It’s a pediatric health care innovation episode of Well Beyond Medicine covering two new tools applicable to improving the health and health care experience of the smallest of babies.
SEGMENT 1: It was a casual exchange between two colleagues that proved to be the point of conception for an infant positioning cradle, dubbed SmolTap, a simple medical device designed to safely, comfortably, and easily hold an infant who is undergoing a spinal tap.
SEGMENT 2: We’ll talk about the smart baby bottle that is helping feed and measure outcomes for premature babies still in the NICU, where feeding issues are not uncommon.
Guests:
Robert “Bob” Cooper, CEO, SmolTap
Tom Hickey, Communications Advisor to SmolTap
Tommy Cunningham, PhD, Co-Founder & CEO, nfant®
Producer, Host: Carol Vassar
EPISODE 46 TRANSCRIPT
Carol Vassar, host/producer:
Welcome to Well Beyond Medicine, the Nemours Children’s Health Podcast. Each week, we’ll explore anything and everything related to the 80% of child health impacts that occur outside the doctor’s office. I’m your host, Carol Vassar. And now that you are here, let’s go.
Music:
(singing)
Carol Vassar, host/producer:
Welcome to a pediatric healthcare innovation episode of Well Beyond Medicine. Today, we’re covering two new tools applicable to improving the health and healthcare experience of the tiniest of babies. In a few minutes, we’ll talk about the smart baby bottle that’s helping feed and measure outcomes for premature babies still in the NICU, where feeding issues are not uncommon. Right now, though, were you aware that children under the age of one are among the most at risk for bacterial meningitis, and the only way to definitively determine a diagnosis of bacterial meningitis is through a spinal tap. The spinal tap procedure collects cerebral spinal fluid or CSF to detect meningitis and other serious bacterial, fungal, and viral infections. It’s an uncomfortable process, and babies undergoing the procedure wiggle and squirm and cry and kick and scream, often requiring they be held by multiple people in the hopes of getting enough blood free CSF for testing.
According to the journal Lancet, the success rate for this procedure in neonates is low, between 50 and 60%, not exactly ideal, which brings us to a hallway chat at Brown University in 2019 between Dr. Brian Alverson, now with Nemours Children’s Health, who was frustrated with the spinal tap situation, and Dr. Ravi de Cruz. This casual exchange proved to be the point of conception for an nfant® positioning cradle dubbed SmolTap, a simple medical device designed to safely, comfortably, and easily hold an infant who is undergoing a spinal tap. For more on this innovation, we turn to SmolTap CEO, Robert Cooper, and Small Tap’s communications advisor, Tom Hickey. Here’s Robert Cooper.
Robert Cooper, SmolTap:
SmolTap is a device, it looks kind of like a massage chair, but what it does is it positions infants from newborn to about two months to hold them in the optimal position as they get an infant spinal tap to gather CSF for testing to make sure they don’t have meningitis [inaudible 00:03:05] viral bacteria.
Carol Vassar, host/producer:
I went through the experience of my son. He was a little bit older when he had his spinal tap, but it is an excruciating procedure.
Robert Cooper, SmolTap:
It’s automatic and awful for everyone involved.
Carol Vassar, host/producer:
So what was the background in creating SmolTap? And describe this instrument to me, if you can. And maybe we’ll get a picture of it into the show notes but describe it.
Robert Cooper, SmolTap:
Sounds great. So, imagine a massage chair for a baby, where they’re literally sitting in a chair, they’re being held with some straps in, almost like they’re being swaddled. There’s an opening for their face, and we have a seat that actually tips their pelvis and puts the back in this perfect position for the doctors to go in and gather the CSF. So that’s what it looks like. The genesis of the product is today, the standard of care is for a couple of nurses, or residents, or med students, or techs hold the baby on their side to cubitus, and then they squish them into the C position to expose the vertebrae so they can get a needle in and extract the CSF out of their spine. So, when Dr. Albertson… In 2019, Dr. Albertson, one of the heads of the residency program, training program at Nemours, was at Hasbro Children’s Hospital up in Rhode Island. He tried to get a tap on this very typical baby and failed to get a clean spinal fluid, was incredibly frustrated.
They had to unnecessarily admit that baby, start them on a course of antibiotics. And he ran into Dr. De Cruz, who’s the other founder. They teamed up together to design a solution so that nurses don’t have to hold anymore, and they can stop the variability that exists with having different nurses holding or having to hold a baby who’s wiggling and kicking and crying and desaturating. And now, the baby literally sits in this chair and this wonderful position. They’re calm, hips and shoulders are squared of the spine, the spine is arched, and you’re able to get a much higher success rate.
Carol Vassar, host/producer:
Is meningitis the only reason that a spinal tap would be performed on a young child?
Robert Cooper, SmolTap:
There are all sorts of viral and bacterial challenges that exist, so they’ll test for other things. We’re starting to also work with neurology cancer centers in the associated issues in those areas.
Carol Vassar, host/producer:
It’s a very simple tool, but it took until, I believe, early 2023 to get it onto the market. Talk about the process of getting it from idea stage to market stage.
Robert Cooper, SmolTap:
Started in 2019. That concept, that idea, that decision to go ahead and try to develop this product started in 2019. They came up with the initial design, went to Brown University, raised some money to start the process of going in and out of the clinic and designing various designs. And so they were getting feedback from the clinic, they’d work that into the new design, they’d bring it back into the clinic and test it. And so probably the version we have now is probably the 25th, 26th version of the product, and it has all sorts of little innovations that you wouldn’t really naturally know. It looks so simple, but there’s an incredible amount of thought and innovation that went into getting the chassis arch strike, getting the seat tilted right, make sure there’s a floor, making sure it has this wide base so it’s very stable, making sure we’re holding the baby across their back so that they’re not desaturated.
So, it was about from 2019, and then we launched in Q1 2023 when it first became available. Now, we literally have dozens of hospitals that have the devices that are using it, and we have literally hundreds of other hospitals that are looking to bring it in. And it was developed and invented by a Nemours doctor.
Carol Vassar, host/producer:
Tom, it sounds like this is moving forward very quickly. Talk about the patient benefits. What are they?
Tom Hickey, SmolTap:
Yeah, so first of all, from the patient’s benefits, and you mentioned earlier that you had observed one of these, so for the parents, it’s very stressful. So we can design a system that’s going to help get that first tap a successful tap, so that the patient doesn’t have to go through multiple sticks to have a successful tap. So that’s the first real benefit for the patient. Then if you get that tap, and guess what, if the patient doesn’t need to be admitted, that’s of course a big patient benefit, but it’s a benefit also to the system as well because they’re not admitting somebody that really shouldn’t have been admitted. So we’re helping the family understand exactly what’s happening very quickly, very efficiently, so then they can go on with their lives.
Carol Vassar, host/producer:
Bob, this has been on the market since January. Do you have any patient stories that you’re aware of, without sharing too much because of privacy issues, that this is really saved some stress for parents and babies and caregivers?
Robert Cooper, SmolTap:
The most outstanding stories is I’ve gotten multiple phone calls from nurses in particular. One story stands out. She called me out of the blue to thank us for coming out with this product. She’s been a nurse for over 25 years. She’s starting to get a little carpal tunnel, her back is sore, and she’s one of the holders. The holder is probably the most important except for the baby, of course, person in the room. If you have a good holder, then oftentimes you can get the tap at a reasonable level, but oftentimes it’s still a 30, 40, 50% failure rate. So [inaudible 00:08:50] called me just to thank me, because if the doctor’s unable to get a tap the first time, she knows that she would have to hold sometimes up to an hour, and it’s almost like isometrics. And with carpal tunnel, she knew after the procedure was done, she was going to have to go ice up her wrist and her back would be sore.
She said, I would almost cry if they failed to get a clean tap the first try. So the nursing staff, who are responsible for holding oftentimes, is really one of the big beneficiaries, not only the baby because they’re getting the tap the first time, but the nurses not having to hold anymore and being able to focus on the baby, the care of the baby and the outcomes, even giving the baby sucrose, either sweeties or kisses, and calming the baby down, make sure they’re safe, make sure the airway is taken care of is really sort of the big story in this. It’s that not asking the nurses to hold the baby in this position. They don’t like it. It’s an awful experience for them oftentimes. Yes, they’re proud when they’re good at it, but it is really unnecessary.
Carol Vassar, host/producer:
Let’s talk about outcomes. Are we seeing a reduction in failure rates here?
Robert Cooper, SmolTap:
We don’t have published data as of yet. I can tell you anecdotally, everyone who’s using this device is seeing an extraordinary improvement in success rates, and I think that’s about as far as I should go with that answer because we will look to have a study coming up within the next six months.
Carol Vassar, host/producer:
Excellent. Tom?
Robert Cooper, SmolTap:
One of the things that we’re finding is yes, we talk about children’s hospitals, we talk about the big educational systems. Nemours has a number of locations, and we’re finding it’s the smaller locations that are away from the big metro centers that are really benefiting from this because there’s not a lot of experience and background in doing taps, and they don’t have a lot of resources to be able to do those taps. And they don’t want to fail because they don’t want to have the entire family up to transport down and move that family and that baby from their community into another location. Although it’s wonderful to be able to go to a hospital like Nemours, oftentimes paying attention to that family and making sure they’re taken care of by those community hospitals or those outlying locations is a wonderful benefit to this. The other big story is there’s a real challenge with nurses and the population nurses, and there’s turnover, and having enough resources. And there isn’t an emergency department or a NICU or PICU in the country right now that’s overstaffed with nurses.
And so if you can keep them on the floor doing their job and not taking, sometimes three nurses to hold a baby to do a tap, instead, they’re doing other important jobs in the hospital, this is such wonderful opportunity to use this device to actually free up those resources and improve the workflow and not create an environment where you’re having to go around and pull people away from doing other things in order to get that tap. And I think that’s sort of the one behind the scenes story to this. It’s just there’s some hospitals that are using our device, now they’re just using a tech for the doctor, as opposed to two or three nurses where the previous-
Carol Vassar, host/producer:
What does the future hold? Tom, I’m going to go to you for this.
Tom Hickey, SmolTap:
Yeah, I think the future holds… I was just going to add that one of the things we’re also seeing is that most people think of emergency departments as where this is going to happen, but it’s migrating to other departments in a hospital, interventional radiology, the OR, some of the floors. So that’s where some of the future is, is being able to address those patients and the need for those patients in their current setting and not have to even transfer them around the hospital. We have found that this procedure occurs in many different locations, so getting the word out, helping get that equipment to where it needs to be at the point of care is really part of the future and where we’re headed with this, and helping to spread the word that this is a very effective device and creating really a universal standard of care to how to approach this procedure to get the best outcome.
Carol Vassar, host/producer:
Up to what age would SmolTap be applicable, or is it weight?
Robert Cooper, SmolTap:
In this particular version, there’s an AAP guideline around meningitis, and it’s usually the first month or two of life. And we design this to meet that guideline from birth to month, month and a half, two months of life. There is a demand, and we’re working very hard right now on some designs for smaller babies and larger babies, and maybe up into adults. So we’re really looking for this idea that we’re really trying to improve success rates, improve the workflow, reduce unnecessary admittance through just a simple design.
Carol Vassar, host/producer:
Robert Cooper is the CEO of a SmolTap, which is responsible for the creation of an infant positioning cradle used during spinal taps. We also heard from small tap’s communications advisor, Tom Hickey.
It was another casual conversation, this one at the University of Kentucky, between a biomechanics grad student and his professor that led to the smart baby bottle known as nfant®. That’s the word, infant without an eye. The problem presented, how can NICU clinicians measure a preterm baby’s ability to effectively suck and swallow during oral feedings? You see, oral feeding skills require physical maturity. Yet for preemies, their sucking, swallowing and breathing coordination may still be developing. The real-time data from nfant® helps NICU clinicians make informed decisions about how best to proceed for a child should they need a higher level of intervention in the area of feeding and nutrition. It’s the creation of Tommy Cunningham who started this endeavor before he himself became a parent, but whose own child benefited from its use. Here’s Tommy Cunningham.
Tommy Cunningham, nfant® Feeding:
I was approached by one of my professors at the University of Kentucky where I was a grad student, and she had an idea of why babies weren’t being able to feed well and leave the NICU on time, and she asked me to design a smart baby bottle to tell clinicians how a baby could feed. And at the time, I had never held a baby in my entire life, but fast forward a few years, had invented a product, started a company. Then I had my son and we were able to use the product with him, so that was very rewarding.
Carol Vassar, host/producer:
So you have invented, created, moved forward in technology something that I’ve never heard of, a smart baby bottle. What is that?
Tommy Cunningham, nfant® Feeding:
Right. So it’s a smart baby bottle, and it measures how a baby’s feeding. So we measure the tongue coordination while a baby’s trying to feed, and that can tell you a lot of important things on the skill level of the baby, their capabilities, and it even has some information on underlying neurological issues that might present later on. Even some research we publish can help show the growth trajectory of the baby through the first year of life, all from a smart baby bottle.
Carol Vassar, host/producer:
Had you ever worked in the healthcare space previous to this?
Tommy Cunningham, nfant® Feeding:
So yeah, I was trained in mainly orthopedics and physical therapy as an engineer, biomechanics engineer, and I always wanted to create products that could help people. And so I learned early in my career how to speak with clinicians and doctors, but also be a conduit to engineers who could help design products. And of course, listening to patients is key. So if you include that in your recipe for design, then you come up with some products that can be used in real world scenarios.
Carol Vassar, host/producer:
I think it’s important to point out that merger of technology and medicine, we don’t think about it very often, and it really is beneficial to the patient. Can you talk about that?
Tommy Cunningham, nfant® Feeding:
Right. So my philosophy has always been if you can add good data to the decision-making process, you will elevate the standard of care. So how do we take, what I like to say dumb products, and make them smart and capture good data, good physiological data? When you combine that with other health information and what the clinician is seeing, you can create the entire health profile of that patient and elevate the standard of care, whatever practice of medicine that you’re involved in.
Carol Vassar, host/producer:
Is there an AI component to any of this?
Tommy Cunningham, nfant® Feeding:
So, there is. So all the data that we capture, we give live biofeedback on how a baby’s feeding. And then with our new Nfant Thrive breast product, we show flow rate while a baby’s feeding. That all goes to our cloud database to where we process and create dozens of metrics in real time and send that back down to the clinician and the parents so they can have numbers behind what just occurred during a feeding.
Carol Vassar, host/producer:
Among the parents who use this product with their child, who are they?
Tommy Cunningham, nfant® Feeding:
Right. So the mission of our company from the has been we want every child to have the opportunity to thrive. And so in order to do that, you have to build a sustainable company and create a technology that’s affordable and can be reached through all sectors of healthcare and demographics. So we started off in the NICU, and we’ve been there for about seven years now, helping babies feed on their own, go home a little sooner, better outcomes, higher breastfeeding rates when they leave the hospital, and they don’t come back. That’s incredibly rewarding, and that’s who we’ve serviced mainly for the last seven years. Now with the expansion of our connected feeding platform, our goal is to reach moms in the home or in the hospital, the total end-to-end solution. A lot of the moms that purchase the product now are of higher household incomes, but I feel strongly that it’s the mission of the company to understand different business models, whether that’s approaching hospitals or other subsidized Medicaid programs to where we can reach every baby born. And with the right partnerships, I think you can do that.
Carol Vassar, host/producer:
You said the magic word: partnerships. You announced a new partnership program here. Describe that for me.
Tommy Cunningham, nfant® Feeding:
So our recipe from the beginning is always listen to clinicians and be part of the medical community. And so every time we have an endeavor, we want to talk to clinicians. And so now with pediatricians, we have a clinical advisory board led by our chair, Dr. Jesse Zach, and several fields, pediatrics, OB/GYN, nutrition, lactation. All information we put out to moms has been screened by our clinical advisory board. We want moms with our Feeding 101 program to know that what they read, they can trust, and it’s written for them so they can de-stress the feeding situation. Well, part of that is also peer-to-peer networking with our pediatricians that we bring on board, so they can have access to the latest research and feeding, but also our clinical database so they can elevate their standard of care, but also, of course, offering discounts to their patients and their practices. If this is something that they’re willing to try and recommend to parents, they should participate with us.
Carol Vassar, host/producer:
What do you see as the future of this product, this innovation moving forward?
Tommy Cunningham, nfant® Feeding:
It’s been a journey, and it’s been very rewarding seeing the data that we capture and how that can actually help and transform lives, both mom and baby. With our Thrive Breast product, I truly believe it’s an absolute game changer for the field. I think it can help increase breastfeeding rates. I want to go prove that with our pediatric partnership program. I think we’ll have a truly end-to-end feeding system that if a baby’s feeding and that’s going well, you will have a healthier baby through the first year of life. You’ll have a healthier mom with lower anxiety. And it takes a little technology to help out with that. And I think marrying traditional clinical practice with technology, if we can show this in our field and that’s feeding, it can help other pediatric companies or other endeavors to say, “This is how Nfant did it. This is how we need to go do it as well.” And that’s how you elevate the standard of care and pediatrics in general.
Carol Vassar, host/producer:
Do you see this product or other products, innovations of any kind helping to really overcome the barriers that are brought forth by social determinants of health?
Tommy Cunningham, nfant® Feeding:
That’s a great question. So let me use nfant® Thrive Breast as an example. So part of the technology, I won’t get into the details, but one of its benefits, it can be used on any color of skin. So pigmentation of skin doesn’t matter. So I’m sure there’s been some other technologies to try to measure milk flow during feeding, and that’s a huge limitation. That’s not true with our technology, meaning anybody anywhere can use the technology. Also with scale, and this is kind of where the business side comes into play, is that with the right partnerships and investment partners, the larger volumes and scale that we can approach allows us to drop our cost of good products. So then now, we can start entertaining, okay, let’s reach out to the rural communities and where these communities are affected and might not have the systems in place to afford list price of our product.
Our mission, again, is to help every baby born wherever they’re at. You have to solve the business model equations and have the right backers and the business models have to work in order for enable you to go do that, to accomplish those goals. And so the technology can be used by anybody for anybody. The question is, do we have the right partnerships and the grit to go accomplish those goals? And we do internally, and part of our partnership program is to find access to those underserved populations that can help drive our goals forward.
Carol Vassar, host/producer:
And certainly innovation without that human touch isn’t really very helpful, is it?
Tommy Cunningham, nfant® Feeding:
I’ve seen there’s a lot of people who don’t have that human touch, and it usually doesn’t end well.
Carol Vassar, host/producer:
Talk about your own personal story using the product. How did it happen to work with your son?
Tommy Cunningham, nfant® Feeding:
We were a startup, and my son Joey was born across the street from where my office was, and he was having trouble feeding and was losing weight in the hospital. So I knew the story all too well because that was the population we were helping, and if he didn’t learn how to feed, they were going to hold him. And so I went back to my office, got our equipment, and our co-founder Dr. Capilouto came over. And in about 15 minutes, we had a crowd of lactation consultants, doctors, and our data was streaming live. And Dr. Capilouto, working with my wife and using our technology, was to say, “Okay, this is the recipe for Joey. Do this. This is what he likes.” And he was feeding within two hours.
Carol Vassar, host/producer:
So it’s individualized, personalized medicine, personalized medicine from birth.
Tommy Cunningham, nfant® Feeding:
Yep.
Carol Vassar, host/producer:
How do you protect the privacy of a patient’s data? You are FDA approved. How do you protect that data?
Tommy Cunningham, nfant® Feeding:
So our smart bottle was the first internet of things product ever cleared by the FDA for use on newborns. So we went through a rigorous process to, one, show data security, HIPAA compliance. Our database goes through a lot of security checks and we put all of that in place. And part of that is privacy, of course. So all of our data that we capture is de-identified. So there’s a lot of ones and zeros and letters that are used to identify in the database. You wouldn’t know who’s who, just the mom and the clinician.
Carol Vassar, host/producer:
You said the magic phrase, HIPAA compliant.
Tommy Cunningham, nfant® Feeding:
Yes.
Carol Vassar, host/producer:
That’s what I wanted to hear.
Tommy Cunningham, nfant® Feeding:
That’s key, absolutely key.
Carol Vassar, host/producer:
Talk about collaboration across the tech world and the health world. Why is that important?
Tommy Cunningham, nfant® Feeding:
It’s so important, because if you’re not healthy, then that’s not a good thing. It’s all about relationships. It’s all about finding the right programs and great innovation. So if you can put the right team together, whether from a local innovation center, which typically includes a hospital and a benefactor, or say like an NIH funded study, you can get some really smart people in a room, listen to patients, and develop and create technology that can help the local ecosystem and beyond.
Carol Vassar, host/producer:
Have you found barriers to collaboration? And how have you overcome those?
Tommy Cunningham, nfant® Feeding:
So I’m an entrepreneur at heart, and I feel like if I would’ve followed the recipe that many do, we would not be where we are at today. So that can be classified maybe as a bull in a China shop would be. I don’t know if that’s apropos, but sometimes you have to play ball by the rules, and other times you have to break a few things to make it happen. And I was able to find, I think, the right recipe to make that happen. But at the end of the day, if your technology works and you’re delivering results for the patients, you have staying power, and then people want to work with you. And so I think a lot of people, at least, at least locally from where we’re from in Atlanta, people have been able to point to our success and us coming up from very humble beginnings as a startup to where we’re at today in over 60 NICUs and servicing over 100,000 households is that we feel like we have a recipe for other pediatric startups to follow.
Carol Vassar, host/producer:
Tommy Cunningham is the creator of the smart baby bottle, Nfant.
Music:
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Carol Vassar, host/producer:
How is technology providing an assist to keep the children healthy? Leave us a voicemail on our website, nemourswellbeyond.org. That’s the place. You’ll also find all of our previous episodes of the Well Beyond Medicine podcast. Go there to subscribe to the podcast as well and leave a review. That’s nemourswellbeyond.org. Thanks to today’s guests for joining us, Robert Cooper, Tom Hickey, and Tommy Cunningham. And thanks to you for listening. Our production team this week is Che Parker, Cheryl Munn, and Susan Masucci. Join us next time as we talk anesthesiology for the non-anesthesiologist. I’m Carol Vassar. And until then, remember, we can change children’s health for good well beyond medicine.
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