NICU Innovations

The neonatal intensive care unit is one of medicine's most remarkable achievements, and one of its most persistent challenges. In this episode of Dose of Optimism, three innovators share how they are working to improve care for some of the most vulnerable patients in healthcare: premature and critically ill newborns.

Dean Koch, CEO at smallTalk, explains how a sensor-equipped pacifier and a speaker device are being used to explore whether contingent voice interaction, where an infant controls when they hear their parent's voice, may support early brain development in the NICU environment.

Saheel Sutaria, CTO and co-founder of Gravitas Medical, describes how a sensorized feeding tube is working to address one of the most common and potentially dangerous challenges in neonatal care: safely placing and monitoring enteral feeding tubes in tiny patients.

Ross Sommers, CEO and founder of Firstday Healthcare and a practicing neonatologist, shares how his company is building a tech-enabled care model that supports NICU families through the transition home, filling a gap that leaves many parents feeling suddenly alone after weeks or months of intensive hospital care.

Together, they paint a picture of a field on the move, where better data, smarter devices, and more connected care models are beginning to reshape what's possible for premature babies and their families.

Connect with Dean Koch:

Dean Koch LinkedIn

smallTalk Website

smallTalk LinkedIn

smallTalk Instagram

Connect with Saheel Sutaria:

Saheel Sutaria LinkedIn

Gravitas Medical Website

Gravitas Medical LinkedIn

Connect with Ross Sommers:

Ross Sommers LinkedIn

Firstday Healthcare Website

Firstday Healthcare LinkedIn

Connect with us:

KidsX Website

KidsX LinkedIn

Children's Hospital L.A. Website

Children's Hospital L.A. Instagram

Children's Hospital L.A. LinkedIn

Transcript

SPEAKER_03 0:00

The best analogy is we want to be muffin stump eaters. If you've ever seen Seinfeld, like no one wants to eat the muffin stump, everyone wants the muffin top. And our goal is to let children's hospitals eat the muffin tops, and we take care of muffin stumps, and we're the best at what we do. So you could be the best at what you do. The question is how to align the interests of hospitals and payers, and that's what we're trying to figure out now. Muffin stumps are still good.

SPEAKER_01 0:23

Muffin stumps are still good. That's a clip from today's episode. And what he's talking about is the business side of running a hospital NICU or neonatal intensive care unit. The first NICU was opened in 1960 at Yale New Haven Hospital. And today there are approximately 1,400 NICUs around the country. Some are small units at community hospitals that take care of premature babies who need time to grow before they can come home. And some, like the one at the hospital where I work, take care of babies who have complex care needs, like congenital heart conditions, genetic disorders, babies requiring surgery, babies who have severe feeding difficulties, complex needs like that. NICUs are often the most heavily resourced units in a hospital. They require 24-7 intensive care staffing. A single NICU bed can require continuous cardiorespiratory monitoring, temperature-controlled incubators, respiratory support equipment, highly specialized nurses with a one-to-one ratio or a one-to-two ratio. It's one of the most technologically dense environments in medicine. And these NICUs can be costly for hospitals to operate. For a standard NICU taking care of premature babies, a day in the NICU can cost around$3,000 to$5,000 a day. And in high acuity NICUs, where the patients require even more complex care, the cost could reach as high as$20,000 per day. So today's episode looks at innovators who are trying to optimize care for babies in the NICU. Can we find ways to send patients home sooner with tech-enabled care model redesign? Can we optimize the medical devices in the NICU that we use to make better outcomes for babies? Can we help improve outcomes by introducing mom or dad's voice into the incubator? We dive into all of these topics and more in today's episode. Welcome to the Dose of Optimism, where I talk to the optimists in healthcare. My name is Omkar Kulkarni, and I work at one of the world's best children's hospitals where I lead innovation. I started KidsX, which is a premier international startup accelerator for pediatric innovation, and over the years I've met thousands of startups, investors, and innovators. Every one of them has a story, and every one of them is optimistic about the problems they're solving. On this podcast, you'll meet amazing people who will share their stories and what makes them optimistic about the future of healthcare. A little note before we get into this episode. This podcast is for informational purposes only. We are not offering medical advice, and we're not endorsing any products. Please talk to your own physician about your health or the health of your children. Alright, let's get started. My first guest is Dean Koch. Dean is the founder and CEO of Smalltalk, the company behind the NICU Egg, a technology designed to strengthen bonding and communication between NICU families and their babies. Dean leads the company's mission to bring evidence-based developmentally supportive tools into the NICU through thoughtful design and through some interesting NIH-supported research partnerships.

SPEAKER_00 3:44

We're focused on premature babies, preterm babies in the NICU, in the neonatal intensive care unit. So, from a problem definition, you have about 10 or 12% of babies globally are born before 37 completed weeks of gestation. But they account for about half of all childhood neurodevelopmental issues. So you have this huge prevalence impact, this outsize prevalence of neurodevelopmental problems in this population. And a really important thing to understand is that it's not a side effect of being born that you have this potential for neurodevelopmental problems. It's actually a side effect of a stay in the neonatal intensive care unit itself, because it's a really bad place for the developing brain. And you're really talking about a critical window in early brain development. And just like any other ICU, it's a super stressful environment, bright lights, waking you up to do painful procedures. And in the case of infants, there's a lack of consistent parental interaction, voice interaction with their primary caregiver or their parents. And this is really critical because parents' voice, ideally the maternal voice, is one of the strongest drivers of early brain development. So you would think one way around this using technology would be let's just record mom's voice and then we'll play that to the baby. And that does accomplish something actually, but not much, because passive exposure doesn't really work. What we need is interaction. And so small talks solution is what we call the active egg. It's a small speaker that holds a parent's recorded voice. And it's paired with a sensor-equipped pacifier that the baby utilizes. So in short, simple therapy sessions, the infants control through an action that they control with their sex strength, the only action they can control. They control when they can hear their mother's voice. And this creates a positive feedback, a contingent learning loop that the developing brain responds to. We know it works. We measure the brain directly when we're doing clinical work. We use a validated EEG biomarker to predict speech and language outcomes before the infants ever leave the NICU. So we have an objective marker that's associated with more of the subjective two and four year speech language and neurodevelopmental outcomes. So that's the way it's all put together. Specific to the instructions, I'd love to talk with you specifically about the design of the speaker device, the sensor device, and our HIPAA compliant apps as well that for moving the voice around.

SPEAKER_01 6:13

There's growing evidence that the first 12 weeks after a baby's born, even babies that are born a term, sometimes it's referred to as the fourth trimester, this concept that there's a lot of growth and develop development that happens after the baby comes home and the first three months of life. Is there a world where this could be something that's used in the home? Could this help babies adjust to the home environment after they've left the hospital? What are some additional use cases outside of the NICU that could work for babies that are born prematurely or babies that are born mid-born at turn?

SPEAKER_00 6:44

So moving into the home environment is definitely an area of interest and that hospital to home is an area of interest in the industry in general. I think some of what we're solving for is alleviated in the home environment. But when you're looking at children that have started their life in the NICU, I do think there's an opportunity there to continue with this kind of exact sort of scenario moving forward. And then when we think about it's really the first three years of life, even broader than that, with voice exposure, speech exposure, things like that. And the idea of connected devices where infant action getting an instant and satisfying reaction and the power in the brain of what that does using language. There is other elements. Our intellectual property covers basically sensor-based devices and speaker devices for the purpose of brain development and language learning. So we do see that. You can easily see how it could turn into some consumer-oriented products, which is a little bit different of an operation than a medical device company. But we definitely see growth opportunities on label, pediatric patients coming out of surgery, coming out of those stressful environments, and familial voice being gastric. We definitely see some growth opportunities.

SPEAKER_02 8:33

We're working on entral nutrition and we're starting with feeding tubes. These are nasogastric feeding tubes, tubes that go through the nose and into the stomach to feed patients who can't feed themselves. And there are a few problems with entral nutrition practice today. Number one, these tubes are frequently misplaced. They sometimes end up in the airway, right? They go through the nose and into the airway, which can be catastrophic if you feed. And even if you don't feed, you can puncture the lungs on the way in. So that's the first problem. Second, there's frequently minor misplacement. So you're aiming for the stomach, but you end up a little bit shallow or a little deep. So now the tube's in the esophagus. And if you feed, that's going to end up with fluid in the esophagus, pulmonary aspiration, things like pneumonia. And then the last problem is once the tube is placed, figuring out when and how much to feed patients. Today, clinicians are looking at subjective cues, like discomfort, spitting up, vomiting, and there's basically no data in the practice today. You basically feed them until it's too much and then you stop, essentially.

SPEAKER_01 9:36

Exactly. Feed them until they're spitting up and then just back off. Why is the placement kind of blind the way it's done currently, in terms of how far to go, where to place it, all the things you mentioned?

SPEAKER_02 9:49

Once it enters the nose, you don't know where the tip is. The tube can coil, it can coil in the nasopharynx, it can end up in the airway, end up in the esophagus. There are verification methods today. In adults, x-ray is the standard. So after every single tube is placed, an x-ray is taken to make sure you're in the right place. Some institutions even take two x-rays. They'll insert halfway, make sure you're in the right place, and then insert fully and take a second x-ray. And the reason you would do that, again, is with the full insertion, you may puncture the lungs. So they want that first x-ray to make sure you're not headed towards the airway before it gets too deep. In babies, you want to avoid the risk of radiation. And so x-ray typically is not done. We've done clinical studies at six sites. Only one site frequently does X-rays in babies. And so instead, they're using manual outdated methods called auscultation and aspiration. With auscultation, you're literally blowing bubbles in the tube with the syringe, and then with the stethoscope, trying to listen for the bubbles. Are they in the airway or in the stomach like they're supposed to be? So manual. The other method is called aspiration, and that's taking your syringe and doing the opposite. Now you're pulling out, trying to get some gastric fluid. It's hard to do. Nurses are typically fishing around trying to get some fluid, and then you can check the pH and see if it has gastric pH. It's frequently inconclusive because one, you can't get any fluid, or two, if you can get the fluid, if the patient is on anti-reflux medications or it was recently fed, those things can all affect the pH. So even if you do get fluid, it's inconclusive.

SPEAKER_01 11:23

It's also a bit of trial and error. So I feel like you're doing it, and if it's wrong, then you perhaps have already done some damage. And so that's the other challenge of it. So tell me more about gravitas.

SPEAKER_02 11:32

So what we've done is we've sensorized a feeding tube. And it's in line with the last couple of projects I've worked on, companies I've worked on, is taking standard devices and sensorizing them. And I think that's the future of medicine. I think every device is going to be sensorized, generating novel data streams from different parts of the body, and that's all going to aggregate up to some amazing predictive analytics.

SPEAKER_01 11:53

So kind of like an endoscope, the sensorization on endoscopes from a long time ago, but applying that to other devices that are inserted.

SPEAKER_02 12:01

Exactly. Like my previous company, we sensorized a foley catheter and we measured intraabdominal pressure from the bladder, and then used that to predict acute kidney injury. So what we've done here at Gravitas is we've sensorized a feeding tube and we can measure multiple things. We can measure temperature, and then we have rings that can measure impedance, ECG, and even EGG, electrogastrogram. With those sensors, we can tell you, first of all, location of the tube, and then second, we have continuous monitoring to tell you if the tube has been dislodged. We can track reflux, we can track gastric emptying and peristalsis, right? Gastric motility. And it's really cool to look at the data because it almost feels like I'm looking at the matrix, all these zeros and ones, but we see everything. We see every swallow, every vomit, every burp. It's all in the data. Yeah, you're like digitizing the gut in a sense. That's exactly it. We've partnered with a few institutions, actually down at UT Southwestern, they're doing some great research on feeding intolerance. And they've shown already that with spot checks of EGG, they can predict feeding intolerance. And the reason they have to do spot checks is because they have these external sticky pads all over the baby and it's irritating the baby's skin and there's wires everywhere. It's just not conducive to have 24-7. But they've showed that even with three-hour spot checks, they can predict feeding intolerance. So we're now working with them and applying for grants because basically we we approached them and said, what if we could give you 24-7 EGG without the sticky pads and with a higher fidelity signal because our sensors are inside the stomach, right? There's not a layer of fascia and fat separating the sensors from the muscle. And so with this continuous data, we should be able to predict feeding intolerance, improve on the algorithms that UT Southwestern's already working on. There's diseases like necrotizing entry colitis that are very little understood today. Diagnosing it, treating it, it's just not understood. And the reason it's not understood is because there's no data. So as we generate these novel data streams, we're going to be able to understand disease states better and treat them in a better way.

SPEAKER_01 14:09

Taking that one step further, how do you think the future of broadly sensorized devices that go into the body? What more could you do with this type of closed loop system? For example, could you actually improve feeding to the place where babies are out of the hospital faster?

SPEAKER_02 14:26

That's exactly the goal. One thing we've already started working on is we partnered with an entral feeding pump company, and we're integrating our data with our pump to turn their pump into a smart pump. And initially, we can do features like we can detect feeding tube dislodgement. So if the tube is dislodged and the pump is still running, we know you're now feeding into the esophagus or the trachea. So the pump should shut off automatically, right? So we can do safety features. And then moving beyond that, with our reflux and gastric emptying data, you can have similar safety features, right? If the patient's refluxing and vomiting and the pump is running fast, that's a dangerous situation, right? The pump should slow down or stop. So we're going to start as clinical decision support and present this data and present alerts. But I think the big vision here down the road, once we have thousands and thousands of data sets, is to close the loop based on the actual status of the stomach, set the pump rate. That would be one area where we could expand. And then I think the future of medicine is the entire body. Every device is going to be sensorized. And a lot of the bigger companies, the Mosmos, the Baxters, they're turning into the brain of the ICU. And every device is going to stream their data into this brain, also into the EMR, obviously, and have tremendous algorithms. What's really cool about today, and what I get excited about today, especially the rapid pace of innovation with AI and machine learning over the past year, is that algorithm development has now become commoditized, right? With data and novel data, we can feed it into these systems and iterate on algorithms so fast today, so much faster than we ever could before. And companies like Rabitas and almost every company today, where the moat is with IP and patent protection, also innovation, I think it's going to move back to the hardware with the sensors and the hardware and generating novel data streams. And then we can do amazing things with today's technology on the algorithm side. Last question for you. Every calorie counts. And when I started looking into the problem statement, I was doing research and I came across YouTube videos of kids, you know, demonstrating doing how-to videos to swap feeding tubes at home. And I was like, there's got to be a better way. And then for even the younger patients in the NICU, I learned that most babies are underfed. And food is medicine, it's the best medicine. And there's plenty of studies showing that early and proper nutrition has lifelong benefits, right? Brain health, growth trajectories. And so if we can personalize nutrition and get the babies the calories they need, that would be tremendous. And actually, the way I stumbled onto the solution, in a previous life, I worked in the oil industry and I actually worked on impedance to detect oil. So I had these impedance sensors attached to drill bits, going five miles into the earth searching for oil. So fast forward to today, it's actually a similar technology. I'm using impedance, but instead of a drill bit, it's attached to feeding tubes and drilling into the body. You can say, so that's how the solution cannot.

SPEAKER_01 17:40

It's awesome. I'm glad you translated oil and drill impedance into helping babies feed better and hopefully have better health outcomes. So thank you, Sahil, for coming on the show and talking about all your amazing innovation.

SPEAKER_02 17:53

Yeah, thanks for having me.

SPEAKER_01 17:57

Dr. Ross Summers is the CEO and founder of First Day Healthcare, a neonatologist who is focused on using technology to bring high-quality neonatal care and support directly into families' homes.

SPEAKER_03 18:16

The best analogy is we want to be muffin stump eaters. If you've never seen Seinfeld, like no one wants to eat the muffin stump, everyone wants the muffin top. And our goal is to let children's hospitals eat the muffin tops, and we take care of muffin stumps, and we're the best at what we do. So you could be the best at what you do. The question is how to align the interests of hospitals and payers. And that's what we're trying to figure out now. Muffin stumps are still good. Muffin stumps are still good. You know, specialized children's hospitals, more infants who are just not 100% perfect and need some help, but they're not able to get that in the current model of public care. So there's a huge population now of more what we call the late preterm infants or infants who are just requiring some additional help but have a short length of NICU stay. But it's just there's no alternative care model delivery for that population. And the population of the more sicker extreme kids is also increasing because as we push the limits of viability, we're overall saving and trying to resuscitate infants of younger gestational age than we've ever saved before as well. So we got these sort of two factors that is in leading to increased utilization of the NICU resource.

SPEAKER_01 19:28

But for a hospital, traditionally the NICU stay more than pays for the cost to care.

SPEAKER_03 19:35

We're already sending babies home with tools and resources like oxygen on a regular basis. It's becoming more common. It's just very totally sporadic and random between hospitals. Now also sending babies home with NG tubes is becoming more commonplace. I think at the end of the day, neonatologists want to enable timely, more timely discharges. It's just we want to know that they're going home in good hands and that they're not going to be readmitted and that they have everything they need in place. So that's really what we've been trying to create with first aid healthcare is that wraparound technically service that is facilitating that timely discharge so neonatologists will feel more reassured when sending this baby home than in our current offerings.

SPEAKER_01 20:25

So baby gets go home faster, which is great for the baby, great for the parents. What's the care like at home with your model?

SPEAKER_03 20:31

In our care model at home, instead of just getting a cap at graduation, say goodbye, you're good to go. Families are transitioned into our tech enabled service while in the NICU. They are trained on the required, let's say the baby goes home on oxygen. Right now we send them typically home with a DME-ordered box monitor, pulse oximeter, for instance. In our model, we utilize a third-party sensor for vital sign acquisition that the baby wears and connects to our Bluetooth-enabled tablet, our proprietary gateway tablet application. And this way the parents are trained on the system while in the NICU and what's like how to place the sensors, how to obtain vital sign monitoring, how to oversee the care they're providing, for instance, the weaning of the oxygen and the weaning of the nasal covaj tube feedings that our command center team is supervising with our neonatologists and our evidence-based protocols for the weaning of these two therapies. So now they're trained on the system, they're introduced to the remote team, and that day of discharge is up to the neonatologist. But now at least they know they have this additional level and layer of resources in place for when that day of discharge does come.

SPEAKER_01 21:48

What's really cool about this is there are not a lot of hospital home models or care home models in PEADs, particularly ones where there is a tech enabled service of. When they get home, they feel like they are alone. They feel like they don't have the support they need to take care of their child, particularly when the baby is out of the NICU, right? They've had intensive care for days and weeks, perhaps months, and now they're going home. So that's a really big gap. And so I feel like this is incredibly interesting from that perspective. I mean, typically when you have a patient, any patient in an intensive care unit, which is what a NICU is, it's a neonatal intensive care unit. Typically, they go to a step down or some sort of progressive unit. Often we send patients from the NICU home. Yeah, what you're offering is kind of like a step down in the home. Exactly.

SPEAKER_03 22:39

You nailed it. In that dull, you may have four layers of transition before they get to be home and be a normal person. Here we're making that jump overnight. And not every parent can make it, first of all. And those who do even suffer, it's known from post-traumatic stress. It's every time they see or something like that, it's very challenging, even years afterwards. So that's always been my motivating drive behind first day healthcare is to help these families. I always felt like I was letting them down and misleading them a bit with this process and that we could be doing better. And I saw that it existed in the adult world. And I saw, as you described, the huge need that is already there. And the toppers that were already halfway there, we're already sending babies home with oxygen. We're increasingly sending babies home with NG tubes. So everything was in place to create this. It was just the mindset that is the change and challenging part is conceptually, it's okay to send a baby home on oxygen or NG tube and something happens, et cetera, and we don't know. But the mindset changes is this continuation of care from the hospital home, which will take some time because pediatrics were different from adults. We have different risk thresholds and it is a more vulnerable population. But my goal is 10 years from now, or however long it takes, we'll look back and say, wow, how were we having done what we were doing in the past of putting a graduation cap on them, sending them home with all this gear and just being like, good luck when we could have been doing what we're doing with first day healthcare? All right. Big elephant in the room question. How does this get paid for? So our goal is really what everyone is trying to find is something that will align the interests of both providers and payers. And obviously, it just in the past, if one benefits, one doesn't benefit. And there are ways to find that we're finding that could benefit all parties involved who are partnering with first aid healthcare. And that's by the fact that, first of all, obviously, if there's a hospital that has some bed capacity issue where they don't have the bed capacity, and we've seen this, that they can't even accept the transfer of a higher acuity patient from a referring hospital, that the it's worth working with us because yes, you may decrease length of stay for a certain amount of days or weeks for these this population, but it's overall benefit by the uptake of increasing acuity of patients who need this care and aren't going to, let's say, a competitor hospital who is always has space available. The other, what we're finding is there's a lot of arrangements are with payers and the hospitals are based on some type of capitated rate or DRG payment, where the hospital is actually going to be incentivized for wanting to allow the child to go home sooner, especially once it reaches capitation and especially in DRG, where they're on the hook for providing this care. And really the goal is through the work with the payers, is the hospitals who work with us are going to become known as centers of excellence. And through marketing, through parent awareness, I really believe that mothers and our consumers of resource. And they always say the maternity service is the gateway entry to hospitals. And women don't want to go to a hospital that is known, going to be known in the future is the one where if your baby goes to a NICU, they stay a longer time. And yes, women want to go to a hospital where they have a birthing center that has a NICU, but they definitely don't want to go to the NICU if it's not necessary. And if they do go, they want to know when's the baby gonna be able to go home. So the goal in the long run is that our partners and hospitals become centers of excellence where they're known by the community and the payers that this is the facility where if a baby needs NICU care, they get the NICU care they need, but they're also able to transition the post-acute care and that weaning of that last stage of care in the home that's being powered by first day healthcare.

SPEAKER_01 26:50

Dr. Summers, thank you so much for joining us. I'm excited to see new care model innovations out in the wild. And you've been at this for a while, and I'm excited to see all the hard work you put into this get into the hands of new moms and new babies. Thanks for your support, OpenCart. All right, thank you for joining us for your dose of optimism. Make sure to check out our show notes to get more information about our guests and the work they're doing. Visit our podcast page on the Kids X website to join our podcast community and to learn more about pediatric innovation. Thank you to our sponsors and to our presenting partner, Kids X. Please subscribe wherever you get your podcasts. And remember, it takes a village to make sure our kids grow into healthy adults. So volunteer at your local library, help out at the community center, and if you're so inspired, donate to your local children's hospital. Alright, see you next time. The content, views, opinions, and information presented on this podcast do not reflect the views of Children's Hospital Los Angeles or of the sponsors of the podcast.