Are We Underestimating the Impact of Emerging Infectious Diseases?

[00:00:00] Jared: Hello everyone and welcome to the medDesign podcast. Today we're thrilled to have with us Amanda Elam. Amanda is the CEO and co founder of Galaxy Diagnostics, a cutting edge medical diagnostics company based in RTP, North Carolina. She's been at the forefront of developing revolutionary testing solutions for flea and tick borne diseases which are becoming increasingly prevalent and pose significant public health challenges.

With a background in organizational sociology, Amanda's journey into the world of healthcare innovation is both unique and inspiring. She's also a research fellow at Babson College's Diana International Research Institute, where she focuses on entrepreneurship and gender dynamics, contributing valuable insights into the academic community.

Amanda's entrepreneurial spirit is evident in her work at Galaxy Diagnostics, where she's overcome numerous challenges to bring groundbreaking diagnostic solutions to market. Her leadership and vision have been instrumental in advancing the field of emerging infectious diseases. Today, we will delve into Amanda's journey, explore the innovations at Galaxy Diagnostics, discuss the rising concern of flea and tick borne diseases and hear how her personal experiences have influenced her support for maternal care innovations like the Couplet Care Bassinet.

So welcome, Amanda. We're happy to have you on the show today.

[00:01:11] Amanda: Pleasure to be here. Thank you.

[00:01:13] Jared: Perfect. And getting started off, very curious about what drives your work today. What drives your passion for the work that you do?

[00:01:20] Amanda: I think making a difference. Honestly with all the challenges that it really takes to start and grow a start up a company in health care.

It's the patient stories that keep me going especially the successes, right? Gives us hope and keeps us going. And I would say the same thing in my research. It's really the entrepreneurs that inspire.

[00:01:40] Jared: And so sociology as a background of research. So you have a PhD, I believe, in sociology and I only have an undergrad degree, but that was one of my favorite courses to study.

It was so fascinating. The study of human behavior at the end of the day Oh my gosh. So how did you get into sociology and how does it influence also the work that you do?

[00:01:59] Amanda: Yeah. Jared, I think we're all sort of students of human society, to some extent or another. And like you I've been fascinated.

And so actually my story really starts with an undergrad. I did a degree at UNC Chapel Hill in international studies. again, fascinated with human society, right? How different cultures, make sense of things and the rules and structures they use to guide their daily practice and organize themselves as systems.

But then of course, I came out of school and it's what am I going to do? Like how do I practice that? And I did a few different things that first year, but ultimately landed at an enterprise software startup in Cary, North Carolina. And that's where I caught the bug for entrepreneurship.

I was with the company for almost five years. And again, this is my early twenties. So I'm starting out as an admin working in HR and then moved to marketing and sales, but I really got to see, starting with a company of 20 people and it grew to over 200 by the time I left.

We were well funded. And it was fascinating to see the way people come together to build a startup. That was one piece of it. What happened internally? And then the other part of it was, how do you get a market to use a product that they don't even think they need? So that's where I fell in love with this process of innovation and early commercialization.

And so after that time, I really just wanted to understand it better. And that's what sent me back to grad school. And I was looking at business, I was looking at psychology and I talked to an old poly sci professor of mine and he said, look at sociology. He said, if I could go back, that's what I would do.

Because he said the theory and the methods were strong. And UNC had, as a top ranked program top five globally. And so I just yeah, so that's what I did. I applied to top programs and places where I could see living and I threw myself into understanding human systems.

[00:03:54] Jared: That's really interesting.

And you also talked about innovation and I feel like a lot of problems with innovation today is that it tends to be not user centered and Ty has a very interesting case study on this, a 500 million loss of a company where they got all the way to the finish line and realized that nobody actually wants this thing that they created and spent all this money on.

And so on your end, how are you able to identify high impact and user centered innovation especially for healthcare.

[00:04:23] Amanda: What a classic business problem, Jared. Professor teaching entrepreneurship and innovation in the classroom. That's a key part of the process. And I think it's captured well in methodologies like the lean startup, right?

The whole idea of agile development and co creating with your market, with your customer base. And I do think in medicine, that's a particular problem. Classically people will come up with drugs or devices and they'll develop them and they'll push them through, to regulatory approval, whether that's in the service side or FDA approval for products.

And they were really won't engage with their market until after they've got a product and they're ready to sell it and they don't understand anything about positioning. They don't necessarily understand whether this is a product that doctors will like or how it will fit in with what they already do.

They don't necessarily understand the patient perspective on it ever like nobody talks to the patient. So at least talk to the doctors. That's customer voice. Typically in medicine. And so I think that there has long now been a movement around, patient centered outcomes research.

So P core and a number of other paradigms that really say, we need to put the patient at the center and I think it goes beyond. The innovation process, right? I think it goes well into the commercialization process when we're looking at insurance. And I think, it doesn't have to be as complicated as everybody makes it.

When I think about galaxy and how I really thought about it, it's like the market, right? What are the 3 reasons people will buy your product? It's quality, it's price, it's convenience. And those are 3 big buckets. There's plenty of detail you can dig into, but if you are at least keeping those 3 criteria in mind, you're of course, you're talking to your market.

Of course, you're talking to your end user, right? Because that's what's going to drive demand and, tell you if you've got a good product market fit.

[00:06:15] Ty: It seems as part of your strategy, you also niched down to some very specific indications as part of exploring the technology and making sure you could serve a very specific quality solution, right?

[00:06:26] Amanda: And that's really interesting in terms of Galaxy's market and story, right? We're spin out from NC State and the first technology that we started with to commercialize was really created because of the organism so elusive, so difficult to detect. So it was a growth medium that would grow up. Bacteria that don't grow well in mammalian cell models.

They're really happy in the guts of fleas or ticks or lice or, different vectors. And so we start with a concept like that. And the answer is these solutions that the sample enrichment, our key differentiator around our technology and solution actually could help infectious disease very broadly.

So why didn't we take it and run with it very broadly? And the answer is because we were trying to solve a particular problem and we've really stayed true to that. From a management sort of philosophy or strategy perspective, you can think of that as blue ocean and red ocean, right? And the red ocean is if we'd taken our technology and gone after competitive markets for so think unculturable bacteria, right?

We could have gone after TB. We could have gone after syphilis. We could have gone after some of these to see if our technology can make a difference. Instead, we focused on our bacteria that really we developed a solution for and that's the blue ocean. Nobody else is doing anything in the space.

And then we built out from there and we know flea tick borne diseases. A lot of these bacteria are neglected, right? Part of neglected tropical medicine. And so we just focused our solutions there, which had pros and cons Ty. Honestly, it's there's no research funding, or we're competing against the COVIDs and Ebola's and Monkey Pox and Zika's of the world.

But at the same time, the patient community was passionate and organizing and the doctors who were willing to be progressive and take some risks and looking at the role. They're very passionate. And then there's a community of scientists in infectious disease and microbiology who are really passionate.

So we really stay true to the science and really true to our market through disease advocacy and supporting and working with those brave clinicians who are really willing to operate at sometimes outside of the guidelines.

[00:08:36] Jared: And I guess also just if you could delve into more about the exact solutions that Galaxy offers and how has this development process been for you over time?

How long has the company been going? And also I think a problem that a lot of startups have is they tend to lose their north star. They see a bright and shiny object over here and they go, Ooh, maybe we should probably do that instead. And you just demonstrated that you stuck with it. And I think that is really challenging for a lot of people to do.

[00:09:06] Amanda: I will say that we have done some pivots, right? When we launched the company out of NC state, we had one test for one bacteria in dogs. We've come a whole long way from where we started. And so staying true to the concept, though, that's what we really remain committed to.

And that's the idea. We have a lot of bacteria that are unculturable. They're highly fastidious. They don't like growing, even on standard plate culture. So there are bacteria, for example. Where you can try to culture them on conventional plate, and it takes 6 to 8 weeks to grow them, and you only get a yield of 1 out of 10, right?

Cultures actually produce an isolate. That's the kind of problem we were going after. And then the organism itself, the pathobiology in the body, very difficult to detect in patient samples, slow growing hides and cells and tissue. It's not bartonella, the cat scratch disease bacteria is where we started, but it's not the only bacteria that is elusive and difficult to detect that way.

And so the concept here for those who are new to this and keep this really simple, but the bottom line is the patient shows up in the doctor's office, and if the doctor is aware and knows to consider, a rare or poorly understood infection, especially in high risk groups.

Populations, right? Like veterinary workers, animal workers, people who live and work with animals or recreate a lot and have high vector exposure context doctors who deal with a lot of patients and high risk before you give them an auto immune diagnosis. You want to make sure that, you've ruled out anything else that might be going on.

That might be easier to treat. And so patient shows up in the doctor's office. The doctor has a high clinical suspicion that infection could be involved. But when you take a sample out to test for one of these slow growing, elusive bacteria, you may only have one or two copies in a tube of blood or in a cup of urine, right?

Whatever your target is. And when we actually test in the lab, we only take a tiny bit out to actually run, proteomics on for urine antigen testing or DNA, RNA testing for a microbe, right? So the concept that we were building on was really what can you do to increase the odds that you're going to capture that bacteria in the test delacroix. And so we started with a growth medium, so called Bartonella Alpha Proteo Growth Medium patented at NC State, and we licensed it out for commercialization. And we use this medium to grow up the bacteria, so we were more likely to capture it out for testing. And that alone could triple the odds of confirming a positive and then we were working with a 2nd technology that actually captures and concentrates proteins. So you might have a cup of urine and only a few targets and the odds of aliquoting at what you need. We could capture concentrate and then test the concentrate and that was a huge leap and sensitivity, right? To be able to do that. And then we started working with a 3rd technology, which is digital PCR.

And the concept here is that you're taking that tiny test aliquot. So looking for microbial DNA and host DNA is like looking for a needle in a haystack. That hay is the host DNA. It's a lot of background noise. So in that test aliquot, instead of testing with one PCR, we take that aliquot, break it down into 10 - 20,000 droplets and one reaction in every droplet.

And that reduces the background noise or increases the signal to noise ratio. And that creates another boost of likelihood of getting a positive result. So today we basically have two prototype assays, a urine antigen test that uses the capture concentrate, and then we have DNA testing and blood.

That looks that uses the grow and the DPCR and we're working with these technologies in clinical samples to see where, where can we get the boost and sensitivity while retaining high specificity. And then more importantly, and this is where we're creating the market.

Because one of our big challenges was we brought a test to market for, a more sense, a better mouse trap for a mouse that nobody knew was important. And so we're using our test to drive discovery around the links between infection with these elusive bacteria. And different disease states.

So we're thinking neurologic, neuropsychiatric disease, heart disease, rheumatologic disease. And again, back to the doctor's office, before a doctor is going to, diagnose you with an autoimmune disease where the first course of treatment's usually aggressive immune suppression to get your immune system to back off.

Wouldn't you like to know if you have an infection first? And you can think about all the Humira and Embryol commercials where they're like, if you have TB or another infection, this medication may not be suitable for you. Please talk to your doctor. We're in that other infection category. Here's the thing, doctors don't know what those are, right?

And so that was our big market challenge. So we've used our tests to basically establish those key disease associations and really drive research into discovery. And I'm getting chatty here, but I'll tell you, we had one big study just come out from NC State and Columbia that showed 43 percent of psychosis patients.

So schizophrenia patients were bacteremic for Bartonella

[00:14:19] Ty: really?

[00:14:21] Amanda: That's significant compared to controls and the really important finding there was that the disease correlates with act with the bacteremia, the evidence of DNA and blood, not with the presence of antibodies.

[00:14:34] Ty: Whoa,

[00:14:35] Amanda: right? And so this goes and again, Bartonella's cat scratch disease and other Bartonella infections, but Lyme disease is very similar.

It presents in similar ways. The bacteria also elusive, leave the blood pretty quickly hide and tissue and cells. And we have a whole handful of bacteria we don't know a lot about.

And they seem to be linked to these mysterious chronic syndromes. They're probably bacteria we collect over the course of our life. And then under the right circumstances, they go sideways, like a car accident, a divorce, a loss of some kind of trauma, and all of a sudden, you or your maybe you get COVID it and you don't recover, right?

It's what else was going on in your system that might contribute to that. And so that's is a whole new frontier of medicine, right? Infection associated chronic illness is the term of art right now. National Academy of Sciences had a big workshop on it last year. So that's the world that we're innovating in and we're trying to advance understandings.

It's huge.

[00:15:36] Jared: And thanks for sharing that finding with us. That was really fascinating. I'll have to share that with my family because we have schizophrenia and some parts of our family. And something I also was curious about is just from an entrepreneurial perspective, you talked about how challenging this was.

I'm curious of how did you get, stay funded for, you said funding is hard to find. How did you initially fund it? Yeah. Man, just what are some of the major entrepreneurial sort of challenges you've had to overcome along the way?

[00:16:00] Amanda: Because we started with Bartonella and not Lyme disease had a little bit of funding earmarked, and the government had some foundations, but we had nothing.

We went to NIH predictably right? We got the first non HIV funded grant for Bartonella out of the NIH, which is fantastic to support development of our enrichment approach. And just background, Bartonello was actually discovered around 1990 in North America and HIV patients.

In other words, this is an infection the patients had before they became infected with the virus and immunocompromised, and it was, it's an opportunistic infection. So it caused all sorts of problems, including tumor growth, right? So it's an oncogenesis candidate. And and so that was a big deal to get the first non HIV as grant from NIH for Bartonella.

We had a lot of corporate sponsorship, right? So we had Bayer Animal Health come in. IDEX was a big partner as sponsor early on as well. And then most importantly, we were selling right from the get go, right? So the test that we spun out of the university, we were selling to veterinary clinics and veterinary medical.

So Hospitals around the country and internationally right from the get go. And then, the first thing we did, because these are infections we share with our pets, the zoonotic vector borne infections with our cats and dogs and other animals we care for and live with. And the very first thing we did was start looking at the implications for human health.

And we did that first through research. And that's where a lot of our sponsorship was focusing, especially in high risk groups. And then we set up, a CLIA lab, so CLIA regulates lab services, and we started making the testing available, validated with research support available to clinicians.

And we started working really closely then with the doctors who were interested in whether, there's this emerging concept of root cause medicine, right? And functional medicine. So we were working with doctors who were really interested in that concept. And then we got connected with the Lyme and tick borne community, because these bacteria are also in ticks.

They're considered tick transmitted Bartonella in Europe, but not in the U. S. And then, of course, the Lyme community says, can you do more than Bartonella? We have the same problems with the bacteria that we're struggling with. So looking at Borrelia, Species bacteria looking at Babesia species, which is a protozoal infection that's rapidly emerging and, and then looking at rickettsial infections to think Rocky Mountain spotted fever, but there are a lot of relapsing fever rickettsias that are in fleas and ticks that doctors don't know to consider. Ehrlichiosis, right?

Very prevalent in the ticks that we have, especially the lone star ticks we have in North Carolina. And anaplasmosis and, there are a number of other infections that ticks are considered, nature's dirty needle, they tend to transmit polymicrobial infections or cocktails of of germs.

And so we got connected with the tick borne and so we expanded our mission. We start looking at another and trying to figure out what technologies would really work. Working with other university partners, innovating, we've built a really good commercialization platform. So now we have a lot of teams who don't want to spin companies out of their universities, in addition to their daytime jobs.

So they're actually coming to us to partner.

[00:19:10] Jared: Yeah, to me. It's 1 of the scarier things because it seems like. It's not something that you necessarily did anything wrong in order to get, you didn't treat your body badly like you were outside maybe at the wrong moment, or, like you said, got scratched by, an animal.

And I remember we, when I was a kid, we adopt, we adopted our childhood cat and the lady that we adopted it from, the breeder, she had Lyme disease. And I remember there was days where she was just feeling too badly to not even, take appointments.

And you just talked about that, people like her were more so I guess I am curious of just what's the prevalence of these sorts of illnesses. Is it something that is rising over time? Is it something that is just always is around at a certain level of the population?

[00:19:52] Amanda: Both.

[00:19:55] Jared: Oh,

[00:19:55] Amanda: right. So it's been with us for a long time. These are not new organisms. We've co evolved to some extent, or they've been present in the world with us for a long time. But we are in a discovery process around them. For example, we knew what the cat scratch disease was for a long time before we figured out what the organism was.

Lyme disease was a different story discovered in 1977. In Lyme, Connecticut. A lot of people say limes. Yeah. It's not lime. It's literally named after, a city in Connecticut, where they had a cluster of juvenile rheumatoid arthritis cases present. And Jared, that really speaks to the story, right?

This idea that these are very elusive infections, the acute version of infection with cat scratch disease or with Lyme disease. And we're talking about, just one or a few species of each bacteria linked to these disease states really are like a summer flu or a cold. You just feel crappy.

You might have a low grade fever. You might have some spikes, but it's a relapsing fever. You might have swollen lymph nodes, aches and pains, a headache, stiff neck. And, and it might persist for a long time. So I think, I know I've had summer colds where it's just three weeks in the middle of the summer, you're just dragging, right?

Never occurred. I'm a backpacker, a paddler, a camper my entire life. I grew up in Canada. Outdoors was a big part of our culture and it never occurred to me that those could be linked to any, grew up with animals. We had fleas, honestly, where the constant battles, especially after we moved to North Carolina.

And ticks were just a thing they were nasty little bugs, but you didn't panic if one bit you, right? And you didn't associate that vector contact and exposure to fleas or lice at school or, ticks out in the woods. You didn't associate that with a summer flu. So I think a lot of people just dismiss that.

And then the symptoms go away. So medicine calls itself limiting. And then later, if it's untreated, it can present as a heart problem or as arthritis, or maybe a fibromyalgia, chronic fatigue, like just can't kind of function neurologic or neuropsychiatric disease can also be an outcome of untreated infection.

Where the world we're living in is a lot of people are treated, but they fail therapy because we have these really short bursts of treatment and we don't know whether those people become sick. So think long COVID if it's because the infection is persisting. Or if it's because there's some sort of immune dysregulation or their body just can't recover.

And I think to some extent, that's a normal experience after think through flu and cold, sometimes you have the flu, it still takes you, two to four weeks to get back a hundred percent. But some people after a year, they're still not better. They

[00:22:47] Jared: literally become

[00:22:47] Amanda: disabled by.

By, what should be a routine and even with antibiotic therapy, they may not recover. And that's that sort of world of what role is infection playing and the cause of chronic illness, how much of it is about the presence of the organism, right? The persistent infection, how much of it is where undiagnosed infection and how much of it is about the immune system or, genetic susceptibility or individual characteristics that may be contributing to poor recovery.

[00:23:16] Ty: Yeah, I know we've talked about this that I've got a family member who had been diagnosed with ehrlichiosis and had presented at the emergency room and it was a gut hunch on the ER doc who said, you know what? I don't know. I'm not gonna get the test results back for several weeks.

Let's go ahead and get you started on a round of antibiotics. And I think it was only through, I think some of the indirect education you've been doing around this community that family member was able to get treatment faster. So it's just, I think it's raising awareness on this, but also just the mysteries of the kind of the microbial world that's just invisible to us and how hidden it can be from us.

It's definitely a challenging vector to really work with.

[00:23:59] Amanda: It really is. And we're looking at multiple infections. Some of the, like what's coming out of the science, it's really exciting to me. I think there's two key streams. One is really, this concept of polymicrobial infection or the patho biome, a lot of work in sepsis around this, right?

You guys remember probably you're both old enough to remember when leaky gut first was being thrown around. A lot of science has come out to show that literally, microbes leak out of our gut when we're under stress, the mucosal lining will thin and disappear. And so our research has supported that, right?

With our media, BAPT GM media, we've done. Basically that looked at the microbiome in blood of sick people and sick dogs and similar profiles. They have a lot of things in their blood. So his blood really sterile is, the 1st thought that came out of those results. And then after it, it was like, okay, of all this stuff we've identified all the DNA for these different organisms.

We've identified what's pathogenic. What's naturally should be there and there's an exploding world of microbiome studies trying to figure out, and you guys have heard that story, right? There are more, we have more microbial cells in our bodies than we do our own cells, and that, they're commensal, and they actually help our body function.

We rely on those bacteria in order to, those microbes in order to function. And so that's where that pathobiome concept comes from, right? Because even in a healthy state in homeostasis, we're still going to be carrying some pathogens in our body and we can live comfortably with them. So think helicobacter pylori or C. diff in the gut, right? A lot of people are naturally colonized with this. Think about strep. A lot of people think when you're treated for strep throat, the strep goes away, but it's literally, you're, they're in your body now. When you get a cold, your immune functions, suppressed and you get overgrowth.

And this is true for, so how do we maintain that balance? The second stream of research that's really exciting to me is the, so we think in infectious disease about bug and terrain. So it's the terrain piece, right? It's about the host body and what does it need for, I always think about it what do we, what does the machine need to stay in optimal function, right?

We got to sleep, we got to eat, we got to exercise, literally exercises, how our body cleans crap out, out of our joints, out of our, the different read gets our circulation gets going and we're flushing flushing. If you love exercise, then you'll know, if you don't get around to it for six weeks, the first time you exercise, you feel crappy for a day.

Some people say that about massage too. It's the, you feel crappy the, if you haven't done it in a while. And again, it's what do we need to do to keep our body healthy? What do we need to be eating? What do we need to? And so I think there's an exciting area of research coming out there too, that's really looking at cellular function.

And what do our cells need in order to be able to clean themselves out? And, in the context of healthy aging, not persist, die when they need to die, turn over what does our body need to generate the new cells that keep us going? So I think that in this infection associated chronic illness world, that these are 2 streams of research that I think are going to be really important to helping us understand that nexus between infection and host response, right?

[00:27:15] Jared: That's really interesting. I was listening to a podcast with Mark Zuckerberg and his wife, and she's a researcher in this field, and so they were talking about how one of the next big I guess advancements is going to be once we start to understand the cell better, because apparently, we don't understand it as well as we thought we did, or as well as they teach it to you in the school.

Anyways, when you're taking bio in school, and And we

[00:27:37] Amanda: don't understand even the individual variation and function. So I have a colleague at Tulane University Dr. Monica Embers, who runs the state-of-the-art primate model. And she's looking at brilliant infections, so Lyme disease and looking at Bartonella infection cat scratch disease, and her primate model.

And, with Borrelia, she managed to document like six or eight different antibody responses. So when she infects the monkeys with the bacteria, what are the different ways they respond? And some of them have very vigorous antibody responses. And some of them have no antibody response. And some of them have different patterns if they do respond.

And that all contributes again to the terrain part of the story, right? How and what individual differences are. But in medicine, we develop one protocol for everybody. And if you don't fit in, 1 or 2 standard deviations from the mean, you're out of luck. And that's where a lot of innovation comes is it really comes at the extremes.

Yeah, and then we can get into the whole story about the institutional, institutionalization and bureaucratization and medicine and how that's actually working against innovation and discovery and actually really harming patients because we're stuck in the status quo.

And even when we have better knowledge, we don't have systems or ways to absorb it into clinical practice with any kind of rapidity.

[00:28:57] Jared: Could you dive into that a bit more? Cause I really wanted to talk about your research in gender and entrepreneurship, but you brought up a real interesting point.

I just read a book from Dr. Peter Attiya that Ty actually put me on to Outlive. And he talks about early in the book that he basically figured out a way to somebody was dying of like sepsis and he figured out a better way to administer the medication that was more unique to them.

That was not necessarily part of the way it was supposed to be done part of the SOP, but he just noticed that for this unique patient set of factors that this would probably work better for them. And he got reprimanded for it and just dragged through the mud. Okay. And and that patient ended up having, after they put him back on the SOP, he ended up having he ended up passing away from the SOP style of treatment.

And so can you delve into that a little bit? Because I think that's a really interesting side of the story.

[00:29:51] Amanda: There we get into the systems of medicine and what are all the hoops you have to go through to support any new intervention, or new diagnostic. With levels of evidence and then other hoops, you have to go through to get it legitimized and priced and, reimbursed in medicine, which is a lot of our medical system in the U. S. is in the marketplace, right? It's decentralized, and that makes it more political in a lot of ways, but the bottom line is that over time. The standards of evidence and medicine have gone up and up. And so the studies that actually make it into medical guidelines, which are supposed to be guidelines like to support doctors in the practice and practicing the art of medicine, right?

Helping deliver individualized care, personalized care to the person in front of them. But guidelines are really about, convergence towards the mean. It's about ideal typing, picking like do you fit in one of these boxes? And if you don't, you're going to fall through the cracks of the system.

And now doctors don't want that to happen typically. And so I would say one of it's the rising standards of evidence. It's really the prospective double blind, five year longitudinal studies, that level of evidence. So if you've got something that's a rare disease, or a small market or something really new in a place where you're competing against more urgent or what are considered deemed to be bigger problems, then you don't go anywhere. There are no resources to help you meet those rising standards. And to put that in context back in the day, and the way medical education still works is really based on case research. It's about what's possible. What goes into medical guidelines is what's probable, right?

And so doctors are somewhat limited by these protocols. They're also occupationally, you understand that administrators have really taken over medicine. So doctors have very little time to spend, the insurance companies, they only reimbursed, for certain types of things. And so there's all this pressure with the way the money systems work the way administrative systems are trying to maximize the value that they get out of every clinician.

It's really not good for the patient. It's not good for the clinician. The clinician doesn't have any time to troubleshoot or look anywhere beyond the guidelines. And for example, in our research through the IRB study at NC State led by Dr. Bright Schwartz and Dr. Riccardo Maggi, my co founders, those patients, before they even get to the possibility that infection could be contributing to their illness.

They've seen 7, 15, 20 doctors. They're literally getting referred because they don't fit into a box and none of the doctors have the time or want to risk the liability of operating outside the guidelines. Guidelines are exercised too often now as a rule book, right? Not as supportive guidance for physicians to help them figure it out, but literally a rule book where you have to follow if anything that operates out that should go, for example, to a specialist at a top medical center, what's the most expensive place you can go to find care, a top medical center.

Right? And so we just, there's so much more to it, Jared, but that's a good example of how convoluted and challenging and anyone who wants to innovate, okay in this space has to go through these hoops first, the standards of evidence, then they have to, when I first started, someone said if you're innovating in medicine, all you need is that one study published in the New England Journal of Medicine or nature and your gold, right?

That is not true. All the team might not only at my company, but all the other teams I'm working with. The answer is you need multiple publications and top journals. You need to really vet it. You're still going to have people who don't believe, what you've got is working the way it has, or they'll split hairs and focus on, concerns that maybe aren't that relevant to what you're actually delivering and with your innovation it's very fractious.

It's medicines, very siloed. It's very political. I had a doctor one time asked me why are doctors so mean to each other? That's the world where that's our market. And again, putting the patient first in the context of that market is leading to a lot of the emerging trends that we're seeing in the marketplace right now, and these are the trends that the FDA is freaking out about. And I'm not saying that all the innovations out there are good innovations, and I'm absolutely aware that patients and even doctors are not well equipped to navigate the medical innovations that are coming out now.

You can think of the complexity and diagnostics for example, around genomics and what's the meaning of a test result and how are people actioning it or the complexity of bioinformatics and algorithms that are driving a lot of the testing these days, it's all well above, never mind.

We're getting into proteomics and metabolomics and a lot of the complexities of multiplex testing. And it is above the heads of most of us, right? And so regulatory is really concerned about it at the same time, the patients are speaking. They want to be able to order their own tests. They want to be able to monitor.

They don't want to have to go to their doc. They don't want to have to convince their doctor. That, and you hear it all the time, patients know more about their illness than their, than any of their physicians. And so you have patients who are putting two to two together and they're finding things that work, but the doctor doesn't want them to continue doing that.

I think about a lot of herbal therapies and supplements can help patients. And then regulatory's worried about the harms and the con, the self-harm, the concerns, you know of what's the patient gonna do with that test result. What wild things are doctors practicing on patients and there is some of that crazy out there, right?

Innovation is always a Wild West, but I'm not sure that the brilliant innovations were really emerged as effectively if it wasn't, if we didn't have a little bit of risk and uncertainty, because I think that's where some of the best ideas come out, crowdsourced. And so it's really challenging, right?

Can't save everybody, but you also aren't going to get really good ideas if you don't let people run with them. Yeah.

[00:36:01] Jared: And I think, you can, you maybe but you can make their lives better, make their experience better. And that kind of brings me to innovation that we're supporting the Couplet Care bassinet.

And I am curious of just how did you actually find out about Couplet Care and how did you meet Stacey McEntyre CEO, or did you meet Dr. Kristen Tully the inventor. And just how did you yeah. How did you discover them?

[00:36:25] Amanda: Yeah. So I actually met the CEO, Stacey McEntyre at VentureConnect.

So the CED pitch competition right here in Raleigh. And I saw her pitch. We had a lot of friends in common, including Ty but I first I saw her pitch and her pitch blew me away because it really touched me. And I recognize that not everyone goes through the problem that she's trying to solve.

That high risk population. But I did, I had a really challenging time. Especially with my first delivery in the hospital. Had a complication. A lot of blood loss, it was very difficult for me to move in and around my hospital room. And so the Couplet Care solution, that idea of having a bassinet, that you could pull right over the bed, there was just a really struck me as an important solution to get out there.

And it was really funny, too. I heard Stacy's story. Then I found, it was only after that I found out Ty was involved in Couplet Care and around the design. And we had some great conversations at Venture Connect around what they were doing and why it was important. And I'm sure, Ty will speak to it.

I might have been a little over enthusiastic. Do you know how important what you're doing is? Because again, I lived it. And I really. For me, it also resonates because I was at a USAID conference recently in DC and I met a physician from India who is running a nonprofit that's really looking at the care, like how the workflows work and how the startup from a patient perspective and newborn delivery context he was talking about how, healthcare systems are all designed, to benefit the clinicians and they're actually interfering with the ability of mothers to bond with their children and to start off nursing and to, really that connection right from the get go. And he was telling me all sorts of stories.

I tell you, it was a week after that, that I saw Stacy on stage and I'm like, this is what he's talking about. That's what I went through. And so I think that's the real benefit of the system is that it really supports the maternal newborn neonatal bond birth. And it really actually supports nursing and I think that's particularly important in the context of hospital care. My kids are all in their twenties now, but, they were short staff back then too, it's supposed to be worse today and handing my baby off to the nursery. I had to wait an hour and a half for them to bring my baby to nurse.

And I was only learning how to nurse that first time.

It was really a traumatic experience in a lot of ways. And again, I think about how that bassinet would have helped me keep the baby in the room with me and would have allowed me to be quite independent.

[00:39:00] Jared: Yeah, and I guess just thinking back to that period of time.

So you're a new mother, you've gone through this really traumatic experience. And does the environment you're in the postnatal unit, does that feel supportive? Are you feeling support in that moment? Are you, where do you feel like? You could have been maybe the system could have helped you more during that period of time to where maybe it wouldn't have felt so traumatic.

[00:39:22] Amanda: I will say that, in the context of when I was in the unit who my nurse was made all the difference. I remember having one nurse who was having a really bad day, literally my first day after delivering my first child, and she's yelling at me to go to the bathroom, and I can't even get out of bed and, that was really hard.

And then I remember having another nurse who came in right on her tails who just made everything better. And calm down and gave me everything I needed. That said, I did choose nursery over in room. And when you're faced with that decision, it's still true today. The answer is you're either 100 percent caring for your child in room or because you don't get any support if you opt for that, you don't get a lot of support. Or you're a hundred percent doing nursery and, be patient, and your milk's coming in and, you feel like you're about to explode, but you might have to wait an hour and a half for the baby to show up. Not a good setup for success, I'm just going to say.

And so I think it's mixed. I think there's some really good people who try to make it better. But I don't think that it's a particularly supportive place for new mothers and I think having family. My husband was amazing and my mom and I had some best friends who were there as well, and they took turns making sure someone was in the room with me at all times.

That made a huge difference. I hate to say that because, again, there are a lot of wonderful people working in health care, but the system itself for me was not a great experience and that's after 3 births, right? The post delivery experience was pretty, on your own.

[00:40:57] Ty: Yeah, it was something that Sarah Hopgood, who's a nurse has been supporting a Couplet Care.

She said that we're trying to ask mothers to do something that's very natural, but do it in a very unnatural environment in a way that the structures around the moms just aren't supportive of that, which what would come otherwise come naturally.

[00:41:15] Amanda: And and that's so true, Ty.

And I think that was my first experiences, I guess the bad news is they rushed the moms out of the hospital. The good news is they rushed the moms out of the hospital. And so for me, my mom, my parents were living in Singapore at the time, but when it was close to delivery, my mom came over for several weeks to make sure she was, there, her first grandchild that was part of the incentive as well as wanting to be there for me.

We all know once the baby's born, we're not so important anymore. And so they're in the hospital. She was there. And then as soon as I got home, that's the natural model. And so I had my mom there. I had my husband there. There are always people in the house. They're checking on me. Every 15, my mom, could see I'm getting tired.

And the baby's a little fussy. It's you know what? I'm going to take the baby for two hours. Put your earplugs in, go and sleep. Don't pay attention. Anything else. I've got everything. I'm going to clean the house. I'm going to make the meals. I got you covered here. That was blissful.

And the hospital is not a natural environment for that. It raises your anxiety. You press the call button for help and you don't know if someone's going to show up in five minutes or, 50 minutes. Yeah, that's a very accurate way of describing it.

[00:42:27] Ty: Yeah. And if it's not family, who's caring for your infant when they're out of the room, you don't have that ability to sleep.

Cause you've got that just unease of being in that environment.

[00:42:35] Amanda: Yep.

[00:42:37] Jared: Yeah. And, Dr. Tully, her work is focused on what people need to know, feel and have happen in the healthcare environments. She tries to make it so that way. The experience of what she designs is like very holistic.

And I think that's the intent behind the way that they've, I guess it's gen five bassinet now. And so is that a thesis of innovation that you also agree with that you find alignment with? Because we talked about a bit how have been designed for the physicians in a lot of cases and not necessarily for the mother in this case or for the newborn as much.

And with this approach to innovation is that something that you find alignment with also.

[00:43:16] Amanda: I completely embrace it. I embrace it in, the company I work with it. I embrace that concept in the teaching that I do. I have to tell you, I did spend all day yesterday at an investor ready workshop and, sponsored by SBTDC.

And one of the ways of thinking that they're trying to help entrepreneurs understand is that investors are your customer. You're selling equity to your customer. You need to understand your customer. And I think so, for me, that's very much the mindset for any system of innovation for any concept of serving or providing, products or offerings to help improve outcomes.

And I think in medicine, it's particularly important because if you're not delivering, interventions or, tools and resources in ways that help produce better patient outcomes. What are you doing? Isn't that the whole point? .

[00:44:09] Ty: Yeah, exactly. And like to that end, I mean keeping in mind each of the stakeholders who are, or constituents really that have a point of view on the value you're trying to deliver to the market.

Investors are one stakeholder. The inpatients are definitely a significant stakeholder, but the health care providers who are like caring for those patients. It's all part of an ecosystem. You have to keep each of those perspectives in mind and then figure out how to resolve if you're trying to make a design decision between one or the other, where there's just no way to make both happy.

How do you how do you optimize? Yeah.

[00:44:43] Amanda: There's a natural tension, right? Sometimes with things is for example, let's go back to the bassinet. They did have in room bassinets when I was there. But it's just they were stocking it full of materials, which is convenient for the clinician. And it was compact.

It's all in one place and you can wheel them in and out. And that makes a lot of sense. But it was again, Couplet Care, you're decoupling, right? The bassinet from whatever stock or materials you want to have in the room or wherever there's a bassinet. And I think there's a natural tension there.

For me, if you're focusing on patient outcomes, you're going to err on the side of what is actually going to support those patient outcomes, right? Because there are other ways to, ensure the supplies are there, or, in the room along with the bassinet without having to, and that's where we rely on engineers Ty, like you to help us think about who needs what, and how can you design things in ways that help answer both of those concerns right?

But again, what's the larger goal? And the larger goal is to facilitate and support the best possible patient outcomes.

[00:45:48] Ty: Absolutely. And there's usually design decisions and trade offs along that journey where you might need to revisit some of the constraints you've put on the environment in the first place to then be able to break it up into manageable solutions as opposed to trying to just put, competing constraints on something and then not have it be able to actually accomplish the objective.

[00:46:09] Amanda: And I also recognize that by doing something like separating the supplies from the bassinet that you're actually possibly impacting the workflow in the unit. Because maybe, they've got a production line of bassinets and they supply them all at once, and then they wheel them out to different places and so I think that is where, you're working closely with the stakeholders and you're trying to weigh, but, I don't know it's one of those classic business problems is that you want to serve the customer, but the customer doesn't always know what they really need.

Or what would really benefit, like how many of us knew that smartphones will become so central to our lives when they were first proposed. And there are different ways of doing things, new ways of doing things, and that goes back to, where I started and that whole fascination I had about how do you convince the market that there's a better way to do something, right?

[00:46:59] Ty: Yeah. And that sociology of change. Yeah, understanding how do you get humans to change behavior and being able to offer more benefit than the risk they take on by taking a change, taking a first step there's a lot of reality has to go into that.

[00:47:14] Amanda: And I think one of the challenges that you're confronting, in medicine and the maternity ward around that really comes down to the idea of what are the metrics that they're measuring again, good and bad, but administrators really run medicine.

And their priorities aren't necessarily the patient outcomes. And again, the clinicians, especially in really large bureaucratic organizations, they're overwhelmed with paperwork. They're usually just interested in executing standard protocols. And by the way, they've got, they're juggling between a gazillion of those and also having to figure out which one really applies best in this situation.

And so everyone's overwhelmed. There are a lot of different ways to do things. Things become institutionalized. Like it's easy to have one workflow, one practice repeated over and over again. It's really hard to disrupt those. But that's where some of the management trends in continuous improvement.

In reengineering, these are old concepts, right? I'm feel like I'm dating myself, but they're, they still take place in big organizations now. And we talk about the more these days in terms of software automation, we're talking about a lot in terms of AI, what can we use, we've automated a lot of the standard things.

Now, can we actually get some kind of software that helps vary the automation and tailor it a little bit more to individual situations, that kind of thing. But our people systems matter to o and we don't tend to think a lot about those very often. And I think the metrics the whole idea of triple bottom line, right?

That we're not just paying attention to profit and margins and costs and, revenue, but we're literally actually looking at, are we serving our customers well? Are we serving our patients? What are the metrics or indicators we need to be tracking there? And you can think of that, take it out of the maternity ward and look at a heart unit.

How many people are surviving heart surgery, right? What are the factors that contribute to that? Might make sense to spend a little bit more money in this area versus that area if it means your survival rate's higher. It's a similar thing in the maternity ward, but we don't measure those things.

We don't measure, the maternal newborn neonatal bond. Nobody's measuring how well nursing launches, right?

[00:49:32] Ty: And when it is time to go collect the data, if that data hasn't been gathered, it's not going to influence that decision as though that, if that data had been provided from the get go, then it's going to be much more persuasive in that decision making frame.

[00:49:45] Amanda: Yep. And so when you're running your pilots or when you're working with your first customers, I know you think about this really well, but that's the data you need to gather because you've got to build the business case for why this makes really good sense for the hospital. And by the way, if you can demonstrate that a new product like that bassinet, even with impacts on workflow and a little bit of reorganization going, is producing better patient outcomes, the hospital marketing department is going to love that, right?

Because those are stats that they can take out to the market and say, you want to deliver your baby here. And I think that is one of the most important things I've really learned through galaxy and working more generally in life science and biotech is that, a lot of entrepreneurs, a lot of investors a lot of grant review, grant proposal reviewers, they don't realize that patients will change doctors.

They will change their buying behavior in medicine based on whether something fits their needs and preferences and those who can are willing to spend more money on it. And I don't think that those considerations, I'm sure you it's been the same for you because you've been in around a gazillion businesses over the year, but it's years.

But it still continues to amaze me sometimes because that always stands out to me as really obvious. So I think about mammograms, right? We've got a more comfortable form of mammography, right? I would change my doctor for that because it is literally the worst experience every year that I have to go through and, some people think of that as a feature to a product, and it's it's a powerful feature. If I would change my doctor to go to a doctor where I could get access to something that, wasn't excruciating for me. And yeah, I think, again, the bassinet is phenomenal. And if you can collect that data, you can actually increase the competitive advantage of that instead of that hospital or that birthing center.

In the context of their market and their survival and success, right?

[00:51:46] Ty: Yeah, intuitive surgical famously follow that strategy of convincing hospitals to buy a million dollar robotic surgical system because they could then put billboards out there to then describe they've got the latest and greatest surgical techniques, whether or not the outcomes were actually better using actualdeliver better outcomes, but it's,

[00:52:06] Amanda: I'm glad you're renovating, but I got to tell you, I'm a, I'm cynical at this point in my life, but for me, it's literally like the big medical systems, right?

The big hospital medical systems. It's great, you're innovating. All that tells me is the Q tips are going to be more expensive because I know how the, but, I know how they price. I know how they spread the overhead, right?

[00:52:28] Ty: Yes.

[00:52:29] Amanda: And CapEx is going to get spread out over everything.

[00:52:33] Ty: Yeah. I had an invoice to me, which was a innovation invoice.

Which was an organization I no longer am a customer of, but they sent me a 1, 000 invoice for all the innovation we've done for you this like what

[00:52:48] Amanda: it's an assessment fee

[00:52:50] Ty: generally hey, we did innovation this year. No, I

[00:52:53] Amanda: know. You're making me think of HOAs though. And whenever they repaint the clubhouse or by the neighborhood, they send out everybody an assessment fee to say you're welcome.

[00:53:06] Ty: Yeah, exactly. No, this was our old professional employment organization. So they were just like, Hey, we're doing upgrades to the system and, our customer service still sucks, but there's some better technology somewhere here. And I was like I never used that. Why am I getting billed for this?

And so anyway. They deliver value, not just add cost to the system.

[00:53:27] Jared: It's taxing people to test for it.

[00:53:29] Amanda: Innovation for the sake of innovation, right?

And where's the good sense in what you're doing? And I'm very supportive of innovation if it produces better outcomes, if it delivers value, if it's going to matter. And I also recognize that, again, the cynicism is coming out, but I also recognize that innovators, there are a lot of sunk costs.

And so they're going to look for any way to make the sale, right? They're going to look for any way to deploy the system. But I think it's really on buyer beware. I think it's on the part of those who adopt the system to think very carefully about the implications. Is this technology really going to make your business better?

Is it really going to solve the problem or do the job that you need to get done.

[00:54:10] Jared: And so we're, we're up here on time and very appreciative that you joined us today. And I just want to end it you've been a successful entrepreneur, a successful innovator, and a lot of the people that listen to this podcast are aspiring to be what you've become.

And so just what's a piece of advice that you could give them to also find their own successes.

[00:54:33] Amanda: Yeah certainly based on our conversation today. I think one of the secret is chase product market fit its customers, understand their world in an inside and out, know how your product is going to solve their problem, know how important that problem is to them.

Where does it rank? I think that's incredibly important. And I think also understanding the landscape you're operating in. That's one of the things we've talked about in terms of medicine. It's highly complex, highly institutionalized, very bureaucratic and I think that if I would leave people with one word, it's legitimacy.

There are a lot of people. Innovating out there, for example, in diagnostics, but they're not publishing, right? And when people come to me and say how do I navigate innovation? How do I tell what the best test is? I say, follow the data, ask them for the data. Where's the publication is better just because it's peer review.

And I know it's not a perfect system, but it's better than someone just giving you data and saying, see, and so that's what I would say. Stay close to your market. And generate the evidence, put the evidence out there and chase product market fit.

[00:55:41] Jared: Amanda, thank you for your time today.

Thank you for all of your insights of wisdom and just good luck to Galaxy and everything that you've been working on there. And also looking forward to more research from you as well.

[00:55:51] Amanda: Fantastic. Yep. Thanks so much you guys and best of luck with Couplet Care as well.

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