Product Insight (PI) - Design & Innovation


Design, Engineering

SmartByte is the only FDA cleared Class II Medical Device for weight management / weight loss.

The carrying case and reader are an important part of the SmartByte System as it allows the user (and their physician or coach) to monitor their usage and compliance.


The SmartByte device from Scientific Intake is the only FDA cleared Class II Medical Device for weight loss and management. The small, removable, custom-molded SmartByte device is comfortably placed in the roof of your mouth, only when you eat. It helps you take smaller bites and eat slowly which gives your body time to realize that you’re feeling full so you’ll be satisfied with less food. A sensor embedded in the SmartByte device collects data that drives the coaching process and provides positive reinforcing feedback, improving patient outcome.

Scientific Intake came to PI with a problem. The carrying case they were using to download sensor data was too large to carry inconspicuously, made many patients uncomfortable, and was prone to failure. Patient acceptance, and therefore the success of their product, depended on obtaining data from the oral device. The case was the weak link in the process, so Scientific Intake reached out to PI to solve their usability and technical challenges.

PI’s solution involved splitting the case into two parts; a minimal carrying case, and a separate reader base to house the electronics for downloading data from the sensor. The carrying case and reader are integral components of the system; the slim carrying case protects the SmartByte and keeps it close by between meals, and data from the embedded sensor in the Smartbyte is transferred to a smartphone app when the carrying case is docked with the Bluetooth-enabled reader.

Many users didn't want to advertise that they are using the device, so the carrying case dimensions were minimized as much as possible so It's easy to hide and slim enough to carry in your pocket. The reader and carrying case feature very simple controls and a design that ensures that the SmartByte device and the reader are properly aligned every time. Magnetic attachment between the carrying case and the reader ensures proper alignment in only one orientation.

Starting the data transfer is as simple as pressing the large button, which lights up into a "smile", providing positive reinforcement that the patient is doing a good job and that the device is here to be helpful and kind.