When Tommy Cunningham, Co-Founder and COO of NFANT Labs, LLC, approached Andy Meadows, Principal, Director of IoT and Mobility for Ad Victoriam Solutions (AdVic), he wanted to do something that had never been done before - create a medical device for infants.
The goal was to create a neonatal feeding system, including a medical device, for infants that could capture objective data in real time about the strength and coordination of the tongue during feedings – something doctors and nurses have never been able to measure consistently over the course of a baby’s time in the NICU. This crucial data would provide clinicians with information about what actually goes on during a feeding session and allow them to track the progress of babies with feeding challenges.
“This was uncharted territory,” Cunningham says. “We wanted to take technology that was being used in other fields and create a medical device that would bring that technology to the healthcare field.”
The system, which was devised by Cunningham and speech pathologist Gilson Capilouto, PhD, would need to collect data from a device with a sensor (in this case, a baby bottle) and send it to a mobile app using low-energy Bluetooth technology. The app would then push the data to the Cloud so it could be stored and reported later for full analysis.
The challenge was getting all of the pieces to work together in succession while adhering to strict FDA and HIPAA regulations. With a prototype bottle in hand, Cunningham turned to Meadows and the AdVic team to create the medical device technology – including the mobile application and the web portal – for what is now the award-winning nfant® Feeding Solution.
“It was much akin to building a bridge. You can’t build a bridge by starting in the middle. You have to start with a good foundation,” Meadows explains. “We had to make the medical device itself talk to the mobile app, which runs on an Android tablet. The app had to capture data from various sensors capturing nipple movement, bottle orientation and battery level in real-time aggregating tens of thousands of data points over each feeding session. Then we had to make sure that the collected data could be sent up into the Cloud for long-term capture and analysis. The approach we adopted was to look at one piece at a time. We had to ensure that the firmware worked as expected, reporting the raw sensor data with reasonable consistency. Then we had to confirm that the app was able to receive and store that data reliably. Finally, we had to make the app communicate with Amazon Web Services in the Cloud, where the stored data could be processed.”
Within that process, there needed to security checkpoints along the way, with information being sent over encrypted channels to ensure that each device attached to the network within a hospital would be HIPAA compliant.
And all of this – from the app to the web services to the portal – had to clear the FDA.
However, because something like this had never been introduced to the FDA, the organization did not have guidance for this type of software. Cunningham worked closely with the FDA to understand the regulatory requirements and deliver those back to the AdVic team, which then implemented any necessary changes.
The team went through rigorous testing as Cunningham worked to document the feeding system’s processes and manage other aspects of the project.
“Having Andy there allowed me to go and write the FDA application, raise capital and manage other aspects of the project without having to sit in front of a computer every day reading code,” Cunningham said. “You have to be able to rely on top-notch talent to manage that process, and he was able to step in and do that.”
Ultimately, the nfant® Feeding Solution received FDA clearance and now is being used in hospitals throughout the country. “The initial feedback has been fantastic,” Cunningham says.
What’s more, NFANT Labs received the People’s Choice Award for Breakthrough Technology from the TAG 2017 Georgia Technology Summit. And through the company’s ongoing collaboration with AdVic, the highly flexible nfant® system continues to evolve.
“Feeding is a window into the brain,” Cunningham notes. “We are using the product to study whether our data indicates what is happening with neurological development, and we now have the tools in place to mine that data to provide advanced clinical prediction outcome models for infants.”
“The key to the success of this device was close and constant communication with NFANT Labs. We were able to develop a new product in a difficult environment and successfully bring it to market because we welcomed and provided open and honest feedback,” Meadows concludes. “And we now have a long- term relationship with NFANT so we can evolve this product and help them bring other ideas in the pipeline to fruition. It’s a revolution in the collection and utilization of patient data.”
Want to turn your next IoT project into a success story like NFANT Labs? Contact Ad Victoriam Solutions for a consultation.