Silicon Labs Enters the NICU: the First IoT Feeding Device Cleared by the FDA Within 90 Days
Feeding babies isn't as easy as you might think. NFANT Labs and Silicon Labs have teamed up on a smart baby bottle outfitted with sensors that provide biofeedback in real-time.
Feeding babies isn't as easy as you might think. As strange as it might sound, up to 70% of premature babies, and even 10% of full-term births can have problems with feeding, according to NFANT Labs. Usually, infants in NICUs (Newborn Intensive Care Units) are tube-fed and are the only bottle or breastfed after doctors feel they are ready for the transition.
The scientific procedure that determines that change involves sticking a finger in the babies' mouths to see if they have acquired the necessary neonatal sucking skill. The problem is that the neonatal test is time-consuming, and as a result, leads to delays in patient discharging.
NFANT Labs and Silicon Labs have teamed up to solve this problem by designing a smart feeding solution, equipped with Silicon Labs' Bluetooth low-energy Bluegiga Legacy modules, the BLE113.
Technology to Improve the Neonatal Test
NFANT Labs and Silicon Labs have announced that they successfully constructed "the first IoT device cleared for the NICU"—leaping from idea to FDA approval within 90 days. When the two design teams set out on the project, they had three stated goals: create a feeding solution with a pre-certified technology stack, a Bluetooth low-energy module, and an inexpensive BoM. They hoped that these goals would help them accelerate device prototyping, breeze through FDA approval, and supply NICU data to the cloud.
NFANT Labs explains, "Any standard bottle can be turned into a smart device using the NFANT Coupling and NFANT Sensor, enabling seamless integration into existing NICU workflow." Image used courtesy of NFANT Labs
Most importantly, though, NFANT Labs and Silicon Labs aimed to design a feeding solution that provided real-time biofeedback on infant's neonatal sucking skills based on the strength and coordination of the tongue.
The two companies announced that they have recently achieved these goals.
How Does the Feeding Solution Work?
The Feeding Solution features a smart baby bottle outfitted with Silicon Labs' BLE113 module equipped with a coupling device and reusable sensor that measures the strength of the infant's tongue. The module within the smart bottle gathers the data and sends it via BLE (Bluetooth low energy) to a monitoring device that doctors can use to see the analytics in real-time.
According to Silicon Labs, one of the virtues of BLE for this feeding solution is that this technology is incredibly power efficient with the ability to run on a coin cell battery for more than a year—a particular strength in busy NICUs. This BLE feeding solution can also connect to a host of mobile devices, from smartphones to tablets, opening more avenues for healthcare workers to monitor the premature babies' feeding abilities.
Block diagram of the BLE113 module. Image used courtesy of Silicon Labs
Silicon Labs also describes this BLE solution as reliable and robust with AFH, transmissions, and 24-bit CRCs. In line with medical privacy laws, this smart device is said to provide man-in-the-middle (MITM) protection and comply with advanced encryption standard (AES)-128.
The feeding solution is supported by all major platforms as well, including iOS, Android 4.3, Linux, Windows 8, and OSX.
A History of NFANT Labs Medical Designs
NFANT Labs introduced the Feeding Solution back in 2015. They received FDA clearance for use in NICUs after just a few months after designing the system, which is denoted as having an HCC classification for a biofeedback device.
The Department of Health & Human Services also gave NFANT Labs the go-ahead to market the solution during the same month (September 2015) the FDA provided its' clearance. In 2018, NFANT's Feeding Solution was deployed to over 15 hospitals, and has been nominated for Georgia Bio's Innovation award, and was named a finalist for SXSW's Impact Pediatric Health Competition.
The smart device sends metrics on the infant's feeding to a physician's app. Image used courtesy of NFANT Labs
Now, with the NFANT Feeding Solution outfitted with Bluetooth connectivity and sensors that provide biofeedback in real-time, healthcare workers can analyze accurate data that helps premature babies transition to oral feeding.
Featured image used courtesy of NFANT Labs
Robert Keim recently wrote an article asking engineers how they felt about their hand in patients' health because they are the ones responsible, in part, for medical device development. This announcement is yet another example of that reality. What are your thoughts? Have you ever worked on a project that had important implications in a person's health? Share your experiences in the comments below.
