Connected, smart devices are integral to digital health solutions; they provide the ability to gather data that is analyzed for information and action. Devices are smart when they incorporate sensors and/or actuators—the former to perceive their environment and the latter to affect it. They are connected when they can communicate with a backend computational platform—usually implemented as a wireless link via the Internet to a smart healthcare technology platform.
In some cases, development of smart device devices can use off-the-shelf sensors and actuators. In other cases, the requisite sensors and actuators must be developed. In fact, there is much opportunity for smart healthcare solutions using sensors and actuators that are yet to be developed—particularly for chemical and biological applications. In other words, developing new sensing and actuation capabilities is strategically enabling for digital health.
The electronics portion of smart device development implements the necessary interface to the sensors and/or actuators, including analog-to-digital and digital-to-analog conversion, computation and memory, networking—wireless and/or wired—provisions, and a source of power. To the extent that the device is miniaturized, tradeoffs between data rate, power and wireless range must be considered—which can be particularly challenging for implantable smart medical devices. There is also the electronics cost factor to consider in such smart healthcare solutions. Higher performance components are more expensive. Wireless radio chipsets also vary in cost. Cellular radios are more expensive and require a data plan—an ongoing ownership cost. In contrast, Bluetooth and WiFi radios are cheaper; there is no extra cost for data communication.
A key challenge with devices incorporating MEMS (Micro-Electro-Mechanical Systems) technology is packaging, i.e., how to allow the sensors and actuators to interface with the physical world while protecting them from elements of the physical world detrimental to them. This requirement affects the industrial design of the smart device, which also must consider user experience/human factors. In this light, it is clear why so many smart healthcare solutions rely on physical and optical sensors. These sensors can be packaged to overcome the foregoing dichotomy. On the other hand, packaging of chemical and biological sensors is much more challenging.
Smart device development projects usually fall into two categories, i.e., smart medical devices or consumer health devices. The former requires regulatory certification, i.e., FDA (Food and Drug Administration) approval in the U.S. The latter does not make a medical claim and is not subject to FDA approval, though other certifications for safety and security may still apply.