Are health wearables passing their physical?

Wearables are available in all shapes and sizes, from the inconspicuous Fitbit Zip to the immediately noticeable Apple Watch. One factor that connects most of them, apart from the ability to tell the time, is fitness and health tracking.

The health features are basic at the moment, but might not be for long, according to dorsaVi CEO Andrew Ronchi. Speaking at the Digital Health Conference in Sydney, Ronchi argued that wearables are going to see a flood of health and fitness related services in the next few years, as the medical industry transitions to a mobile world.

See Also: Is your fitness wearable letting you cheat on your diet? 

Ronchi claims that consumer demand for monitoring, real-time feedback, big data, and health goals will push medical firms to adopt new technologies and devices. According to Ronchi, the first move for the medical industry will be data accuracy; once that is nailed down he suspects the barriers will break down and medical firms will jump in.

Medical grade devices are hard to get onto the open market. In the United States, the FDA (Food and Drug Administration) is notoriously tough on devices that advertise themselves as medical solutions, reportedly blocking a few of Apple’s innovative medical Watch features last year.

So it begs the question, are medical grade devices worth the extra paperwork?

For device makers like Apple and Samsung, getting the all clear from medical regulators might take too long and slow down the launch cycle. The companies would have to file the medical features well in advance, and even then it is not certain that the regulator will permit the feature.

Adding the required sensors and launching the feature at a later date might be a possibility, but again the worry of rejection might weigh too heavily to add an expensive sensor, which may never be used.

wearables

Medical software providers have wearables solution?

It seems more likely that third-party medical firms will be the providers of these advanced features, since they’re not on a strict launch schedule and have more expertise on data accuracy.

The only issue for third-parties is working within the limitations of the device. For example, the Apple Watch can read your heart-rate, but cannot provide any analysis on stress levels and other issues arising from a slow or fast heart rate, and third-party developers are not able to utilise their expertise to add these features for fear of an FDA investigation.

Perhaps as we move into a wearable world where medical wearables are more commonplace, the FDA will relax rules for devices like the Apple Watch, Samsung Gear S2, and Fitbit Blaze, but we suspect the loosening up of regulators is still a few years away.

Facebook Comments