Thank you all for staying. So I have a few disclosures. As a respiratory therapist doing research, I don't get the doctor money that most of the physician researchers get. So I work with several partners in industry, and you all can decide whether or not these are conflicts at the end. So our objectives that I'm really going to go over for the next 15-ish minutes very quickly, because it's hard to get all this in 15 minutes, is looking at the use of 3D pictures or 3D imaging to develop new pediatric medical devices, and then use of 3D printing in the development of devices, but also really just testing our devices, which is where we've kind of been at right now. And this is all through the lens of a respiratory therapist, so we're going to talk mostly about respiratory devices, because that's what I do and where I live. So looking at pediatric-specific medical devices, there is really little innovation in pediatric medical devices. And this continues to really lag behind adult medicine, some of its funding, some of its people willing to do it. A lot of companies honestly just don't think there's enough of a need in pediatrics to make their business case. We're not great at putting out there into the universe how often we use specific devices, so that they have an idea as to how much they could sell, to know that they're at least going to break even with making some pediatric devices. The FDA, because of this, have funded Pediatric Device Consortia across the country. And there are grants through the Office of Orphan Products Development, because it is such a small amount of numbers. There are currently five PDCs. This is the website to kind of go to the FDA to figure out where they are, but to list them, since there are only five, is Children's National, Texas Children's, CHLA, UCSF, Stanford, and the Children's Hospital of Philadelphia, of which I am a co-I in that consortia. And what we do for Pediatric Device Consortiums is we get this nice chunk of money from the FDA to then disperse out for smaller projects. There are $50,000 funding for about eight to 10 people each year goes out of each consortia. And it can help with a lot of different things, with consulting with engineering firms or prototyping firms, development and business planning, consulting with regulatory experts. So we see a lot of the hiccups that people are getting to through FDA approval, and then having discussions with FDA about the regulation and why it's a problem, and are there things that we can do to change or loosen that up. And then really connecting the engineers with the clinical experts to do that clinical testing. The engineers might think this was a really great idea, but then we look at it and we're like, in theory, sure. But that's not how we work, to be able to put it all together. So really making those connections so that the devices that are being made are actually what we want to use. And no longer do we take something out of the package and say, I really wish this hole was moved this way, like a half an inch, and then it would fit perfectly. That was something that they could do in their early prototyping phase by talking with experts. So how do we use different 3D technologies? Medical device-related pressure injuries is one of the main causes of significant morbidity that extends hospital length of stay, it extends costs. And in adults, it's considered a never event, but we're not actually able to get there in pediatrics. There are different sizes of pediatric patients. So you go from 0 to 18 years of age is considered a pediatric patient. So we don't have a one size fits all. And over that course of time, as the child grows, the contours of their body changes, where the divots are, where the fleshy parts are. And that changes how your device should be made so that you don't have these pressure-related injuries. There's a lot less literature to prove that expanded sizes are needed within a business case. And less centers have expertise with partnering with industry to be able to help them prove that need, get them the information that they need, help them develop a product, and then test their clinical performance. And this is something, as I started out as a clinical researcher within respiratory therapy department, that I've been doing a lot of this, and particularly surrounding non-invasive ventilation and different types of oxygen masks, as that's our biggest need. So we also use a lot of these technologies to improve how we use what we currently have. So delivering aerosolized therapeutics, adapting a nebulizer or adapting a canister into the circuitry. Just because you can adapt something doesn't mean we should actually be doing it. There's a lot of bench studies that we have found that when you're delivering aerosolized therapeutics through a ventilator, you're really only getting about 2% of it. And then pharmacy wants you to weight-based dose, which you shouldn't be doing anyway, so you're really getting not a whole lot of medication. So we're able to test these things with realistic airway models by 3D printing these airway models in different pieces to help us connect things. Different diagnostic services, bedside procedures, doing some adaptive rehabilitation and assistive devices to help them with that. Medical transport, being able to help make something that can hold everything on an isolette. There's a lot of different ways that we can be using 3D printing and 3D technology. But as I'd mentioned, the way I use it mostly is within simulation and within bench testing for any of the things that we're 3D printing. So some examples of what I've done recently. We use 3D imaging to help redesign the CAP1 mask, which is a mask that Neon Codin makes that is an open system oxygen mask with mainstream end tidal capability. And then a current study that I'm working on doing non-invasive, trying to figure out what are the sizes that we need for non-invasive interfaces. And I'll go through those just a little bit. And then for 3D printing, mostly doing bench testing. And then coming up soon, trying to make a 3D printed individualized masks for patients with facial anomalies. And this is something that we've stumbled over for many of years but greatly need. For the CAP1 mask, we did a redesign of a mask. So they made the mask in Japan for Japanese faces. And the American mixed race faces have much more depth to them. So we did use the Microsoft Kinect sensor to do 3D surface scanning to then make measurements on the back end within Mimic software to be able to help redesign how this face, how the mask should really fit. And these were the main measurements that we made in the background to help them figure out the depth and changes. And really also where there's a little air connector collection cup to where the end title actually connects up. And you can see the original in box A here, which is a much narrower mask versus the redesigned mask in box B, where we actually had some mechanisms on the side for the fleshiest parts of the mouth or the face that when you put the straps around the face, it made the air collection cup move where it needed to underneath the nose, which was some really good engineering on their part. It was really me going, this is the problem. Can you figure out how to make that better within the pictures? But now this is a mask that is used throughout the US as well and works really well with mostly the sedation cases as kids won't keep those nasal cannulas on. So other ways that we're using it currently with non-invasive interfaces, those within pediatric critical care are very well aware that we do not have appropriate non-invasive interfaces for our children, particularly between ages eight months to nine years of age. And we really don't have nasal interfaces with an occlusive prong. So because of all the challenges that we have with ill-fitting masks, not being able to help us capture the patients to do bi-level ventilation, as well as not being able to having way too big of leaks, not having options to alternate your interface to offload pressures, we got a small grant from the PPDC to be able to do a clinical study where we're doing whole head 3D imaging, which is really a surface scan again, and then making a series of 28 measurements on the backside so that we can then, in statistical modeling afterwards, say, these are the sizes that we need within a certain age ranges. And this is exactly the shape that that mask needs to be or the nasal prongs. We're going to publish that and make it open source so that all industry partners are able to use this and start making us a mask. This isn't something that can be patentable, but we just need them to have the information to do better. The other thing that is done predominantly at a colleague of mine, Rob DeBlasi at Seattle Children's Hospital, he is the one who does this much better than I do. In fact, I use his models because to do it all over again at our center, it's just time and cost prohibitive. So doing rapid prototyping of non-invasive masks, occlusive prongs, headgear, we're currently trying to do that with an SBIR grant so that we can do our individualized for kids with abnormal facial structures, particularly as they're going through all their surgical repairs. A vast majority of them we know now have obstructive sleep apnea. So needing to fit them with non-invasive masks while they're going through their surgical corrections is really important. But even with what we have available and what we're trying to do, we really need that individualized, let's do a surface scan, let's print it for them, and then let them use it. There's a lot of FDA regulation that's kind of getting in the way of that one that we're trying to barrel through, but we're working on that. And then creating accurate models of the airway so that we can do a lot of the testing for air slice therapeutics, as well as just what's the function of how a lot of our machines work in the airflow. So this is one of the models that Rob DeBlasi uses. And you can see here, if you're delivering through nasal prongs an aerosolized medication in a child that's lying down, you may or may not be able to see that. But all of the fluid is collecting in their airway. It's not actually going down. So that's a challenge, because none of these devices are FDA approved to nebulize through medication and go through all of the circuitry. So their particles change size, and it layers out. So you're not getting a whole lot of the medication. So a lot of the work that he has done with a lot of the 3D printing of different devices, which you can see all the different size airway models and faces that he uses in a lot of his testing here, to really get a good idea as to where the aerosols are raining out, because we know they're not getting down to the lung with testing that we've done prior. So he's kind of taken it up another notch in his testing to really help us figure out, this is the best way to do it. And here's a couple other of the airway models that he's done with getting those really good realistic models. In the early stage when we were doing aerosolized bench testing, we just used the CPR dummies, but that's not a realistic airway model. It doesn't have all the curves. So he's been doing a lot of really great work on a lot of that. And then for this one, even seeing what rains out on the face. So here's the differences. You can see all the debris that's stuck within the eyes and on the face, and this is with giving an MDI through a mask. So even when we're doing MDIs with a holding chamber on the mask, a lot of it still just sticks to the face and isn't getting all the way through there. So it's interesting seeing how a lot of this kind of falls out. So in conclusion here, 3D technology and access has greatly improved our ability to test devices, and now hopefully being able to make better devices, and using pediatric device development for accuracy of bench testing, and hopefully soon rapid prototyping of our products so that we can get the devices that we need in the right sizes for our patients. And my email there if there are questions, or I guess if we're able to take a couple now. Thank you.

3D imaging

3D printing

pediatric medical devices

Pediatric Device Consortia

collaboration