#452 - 🚀 [Tech Tuesday] - Why Midline Positioning Matters More Than We Think

In this episode, Ben and Daphna sit down with Dr. Scott, pediatrician, neonatologist, and inventor of the Tortle. She shares how a simple observation in her Idaho practice, babies developing flat heads despite diligent parents, sparked a second career in medical device innovation. The conversation covers the evolution from the original corrective beanie to the Midliner and Transportal, the physiologic rationale for midline positioning in IVH prevention, and real-world data from a Tennessee children's hospital that cut its IVH rate from 28% to under 6%. She also offers candid advice for clinicians looking to turn an idea into a product.

Transcript

Ben Courchia (00:00.667) Hello everybody, welcome back to the Incubator podcast. We're back today for a special episode. Daphna is in the studio with us. Daphna, good morning. We are very happy to have in the studio today, Dr. Scott. Dr. Scott, welcome to the program.

Daphna Yasova Barbeau (00:08.558) Good morning, good morning.

Dr Scott (00:19.428) Thank you so much. Thank you for inviting me.

Ben Courchia (00:22.107) Daphna and I have been looking forward to this conversation. You are a world renowned physician and entrepreneur, a dual trained pediatrician and neonatologist, a bestselling author, and the creator of the Tortle, a device designed to assist with infant head positioning. You were born in Africa, completed your medical education in the US, and did your residency in pediatrics and neonatology fellowship at Duke. Over the course of your 30 year career, you've practiced in Denver, and you're also a mother and an author. We're excited to talk to you today specifically about your work as an entrepreneur and the Tortle. So let's start right away: what is the Tortle, and what are its intended purposes?

Dr Scott (01:33.474) Tortle started as an infant head positioner. I was in practice out in Southern Idaho, in a fairly small city where everybody knew me and was very responsive to me. I would tell them about repositioning the baby's head to prevent flat spots and torticollis, and I thought I had done a good job, except they would come back with a flat head. These were really responsible people who listened to what I said, but they were still having problems. That told me they needed a tool.

So I started designing one, and I included two of my children in the process. I started sewing hats with a little roll at the back that I thought would stop the baby from lying on that spot and would help turn them to a non-preferred position, since the weight of the head would push in on that area. My patients in the practice were wonderful. I would come in sometimes with a seamstress and a tape measure, and they would let me put the hat on their babies so I could get it right and see if the parents could use it well. That's how it started.

Why did I call the company Tortle? We were dealing with a lot of torticollis, so it was a play on the word, but I'd also chosen a little green turtle, because the carapace helps shape that little turtle. A green turtle and torticollis: Tortle.

Ben Courchia (03:49.291) Thank you for that walkthrough. These hats are beautifully designed, and they're not just an outfit for our patients, they truly have medical indications, as you mentioned. And if I'm not mistaken, they're FDA (Food and Drug Administration) cleared Class I medical devices. Is that correct?

Dr Scott (04:14.264) They are. That was very important to me, because I knew the public would be using our products, and I needed them to understand they had to comply with safe sleep. Parents don't always want to take the hat off at nighttime, because they're anxious to fix the problem, but I've learned to get around that. I talk to a lot of parents on the phone if they're concerned, and I explain that it's important to take it off when they go to bed and start again in the morning. They actually get a better result, because the child can't do therapy twenty-four seven. Once they understand that, they still get the problem taken care of, but the baby retains full range of motion around the neck and ends up doing quite well.

Daphna Yasova Barbeau (05:10.338) I want to make sure people listening who may already be using the Tortle understand that this is really the preliminary design for what is now the Tortle Air corrective beanie, specifically for babies with torticollis. But you have a whole spectrum of tools, as you say. How did the corrective beanie translate into the Midliner and the Transportal?

Dr Scott (05:40.824) I had gotten started selling the Tortle Air, with little designs to make it attractive for families. A physical therapist called me from St. Louis and said they'd been seeing what I was doing and needed a hat that would keep babies in a neutral position. Would I come see them and extend my designs to help the NICU (neonatal intensive care unit)? It was my pleasure, that's exactly where I wanted to be. By this time I had pretended to retire. I went to St. Louis, spent time with them, got feedback from both the doctors and nurses, and proceeded to design the Midliner.

It was very important to have great materials, since now we were dealing with premature babies and fragile skin. The Midliner has rolls on either side to keep the baby in midline consistently, and straps that go over the forehead with a foam lining. That foam lining has protected these babies, even the smallest three hundred gram baby, from breakdown. It has some stretch, so it can be contoured up and around, and the beauty of that is we're not pulling on a tight hat. We've learned a lot about how immature these brains are, and pulling a tight hat down makes them startle and changes pressure.

The straps close with Velcro, the foam protects the skin, and the outside of the material is Velcro receptive, which means we can put little eye shades on in a second or two, or a chin strap that comes off quickly. Everything is designed for quick, reduced contact and reduced interference with the baby. They can wear the hat to keep them in line with CPAP (continuous positive airway pressure), with cannulas, while intubated, in any position.

I had always noticed that nurses varied a lot in their ability to position infants, and this gave it consistency and simplicity. Because it has a roll, the baby can lean onto it, or onto a Z-Flo mattress pushed up on one side, so they can be in a partial tilt and get off the same pressure points. We're seeing a lot of breakdown and edema in babies lying supine in midline for prolonged periods.

Ben Courchia (09:32.667) That's something I wanted to commend you on, because the Midliner collaborates very nicely with the other tools we have in the hospital. It's not one problem, one solution, it embeds itself with all the other interfaces. It allows a secure amount of non-invasive interfaces on the nose, and eye shields for phototherapy. Was that a design feature you decided on right away, or something that came later?

Dr Scott (10:29.252) Being a neonatologist, I know what everybody needs. I have an advantage over someone like an engineer, who might be great at design but wouldn't know what the nurses and I needed to deal with. It was also supported by new research showing that minimal stem is huge.

I know how difficult it was to put bili shades on and wrap them around the baby's head. Not with this. Newer research shows there should be no light on the retina of an infant, almost fetal, because it affects the development of the rods and cones. So I recommend using the eye shades any time you're bringing a bright light source near a baby under that gestation. They go on in a second, with two little Velcro pieces on either side. Put them in your drawer, and when you're going to work with the baby or have a light nearby, pop them on and protect those eyes.

As for chin straps, many of my colleagues didn't want to use them, and I didn't like them either until I came up with a solution. The chin strap is made of the same foam-lined material, narrow, with a little slit that fits right over the bony prominence. You can thread it underneath the straps to the midline CPAP on one side, and one piece of Velcro attaches it to the Midliner on the other, not compressed or tight. If a nurse needs to suction the baby, it's off in one second.

Ben Courchia (13:23.813) I wanted to ask, before we get into the data behind midline positioning: I think a lot of us neonatologists sometimes stumble upon a problem, as you did, but we're reluctant to be part of the solution. We settle in and let someone else figure it out. You took a very different approach, you made this the next chapter of your career. What motivated that transition? Do you have any background in business or product design, or did you just learn as you went?

Dr Scott (14:00.004) All new situations are a challenge for me, and I enjoy and embrace that, I love change. With my four children, everybody has different skills, IT, design, sales, financial, so we went out as a team. With my degrees and experience, hospitals were very welcoming, they'd bring me right into the NICU and say, show me how to use it, put it on. I would listen, and they were comfortable enough to ask pointed questions, or tell me they didn't like something, and I could make a change. There have been changes over time.

The basic concept was really using my research and feeling like we've got new medicine, we need new care, and we need new tools. Many nurses feel strongly they've been doing a good job for twenty or thirty years, why change? Well, because outcomes haven't improved over decades, and they should have. With the knowledge we now have, that we didn't have before, you can't be upset about what you didn't know. But we now know how fragile these babies' vascular structures are, and that a twenty-two or twenty-three week baby is still making nerve cells. It's a very loose system, we have to deal with them differently. I'm trying to be the voice for the voiceless and give the nursing staff new tools, and I do a great deal of video education to support that.

Ben Courchia (16:19.067) I wanted to transition to some of the clinical data. The concept of midline positioning fascinates me, because from a physiologic standpoint it makes complete sense, hemodynamically and anatomically. But when you look at the data, it doesn't really support it wholeheartedly, the Cochrane reviews put the level of evidence as very low. And yet every neuroprotection bundle I've seen contains some form of midline positioning. I love that the physiologic rationale wins the debate because it's so obvious, but you've been intimately involved with this intervention with data on the ground. What has your experience with the Tortle across institutions shown in terms of why this matters, maybe even more than we think?

Dr Scott (17:42.424) It can be frustrating, because you feel the information is out there, but I think the issue is that some of this data about handling children and being consistent isn't necessarily known uniformly by bedside staff. We understand it well, we're asking for neutral positioning, but I don't think they always understand what's going on, that these babies, literally born fetuses, have such low blood pressure that even turning the head, the strap muscles can cause obstruction by pressure on those extremely low pressure veins, as well as walls that are like membranes. I don't think they necessarily get that. They feel, perhaps, yes, of course we need to be in neutral position, and then the rolls slip away, or they take it away to do a procedure and don't put it back.

There must be inconsistency going on even though the nurses are trying. My belief, and I've got data from a hospital that kind of indicates this, is that once you have a tool that's easy to use and enables you to add these various accessories on, but most importantly to keep that baby's head in line, it's different. A tool like this doesn't fall away, it stays there as you need. They can nest in it and open the straps if wanted, and from one cares to the next, the hat stays stable. Part of that is the materials the hat is made of. It makes it easier, especially for new nurses coming in, to recognize that half an hour here or there may be too much to be out of position. I don't think they necessarily know that. But referring back to some data I've been fortunate to receive from a children's hospital in Tennessee: they set up a positioning plan for IVH (intraventricular hemorrhage) as their protocol, and spent a lot of time researching and trying to do it diligently. It was a nurse-driven program, and they were worried because their incidence of IVH was up around close to 30%. All of their children were brought in on a transport, so yes, they did have risk.

They were ready to roll that out in 2016, and got introduced to the Midliner. They embraced it, taught the transport team how to use it, and started as soon as they got out there. They did it religiously: brought the baby back in the transport in the Midliner, and the hospital completed the 72-hour IVH protocol with it. They had about 50 patients a year, just for scope. The very next year, they went from 28% down to 17%. They were ecstatic, and they believed this made a difference from what they'd been trying before, so they got very careful and compliant. That compliance worked, because the next year it went down to 11%, to the point where they literally don't need anybody monitoring them on the IVH protocol.

The other thing I did was get funding for a transport situation, and now we have a product called the Transportal. It has a lot of the same features. The headset does the same as the Midliner, except it holds earmuffs that drop the decibel sound by 25, which is enormous. They can use the little eye shades. The baby's headset is anchored on the side of what we call a pod, and there's a pod within a spacer. The spacer fits the incubator tray perfectly, and the pod is more of an oval shape for the patient. That pod can be lifted out and the baby can be stabilized on an open radiant warmer. They can use a gel mattress if it's a tiny baby, and the baby has support rolls around and a foot roll to nest that baby in a very stable fashion.

When they're ready to go to the transport incubator, instead of having to lift the baby up, which we always used to have to do, and that's precarious because you've got lines and tubing, they just lift the baby. There's a plastic base at the bottom of the pod, so it's like a little baby stretcher, with securement straps. They lift the baby from the radiant warmer straight into the transport incubator. There's also a 15 degree wedge so the head never goes into Trendelenburg, it's always held up safely. Then they do whatever cares are needed when they get to the tertiary care center. We have a warmer mattress with an insert that can be removed, and the pod just slips right in. So the baby goes from radiant warmer in a community hospital, through transport, into the NICU, and is never lifted up.

With that combination, I believe this hospital was able to get down to an IVH incidence of five to six percent.

Ben Courchia (24:37.741) I'm going to invite people to check out the website so they can see it, because in the picture of the Transportal there is so much cushioning and padding, I think it does alleviate at least a little of the stress of transporting babies at risk of IVH. And we'll put the link on our website. Daphna, go ahead.

Daphna Yasova Barbeau (25:12.141) I commend you, you've not just made one product, you've made a continuum of products, finding where there was a lapse and filling it. That's really tremendous. We'll disclose, we use the Tortle. I love it, especially for developmental care past even the first 72 hours, past the first week.

Dr Scott (25:34.85) Long past. Yes.

Daphna Yasova Barbeau (25:38.785) For our unit, it really became an opportunity for discussion. Yes, head midline, yes, keep the head slightly raised, but why would we be doing those things? Why is containment so important? It's really changed the way that discussion goes, giving our bedside staff the background and the knowledge has changed the way we do developmental care.

I'm so impressed by our nursing staff, they want to do the right thing, they just want to understand why, and don't we all? I know we're getting close on time, but I wanted to talk about this transition from physician to doing product technology. There are so many things we're not trained for in medicine, engineering, dealing with financials, manufacturing, marketing, patents. What are your recommendations for somebody who says, I've got an idea, I'd like to move this forward? What does that process look like, and how do you deal with the frustrations along the way?

Dr Scott (27:10.242) I'll tell you, Daphna, I'm certainly a person who, if I think I need to do something, I'm going to go and do it, whether I know exactly what I'm doing or not, I will learn. I'm very willing to learn and talk to people, and honestly, my experience has been that no matter where you are in the world, if you come and talk to people and ask for information, they're usually very willing to help you and be good partners, even if there's a major language barrier.

For manufacturing, I'll be honest, I'm still making in China, because the seamstress work is technically right, and we can't afford to have this made wrongly with a heavy stitch or something. It has to be consistent, quality, and very clean, we cannot have anything that would give an infection to a child with basically no immune function. So I've had to be very sure of quality and cleanliness. I've tried, and ultimately I think I'll be able to bring it back to America, but at this time I'm not willing to give up the quality for those babies, it's too important. In terms of the business, I felt like I've run a home pretty well, and my daughter is a financial analyst, so she was very helpful to begin with. A lot of it has been working as a team with people. People are just nice, and if they have the same motivation, they will help and answer questions without being irritated. So frustration, not so much. It's outshone by seeing these babies do well and have a full quality functional life. That's the bottom line.

Daphna Yasova Barbeau (29:36.795) Can you give us an idea of the timeline from idea to first prototype, and then to professional production?

Dr Scott (29:49.966) The first product was very quick, that was the Tortle Air. I didn't have much difficulty getting FDA clearance, I went to an expert to do that, she liked what I was doing, and I had clearance within the first year. It was quick.

The biggest thing was making sure the instructions were written very simply, since I talk med speak and that doesn't work for the person at home. I did focus groups where I would show what I needed to get solved, both the wording and the pictures and the device, and these ladies would tell me straight up, I prefer it to be this way, or I didn't quite understand that, could you write it that way? My practice patients were extraordinarily helpful in getting me to where I needed to be. So I got my FDA clearance, and at this stage I've got CE (Conformité Européenne) marks and all sorts of things.

For regulatory design, I use an aerospace engineer who's a friend of my grandchildren, he loves to be helpful and can do any drawings I need. So, lots of help just from friends and my circle.

Ben Courchia (31:39.385) I think that's a great lesson: don't try to go too far, just look in your own circle for the people who can support you. Dr. Scott, this was a phenomenal conversation, we really appreciate you taking the time. People can learn more about you and the work you do at tortle.com, spelled T-O-R-T-L-E dot com. We'll have all these links and information on our website as well. Thank you so much for taking the time and for joining us on the Incubator podcast.

Dr Scott (32:08.676) Thank you both very much indeed.