Key Consideration in Smart Device Development

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. 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.

Smart device development at QuantaEd Solutions comprises the integration sensors, actuators, electronics, software, packaging and user experience. Our engagement starts by understanding the application of interest to our customer and assessing if we are a good fit to the project. The next step is to gather sufficient information on requirements and specification to lay out a project plan including milestones, timetable, deliverables and budget. The customer may have all or some of the needed information; we work with our customers to gather the balance of the needed information when needed.

As noted above, smart healthcare technology devices require sensors and/or actuators to interact with the physical world. In some cases, smart device development can use off-the-shelf sensors and actuators. In other case, the requisite sensor and actuators has to be developed. In fact, there is much opportunity for smart healthcare solutions that will use sensors and actuators yet to be developed—particularly chemical and biological. Our team has tremendous expertise and track record in the area of sensors and actuators using MEMS (Micro-Electro-Mechanical Systems) technology. We know what is commercially available, what is still in research stage and what is theoretically possible.

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 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.