Pediatric Innovation and Patient Advocacy: Leadership Lessons from Neal Piper

Ty Hagler: Hello, Neal. And welcome to the medDesign podcast.

Neal Piper: nice to be here. Thanks for having me.

Ty Hagler: Neal, I know you and I have had conversations over the years, of course, but, maybe if you could, for our listeners, let's start with having you tell us about your family, especially your son, Noah, and the struggle that you've had with tube feeding.

Neal Piper: Yeah, thanks for having me today. back in 2019, my wife and I live here in Charlottesville, Virginia. and we started noticing our son. he was choking on his saliva and food and, went, to University of Virginia Children's Hospital and learned that he had a tumor in, the base of his skull. And suddenly our entire world was turned upside down, and, we got the news. It's almost Charlie Brown episode where someone's talking, the teacher, but. everything's mumbled, right? And, we, had a, two year journey, getting, chemo with our son, and, as a result of his, disease state, he ended up needing to be fed, directly to a stomach with, internal nutrition or, tube feeding, which is a, type of therapy where, you come home with, pump, head space or gravity, feed, a, bag you replace every 24 hours.

You fill that bag up with, enteral formula. It looks like Ensure, Push that and deliver it right to the stomach. And then you sit and wait, we were tethered, in our family, specifically to, to an I. V. poll. That was what worked well for us. And, over 12 hours a day, just sitting on the couch, no data tracking and, and it was just a really difficult, part of getting him better.

luckily for us today, Noah's healthy and strong as a. a kid in third grade, he's got a scar from where his port was and his gastrostomy, but overall it's doing really amazing. And we're so grateful for this life sustaining support and this nutrition he had during that time.

But, for, us as a family really struggled with. current standard of care and, now over the past five years, dedicated my life to helping, over 3 million people around the world that need this type of therapy.

Ty Hagler: Okay.

So could you maybe then that moment when you went from, like going through this traumatic experience and then. Understanding and recognizing you needed to start your company. Cause that's, a big, not everybody makes that comes to that conclusion going through this experience.

Neal Piper: I think with, each day we were at UVA, children's, about the 5 days a week getting chemo I think I was just trying to control the controllables, right? what can I focus on in this moment? while. We're going through this experience, and I couldn't quit thinking about the problems associated with the current technology. is an amino copper miles, the last thing you want anyone with any chronic disease state, whether it's cancer, neurological disorder is to, be malnourished because. someone that's malnourished, and, re admitted, they have a 5X, increase of, mortality. In fact, 20 percent of people that die of cancer die from malnutrition, not of the disease itself.

And, was just struck by the fact that, we, we've got decades old technology that we're handwriting logs and when we last fed versus when grandma and grandpa and a nurse fed and, we're tethered to a pole all day in a sedentary way. and there was no personalized approach to ensuring he's on the right macro micro nutrients, for his specific disease state.

we were given more of a sugary formula. and, the zero value of, that sugar content for his specific needs. And so just really struck by how fragmented the technology, on the market was today. And I spent about a decade at Pfizer and then, healthcare products, both in the U S and about 18 countries across Africa and Asia.

And, and, because of that Pfizer experience. I was able to really dive in on clinical research and better understand the market size, the, the current state and standard of care and to be able to use what I learned to be able to interview providers that were there with me to better understand, why this technology is the way it is today.

And yeah, I was, doing that, throughout the week and then. A friend of ours, runs Cville Biohub here in Charlottesville, which brings together the, MedDevice biotech ecosystem. And, yeah, I didn't really know where to start at that point. And she helped invite me into the network and, introduce us to some IP lawyers and to, ultimately into some, engineers.

and then, yeah, I was running a family office startup at the time. and, and, was fortunate to, have access to folks and, my, my network, to have access to capital. And so learning that, there was a huge need. And then, I remember it was, March of 2020, right after the pandemic started. And we're trying to think of a name that was a first step, right? and when Noah rang the bell at UVA Children's, there's a, painting like a rocket ship, on the, oncology floor. And we talked a lot about space, and so I merged Noah's name with, lumination, the measure of light between objects, to make Luminoah to create a brighter future for people that need internal nutrition. and, And the domain name was available, which is great, right? So I was like, the name of the company. So my wife and I agreed. And, and, then. from there, we were off to the races.

Ty Hagler: , you mentioned you have access to maybe family offices and your personal network. And of course the Pfizer background, but maybe could you talk to us about fundraising because it sounds like you've been successful with working with angels and family offices and VCs.

Neal Piper: So I, started with kind of a personal investment. So we, family and friends, and then, raise the seed round, in 2021 and, that brought together, a family office, institutional, venture capital firm and, individual angel that came in on that round and, in the early days, when you have, an early day, product, at the beginning, typically, as many of your listeners know, is, you're focused on, proving out, right?

It, what is current problem that you're trying to solve? And typically people are experiencing something firsthand, whether you're a at a hospital and, or an entrepreneur or, a parent like us and you see a need and many of us see needs all the time, but they become passing thoughts, right?

But there's something that then drives a passion to better the problem. And I think that's the number 1 thing, especially in that family and friends stage, is, understanding the problem, up with some ideas on a solution to that problem. But then, understanding the market size, is this a large enough market that. capitalize now, and build something, are we going to build a, a 10X plus multiplier, downstream for, which will ultimately become your partners and building a great company. And in the early stage, it's important to really prove out the five P's. And, I always, think about, proving out in a capital efficient way, the areas of the business early on, and then you're going to ultimately need to add additional and larger amounts of capital to those areas later. but the five P's are really first understand the problem and then. Your solution to that problem. interviewing, users or, providers and ultimately purchasers of that product, because, although the end user, really important to, get good product market fit. Ultimately you got to sell into some channel, whether it's a whole medical equipment channel or DME or hospital or direct to a provider, right?

So really understanding fully, who is your customer and then patenting around your technology, make sure you have a good, I, P firm, good general counsel. It's making sure to get the business set up appropriately and then understanding the regulatory pathway. Because if you're a class 2 class, 1 or 3, that it's a very different capital stack, for, getting, to market, and then developing a robust plan around a product plan and then a commercialization plan, and, really understanding how you're going to, enter the market, who the key players are, more, most importantly, in those early stage, especially in the angel is, who's running the business, what's their experience.

They exited a company in the past. or, what's their experience that they bring into this organization that as a first time founder can, have demonstrated leadership skills so that, if you're giving them an investment that they're going to return that investment, 10 X plus, right? and that they're driving value and we, many of us have bracelets to say, add value because, one of my mentors. Rick goings went once said it's like you're going to spend a dollar. You need to add a dollar to 10 in value, right? Because that's the expected multiple. And so don't waste a dollar on. The wrong things and early on, can use your big, firms, and in those early stage and your burn rate goes up. It's really important to know that you're partnering with, contractors and we work with trig early on, our design phase and. And that was really critical because we went through, probably 50 plus iterations, the designs of what the product could look like more than industrial design. And it really helped us better understand and dial in, what our users are really looking for. And so making sure you find the

Early on and pressure test those five piece.

Ty Hagler: And just for that part of that industrial design process is, being capital efficient there. And we like to talk about cost per lesson learned. Is that for each one of those concepts we played with, our cost for each one of those was relatively low compared to doing a full prototype build on each of them.

And so we were able to reduce risk by doing, by having a high rate of a test and then go back and talk to the stakeholders and validate whether or not the solution meets the use case. So yeah,

Neal Piper: Because as you start moving down that process, 3D printed prototypes to injection molded, those changes become incrementally, and much, much larger capital outlay expenditure.

Ty Hagler: right. Yeah. And you touched on a number of different things. Did you ever, from a funding standpoint, did you ever get any kind of non dilutive grant funding or was it all a private investment?

Neal Piper: fortunate to get about a million dollars in non diluted funding, for those in the pediatric, space, there's a, P FDA, grant that's available. Many, children's hospitals are associated with this program, Children's National, Texas Children's, LA Children's, SWPDC, CTIP, they're fantastic grants and, not only do you get, diluted funding, but you get medical experts that support you, regulatory support, and, I was just in New York yesterday with some of these, hospitals and. folks, a part of the program, and, grants are really critical early on. there's NSF, there's NIH grants. those tend to be, longer duration. You need a P. I. typically a P. H. D. that can help submit those longer, timelines as a Virginia callous grant in the state of Virginia.

That's, Fantastic bringing together multiple universities. and then each state tends to have a grant. for instance, in the state of Virginia and the Commonwealth, we have a grant that provides support. but, each state, on what state, folks are in can provide a lot of support early stage, which is really critical when you're refining, improving out a concept before you get into. More of the institutional dollars and angel funding.

Ty Hagler: Was anything from your Pfizer training or leadership group? like you'd mentioned earlier that as investors are looking to, look to that leader for a startup, but was that something you would point back to for, like being able to make sure if you were given a dollar, you were.

Able to return 10. could you touch on some of that, like some of your background there?

Neal Piper: right out of college, I joined Pfizer's neuroscience division and I carried the bag. I was going to, providers and hospitals, across the state of Georgia, and, I learned a lot about, really understanding the needs of a provider and, The challenges that they're, facing and, how our products would fit into, help helping support them from a pharma pharmaceutical standpoint. And then, later. led a group, of Pfizer alum through a global health fellows program where, we, had 350 Pfizer leaders that were, emerging markets assignments, all around the world. And I ultimately lived in, Southern Africa and Swaziland, now I was in Swatini for, about 6 months.

And then. from that experience went on to Population Service International, the largest, healthcare NGO in the world to help with, HIV and child and maternal health programs and places like Somalia and Nigeria and Nepal and Cambodia and, and through that work, we, were in under resourced environments where, You need to go into a new country for me, you're in the field for, a couple of weeks, seeing the healthcare systems and then running a multi week training and then, providing some ways to better optimize distribution, pricing, go to market strategies and, marketing strategies.

and that was with, with, A very small, amount of resources, doing this. And that, that experience really, taught me to, to one before coming out with, a solution to make sure you're just listening to as many people as you can, and, not just assuming out of the gates that based off of what's happening in one country or in one market is something that will work in another. And that was very humbling experience and in my, 30s earlier on in my career to be able that. and, so I've, brought that back into the work that we do. Also, I learned, I dealt with a lot of challenges working with different, government officials around the world and learn that leadership oftentimes was, the problem, right?

Where, you have broken health systems and, And and that's hard to solve. And so when you're running a startup for anyone that's listening, that's looking, to start a startup, don't go into the journey thinking it's easy. and there's no, no use of telling yourself it's hard each day. Just assume you're signing up to something that's very difficult that no one else has solved. From a technology perspective you're building, will be speed bumps along the way, but just assume that's what you're signing up to. And if you're not ready to sign up for something that's really, difficult, and you can't lean into that, don't do it.

Let someone else take care of the problem. But if you're ready for that, sign up, because it's an incredible journey. but I, learned a lot of skills that ultimately, those skills became muscle memory that I could, overlay into, a lot of resiliency and, driving a vision forward hiring and building a company that can truly transform the lives of millions.

So I feel honored to be a part of that.

Ty Hagler: that's inspiring and incredible. the, working in low resource settings and then moving into a pediatric device market, which itself is a pretty small, like market size. and then to be able to lead effectively into that space, which sounds like a lot of grit and integrity.

that's just, it's really cool what you're doing. I'm so glad that you're on to talk to us about that.

Neal Piper: Thank you.

Ty Hagler: I wanted to maybe also talk about patient advocacy, because I know that you yourself were, advocating on behalf of your son, but then also how you've been able to stay connected to other people in the patient population.

And how, I think maybe some of your ongoing engagement with some of those patients, how could you speak to some of that is like you're making sure you're aligning back to what the overall needs of parents and then their Children, would, have.

Neal Piper: we just use our network of people who had kids that, that were too fed and then meeting with providers and other health care our network to connect us to the other patients. then that network group, Quite significantly over time, we did a pretty large human factor study. and, and then we're a part of only and Aspen, which are 2 patient advocacy and clinical, organizations. And so we're, at those conferences, each year and and so now we, we're connected to, probably hundreds of people that, you know. Are really looking for some new technology and we've been getting feedback, and summative informative feedback, through this process and, and there's times that people when they, are in those settings, that are in tears, 1, when thinking about what, they're struggling with day to day as are managing chronic disease With with just in general, but then as I think about what's possible for them in the future, it's an overwhelming response of how life can change as a result of a modern technology that, really detaches you from clucky. technology that tethers you to, to, your home, to something that fits in your pocket that, can, pump against gravity and, really personalize. Care and provide better outcomes and really enable people to just live their life the best that they can. and and be empowered with their own data and help as a result, improve the outcomes of their disease and shorten the duration of disease. and, And just a whole different way of thinking about life. and to me, that's why we started. And, every single person that we hire, they have to be on that same mission with us. we've, actually never had to use a recruiter to, to bring in a team member. And, oftentimes it's someone that's been impacted with a loved one, whether it's a kid or a parent that, that knows that. That has experienced the pain points that we experience that has engineering or commercial expertise for someone that came and pioneered the artificial pancreas, insulin delivery space that wants to do that in a similar therapeutic or a different therapeutic class. But to us, what I'm most excited about is the day that, we're FDA cleared, and we finally get to see a child or a mother or a grandparent, our device and, the impact that it has on them.

Ty Hagler: You were talking, touching on the human factor studies that you were doing as part of your FDA submission and, as much as that is a requirement, I think the effort you went through in the stories that you gathered as a result of making sure it's safe and effective for use.

that to me is there's so much value add from that requirement in the process, it seems like just, making sure you get those stories and making sure you've like really added value for everybody.

Neal Piper: You learn a lot. the more you can talk to, In users, right? In general, we do it one because we love it. And two, though, as you're refining your product, making sure that truly listening and specifically engineers, can you're getting focused on, a product through, the development process and it could, be easy to try to just move that process forward.

But more that as an engineer or an entrepreneur, anyone in that development cycle, that product management cycle can just continue to listen and refine. the, better product market fit that you'll have and the better outcomes because that's. That's why you're there. I remember, we're all here because we want to improve lives. And that's a great thing about healthcare as an entrepreneur. And as you're getting into transform a technology, you get the wake up every day. building something that's going to change the lives of people.

Ty Hagler: Yeah, it's such a privilege to get to work in this space. So very cool and very inspiring.

so I wanted to touch on just maybe some books that you've been reading recently that have inspired you. You've gone to for wisdom. Is there any recommendations you might have?

Neal Piper: we do, we have a book club at our, company and, share different titles, read and talk about it. And, one, one we wrote, read recently was the Ideal Team Player. and, it's about, who is the ideal, Person to work with in a company when you're building, and it talks a lot about finding people that are humble, hungry and smart. So humble, meaning, you're bringing some of the. The best thought leaders and the best engineers and quality leaders in the space to build your company and, you don't want anyone with an ego. that you want people that are. Lifelong learners that, don't know everything and they bring a lot of expertise, but are open the new ideas.

people that are hungry. They're waking up each day thinking about, solving this problem that are able to do that with some autonomy and just get stuff done. and, And then you want people that are really smart, and you would think that just, IQ, but EQ as well. they're, best in class as it relates to their technical function, but they have good people skills and just, going to build a culture, right? Because like, when you move from, Employee 1 to 2 to 10 to 50 to 100, culture continues to change and shape. And something I'm proud of is that we've got, a startup looking vibe and culture in our, office.

Or we've got this living room setting where people at lunch are naturally gathering and, they're talking about. Life, but also just brainstorming ideas on some, different products and they are, what, they're, solving that day. and then we've got a, a manufacturing facility and R and D, all in the same building. but, without finding the right people that have these. qualities of humble, hungry, smart, really changes the dynamics. And so got our values are published on our website. when people join the company, as part of the interview process, they, we're. Assessing these values just as much as we're accessing their technical expertise. And, I, interview every hire as the last interview. Assume they've got through the technical stuff all the time. I'm doing the interview, but I'm really assessing cultural fit at that point. I've done that Every hire will continue through higher 50 higher 100 as we, we grow and scale.

Ty Hagler: That’s phenomenal. I love that. I’ll definitely have to check out the book. Okay. So, you're doing your own manufacturing. I didn't want to let that slide, which that's unique also from a startup standpoint, could you touch on that? Cause that's a huge decision.

Neal Piper: We brought a lot of people in from diabetes care space that transformed that industry and got a lot of expertise of building up manufacturing, getting into automation at scale. and our durable pump. We’re building here in Charlottesville, Virginia, at our manufacturing site here. And, and we've got, manufacturing engineer, we've got a VP of operations, we're hiring technicians after, here soon. But we want the pump to be close to us, where our engineers are, because as our pump is launched, continue to, and continue to evolve, continue to, the technology and, and we want to be able to do, have, good control. We also want some supply chain resiliency and, we're selling in the U. S. We want to build here in the U. S. And you see some of the supply chain disruptions have happened, just even recently and in the U. S. and then, we're going to, do some near shore manufacturing with our daily administration sets because the volume at scale gets pretty large.

And, because the daily use, set and but, supply chain is important. You've got patients that are depending on, they're, nutrients and, we want to make sure we're, thoughtful of how we're developing out the supply chain, as we grow and scale.

Ty Hagler: That's incredibly unique and forward thinking. there's definitely a on shoring, near shoring trend that's been, we've been seeing it since COVID. And, it seems like you guys are on the leading edge there bringing manufacturing, and just starting with that in mind, which is really unique because, as I'm sure hardware is hard and, getting all of this right.

I think bringing that in-house is really smart. I just couldn't let that one go. It’s so cool.

Neal Piper: We, we apparently like hard stuff. We’ve got hardware board software, and mobile cloud analytics. And, so it's, but. great when you can build a team that's got expertise in all these areas and see that come together. It's exciting.

Ty Hagler: Really exciting and really cool to hear what you've been working on.

Neal, what's the best way for our listeners to connect with you and maybe support your work with Luminoah

Neal Piper: so welcome to message or connect with me on LinkedIn. You can follow our website at luminoah.com. I think those are probably the 2 best ways to connect. We've got a newsletter that you could subscribe to, and, but, anyone out there is, Connected at any point. Feel free to reach out to me.

Ty Hagler: That’s wonderful. Neal, thanks so much for taking time to hop on the podcast and talk to me here today.

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