Author: Dan Sterling | Date: July 29, 2015
Successful FDA submission of your mHealth product not only hinges on the accuracy of your data and reliability of your software, but on your development process as well.
Modern-day mobile medical technology is breaking molds in the medical device industry, opening up new opportunities for doctors and patients. What you see nowadays is integration of medical devices, including pumps, monitors, and other instrumentation with ubiquitous mobile devices such as an iPad or Android phone using technology such as Bluetooth/wireless (802.11)/cellular.
When people hear the term mobile medical device, mobile medical apps usually come to mind – categorized as mHealth. Not so long ago, mobile medical technology only referred to connected devices that communicated in clinical and hospital settings; a device implanted in a patient directly communicates with an external device through RF (radio frequency) protocols. Though these devices are still used by clinicians to monitor their patients within the confines of their hospital’s walls and are important for patient care, today the mobile trend is “wearables.”
Wearables are devices that can be worn directly on the body or on clothing as an accessory; think smart watches and bracelets that track exercise activity and heart rate. They are popular among athletes and people seeking to improve their overall fitness via an active lifestyle. Analyst firm, IDC, predicts a large number of healthcare organizations (70%) will offer wearables and provide remote health monitoring and virtual care by 2018*. What’s more, wearables are now being used by researchers in clinical studies; a recent example is the introduction of a solution that gets data from mobile health wearables into clinical trials**.
Since medical device technology companies are subject to FDA regulations of their mHealth devices, they are in the unique position of having to balance innovation with regulations, keeping in mind that any software dependent device, and the data it generates, is verified and validated. Other FDA considerations for medical device companies include software verification and validation, cyber security, off-the-shelf (OTS) software, and special ISO considerations like ISO 62304 and ISO 14971.
So how can mobile medical device app developers, traditional medical device manufacturers, and pharmaceutical companies ensure that their mHealth product is ready for FDA review? Getting any medical device cleared by the FDA is a complex, detailed process that involves many steps. Here are 4 realities you must consider:
There is no doubt that other factors will continue to challenge mHealth’s future as we approach new frontiers in medicine. Balancing innovation and regulations can be a challenge. But if the ultimate goal is to improve health outcomes, then mobile medical devices will go through the rigors of the FDA approval process to help transform healthcare for the better, today and tomorrow.
Stay tuned. In a future white paper, we’ll discuss best practices to help ensure successful submission of your mobile medical device product to the FDA.
* Medical Device Summit, “Four Health Trends for 2015,” December 17, 2014
** Medical Device and Diagnostic Industry, “Expect More Trials with mHealth Data,” June 18, 2015
*** FDA Center for Devices and Radiological Health Office of Compliance Division of Analysis and Program Operations, Medical Device Recall Report FY2003 to FY2012
October 7, 2013
February 18, 2021
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