Author: Erik Hilliard | Date: August 10, 2021
Mobile devices are ubiquitous in today’s day and age; they’re everywhere—and for good reason: your smartphone is a hand-held computer allowing you to stay connected at all times. As a result, the use of mobile technology in medical devices has gained traction in recent years and is expected to pick up steam.
The FDA defines a mobile medical device as “a mobile app that incorporates device software functionality that meets the definition of device in section 201(h) of the FD&C Act, and is either intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device.” A mobile medical app is a software application that runs on a mobile platform intended either for use as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device.
Offering a range of benefits, mobile medical devices have the potential to profoundly help physicians deliver better patient care with greater ease:
Given the vast benefits a mobile medical device has to offer physicians and consumers alike, why aren’t manufacturers including mobile technology in their products? As with most things in highly regulated industries, it comes down to consumer safety.
Whenever you’re dealing with an off-the-shelf, commercially available product in a medical device, like an iPhone, there are risks to the patient. Let’s say, for example, you do an iOS update. At this point, your software isn’t validated, and you may be dealing with many unknowns depending on which updates were made. That will inevitably affect the patient and expose your organization to risk. Regulatory agencies are particularly stringent when it comes to mobile medical device development. While they don’t necessarily want to stifle device innovation, their goal is to protect the consumer.
Many industry pioneers have found ways to incorporate mobile medical software into their device systems—paving the path for a future that will likely see a rapid proliferation of mobile medical devices.
It all comes down to the approach—managing the process in a way that accounts for all the potential risks while delivering the features and functionality that physicians want. At Sterling Medical Devices, we have extensive experience in the digital health device market, with a proven track record incorporating mobile devices into medical applications. Offering everything from software development and full system development to hardware development, we know how to apply many different technologies into a successful, safe medical device. While the quickest path is to incorporate a commercially available device into an existing system, we can also help you create your own, FDA-approved mobile device.
For more information about developing a mobile medical device or how to enhance your existing device with mobile medical software, contact our medical device design experts at 201-227-7569.
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