In the midst of the digital revolution, no industry remains untouched. Every sector from finance to manufacturing to transportation is seeing itself been drastically redefined by the influx of new innovations and devices. The healthcare industry, one of the most sensitive sectors when it comes to change (after all, the stakes are rarely higher than your well-being), is learning both how to adapt to the new technology while maintaining a high-degree of oversight. After all, the healthcare industry is not averse to data breaches.
One of those oversight checks, the U.S. Food and Drug Administration, is known for having a stringent and thorough approval process that can take years to navigate. Some commend the FDA for having so comprehensive and diligent a process, while others bemoan the fact that new and potentially life-altering medicines are held up for years at a time in regulatory limbo. Some even believe that the future of digital healthcare lies outside the parameters of the FDA, at least on a consumer level.
But no matter which side of that debate you fall on, the FDA is still the primary gatekeeper to one of the largest markets in the world, and as such is a crucial part of the transition into more digital healthcare options.
Which is to say that obtaining FDA approval is critical not only in a sense that a company cannot operate without it, but is also important because it will shape the way digital healthcare evolves in the years to come. In fact, the FDA is undergoing a bit of a revolution itself as it works to keep up with the changing face of digital healthcare.
In the market today we already have digital healthcare solutions like patient monitoring, blood sugar level readers, heart monitors, mobile messaging playing a bigger role, new cybersecurity models, and a great many other devices or apps that marry healthcare with digital innovation.
With that in mind, let’s take a look at three companies that have received FDA approval for their digital healthcare tool, each representing a different type of partnership between digital devices and healthcare.
Medtronic: mobile glucose monitor (CGM)
Medtronic received FDA approval for its Guardian Connect mobile CGM and app, and the company hopes to be one of the key leaders in glucose monitoring.
“The response from the diabetes community has been tremendously positive and we are proud to be leading this remarkable period in diabetes history in partnership with the clinical and advocacy communities,” said Alejandro Galindo, president of the Intensive Insulin Management division within the Diabetes Group at Medtronic, in a statement. “We’ve essentially designed a smarter insulin pump that alleviates some of the burden associated with diabetes management, which can be unrelenting and exhausting. We are very excited to see that real-world insights from our Customer Training Phase reinforce the positive outcomes demonstrated through our pivotal trial of the system.”
A blood sugar monitoring app has long been one of the most attractive uses of mobile healthcare. The technology world was actually set alight for a bit when Apple CEO Tim Cook was said to be wearing a prototype of such a device at work, prompting people to begin questioning what Apple is up to in regards to digital healthcare.
Much like a Fitbit will track your physical condition during workouts, the glucose monitor operates on the same principle in that it can continuously give you real-time updates of your sugar levels using a non-invasive method.
While there is some debate as to just how accurate these apps are in general, having FDA approval is certain to help Medtronic make headway in the market.
BioGaming: video games as digital healthcare distributor
One of the more novel uses around, the idea that video games can actually make you healthier is welcomed news to children and gaming-adults everywhere.
BioGaming is looking to take advantage of motion tracking technology in order to help administer physiotherapy regimen to patients from the comfort of their own home.
The application is called YuGo and is available on Microsoft Kinect.
“Adherence to traditional physiotherapy approaches is painfully low, and boring routines often demotivate patients and fail to improve patient health as intended,” Dudi Klein, founder and CEO of BioGaming said in a statement last November, when the company launched its product in Europe and Israel. “We’re taking the proven physiotherapy routines, real-time biofeedback and personal encouragement of sessions in the hospital or clinic and bringing it home. It closes the gaps in the current physiotherapy process to boost adherence, transform the therapy cost equation for providers, and empower our customers to deliver better patient outcomes.”
It’s certainly an unlikely match, using videogames to administer physical health routines, but it’s these types of outside-the-box ideas that are opening due to the innovations taking place in the digital healthcare space.
InfoBionic: heart monitoring
InfoBionic rounds out the list with their MoMe Kardia monitor, which is designed to help detect cardiac arrhythmias in patients by sensing ECG, respiration, and motion. The device can be worn as a necklace or be attached to the belt.
MoMe uploads data to a cloud-based platform where the data is then analyzed. It makes use of decentralized data storage and other newer tech developments to help allow remote access while also minimizing false positives. The device also comes with three different monitoring modes that a physician can adjust on the fly.
Is Apple Next?
While the aforementioned three have received FDA approval, one of the most intriguing developments in the digital healthcare space is the possible insertion of Apple into the mix.
With news of Tim Cook’s live testing of a glucose monitoring system, rumors are swirling that Apple’s future may hold a foray into the digital health space.
If that is the case they will definitely have to obtain FDA approval, which would complicate things as Apple would have to halt production on an entire line of devices should that approval ever be revoked (or at least, they would have to deactivate the glucose monitoring system).
Some believe that an add-on device or a special type of Apple Watch could release so that Apple could navigate around the FDA gatekeeper should they fail to meet the requirements, but still, the possibility of Apple entering the digital healthcare space is exciting not only for the industry at large but also for the millions of consumers who already make use of their products without the added benefit of digital healthcare apps.