TGA medical devices

The disruptive trend for medical wearables and wearable medical devices

The BioMelbourne Network event on Wearable Medical Devices and Diagnostics that PharmOut attended in Melbourne on March 17th certainly confirmed the two directions that wearables and wearable devices in medical metered-dose-aerosoltechnology are currently taking.

On one path are devices and apps that residue in a “pre-diagnostic world”, supplying users with information on sport and fitness, for example. On this path are companies that are skirting around the edges of the regulated environment with wearables that may be used to measure or monitor functions of the body and are not being classified as a medical device.

On the other hand are those organisations who decide to classify their devices and applications and make claims which interest the regulators.  These have the potential to disrupt the entire healthcare system, or simply ensure more cost effective use of drugs by monitoring compliance and/or reminding patients to take medication. Wearers are becoming more empowered with their own health as they use devices that monitor a variety of conditions.

These devices can provide monitoring in real-time, generating data and sending it into the cloud or “hospital servers”.

Only last month the Hollywood Presbyterian Medical Center was paralyzed by Ramsonware hackers, they demanded $3.6million in Bitcoin to restore the servers after they had “broken into”, the hospital staff are working with investigators from the Los Angeles Police Department and the FBI to find the hackers. This is just one aspect of the consequences of the emerging technologies and precautions around data integrity and security.

On a more positive note, and quoting just one great example of these new technologies and there were many, was the Platform technology, Smart inhaler™ supplied by Adherium. As I understand the platform technology, it is attached to a standard Asthma inhaler, the technology measures the frequency and dose each time, using BLUETOOTH® Communications the “device” transmits data to a smart device / app and then to the cloud. The Touch-Enabled or the SmartTouch™ range of devices also includes touchscreen options for viewing medication usage charts and updating preferences, so the patient feels in control.

And in the middle of this innovation are the regulators, who are using “old” regulations, codes and standards, and inconsistent international classifications to highlight the grey areas of these devices, whilst being extremely supportive this technological boom, where Australia certainly seems to be leading the way.

Also during the event, the Government of Victoria launched the sector strategy for Medical Technologies and Pharmaceuticals, including a new funding scheme, the Future Industries Sector Growth Program. Good news for Australia.

Do you rely on the “medical data” that you get from wearable devices?

To read more about cloud computing, data integrity and security, click here.

Read more blogs on Medical Devices here and here.