4 Factors to Consider When Developing Your mHealth Product

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:

  1. Some mHealth apps require FDA clearance: Mobile tools are popular among consumers seeking to improve their overall well-being by tracking their daily exercise, calories, food intake, and vital signs. These types of consumer wearables, which help to promote general wellness, are not medical devices and they should not be marketed as products that can treat, diagnose, or restore the health of individuals who have been impaired by disease. Here are some criteria to consider based on recent FDA guidance to determine which mHealth apps are “medical devices” and are subject to FDA approval.
  • The mobile application is a “device” according to the FDA definition and either:
    • is used as an accessory to an already-approved medical device
    • transforms a mobile device such as a smartphone or tablet into an actual medical device providing diagnostic or therapeutic assistance
  • A mobile application can: run on a mobile platform or, be a web-based application customized to a mobile device but executed on a server.
  1. Data must be reliable. By introducing a mobile device into a medical system, you empower physicians with data; they can extract relevant information out of these medical devices such as patient history or usage. Let’s use the example of an infusion pump. A mobile medical device can allow physicians to monitor the frequency and timing of dosages with the data being presented in easy-to-read graphs and charts. This data becomes a record, accessible to physicians from anywhere with a few finger swipes and taps to evaluate the best treatment for the patient. In other words, the way health data is generated, collected, and analyzed is increasingly important to patient treatment and care. Therefore, the FDA requires that the data be validated for accuracy.
  1. Software failure can create big headaches: With this evolution of mobile medical devices, the integration of software to control the medical device operation evolves as well. Just last year, the FDA released a report*** pointing to software design as the biggest cause of medical device recalls. The expectation is that the FDA will conduct more rigorous reviews of medical devices that include software, including mHealth devices such as mobile medical apps and wearables. But instead of looking at the FDA as a barrier to market, mobile medical device manufacturers should look at regulations as essential to ensuring the effectiveness, reliability, and safety of their software and overall device.
  1. The process used to develop your product is important to the FDA: 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. Think about your quality systems and consider the approach you are using in developing your mobile medical device. Are you properly handling the necessary risk? Has the software and the data gone through proper verification and validation (V&V)? And just as important, do you have the documentation required to back it all up?

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.

Discover how Sterling Medical Devices can help you with your mHealth project.

References

* 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