The successful approval of atrial fibrillation detection on the Apple Watch by the US Food and Drug Administration in 2020 marked a notable milestone for a device aimed at the general public.
It was seen as a potential challenge to traditional medical device manufacturers and a glimpse into the future.
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Today, it stands as an exception.
Apple chose not to pursue class-2 medical device certification for the pulse oximetry function added to the Apple Watch 6, instead categorising it as a wellness feature, which is a less stringent designation.
Meeting the rigorous standards of efficacy, accuracy, and safety imposed on medical devices is a daunting task, particularly if not considered from the outset of development.
As a consequence, consumer electronics companies that aim to incorporate medical-grade features into existing products face significant hurdles.
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By GlobalDataThis differs from established medical device manufacturers, who find that integrating smartphones into their offerings provides substantial benefits to users and allows them to consolidate their hardware and software.
A key example of this can be seen with continuous glucose monitors such as the DexCom G7.
Wireless sensors can directly interface with smartphone apps and eliminate the need for a separate, bulkier, and less user-friendly device.
The fusion of precise medical hardware with adaptable and user-friendly mobile applications is highly appealing to consumers and enables manufacturers to streamline their product offerings.
The anticipated disruption of the medical device market by consumer electronics companies has yet to materialise, as they have little motivation to adhere to the stringent requirements of medical devices when wellness features can be marketed just as effectively.
Instead, the move towards more comfortable and user-friendly medical devices is being driven by companies within the industry that embrace the integration of their hardware with mobile apps running on consumer electronics.
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