a Medical Device’, it speaks to a rising trend where medical devices are no longer mere physical objects – or even software wrapped within a hardware case. They encompass, for instance, the algorithms used to understand a patient’s medical data, or else the video recordings showing their condition. They clearly don’t fit into an analogue world of hip replacements and stents. Yet, speak to the experts, and it’s equally obvious that SaMD can be vital to a patient’s wellbeing. “The analysis provided by the software helps to identify abnormalities and assists physicians in diagnosis and treatment decisions, in monitoring patient progress and response to treatment,
Medical Device Developments /
www.nsmedicaldevices.com
ArtemisDiana/
Shutterstock.com
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