Can the Internet of Things tug at your heartstrings? After my interview with Tommy Cunningham, co-founder and COO of NFANT Labs LLC, I know the answer is “yes.” He shared insights into his new company, which focuses on improving the outcomes and lives of neonatal infants through wirelessly connected medical devices. This interview is VERY timely since my sister-in-law is literally in labor as I write this!
Tell us about yourself and your company.
I have a background in biomechanics, and am the co-founder of NFANT Labs. We’ve come a long way in a short amount of time. We basically built the organization from just two researchers and an idea, bootstrapping with next to nothing to start; every dollar we spent was important. In less than two years, we’ve performed clinical research, secured funding, designed and produced the product, brought on staff, and obtained FDA clearance. Needless to say, it has been a real roller coaster ride.
How did you get the idea for the nfant® Feeding Solution?
Back in school, when I was working on my PhD, I would meet with clinicians who had great ideas but didn’t know how to build anything. By the time I graduated, I had about 10 different projects under my belt, and had learned how to work on a low budget.
One of the project ideas came from eventual co-founder Dr. Gilson Capuluto, who proposed creating a device to measure tongue strength during infant feeding. Currently, deciding exactly when it is safe to begin oral feeding and determining how to best advance an infant’s feeding is based on a caregiver’s professional experience and trial and error. We set out to build a device that would help determine when NICU infants are ready to transition from tube feeding to bottle- or breastfeeding based on objective data. This is a really important step because babies can’t leave the hospital until they demonstrate this feeding ability. Many infants might know how to feed, they just don’t have the lingual strength and coordination to accomplish the task. The thought was to build a tool that could first diagnose strength and coordination deficiencies before clinicians intervene.
There was another device on the market that did something similar, with a pacifier, but it was complex, costly, and cumbersome. After listening to feedback from doctors and nurses, I learned that these huge, wired machines were not targeting what the market wanted. What was needed was a small, wireless device that fit into the workflow of hospital clinicians and gave them bedside, actionable data during actual feeding.
We also recognized that while lots of people talk about connecting health metrics, nobody was actually doing it in the NICU, or really anywhere in the hospital, for that matter. The key to the future of medical technology is to take any dumb medical device, make it smart, make it wireless, and push physiological data to a mobile device and the cloud for analytics.
How are you using Silicon Labs products today?
We started out in an unconventional way. The initial design criteria that I gave our engineers was, “Here’s the Bluetooth module I want to run our board. Let’s design around this for our first prototype." We didn’t want to be endlessly breadboarding with wires hanging around because the NICU is already a very scary environment. It’s stressful. You are often dealing with life or death situations, and anything that looks intimidating is bad news. Designing initial prototypes for manufacturability from the start was risky, but it turned out to be critical to our rapid success on many fronts.
We kicked the tires on a lot of options, but finally went with the BLE113, which was proven and had a great reputation.
I intentionally chose components and sensors that were both mass produced and cutting edge to get the best technology at an affordable price. That made our product less expensive to produce. We were able to launch it at a fraction of the cost, and adopt a more flexible, analytics-driven business model than I think our industry had seen.
What was your biggest hurdle bringing your product to market?
The most intimidating factor was that we were blazing a trail. We were bringing something entirely new to the market in a highly regulated industry filled with entrenched practices, bureaucracy, complicated business processes, and painstaking evaluation practices. Despite the challenges, we pushed from concept to FDA submission in a matter of months, and emerged with clearance nine months later. As you can imagine, EMC compliance testing was vigorous during this process. We are fortunate and relieved to have gone with such a proven technology stack.
What’s the next milestone on your horizon?
We’re already seeing immediate value with the product at bedside with real-time biofeedback. It’s helping clinicians do the important work of navigating infants home safely and effectively.
The long-term goal of the company is to build a connected NICU that will help these medical professionals figure out how to iteratively improve treatments for their patients. Clinicians have to rely primarily on personal experience to know what to do. We are breaking down those silos and capturing many parameters to build predictive models to act on. Leveraging insights gained from our technology, clinicians will be able to enhance their daily medical practice with data-driven evidence.
This is a great example of Internet of Things. How would you define Internet of Things?
IoT leverages great technologies, like low-energy Bluetooth, to acquire data from a device, capture and push that information to the cloud, and then make sense of it.
In some cases, that’s all hype. Today, people can capture data on just about anything they want. But to be useful, they need proper constructs or else they’re just collecting data for the sake of it.
We set out to conquer an issue: an infant's inability to feed. We stream physiological data to a mobile app and capture clinical parameters surrounding that data to help us create context. Aggregating and analyzing this data in the cloud and pushing back down for clinical interpretation will shift the standards of modern medical technology.
What does a more connected world mean to you?
The more connected we are, the more patients we can help.
By providing a means for data-driven decisions, we are empowering clinicians, patients, and even payers; everyone will benefit. This is the true essence of an evidence-based practice of medicine. We’re providing just that.
Learn more about Tommy and NFANT Labs on their website: http://bit.ly/1WrEY9z.
For more information about the BLE113 Bluetooth Smart Module, and to purchase the Bluetooth Smart Development Kit, click here.