Integrating Wireless into Medical Devices

Patients are increasingly using mobile healthcare devices in the home, and everyone, including patients, caregivers and insurance payers, is interested in access to the wide range of data associated with patient healthcare.  This is driving increased demand for wireless communication of healthcare data.  While the industry works through regulatory and patient privacy issues associated with data sharing, we product designers are thinking about which wireless technology is most appropriate for use in home healthcare applications, and which devices should communicate that data.

There are several choices in wireless technology today, all familiar to mobile phone users.  Bluetooth technology is best suited for medium amounts of data over a short distance, but it can be cumbersome to pair the two devices, and the technology presents security challenges. Using a WiFi network for communication can accommodate larger amounts of data and provide security capabilities. However, all communicating devices must be configured with that network before it can be used, and WiFi also requires more power. While cellular data allows for communication virtually anywhere, one drawback can be lack of coverage, and thus accessibility, for patients in remote areas.   Furthermore, designers must establish smooth and timely communication between the cellular network, the Internet, and the device.

Beyond wireless technology, the designer must consider what the user interface (UI) will look like and where it will be housed. One obvious solution is to integrate a mobile phone with the device. With a mobile phone, all three forms of wireless communication are readily available. By using an existing wireless device, designers also avoid the painstaking process of sourcing materials to design screens, touch panels and other hardware. Furthermore, mobile phone manufacturers provide software development kits (SDKs) and other support to help designers with software development. And a persuasive advantage to consider is that many patients are already very comfortable with mobile phones and would transition more smoothly to using their mobile medical device. Yet while familiarity is advantageous, there are some drawbacks worth noting.

Mobile phone product life-cycles are short, based around a nimble consumer market and not the regulated medical device market.  For this reason a mobile phone’s form and capabilities are going to change much more quickly than most medical devices, which can be expensive to keep up with. Regulatory guidance for the integration of mobile phone apps to control medical devices has also been fairly limited and will continue to change as the market matures.  In addition, the use of a mobile phone requires the designer to work within the framework of mobile phone apps and device capabilities. Within this design space there is the potential for inconsistent data throughput and OS functionality , which limits the performance of even the most well-designed app. Patients would also be required to have their phones charged and present during use of the mobile medical device, which may be challenging for certain patient demographics.  These issues can be avoided by designing a custom device without a phone or tablet-based user interface. A custom framework allows for full development of high-integrity software compliant with IEC 62304 medical software regulations. Not only can software be specialized, but other features such as battery life, wireless throughput, and processing power can be tailored to maximize device performance and efficiency. The device can also be tailored both in its physical form and UI to work most conveniently for the application at hand.

Every wireless device brings unique challenges and we’d love to talk about yours. For further guidance in designing a wireless UI for your medical device, feel free to contact us.

Jeff Gunnarsson
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