The Leading Difference

Dr. Kenneth Brown | Atrantil | Gut Health, Brain Health, & the Advantages of Being a Generalist

Dr. Kenneth Brown is a private gastroenterologist with a clinical research division at Atrantil. Dr. Brown shares his journey from traditional medicine to a more holistic approach, blending natural therapeutics with traditional methods to treat gastrointestinal issues. He also discusses the advantages of being a generalist, how to care for your microbiome, and the need for more education about the link between gut health, brain health, and overall wellbeing. 
Guest links: https://www.linkedin.com/in/kennethbrownmd/| https://atrantil.com/
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 021 - Kenneth Brown
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Dr. Kenneth Brown. Dr. Brown is a private gastroenterologist with a clinical research division. In his practice, Dr. Brown uses a mix of traditional medicine and natural therapeutics to treat patients suffering from gastrointestinal issues. He hosts the Gut Check Project podcast where he and his team address topics surrounding gut health, healthcare economy, patient safety, nutrition, and more. Thank you so much Dr. Brown for joining me today. I am so excited that you're here and welcome.
Dr. Kenneth Brown: Thank you so much, Lindsey. I'm super excited getting to be a guest on The Leading Difference podcast. Awesome. I typically am always asked to do medical stuff, so this is a little bit out of my scope, but very exciting nonetheless.
Lindsey Dinneen: Great. No I'm very excited to have you and talk with you, and I would love if you would start by just telling us a little bit about yourself and your background and how you got to where you are today.
Dr. Kenneth Brown: Yeah, absolutely. So I'll take you way back. I was in medicals, I basically raised in Omaha, Nebraska. I was in medical school scraping ice off my car and realized one day, "I don't have to do this." And so I immediately drove down to Texas as quickly as I could, did my residency and fellowship, and became a gastroenterologist and still residing in Texas. I seemed to like the warm a little bit more than that scraping ice off cars.
So I started my practice about 20 years ago. Initially, I started doing clinical research specifically for the pharmaceutical industry. And I was helping launch some small biotech firms that were developing products. We were doing research for them, and in that time I realized there was this unmet need. In other words, no drug was being developed, or no drug existed for this big space called irritable bowel syndrome. I started to do research for the first drug that was trying to address this when I was in training. IBS, Irritable Bowel Syndrome, was considered more of a psychological diagnosis and literally I was taught that if you do tests on people and everything is normal, then more than likely, it is a psychological thing.
We used to think the same thing about ulcer disease. Whenever it was 50 years ago, if you got an ulcer, it was because you were too stressed. You need to back off work, do something like that. Then we found out that it was probably due to a bacteria called Helicobacter, H Pylori. And the person that discovered that got a Nobel Prize. That same massive paradigm shift was starting to take place when I was doing this research about 15 years ago. And that was that a doctor had shown that irritable bowel syndrome is actually caused by bacteria growing where it shouldn't be. And that's called small intestinal bacterial overgrowth. So it's just that bacteria growing where it shouldn't be.
And I was doing the clinical trial for them to look at treating people that had irritable bowel with diarrhea and in passing, I was having a conversation with the lead investigator and he said, unfortunately we'll never be able to help the bloated person with constipation because the type of bacteria that is causing it is a very old, ancient type called archaebacteria, and no modern antibiotics affect it." And that was kind of interesting. And and he said, "the issue is that this type of bacteria produces a gas called methane."
So I'm writing on my whiteboard in my office, "archaebacteria methane." And I start thinking, I started the story in the very beginning, 'cause I said I was raised in Nebraska and I scraped ice off my car to come down in Nebraska, the prime export would be agriculture. And what they were trying to do is mandate that these ranchers and farmers give different feed products to the cattle to decrease methane production that they're admitting for the Greenhouse Effect.
And I looked at that and I just went, "they've been trying to do this in Nebraska for a really long time. What is it that they're giving these cattle and can it be transferable to humans?" And so that sort of started the "aha!" moment of a bloated cow producing methane could be something eventually that might help the millions of people, and I mean millions, like 20% of the US population suffers from some form of irritable bowel syndrome and many more suffer from bloating and have never been diagnosed.
So I spent the next several years, me and my research manager, and we were looking at all the data in animals, and then we came across this combination of three large polyphenols, which are the molecules that make vegetables and fruits colorful. And realized that one of the major ones in there is something called Quebracho Colorado that had never been used in a supplement before, but it is used in wine making and beer making and many other things that humans are already consuming.
Went through some trouble of trying to get some Quebracho. This is in the like, weird things that happen with entrepreneurs. The only place that it is being developed is Argentina. And I happen to be half Argentinian, so I'm emailing, I'm calling, I'm trying to do anything to get hold of somebody to get me some of this product up just so I can do a clinical trial on it. And nothing was happening, I'm getting no response.
And so I actually called a cousin who's a physician in Argentina. She physically drove to the manufacturing facility, walked in an office and said, "there's a doctor in Dallas that's needs your product. He thinks he found a reason to give it to humans." And so that started this whole domino effect. And then eventually I get this shady bag of material sent to my office and I had to spend a lot of money to have analyzed and everything because they're used to working in the agricultural business where they would just send bags of stuff.
And so I was able to get this analyzed and all this other stuff, and then we encapsulated it and then put it with a few other things, and then ultimately did two clinical trials and found that it was remarkably successful in this patient population. And, we were able to launch this company called Atrantil. And that was about seven years ago that we were able to actually launch the company. And we have just been learning more and more about the science of all of this.
I've been fortunate enough to do this at the exact time where you and I were talking off air about where there seems to be this push for more awareness about nutrition, more awareness about doing things naturally, and not always relying on drugs to do everything. So I feel like I'm very fortunate to be in this great space, learning a ton. And being able to help millions of people at the same time. So that's where we're at now.
Lindsey Dinneen: Yeah. I love your story. Thank you for sharing that. There's a few different things that really stood out. First of all, I'm curious, did you always want to be a doctor? Is that something that was always a bit of a goal for you, or what made you decide to go into the medical field?
Dr. Kenneth Brown: I don't know how detailed you want to get into this, but I will tell you another quick story since this is, that one's very specific because, when I was in eighth grade, summer of eighth grade, my childhood friend got severely burned when he was on vacation with his mom. Third degree burns, ICU, whole nine yards, both him and his mom. And I get a call, you know, I was in touch with him, this is back before cell phones, so it's landlines. I get a call from him and he goes, "they say that I need to get outta the hospital because, mom needs to stay in here a little bit longer." Like they were in the ICU for a long time, so he had skin grafts and everything.
And I said, " just come live with us." And didn't even ask my parents and I just said, "Junior's gonna come live with us." And so he came and ended up spending a year living in our house and I was changing his bandages and all this other stuff. One night, at like 8:00 PM at night, doorbell rings and it's a guy-- introduced himself, his name was Leonard Woods. He said, I'm a physical therapist. I hear you have a young man who could use little help. I'd like to volunteer my services.
So he just basically rehabbed and then we all became friends, all of us. And of course I'm watching this guy that comes over and volunteers his time and I for sure am gonna be a physical therapist now. And I'm like in ninth grade, go through high school, always kinda shadowing and then during college doing some internships and stuff. And this guy saves my friend and he's this super cool dude and this is what I'm gonna do. And then he pulled me aside and he just said, "Hey, I know that you think this is what you should do, but I really think your calling is to be a doctor and I think you need to apply for medical school."
So I went, "okay." I just, at this point, I'm gonna do something in healthcare, just to help people. And the fact that your hero slash mentor is telling you to not do the job he's doing that he loves, I'm like, "okay, I guess I'll apply to med school." And then I ended up graduating college early, so I got a chance to spend a year, and I worked officially for him and he knew I was going to med school and then he spent that year teaching me how to manage employees, teaching me how to manage patients, how to run a busy clinic.
And he just said, " dovetail me so that you can see how the business side of this stuff works." And I was fortunate enough to go to medical school already having some idea of how I would do this and then I thought I would be a surgeon and then quickly realized that's a horrible lifestyle. I think I need to shift gears and was internal medicine. And then found gastroenterology and that fit me like a glove. So a gastroenterologist is an internal medicine trained doctor, so they already have a predisposition for a little bit of intellectual curiosity, but you get to do procedures. So you get to get in and immediately fix or help or prevent various diseases.
And so as a gastroenterologist, you basically are treating things from the esophagus to the anus. So I got into fellowship to be a gastroenterologist. I'm loving it. And then that's when I started realizing, "wait a minute, all health begins and ends in the gut." I was seeing all these people, they had gut issues years before they had something else. Everybody would complain that they had something else, and so, when I started private practice, that's how come I was drawn immediately after just a few years, I started the first research division of our company and I did research for about 10 years and it was just this beautiful sequence of events that led up to that point where I'm thinking about a bloated cow.
I mean, it took a really nice physical therapist to show up and then physical therapist to tell me to do something different-- possibly more, depending how you look at it-- and me to realize that all health begins and ends in the gut. And I basically continued that with that complete curiosity. And I'm continuing to learn all the time as everyone else is, as we're all learning that the gut is probably the root of disease and health.
Lindsey Dinneen: Yeah. Thank you for going to that story. I love hearing the why, what prompted somebody's interest or passion in what they're doing, and it really struck me-- both kind of stories you've shared with me so far about how synergistic from an outsider's perspective your life has been in a few different ways where like, seemingly no connection. So grew up in, in Nebraska and just you didn't like the snow, which I totally relate to by the way, side note. And then drawing from that experience is what helped you translate that into your work more recently. And that, that seems so disjointed, but it actually was this synergistic connection. And then you also have something like, you mentioned the one random place in Argentina and you had the connections, and I just love those stories when what's meant to be comes together in such a way that you could never predict.
Dr. Kenneth Brown: For sure. And the other thing about it, you say the story, but I look back and it was months and months of just radio silence. But I knew that we had something there. So it was me asking around, call my mom, "do we have anybody in this part of Argentina?" And so it took that continual pursuit of doing that. It wasn't just, oh, dumb luck. It's there, but it's the knowledge that it's there and it's the knowledge that you have an angle and it's the knowledge to utilize your network to try and get there.
The story sounds like it just kind of fell in place, but I think with every entrepreneur that you speak with, there's that classic line, "it only took 10 years to be an overnight success." There's so much more that happens back over here. And I look at this and I realized that some of these decisions that were made-- I don't know if you gave me another shot at this. Do you ever think about this?
I mean, you have this incredible dualistic career of being a ballerina and then being in the medtech, entrepreneur space and marketing and it's funny 'cause you love your life and you've got this great situation that you have going, when people say, "would you ever do it again?" I'm like, "no, no way. 'cause I don't know if I would make the right decisions, even though I know what decisions I made. I don't know if I would make the right decision to get exactly where I'm at right now, 'cause I kind of feel like I'm just beginning about where we can go with all this."
Lindsey Dinneen: Yeah. But that's the fun part, right? So it is kind of an interesting exercise to look back and think about the "what ifs." And if you were to redo it, would you make the same decisions? I've thought about that many times with different aspects where I chose between two seemingly really good options, but I'm so thankful I went with the one I did because that got me to where I am now. But you know, I was chuckling about your overnight sensation comment and I have thought about that so many times where, agree-- from an outside perspective it always looks different-- but I've always appreciated the quote, something like, "the harder I work, the more luck I have," or something like that,
Dr. Kenneth Brown: Exactly.
Lindsey Dinneen: I also think there's something to be said-- you talked about drawing on your network and the months of work that it did take. But I do think that there is something to be said to being open to possibilities that you wouldn't ordinarily pursue, or opportunities that you wouldn't ordinarily consider, because sometimes those, again, seemingly random, disconnected moments, somehow do all come together. And it might not be this overnight thing, but...
Dr. Kenneth Brown: Have you heard of a book called "Range" by David Epstein?
Lindsey Dinneen: Nope, but I'm writing it down.
Dr. Kenneth Brown: So the book is called "Range: Why Generalists Triumph In a Specialized World." It's really interesting because it's an analysis-- who's looking like business leaders and things like that, and generalists that learn a little bit-- it's always thought like in medicine it's " jack of all trades, but master of none." So it's that whole thing of jack of all trades, but master of none. And so in my field, you wanna become the most specialized of subspecialists that just, you're the expert. And I think because of my path coming in, there was never this devotion to this one thing immediately or I'm gonna be the experts' expert. I'm a generalist in life and I eventually end up in this space of a specialized world. But I seem to be better off 'cause I was a generalist.
And what I mean by that is in his book, what he describes is that when you have lots of life experiences-- if you've been in marketing for a little bit, and then of course you did have that, brief minor in accounting during college, and then you dabbled into sales over here-- and what he showed is that if you are adept at looking at this and you're still passionate about everything, you make the neural connections between these different experiences so you can see a connection between something where others are not. And almost by definition, that's kind of what genius is, where you can continually see things and go, "yes, this idea over here relates to that article that I read five years ago."
I see where this happens, and that's how you end up having an electric car company and a rocket company and a whatever that Elon Musk does, right? He's just pooling from all this knowledge and forming something. So I think that is probably the most important thing, and I'm, and I say all this because my massively transformative goal for the rest of my life is to cure something that to me is the, like, the worst thing that can happen, which is robbing you of your memories.
So dementia, it's an epidemic and it continues to go on, and I feel like what you lose when you have any type of brain trauma, even minor trauma, CTE, when you have toxins, when you start developing Alzheimer's and things, you lose the dendritic, meaning the connections between the neurons that allow that use of prior knowledge to now be integrated with new knowledge. And so that's why I think it's so important to protect the brain through the gut. Is any of that making sense? I feel like it just went down a rabbit hole.
Lindsey Dinneen: No, I love rabbit holes, first of all, so that's great. But also I think that is such a fantastic goal and it's so important and actually very encouraging to hear people working on these kinds of things, and the losing your memories and not being able to recognize people you love but realizing that maybe there are ways to slow that process or reverse or cure, that's a wonderful, hopeful thing.
Dr. Kenneth Brown: So that's the thing. Nobody's talking about that, but there's so much evidence out there. So one of my most frustrating things being in this space-- so what's happened since the-- I did, traditionally trained gastroenterologists, and then I'm doing pharmaceutical research and then I figure out that there's this space where maybe natural products can start filling the void, and that has really just shifted me to what I would consider myself more of a functional gastroenterologist. I still do traditional gastroenterology stuff, but I sure would like to find a more natural solution before we just knee-jerk and put you on drugs.
And one of my most frustrating things when talking to colleagues is, and I'm not throwing any individual under the bus here, but I start talking about, "oh, did you see this?" For instance, "hey, I just read a great article on the neuromodulatory effects of flavonoids, polyphenols, my world and gut microbiota through the gut brain access and how we can ultimately start healing our brains by having the right microbiome plus flavonoids. So that's an article. Just reviewed it. Super cool. Neat." And discussing that amongst my colleagues would be like there's no data on that.
And I went to a meeting recently and I was preparing to give a talk on, if you keep your microbiome young, you'll stay young. And, and it's all about manipulating your microbiome. And there's evidence to show that our supercentenarians, the ones that live past 95 or whatever, they actually have a microbiome, the microbiome is the collection of bacteria in your body, the collection of bacteria primarily in your colon that they have their own genome. You and I have a 99% identical genome, but we could have a 90% different genome in our microbiome, which may be one of the reasons why I age quick and you don't, one of the reasons why I get cancer and you don't, got it? The microbiome, it's the collection of the bacteria in our body.
So I was in a meeting, so I'm already preparing for this talk about the microbiome. And so I'm going to Croatia to give it. So I'm like really excited and it's, it's motivating 'cause I'm learning and everything. And I go to a meeting where a professor emeritus is gonna give a talk on probiotics and he gets up and the actual title of the talk was the "Probiotic Guide to the Gastroenterologist in 2023." And he said, "I think we can finally agree to this," and this is his words, "that the data does not support the use of traditional probiotics and we need to move away from this, and this is data. So some people do well in probiotics, but the data really is showing that probably traditional probiotics don't survive the digestive tract." And he said, "but what we really need to start thinking is we need to work on our microbiomes, but unfortunately, there's no data out there."
I'm in the audience and I have a folder of about 200 articles and a Mendeley. Mendeley is a journal repository on my computer of like another 300, and I'm like, "no data out there?" And it just got me thinking. I'm like, unless you have a specific desire to go look at something, the data that you're referring to is when a drug rep shows up at your office and gives you a detail piece 'cause that's how we're being reminded that there's new research. Here's the new drug, not are there any new, because this is like bench research that's going on all over the world.
Now we live in unprecedented times. I can find an article that hasn't even been translated in English yet, translate it from some postdoc candidate in Thailand doing crazy work on the stuff that I'm working on. And this is a true story. This is exactly what happened, and it's helping me develop more products because I'm like, "Oh, this person did do the heavy lifting already." And it was done 10 years ago and nobody's probably even heard of this. It's out there. It's just, do you have the motivation and the time to go look for things? Right now doctors are super busy and the time that they have is the five minutes they get with the person that brings them lunch.
Lindsey Dinneen: Wow. Yeah. So pivoting just slightly. I'm so thankful again that there are people like you doing this research and analyzing this data and helping us live healthier, fuller lives. So first of all, just thank you for that. I am curious if there are any moments that stand out to you throughout your career as really affirming that this was the right career path for you.
Dr. Kenneth Brown: Yeah. There was a-- I can't call it "aha moment" or anything. It is a, " you cannot not do this" moment, is what it came down to. So I'm an adult doctor and a woman who quit her job brought her 18 year old, severely autistic son in to see me. And I don't have any particular specialty in autism or anything like that. And what she said to me is, she goes, "I need help, 'cause he's now a young man. He's big and he's strong." And she said, "Nobody will take him. Like nobody will babysit him because he can be aggressive. And he's getting much worse with his autism and things are very rough on me, I had to quit my job. I have to spend all my time with him at home."
And I said, "I'm just curious, why here?" Now this is years ago, so it isn't like I was really deep into the functional medicine yet. And she said, "I've noticed one thing. I've noticed that when he eats, he's much more combative, and he's non-verbal so his communication is just really limited." And she said, "There has to be something with his gut if it's doing this." it didn't take very long to realize that he was getting super bloated after he ate and his belly hurt and he couldn't say, "I'm hurt, I'm hurting."
And so now we're in my wheelhouse. I started doing some research real quick and it's very evident that people on the autism spectrum disorder can have dysmotility or changes in the motility of their intestines, which can predispose to developing bacterial overgrowth, which is exactly my space now. And so we treated him and we treated him with both an antibiotic and my product and then changes diet. Changed lifestyle, change his diet, just made some changes. No processed foods. Don't open a bag. It's whole foods.
I personally, with the way that we grow our crop, I really try and get patients to avoid gluten as well. I think it's very neuroinflammatory. And so she came back three months later and she was crying. And she was so happy. And this young man was calm. He was talking. She's like, "he can eat." She's like, "I haven't seen him like this in 10 years since he was like a little kid."
And I'm like, "Okay, this is the n-of-1 that tells you, the brain and gut are connected and you have to keep pursuing that." And so that was oof, I dunno, six, seven years ago or guess well, like shortly after we launched. So I guess about, yeah, I dunno, six years ago or so. Yeah. So when you say that, I always think about that, if that's ever a case. I've heard that many other times since then and I don't think it's just the product or the antibiotics, I think it's the lifestyle change as well.
Lindsey Dinneen: Yeah. And how it all comes together to support Oh my word. Wow. Thank you for sharing that story. That is really powerful and I can see why it would be such a moment that would make you say, "yeah, this is what I'm meant to do, this is the impact I can potentially have on changing someone's life." There's nothing quite like that.
Dr. Kenneth Brown: Yeah. And then the more that you get into it, it just more reaffirming. So then it just becomes all consuming. You're like, you have to do this. And I think everybody that owns a business or is an entrepreneur-- I'm the visionary. We need an implementer to make things run at the company and all this. So if I had all the time and all the money in the world, it would just be 24/7 trying things out, looking at these natural products.
The beauty is we're learning that the modulation of the microbiome, the gut microbiota, the thing that seems to positively affect them the most are these large, stable polyphenols. And it's these large, stable polyphenols that get broken down into smaller phenolic compounds that work in an anti-inflammatory way and can cross the blood brain barrier, which is what I think is happening. Just go ahead and name any neuro-inflammatory disease from anxiety, A D H D, dementia, autism spectrum. There's different neurologic mechanisms primarily excitability and overactivity due to inflammation, creating all of it.
So knowing that's the root cause, where does most of the inflammation come from? It actually can start in the gut. So knowing that, how do we stop that inflammation? And then how do we improve the microbiome to produce anti-inflammatory aspects that then heal the brain? And the science is mapping out there. I think the traditional scientists will say that we don't know enough about it.
And that's true, 'cause you can't manipulate it in a way that people wanna manipulate it, but, I'm kind of taking that functional approach. Let Mother Nature figure it out. Just give your body what it wants, give it the foundation. Make sure you have a good sleep. Make sure that you socialize. Make sure that you exercise a little and make sure that you eat the right foods and all of it will sort of work itself out If you have your foundation right.
Lindsey Dinneen: Yeah. So last year, I had the opportunity to spend a little bit of time in Puerto Rico and there was this beautiful rainforest that we did a hike in. And it was really interesting, our guide was telling us that with the hurricane that they had just a few years back, had destroyed like, I wanna say maybe 80%, it was a very high percentage of the flora and fauna of the rainforest. And when we were there, there was no way we would've known that had she not pointed it out. And it really struck me how resilient living things are.
I think about this with humans as well. And when you intentionally try to nurture and cultivate and take care of yourself or other living things, how much we can bounce back from and how much we can heal and regenerate and make new, and I just thought of that when you were talking about the possibilities that if we can heal our gut, maybe we can heal our brain and heal some of these other things that come from, from that inflammation.
Dr. Kenneth Brown: Yeah, for sure. So let's use that same analogy with the hurricane, because what we do to our microbiome is a tropical forest. Exactly what you are walking through. There's trillions of bacteria. There's thousands of species. The more diverse it is, the healthier it is. Just like the rainforest you were walking through. Now you take antibiotics, you eat a highly processed diet, you do something to disrupt it. That's equivalent to that hurricane disrupting the rainforest.
The difference is we continue to do that and what we try to do is, we try to take control of it and take drugs or take different things to try and say, "oh, I'm gonna heal it with this." So the equivalent would be, when the rainforest was knocked down, somebody comes in and goes, "the rainforest was destroyed, but what I'm gonna do is I'm going to plant anything, name it, corn. I'm gonna plant grass, anything."
And so now you have a big lush field of grass. Now on the one side is just grass, and on the other side is a dense tropical forest. The dense tropical forest is the healthier version. We tend to focus on one bacterial species. That's where the science is. It's like, how do we grow more of this? How do we do more of this when it's the diversity that has to happen? They left the rainforest alone and it figured it out. And grew back quickly. The more that they would intervene with that, the slower that process would be.
Lindsey Dinneen: Yeah. Thank you for taking my own thoughts and putting it in, into exactly what we're talking about 'cause I appreciate that. Okay, so I am gonna take the conversation slightly differently, so just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be related to your work, but it doesn't have to be. What would you choose to teach and why?
Dr. Kenneth Brown: Oh my goodness, it's gonna be so boring 'cause it's, I mean, the masterclass would be this exact same topic. It's, you can protect your brain through your gut, would be what it is just because there's too much evidence that so little people are talking about it. And would it be a masterclass, 'cause I'm still learning? You'd pay me a million dollars and we would have to share it, 'cause it would be a group learning session. That's what it would be like. Everybody that attends, we all teach each other and share the million.
Lindsey Dinneen: There you go. You can use part of it to further your work because you were saying, if you had unlimited resources, how much more could you do? So, we can share the love.
Dr. Kenneth Brown: Yeah, I just, immediately was thinking, "my ego would not allow me to accept a million dollars to give a class". I'm like, "oh my gosh." What kind of a, like, there's my PowerPoint. Could never be that good deserving a million.
Lindsey Dinneen: Oh, yeah. Like We'll just give it to your organization and I'm sure you could find good ways to use it. I'm sure that would be a worthwhile masterclass to take, and it would be just a good learning experience for everyone. So, good answer. What is the one thing you wish to be remembered for after you leave this world?
Dr. Kenneth Brown: I wanna be remembered as a curious and kind person.
Lindsey Dinneen: Yeah. I like that. And then final question, what's one thing that makes you smile every time you see or think about it?
Dr. Kenneth Brown: Dude, I'm so boring on these questions. Like my knee jerk is like, oh, my family. I want to give something cooler than that. Oh my gosh. I try to practice some mindfulness type things. Have you heard of neurolinguistic programming? NLP? And so you know how there's an anchoring technique so that you can get yourself excited or happy? I will say that my happy memories would be, I took my family to Spain and we went to a Michelin star restaurant and had a chef's tasting menu there. And just thinking about that is my, anchoring to be happy. And then this summer, we went to Portugal and did the exact same thing, except the kids are older and all this other stuff. And so something that makes me smile immediately. Alright, there we go. It doesn't even have to be me. Something that makes me smile immediately is when people are loving and caring and they're breaking bread with each other over a nice Mediterranean meal.
Lindsey Dinneen: That is a great answer. Yes. I would have to say that I, I can fully support that. I love both Spain and Portugal, and some of my fondest food memories would have to be there too. So see this.
Dr. Kenneth Brown: It's just that feeling of, just openness and enjoying and discussing. There's something primal about breaking bread with other humans in a way that is, I don't know. And of course, it's a chef's tasting menu, so you don't know what's coming. There's that dopamine anticipation, and then it gets put down and it's like nine courses. It's just stuff like that that's awesome.
Lindsey Dinneen: Oh, I love it. That's amazing. Thank you so very much for joining me today. This has been such a great conversation, and I learned a lot. I'm very thankful for the work that you do and just all the ways that you finding to help people live their best lives. I just wanna, again, say thank you for your time and as just a small token of that, we're honored to be making a donation on your behalf to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. And we just appreciate again, your time, your efforts, and we just wish you continued success as you work to change lives for a better world.
Dr. Kenneth Brown: Thank you so much, Lindsey. Thank you so much for having me on. And I really enjoyed this and I enjoyed our 10 minute off the record banter and I feel like you would be a great guest on the Gut Check Project, my podcast, and we can talk about the ballerina days and all that. Let's do it.
Lindsey Dinneen: That sounds amazing. Alright, well, thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Allison London Brown | CEO of LUMINELLE 360 | Femtech Innovation, Fundraising, & Personal Missions

Allison London Brown is the CEO of LUMINELLE 360, a company focused on improving women's health through innovative medical technologies. In this episode, she discusses the challenges of fundraising, particularly for startups and women-led organizations, and the importance of personal mission and storytelling in leading a company and securing financial backing. Allison also emphasizes her commitment to changing diagnostic practices for women's health, particularly uterine biopsies, by developing a device through LUMINELLE 360 that enables physicians to perform these procedures more effectively.
Guest links: https://www.linkedin.com/in/allisonlondonbrown/ | https://www.luminelle360.com/ 
Charity supported: Tunnel to Towers
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenProduction: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 020 - Allison London Brown
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:10] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:39] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:43] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Allison London Brown. Allison is the CEO of LUMINELLE 360. She is a visionary leader with a passion for changing the lives of patients, providers, and caregivers and inspiring teams to achieve their full potential. She has experience working with startups, venture backed organizations, global partnerships and corporations, as well as associations, NGOs, and global government agencies. Thank you so much for being here. I'm so excited to talk with you.
[00:01:28] Allison London Brown: I'm excited to be here. It's, it's great to meet you, Lindsey, and to talk to your audience, and I look forward to it.
[00:01:35] Lindsey Dinneen: Wonderful. Well, I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background.
[00:01:43] Allison London Brown: Yeah, so I am currently the co-founder and CEO of a company called Luminelle. And we in essence are a company that's focused in women's health. And we do that using our insights into what happens for women in diagnosis, especially in the office place. And we have a proprietary visualization system that physicians can use in their office. I wouldn't say it's just my job. It's actually a mission for me.
[00:02:17] So a little bit about me. I am a recovering scientist. I started in chemistry and engineering, so I still have a little bit of that, I'm a nerd, whatever, and I was with J&J for a lot of years in GE and some really great, amazing companies and was trained in both the medical device and as well as in the consumer and pharma world. So I've had some really spectacular experiences with tremendous people and great physicians and their patients. And, I've been in the women's health industry for a really long time.
[00:02:53] And in the company I'm in now, a few years ago, some physicians came to us and started talking about a problem that they were having and I had to say, I really didn't understand or believe it because I've been, again, been doing this for forever, and they were telling me that the difficulties of something as simple as getting a uterine biopsy. What we started looking into is that the failure rate for uterine biopsies is 50%. And that just seems really unacceptable, right?
[00:03:29] And so then the more I dug into it, the more I was learning about uterine cancer and how it's the fastest growing mortality rate. And that African American women, if they're diagnosed with uterine cancer, they have a 90% mortality rate. Hispanics have a six times mortality rate.
[00:03:50] So, just doesn't make sense, right? What is going on? And really what I discovered was that the way we do endometrial biopsy is they do it blind. So it's like this little straw that goes in to, to try to take a sample and you're not taking the right spot and you're not taking enough tissue. And so we get these really high failure rates. And the reason I'm saying all this about that is it was shocking to me, A: as a woman and B: as a person who felt like I was extremely knowledgeable and had been doing this for forever. So I was honestly shamed, that I didn't realize that this is such a major but small, a simple problem, right?
[00:04:40] So we've shifted all of our efforts really into creating this new device that we are going to launch any minute now which is allowing physicians to do very easy sampling. And I will tell people it's the most meaningful thing I've ever done in my career. And again, had great opportunities to work on major launches, but this is, I feel like is kind of that legacy moment, people talk about that legacy moment and I feel like that's this for me.
[00:05:10] Lindsey Dinneen: Oh, I love that. Yeah. You talk so much about it being so important and underrepresented and can't believe that there's this gap, and you know, that seems to be coming out more and more. There's so much more awareness, there's chatter, there's emphasis on women's health. However, there's also, it feels like there's still such a barrier to progress. Yeah, and I was wondering if you could touch on that, because obviously you're at the forefront of this. You are the one who is paving the way, but it is tough.
[00:05:45] Allison London Brown: Yeah, so people always ask me this question about, oh, as a CEO, my job is 99% of the time I'm raising money. Right? That's what you do when you're in a startup. You're raising money. You can never have enough money. You're always raising money. And so the question inevitably is talking about all of the statistics about how women founders don't get cash and the VCs don't fund us, and blah, blah, blah, blah, blah.
[00:06:11] Yes. Okay. So all of that may be true, but I do think that the bigger challenge is not 'cause I'm a woman, but because of the fact that I'm dealing in women's health. And, it's difficult. I've worked in a lot of different male down there care issues, and I have difficulty understanding all of it. And I'm sure that for investors ,who are predominantly male, are also struggling to understand why this is so impactful. I think the other thing is there's been so much legality in the United States around women's health. There's, lawsuits left and right, and so it does make some investors a bit wary. So on a positive side, we are seeing some significant wins when it comes to reimbursement. And so doctors are actually getting paid for their work. I think we're seeing some innovation come. But it's a whole lot too late maybe. I dunno, can I say that?
[00:07:15] Lindsey Dinneen: Yeah, that's fine. . Yeah. But now you have a bit of a unique fundraising experience if I ascertained correctly through some of your posts, and one thing that really stood out to me is there was a comment at one point where you said something to the effect of, if you're not comfortable raising money or asking for money or whatnot, then maybe you need to find a different occupation or different job title. Yeah. Yeah. I love the boldness of that. I was wondering if you could elaborate a little bit on that, because obviously, like you said, that's a huge component of what you have to do.
[00:07:54] Allison London Brown: Yeah, I mean, I think. The essence of all that anybody does really is we're all storytellers, right? We should all be telling a story. If you want someone to buy into what you're doing, whether it's to write you a check or to join your team, or to stay on your team, we talk about leadership and loyalty and recruiting and all these things, but in essence, all of those things really go down to, you gotta tell a good story. You gotta believe your story. And I don't mean like making up a story, I mean, you're sharing this common experience with somebody, or you're sharing how you've come to something with somebody.
[00:08:28] And so I think the challenge is it's easy for some people to ask for a sale, right? I'm selling you a product, I'm selling you a widget, I'm selling you a contract, whatever that is. But when you are raising funds for your company, you're kind of selling yourself. You are saying to an investor, trust me. Trust my team. Trust that I am going to take care of your money. I'm a good steward of your money and that I will not waste your money. And not only that, but that I will give you a good return.
[00:09:09] And I think when I talk to a lot of younger, newer entrepreneurs, the idea of selling yourself in a way and then getting the close on the deal, getting that check right? You gotta close the deal for whatever reason is very troubling for some people. And I mean, that's the whole point, "I'm telling you my story so you can understand why am I doing this, why I know I can be successful, why my team can be successful, and write me a check. Show me the money."
[00:09:46] Lindsey Dinneen: Yeah. And now you have approached it in, well, my perspective, a little bit of a unique way, and that is that you mentioned at one point that you raise a lot of capital through your own networks and through maybe not just Angel Investors or VCs or whatnot, but that you have been able to draw on your own social network, and so I was wondering if you could share a little bit about that process and if it's still an option, what opportunities still exist for people to invest in your company?
[00:10:18] Allison London Brown: Well you're welcome to invest, of course I'm always raising money, so, yes, thank you for asking. So the first part of that question, though it's kind of personal and I think people talk about doing like a friends and family round. That's not what I'm talking about here. The way that I have approached our fundraising, done a lot of Angel Funds, we've done a lot of high net worth individuals. We've been very judicious in our spend. We've been very fortunate. I mean, raised very little money, and have four or five, 10Ks, five patents, we're commercial, we've got contracts.
[00:10:55] But we are now at that stage that so many startups find themselves in, which is, I hate this word, but it's the "valley of death" where you finally have got everything ready to go and you run outta cash. A lot of us are in that boat. This has been a horrific year for raising money. So I, earlier in the year really tapped into my network. But I raised actually a little bit over a half a million dollars in two weeks, and most of it was from people in my church and their contacts.
[00:11:28] Lindsey Dinneen: Wow.
[00:11:29] Allison London Brown: So when I talk about it being personal, when we say this is missional, it is missional on a mental, emotional level, but for us it's also on a spiritual level that we really believe in what we're doing and we believe that kind of, for such a time as this, is why we're doing it. There's a reason why this idea came to us at this time with this group of people, with these physicians, with the technology that's available today. And honestly, that's not lost on a lot of people who know me personally, they understand why we are doing what we're doing. We will not quit. we will do whatever it takes to keep us going. And so in terms of fundraising, yes, we are still fundraising. We have a note that's out. We are opening up a seed round in the first quarter. And we have some very big plans for how we are going to launch this product. Not expensive plans, but big plans. Anybody who's interested, you can find me on LinkedIn. I think I'm on the only last name, London Brown. So easy to find.
[00:12:46] Lindsey Dinneen: Amazing. Yeah. I love what you said, and you've now said it a couple of times, of being so mission focused. Like this is not just a job to you, it's not just a company to you. This is a life's work and I love that. And I'm wondering if you can speak a little bit to, you've found this purpose, you've found this goal, and this mission to orient around and then how are you able to, like you said, story tell and express that to people who may not have experience or concern?
[00:13:21] Allison London Brown: The organ! They, they don't have a uterus! That's OK.
[00:13:25] Lindsey Dinneen: Exactly so, so, right, or people who might think, oh well, "I'm healthy, I'm fine." But that doesn't necessarily mean anything. So I just love to hear how do you share that heart and that passion and really help people care and understand like you do.
[00:13:39] Allison London Brown: Yeah, I mean, it does depend on the audience and everybody will say that, " it depends," but it does. I mean, you have to know kind of who you're speaking to and what's gonna matter for them, what's gonna get them to a, yes. Typically when I'm meeting with a group of, especially let's just say older gentlemen, it's easier for people to think about, "oh, have you had a colonoscopy?" Right? "Have you had a skin biopsy?" Have you had, all these different things that we kind of take for granted, right?
[00:14:08] These wonderful abilities to do diagnoses, and it's all driven by the ability to see. My business development manager, Jamie Harding, she goes on rant all the time about how sight is one of the most critical things in medicine, and yet here we are doing something blind. And, for a typical biopsy, the failure rate is 2%. So I think for a lot of guys they can get their head around, "oh, can you imagine no anesthesia, and the doctor starts just using some probe, and no camera, and it's just like digging around to try to figure if you have a problem." Okay.
[00:14:56] Or, you know, it's hard sometimes, but it's like getting a root canal without anesthesia and he's not looking. I mean, it's, there's a lot of different ways could say this, but at the bottom of this, it's like you gotta be able to see, right? So that's not a hard thing, I think for a lot of them to understand. Many times I'll spend more time talking about the technology, or I'll talk about the dollars, the actual economics of the situation versus the problem itself, because that can be, again, it can be a little bit distressing for some audiences.
[00:15:30] But, get 'em in the mindset of what if this was happening to you, and then what if this was your mother or your sister or your daughter or your granddaughter, you know? And she goes in, she has this horrific experience. It's extremely painful. And then. You wait a couple weeks and the doctor says, "oh well, either we didn't find anything or we are not really sure because it was Inconclusive." Inconclusive! That is the word that nobody wants to hear, right?
[00:16:05] Lindsey Dinneen: Yeah. Yes.
[00:16:06] Allison London Brown: Inconclusive. What does that mean? You can't tell me what's wrong with me. So yeah.
[00:16:13] Lindsey Dinneen: Yeah, so part of it definitely is sort of putting it into almost like, like you gave some great examples of putting it into terms where it's like, yeah, "can you imagine if you had a root canal where the dentist wasn't looking at you , and you had no anesthesia, what would that feel like?" That's ridiculous , and there's a solution for that.
[00:16:35] Allison London Brown: The other one is, I like this one, is a skin biopsy. You go in, you have something on your arm, you can see it, it's on your arm. Everybody can see it. It looks weird. Your wife has said to you, "you need to go get that thing checked. You need to go get that thing looked at," as we would say in the south. You go into your doctor, the doctor sees it, the doctor gets out a tool, then the doctor turns off the light and then tries to find where it was. I mean, it's kind of that same thing. Things you don't do blind. This is like a whole, like if I had a bazillion dollars, I'd be doing commercials about things you don't do blind, right?
[00:17:10] Lindsey Dinneen: Yes. Oh, I love that though. . I'm already starting to think of so many great ideas with that particular...
[00:17:17] Allison London Brown: Exactly.
[00:17:19] Lindsey Dinneen: You know, looking back, let's say years ago, and I recognize this as a little bit of a, a newer venture, although you've been very involved in med tech and science your whole life, did you always have an interest in science and healthcare from an early age? Is this something that you thought you might ever do or was this sort of a, an evolution over time?
[00:17:39] Allison London Brown: I can tell you the exact time where I decided this is what I wanted to do. So in high school, I thought I was gonna be a musician. I actually had a full scholarship in music and piano, voice and drama and really thought, that was my journey. And I took a chemistry class. I had put it off until my senior year. And fell in love with chemistry. I mean, I always liked math and then, at the time there were all these really interesting things going on around genetics and just so many different breakthroughs in medicine and I just felt like that was my path. So I started studying in chemistry. I started looking at the different careers in chemistry. I knew I didn't really wanna be in the lab, I didn't wanna be like a bench top scientist or anything like that.
[00:18:37] But medicine was so intriguing, I kind of thought that I was gonna go be a researcher at like NIH or National Cancer Institute or something like that. Some big, huge impact on the world. And, over time, I just, I found myself feeling more and more drawn to really understanding another form of science, which is understanding, "why do people make the decisions they make and why do they buy the way they buy?" Which, you know, behavioral decision making. And so marketing and sales was very intriguing to me. So I think I've I just leveraged a different part of my brain on the commercial side to really figure out how do you get someone, again, you get somebody to that yes.
[00:19:26] Lindsey Dinneen: Yeah. So very multi-passionate and multi gifted. Do you still do anything with music, voice, or drama, out of curiosity?
[00:19:36] Allison London Brown: I don't do drama anymore. I mean, well, ask my friends-- might tell you I'm dramatic all the time. I don't, I dunno that I am, but don't like drama. Let's just that way. I try to avoid drama in my life. Look, I'm very comfortable in front of an audience, and think all that upbringing of being on the stage, and I had the opportunity to sing at the Grand Ole Opry, so it wasn't a foreign concept to be in front of a large audience. I think that's very helpful. I'm in a band at church and I do that kind of stuff, but I don't have time anymore. I, you know, I'm trying to raise money. Right. I don't have time for that.
[00:20:12] Lindsey Dinneen: Right. But I love how that performer background may have helped contribute a little bit to your comfort on stage and giving presentation, being in front of people because that would be a very useful skill that, that, would intimidate some other people sometimes if they're suddenly in this role where, oh my gosh, now I have to be the face of the company, which means I have to do Y, and Z.
[00:20:34] Allison London Brown: Yeah. Right. Isn't that like the number one fear I think people have is speak in front of a crowd?
[00:20:39] Lindsey Dinneen: Yeah, . So there you go, you already had a little bit of an edge there 'cause you had that comfort, that's amazing. .
[00:20:46] Allison London Brown: Yeah, I mean, I think that's helpful, but and I tell people this all the time, again, if you cannot communicate your ideas or your story, then it is gonna be very difficult for anybody to buy in. I may have been a scientist, but again, that training in drama I think helped because a lot of people in science, they have a hard time articulating their ideas at a level that if you're not a PhD, you can't understand it. I am not a PhD. There are many brilliant people around me all the time and I'm like, "can you please dumb it down for me." Like I can't communicate it back to you in a way that makes sense, it's not gonna stick with anybody.
[00:21:29] Lindsey Dinneen: Yeah. And speaking of not having time anymore, you are a board member of multiple other organizations. Can you share a little bit about that? And also, do you get a chance to sleep or...
[00:21:43] Allison London Brown: Yeah. Yeah, I've actually had to back off some of my work. I've been involved with CED, which is the Council for Entrepreneurial Development here in Raleigh, for a long time. I guess 10 years. And this year I've had to really back off of that work, even though it's a passion of mine to help other entrepreneurs. I do sit on the board of Clayco Therapeutics. I really believe in what they're doing. They're working on a new biologic for necrotizing enterocolitis, and I know that's a big word, right? Basically it's when babies are low birth weight or premature, we talk a lot about like lung development, right? They can't breathe well or whatever. A lot of times their gut doesn't work, so their stomach doesn't work, and there's not a good diagnosis for it at all. And there's also a really not a great therapy for it. There's not like a drug. Some of these kids end up having multiple surgeries, it can lead to slow development, it can cause, just a myriad of other really horrific things for kids. And so they have a product that we believe is gonna be able to literally reset the gut, and allow the children to be able to feed properly. So I mean, these are like itty bitty little babies, right? So it's, I guess, adjacent to the women's health world, but it's, I just think it's a fascinating area of medicine, which is biologics, using natural substances to heal our bodies.
[00:23:15] Lindsey Dinneen: Yeah.
[00:23:16] Allison London Brown: Not synthetic things. And its a great mission, yes, I do get to sleep.
[00:23:20] Lindsey Dinneen: Okay, good.
[00:23:22] Allison London Brown: I do get to sleep. But I do try to get involved in things that, A) where I think I can add value. I try to get involved in things where I really know make a difference or help the entrepreneur, and it's something I, I believe in.
[00:23:34] Lindsey Dinneen: Yeah. Oh, I love that. Yes. And paying it forward is such a wonderful thing. So what are you looking forward to, as the company continues to move forward, either personally, professionally, what are some things that you're looking forward to?
[00:23:48] Allison London Brown: I'm looking forward to a vacation I don't, dunnah know if that's a good thing to say, but I'm looking forward a good, a vacation, that would be nice. We did not do a vacation this year 'cause it's just been one of those years. No, so in terms of the company, I have this vision in my head of having a building and having 20-30 people and 10 to 15 sales reps and just this humming, working, hive of people all focused in the same direction, working and aligned on the same outcomes, and just this community of believers that have come together to really make a difference. So I kind of have this idea of that place where we are all together doing something. And I think that could happen for us this year. So I'm extremely excited about that and giving people jobs, right, and giving people an opportunity to join with us in this mission. So that's exciting for me.
[00:24:53] Lindsey Dinneen: Absolutely, are there any moments in particular that stand out to you, that really solidified for you, "yes, this is why I'm here doing what I'm doing"? Because of something that happened that just was such a reinforcement of, "yes, I'm in the right place at the right time."
[00:25:13] Allison London Brown: Yes, I have. Two things. The first thing is we were doing research around this new biopsy tool and listening to physicians talk about what they're doing today, how they're doing it today, and hearing. doctor, after doctor say, "what I'm doing today is just fine, not good, not great, just fine." And I thought, "you gotta be kidding me." Like, how is that an acceptable answer? And not trying to diss the doctors, please. That's not at all what I'm trying to say. To me that just sounded like they have acquiesced or they don't feel like anybody's gonna pay attention to them or their plight or their concerns. And so why bother? And it felt very defeatist. Again, for people who-- my friends who know me, like, give me a challenge. Like, just go ahead, tell me, "no." let's see where that goes. So that was one thing.
[00:26:20] The second thing is much more personal. And in my prayer time, in my devotional time, in my, crying out to God to ask him is "Is this really real? Is this really gonna happen? I'm running outta money." All those fun things that we think about as entrepreneurs, "what am I supposed to do?" kind of at your wit's end and just having this huge sense of, " yes, move forward. Yes, go forward. Yes, I'm here with you. Yes, I'm in it." And I know that sounds kind of kooky, for people who are not maybe into that kind of thing, but a few years ago I would've said, "that's crazy." But I will tell you, it was extremely meaningful event for me and it stays with me. It keeps us going because I just, I believe in us. I have faith that this is what we're supposed to be doing.
[00:27:19] Lindsey Dinneen: Thank you for sharing those stories. Those are both very meaningful and it is encouraging because feeling that belief and that reassurance that "yes, you're in the right place, doing the right thing at the right time" is so important because it's not easy. Nothing about what you're doing is easy , so you have come back to that.
[00:27:40] Allison London Brown: Yeah, and I feel extremely blessed that I do have that, because I, a lot of my friends are thinking through what is their purpose? What should I be doing? How blah, blah, blah, it's tough when you are seeking for something that's meaningful, right? And I do believe that we've been given that opportunity.
[00:28:00] Lindsey Dinneen: Oh. I love that. I, yeah, absolutely love that. Pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything that you want. It can be in your industry, does not have to be. What would you choose to teach and why?
[00:28:20] Allison London Brown: Yeah. There's a lot of things I think I would like to teach people. It's something my girlfriends and I have been talking about quite a bit lately, which is, as a woman-- and it's probably not a masterclass, it may be more of discussion group-- but it's, how do you move through those different periods of your life physically, emotionally, mentally, all of those things and still be true to yourself. And I think, I look back on my twenties and my thirties and I think "well, wow, was that really who I was? Did I have to evolve through that to get to where I am?" And if there's a way to impart any knowledge to someone to say, here are some skills you can use, here are ways to leverage your brain or deal with hormonal issues, or deal with the fact that you're having to take care of your family or whatever it is. I feel like we chunk it up a lot. We talk about, oh, mothers in the workplace, or we talk about now the big thing is menopause in the workplace, which I think is hilarious. But it's great that we're talking about all these things, but there's not a kind of path, how do you go from being an 18 year old to a 22 year old, to a 30 year old, to a whatever year old, right? So to me it's really sitting down and thinking through how do you go through each stage of your life. That would be one thing that may sound kooky, but...
[00:29:50] Lindsey Dinneen: Nope. I would sign up for that Masterclass. No, I love that. And because that's not something that is really talked about and like you said, each stage is different and it brings its own unique sets of excitement and challenges and considerations and you don't really hear enough people saying, "Hey, here's some things to think about. Here's some things to watch out for." So, yep. I'm on board.
[00:30:16] Allison London Brown: Yeah, I have a friend that she's in her thirties and she listens to a group of us talk and she's like, "oh, so this is what I have to look forward to." And I'm like, "oh, yes."
[00:30:25] Lindsey Dinneen: Yes. Indeed. Indeed. Yeah. So, what do you wish to be remembered for after you leave this world?
[00:30:35] Allison London Brown: Well, besides what we're doing here at Luminelle, I certainly would love to have that as a legacy as something that really impacted how, maybe not just how women were diagnosed, but how physicians started thinking about diagnosis differently. But, I guess I would like to be thought of as somebody who liked to have fun and laugh and brought joy to other people.
[00:30:56] Lindsey Dinneen: I love that. I love that answer. That's a wonderful thing, . And then final question, what is one thing that makes you smile every time you see or think about it?
[00:31:08] Allison London Brown: I probably should say my husband's face. I get points for being a good wife to say that. And it's true. It's true. It's not-- I'm not making it up. It's true. I'm a sucker for I really am a sucker for the movie "Elf."
[00:31:23] Lindsey Dinneen: I love that movie.
[00:31:26] Allison London Brown: I have three movies I watch every holiday, " Elf," " Scrooged" with Bill Murray and "Die Hard." And I'm not allowed to get those movies out until after Thanksgiving.
[00:31:41] Lindsey Dinneen: Oh, So what works for, what works for our family is my husband and I have a tradition of always on Thanksgiving Eve, so to speak, we break bread to get it ready for stuffing so it can, kind of dry out overnight. And we spend the evening watching "Elf," and that's like the start of our holiday season. It's like a really fun tradition, do you think you could get away with that?
[00:32:06] Allison London Brown: I don't know, because I will watch it like 500 times during the holidays.
[00:32:12] Lindsey Dinneen: Fair enough.
[00:32:13] Allison London Brown: I am a sucker for like --not stupid comedy, so I'm not, I don't like slapstick or anything like that, but I just think "Elf" is such, I mean, it's a great story. It's got great songs. It's got Will Ferrell's hilarious. It's got a great ending. It's kind of that. It's, it, I just, and I love James Kahn. Let's just, okay, sorry, but love me some James Conn. I think he's amazing.
[00:32:39] Lindsey Dinneen: That is a fabulous answer. Definitely, that goes to the top of the most unique and that is so fun. I'm so glad you enjoyed that. Oh, my word, Allison, this has been such a fun conversation. I'm really inspired by what you're doing and by your focus on mission and impact and the way that you are working so diligently, even when it's tough and it's gonna be tough to share your story, to bring this to market, to change lives.
[00:33:10] And we are so excited to be making a donation on your behalf Today to the Tunnel to Towers Foundation, which since 9/11 has been helping America's heroes by providing mortgage-free Homes to Gold Star and fallen first responder families with young children, and by building specially adapted smart homes for catastrophic injured veterans and first responders. They are also committed to eradicating veteran homelessness and helping America to never forget September 11th, 2001. So, thank you so much for choosing that organization to support. And we just really appreciate your time.
[00:33:47] Allison London Brown: Thank you. I really appreciate it. And I hope that if one person hears this one post, one mention can sometimes change a life. And so if you're a woman out there, and if you've had abnormal uterine bleeding. That is your warning sign. And so go get checked. Don't wait. Do not pass go. Do not collect $200. Go to your physician and do not accept a subpar answer.
[00:34:17] Lindsey Dinneen: Yeah.
[00:34:18] Allison London Brown: So I think if I can get, just as important as it is to get physicians doing the right thing is for us to be asking for the right thing and being our own advocate. And write me a check. while y'oure at it, write me a check, I'm not sure I'm actually allowed to say that. There's probably some like SEC violation I just did. But
[00:34:40] Lindsey Dinneen: Write the company a check. It's important.
[00:34:42] Allison London Brown: Yes. Write the company a check if an accredited investor, please. Yes, no, I'm happy to talk to anybody who would like to know more.
[00:34:51] Lindsey Dinneen: I love that. Well, thank you again. I just wish you the most continued success as you work to change lives for a better world and thank you also to everyone who has listened to this episode, and if you're feeling as inspired as I am, I would love if you would share this -episode with a colleague or two, and we will catch you next time.
[00:35:11] The Leading Difference podcast is brought to you by Velentium.
[00:35:17] Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
[00:35:32] Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
[00:35:49] Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
[00:35:56] Visit velentium.com to explore your next step in medical device development.

Joe Landolina | CEO of Cresilon | Vetigel, Entrepreneurship, & Saving Lives

Joe Landolina is the co-founder and CEO of Cresilon, a biotech company that developed a plant-based gel technology to stop bleeding within seconds. Joe shares his unique journey from inventing this groundbreaking technology at the age of 17 to building a manufacturing facility in the heart of New York City. The gel, known as Vetigel, has saved numerous animal lives and recently received FDA clearance for human use. Joe discusses the challenges of building the company, the importance of community support, and his passion for helping the next generation of entrepreneurs.
Guest links: https://cresilon.com/| https://www.linkedin.com/company/cresilon/
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 019 - Joe Landolina
Joe Landolina
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Joe Landolina. Joe is the co founder and CEO of Cresilon, a Brooklyn based biotech company developing and manufacturing a plant based gel technology that stops bleeding in seconds. The revolutionary technology, which was created by Joe, recently received its first FDA clearance in human use. Well, welcome, Joe. Thank you so much for being here. I'm so excited to talk with you.
Joe Landolina: Definitely, Lindsey. Thank you so much for having me on.
Lindsey Dinneen: Of course. I would love if you don't mind by just starting by telling us a little bit about yourself and your background and how you ended up in medtech.
Joe Landolina: Sure. So I have a bit of a unique story coming into medtech because I got a really early start. But to start from the basics, I'm a chemical engineer by training. I did both my undergrad and my graduate work at NYU in New York. I'm a New Yorker, born and raised. And my grandfather was a Hoffman LaRoche executive, that in retirement, started a vineyard. And he also learned lab safety in the sixties. And so that meant the day I learned how to walk, I was taken into a chemistry lab with my grandfather and told, "Mix some things together, don't kill yourself, kid." And so, from a very early age, I got an intro into lab research.
And so that led to me inventing the technology that Cresilon was based on at the age of 17 when I was a freshman at NYU. And over the last 13 years, I've taken that passion and that invention and turned it into what Cresilon is today, which is a biotech company that has sold our products in 30 countries outside of the US. And we do all of our manufacturing and are headquartered here in Brooklyn, New York.
Lindsey Dinneen: Wow. Oh my goodness. Well, first of all, the fact that you started off in a lab and we're just kind of told, "Go have fun." Okay. So what are some of your first memories of experimentation?
Joe Landolina: So, I'm not sure if I can tell all of the first memories on a podcast as upstanding as this one. But what I can say is that my, my first several experiments created such fear and anger in my parents that they cut me a deal, and the deal was I had to go learn how to do lab research the right way, anywhere, please, quickly. And so, the end result of that was at the age of 13 or 14 years old, I did a summer research program at Columbia University in tissue engineering. And that program really opened my eyes up to the field of medtech, because at that time, I had a simple worldview where career paths were either doctor, lawyer, accountant, and so on. And so realizing that there were so many other shades of possibility within this industry was something that, that I realized thankfully at that age, and it started this path of really falling in love with this type of research and I dove headfirst into it.
Lindsey Dinneen: Yeah, absolutely. It sounds like in general that you've had a passion for basically what you're doing now from a very young age. So how did Columbia help you narrow down this passion into a more specific area of focus?
Joe Landolina: Definitely. And so let me talk a bit specifically about what I was working on at Columbia, because there was a lab there that was using plant based scaffolding. Meaning polymers that come from plant based materials to grow stem cells that come out of a human patient and have them differentiated into a target tissue. And this lab was working specifically on chondrocytes or cartilage. And so it was just amazing for me to see this material taken completely from nature that was able to be repurposed to take a patient's own stem cells and turn them back into cartilage that could potentially be put back into that same patient.
And so it set me down this path where at the time I only had access to-- the internet was good for a lot of things, but not really finding information yet at that point. And so if you wanted to learn, you had to go to a library, you had to, whether it was a public library or a university library. And so I surrounded myself with Eastern medicine books, and books that looked at how pharmaceuticals derived from nature around us, because the one thing that I had, I grew up on a vineyard. And so I was able to grow anything or collect anything that I wanted to. And so I had a real interest in finding solutions to the experiments that I was trying to run in nature.
And I got fairly good at identifying these sources of material, because again, no one would sell a winery lab or a 13, 14, 15, 16, 17 year old, agents to do these types of experiments. So, I had to get creative. And so that was really my entry point into that and Columbia opened my eyes that that was being done at the highest levels.
Lindsey Dinneen: Wow. Okay. So nature based solutions. And as you have continued to go down this path and then of course develop your company and your products, can you tell me a little bit about the origin story of the company? Because, gosh, doing this at 17 years old, that must've been a remarkable breakthrough. I'd love to hear more about that.
Joe Landolina: Sure. So, to start with, I was running this experiment in the winery lab where I was trying to make a plant based scaffold to effectively replicate some of the stuff that I had seen at Columbia. And that experiment went terribly because instead of having a multimillion dollar university funded lab, I had a winery lab, which you can interpret that as effectively a glorified kitchen counter with a bunch of equipment that was "borrowed" from Roche in the late 70s when my grandfather retired. And so it wasn't very fancy by any means. And so I didn't get the result that I wanted.
But what I did get was this material that was this mess that came out of algae that would form a gel that would simply stick to skin and wouldn't let go until you wanted it to. And I had this idea, which was, what if you could take a material like that, inject it into a bullet wound, and at least plug up that bullet wound from bleeding so you can get a patient and move them from point A to point B without them bleeding out. And at around the same time, as a freshman, this was my first week of school, there was a poster in the engineering quad at NYU that said "best business plan idea $75,000 top prize."
And what really drew my eye was that they would give free MBA classes to anyone who got into the quarterfinals. And I thought, you know what? There's no way I win, but I wanted to be a doctor and I was an engineer's engineer and I was really looking for things that were around me on my resume. And I thought that this stuff isn't going to work and it's not going to become a company, but I may as well join this competition. And worst case scenario, maybe I can talk my way into getting some free business classes and get me an internship over the summer. And so I met my co founder, Isaac, who was a student at the business school at NYU at the time, and we entered the competition and we ended up taking first place at the engineering school, and second place at the business school where he was at, and and the rest was history.
Lindsey Dinneen: Wow. Oh my word. Well, congratulations. That's a fantastic origin story. And I love the fact that you just went into it with this mindset of, even if we don't necessarily win, we're still going to see the benefits from this other education. And I think that's so important to have a lot of cross experiences that eventually help lead into the success, and sometimes you don't see how they all interrelate, but eventually they do. I love that that's how you approached it. What a great mindset.
Joe Landolina: Thank you.
Lindsey Dinneen: Yeah. Well, so, okay. how many years have you been in business?
Joe Landolina: 13 years later.
Lindsey Dinneen: 13 years later. Okay. So 13 years later and you have now gone through several rounds of funding. And so I'm curious how that process has gone for you, 'cause that's a whole other kind of learning curve as well. How has that been for you?
Joe Landolina: So we've been very unorthodox in a number of ways here at Cresilon. And the way that we raised funding was was no exception to that rule. And so we've done over a hundred million dollars in funding to date across several rounds of funding. Our first round was in 2013. So our seed run was raised from angel investors, high net worth individuals that read about us in social media. We were lucky in those early years, we had a lot of press coverage, both because of my age and really just because this technology is unlike anything else that I've seen in that you can, in a 20 second video, understand exactly what it does and what the value is.
And we had this video of a steak that I cut and we pump blood through it and it's this massive bleed. You put the product on it, it stops instantly. And that video had over 140 million views on it, all in all, so we get a lot of attention in the beginning there. But then, those investors that we brought in to raise a couple million dollars in our seed round, ended up reinvesting time and time again, just all the way through the company's history, and so those same investors-- along with some other investors that we collected along the way-- ended up being the bulk of the funding that we brought in.
And that's incredibly rare in this industry, especially in biotech, where there are usually different VC funds that come in at each stage, it's not like we don't have venture investing or investment here at Cresilon, but primarily our largest investors and the average investor is a private individual. And that's very rare for this type of funding, but it's allowed us to build a cohort of investors that primarily are end users. We have a number of surgeons and doctors and veterinarians who have used the product and who were very vocal in helping us design the product in the very beginning, and it allowed for this healthy conversation where if there's an investor who has money behind something, that they're not going to pull their punches when they tell us what they like. And then more importantly, what they don't like about the product. And it allowed us to get really raw, involved feedback from day one effectively.
Lindsey Dinneen: Yeah. Which is so important and what an interesting funding experience you've had, like you said, it's definitely unique. Now looking back over the last 13 years: what has been one of the biggest challenges in either starting or building the company. What has been either unexpected or the largest obstacle to overcome so far?
Joe Landolina: So I think that the biggest obstacle by far has been the middle phase of the business. And so when I say the middle phase, from the end of 2015 until the end of 2020. And so if we look at the business in sort of five year packets of time, from, 2010, which is when we founded the company and had the idea, to 2015, we were building a product that worked.
And so at the end of 2015, we had Vetigel. We knew Vetigel would work and we were able to manufacture it. But we realized that the market demand far exceeded our ability to manufacture. And in fact, we were too reliant on third parties. And so, in 2015, the goal was to effectively outsource everything that we could.
And unfortunately, when you make a highly novel product like this, we were finding that we were unable to find partners that could outsource. So in fact, there was not a single manufacturer that could manufacture Vetigel gel. We had to do everything ourselves, but there weren't even labs that could do the testing that we needed. And so we were getting false positives and false negatives.
And so in 2015, we were ready to launch and I made one of the hardest decisions that I ever had to make. I pulled the plug on the whole thing. I went back to our investors and told them, "Look, if we can't do this the right way, if we can't ensure the safety of our product, we're not launching." And we raised 10 times the amount of money that we'd raised up to that point, just to build brick and mortar manufacturing. We brought in individuals who had built quality labs and done this at scale for large vaccine manufacturers.
And Cresilon at that point became the very first or the very only sterile manufacturer in the five boroughs of New York, something that we're proud of. But it took us five years, and that was a very hard, onerous time where, frankly, we didn't know if it was perfectly possible or completely possible to do what we needed to do. And so the entire time we were working on perfecting, on validating, on standing up this factory where we had to design all of the equipment from scratch.
Our product is like the consistency of hummus. So it's not incredibly viscous and there are lots of machines and manufacturers that make vaccines and lots of machines that manufactures and make hummus, but no one dumb enough to do it together. And so, we were lucky enough to be the first and we had to figure out a way to get it done. And so we had to design clean rooms. We were one of the first production clean rooms that had to be made in New York City under New York building code. So we had to even custom design things like sprinkler heads to comply with FDNY regulations, but also maintain the sterility of our clean rooms.
And so it was literally nuts to bolts. Like every test that's run on a syringe today was designed by a Cresilon employee and something we're proud of, but it was hard. We were going effectively month to month where we couldn't sell. We couldn't make revenue until we got these pieces put together. I mean, obviously when you're doe eyed and naive, you think it's an 18 month process to stand up a factory, but it took all of five years and it culminated with launching in the very best time to launch a new product to a direct customer in an operating room, which is at the height of the COVID pandemic in October of 2020.
Lindsey Dinneen: Oh, my goodness. Yeah. All those years of just waiting and planning and executing, but not, not quite being there. Oh, my word. Your patience and your stress. Good for you to have gotten through that. I would love to hear about what you consider your biggest win, but I recently read something that I wonder if we'll be on the same page here with that, but tell me what your biggest win is so far to date.
Joe Landolina: So frankly, Cresilon's mission is saving life lives and the biggest win still to this date, right, it's saving our first animal life, right. I'm, my guess is that you're going to mention that the recent FDA approval for humans, but what I tell my team is it's not about the paperwork. It's not about the regulations and that's an amazing accomplishment that I don't want to minimize by any means. It's about what we do for our patients and what we do for our clinicians. And so, you know, for me, I'm an engineer by training, and so that means I'm a natural pessimist. And so I always look for flaws in products because I like to fix flaws.
And the thing that you can't argue with is when you take a patient that would have not survived a procedure and translate that into a successful outcome. And we've now done that over 45,000 times on the Vetigel product line. And what I'll say is that excitement doesn't diminish. And we're now ever closer to being able to do it for the first time in a human patient. And that's something we're looking forward to. But we still have some some ways to go before we can achieve that.
Lindsey Dinneen: Yeah. First of all, that's incredible how many lives you've already impacted through what you're doing. And I love your mission statement. I think you're so right to get back to the heart of it. But also I do want to say congratulations for the FDA approval, because I know that was no easy feat. That's really exciting that you're there now too. So on both ends, lots of lives being saved. Thank you for what you're doing.
Joe Landolina: Yeah, thank you so much. It was a journey and a half to get to that point. It takes a lot, especially for the first time on a new technology to get it through. But I can take no credit for it, it was all my team. And they were the ones who put in the countless hours and overnights to get it done. But for now, that means we can start growing.
Lindsey Dinneen: Yeah, absolutely. Is there any specific instance or memory that stands out to you as reinforcing the idea that you were in the right place at the right time? Like, this is your field, what you're doing, your specific path. Did you have a moment that was just like this affirmation of, "Yes, I'm in the right place."
Joe Landolina: I'd say that's a really good question. What I'll say is that we've been very lucky throughout the entire journey. I think that the silver bullet that allowed us to stand up our factory was something that was only invented itself in the same year that we implemented it, meaning that if we had gotten there, even a year earlier after developing the technology, the thing that allowed us to solve our problems wouldn't have been there. And to get it back to, to what I was mentioning earlier, I think that there are definitely cases where surgeons that we've just trained have a case come in that day, where on a Monday, we teach them about the product and on Tuesday morning, they have a dog that's been hit by a car that would have been unsavable a couple days before without our product. And, and there are countless cases like that that we hear about and it just shows that the world keeps turning whether or not our products are out there, but the fact that we can be there and make a difference and truly save lives is something that, that just is validation enough.
Lindsey Dinneen: Yeah, Oh, absolutely. Speaking about being able to use this product with animals, I noticed on LinkedIn that you seem very passionate about animals and especially shared some really heartwarming rescue stories and whatnot. So I have to ask, have you always loved animals? Is this always been a passion of yours?
Joe Landolina: So I grew up on a vineyard with a bunch of property and I always joked that my parents had a menagerie at home and so we always had everything from dogs and cats to llamas and alpacas and ducks and they're interesting animals going around and and so I've always been a lover of animals. It's hard living in Brooklyn now. My wife and I recently took a plunge last year. We adopted a German shepherd puppy who very quickly grew to 85 pounds. She keeps me fit. We do 10 miles a day together. So she's adapted well to the Brooklyn lifestyle. But it's it's definitely nice to be able to do that in the city because I went for years without having a pet of my own.
Lindsey Dinneen: Oh, yeah, and dogs are just such great companions. It's hard to not fall in love with them. So what's next for you and for your company and what are you excited about coming up?
Joe Landolina: So on the back of this FDA clearance of of our technology, what's next is translating that into our first human life saved. And there's a lot of work that still needs to be done. We still have to scale everything up and get ready for that launch to do it the right way. But it's coming; it's scheduled for next year. And it's something that, that we're looking forward to is it just allows us to extend and expand our mission beyond what we've already been doing.
And then on the Vetigel front, we've been seeing really amazing results in indications that frankly, when I came into this market, I never thought that we would be doing surgery. And so Vetigel is being used today in brain surgery, is being used in spine surgery to help dogs that were paralyzed that now can walk again because their surgery time is short enough that they're no longer at risk of of going under that procedure.
And so really amazing things that are coming out of that market that we've been working with commercial partners to make sure that we're able to get that in the hands of any vet that is able to use Vetigel, or willing to use Vetigel. And so a lot of growth is ahead of us and it's just trying to put our heads down and come back to mission which is making sure that we can save lives.
Lindsey Dinneen: Yeah, I love that. So is the plan to continue for both animals, and now because you'll have the opportunity to test with humans as well. So is the goal to always have both things going simultaneously?
Joe Landolina: Definitely. And because we're in the human market, it doesn't mean that animal becomes an afterthought in any way. And so our team in animal health-- we have a direct sales force here in the US, the partners that we have abroad are still staying. And so we're still growing those teams pretty substantially. It just means that, for better or for worse, we have a lot of hiring to do. We have like 45 open positions right now as we start to beef up the human commercial side of our business.
Lindsey Dinneen: Wow. Well, that's exciting. So anyone listening could potentially go to your website and learn more about working with y'all.
Joe Landolina: Exactly. We have a careers page on Cresilon.com and if anyone interested checks that out, we have a number of roles open for for people who are interested and willing to join our team.
Lindsey Dinneen: Awesome. So one thing that I noticed also on LinkedIn was I saw a couple of different posts about various speaking or resources that you seem very passionate about helping the next generation of professionals in the field to level up their skills, feel comfortable, gain the experience and the knowledge. Would you want to speak anything to that and in terms of your interest in helping the next generation? I really appreciated seeing that.
Joe Landolina: Definitely. I think that I'm not the only one by far that's doing this, but it's just, founder resources are tricky because there's a level of healthy competition that happens in startups. And so something that's been very near and dear to my heart is just talking openly about sharing of resources, talking openly about mental health challenges that the founders go through, and being there for the communities that I'm a part of, and that may mean the New York community, that may mean the NYU community, or that may just be the larger entrepreneurship community as a whole, but in my opinion, this only works if the community comes together and supports one another.
And I think that I've gone through this journey and there were resources that I had that were amazing, and there were resources that I didn't have, and what I'm trying to do is if there are entrepreneurs out there that don't have the same resources that I did have or that are looking for something that I also couldn't find, if I can be a little part in helping alleviate something, then I'm all for it.
Lindsey Dinneen: Yeah. Yeah. Well, I love that. Thank you for paying it forward. I think that's really important and it's very encouraging to continue to see people speak out about various struggles and obstacles. And when you're real and honest and transparent with those kinds of things, you can really help somebody else who might be going through similar challenges. So thank you. I appreciate what you're doing.
Joe Landolina: Definitely. Yeah, it's been a lot of fun. And in fact, I have much younger siblings. So my parents, when I was in high school, wanted to try for a daughter and ended up getting triplets, two boys and a girl. And one of the triplets who turned 18 last week has just founded his first company. And so it's it's nice to see it run in the family.
Lindsey Dinneen: Oh my goodness. Yes. Congratulations. That's pretty cool. All right. Well, pivoting and just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your field or industry, but it doesn't have to be. What would you choose to teach and why?
Joe Landolina: I think, negotiation would be what I talk about . Because it leans into entrepreneurship, right? And what I find is both in young entrepreneurs and in candidates that come to work for us, or members of my team, or even myself, people don't realize that the way to affect change, whether it's in, in their personal lives, in, in their work or as they're starting a company, it all comes down to how you position it and what you ask for.
And so I think that it's something that people realize maybe too late on average that if you want something, all you have to do is ask for it. And one of the best learnings I had early on was that the beauty of New York is that there's so many resources just around us and at our fingertips. And if you want something, most people, their tendency is to say, "I'm going to keep that hidden. And I'm not going to, I'm not going to tell anyone else that I want this thing, but the worst you can get is 'no'."
And if you ask enough people, odds are, you'll find someone who will say "yes" at the end of the day, right. And that's how we got our first lab space. That's how we got our first checks. That's how we started putting the pieces together to build the business. And so understanding how to do that is just such a great launch pad. And maybe I'm not the best professor or teacher of that in myself, but it's been a skill set that I find has helped me greatly and that people, on average, don't seem to realize that, that it's a possibility in pretty much in any circumstance.
Lindsey Dinneen: Yes. Great. Great answer. And I would definitely attend that masterclass. I'm really passionate about this topic too. I think there's so much hidden power in just asking. And like you said, the worst someone can say "no". And a lot of times that "no" is "not yet". So if you've got a great idea, if you have something you need or want and you do put it out there, there are so many people that are willing to help. So yeah. I love that. What's one thing that you wish to be remembered for after you leave this world?
Joe Landolina: I think that I feel bad giving the same answer, but it's true. So I so I'm going to say it again, but it's just-- if there is one patient that had their life or had a family member affected because of technology that we put out, that's enough. And so the way that I view what we do, right, I want to have made a difference in someone's life. I want to have made a product that swings the needle in, in, in the direction of good, rather than worse.
Lindsey Dinneen: Yeah. And just think of all of those animals already. That alone to me is very cool as well. And this is just the beginning. So yeah, that's exciting. And final question: what is one thing that makes you smile every time you see or think about it?
Joe Landolina: I'm going to say my German shepherd. Yeah. She's been a a massive positive influence in my life. So I think doing what I do, it's hard to stay grounded and stay present. And having a dog forces you to be grounded and present at least for a good part of your day. And there's something here that relies on you. And so she, she makes my day every day.
Lindsey Dinneen: I love that. Well, thank you so much for joining us today, Joe. This was so much fun. I'm so excited about the work that you and your company are doing. Obviously you're making a huge difference in people's lives, you're living out your mission, and I just commend you for that. Thank you for contributing so positively to the world. We're honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thanks for picking that organization to support and we just wish you continued success as you work to change lives for a better world.
Joe Landolina: Definitely. Well, thank you so much, Lindsey, for having me on. This was an absolute pleasure.
Lindsey Dinneen: Wonderful. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Rebecca Whitney | Spine Global President at ZimVie | Tether, Leading Teams, & Traveling

Rebecca Whitney is the Spine Global President for ZimVie. The episode explores Rebecca's journey into MedTech, her leadership philosophy centered around trust and mutual respect, and the profound impact of innovative spinal solutions, such as the Tether device for pediatric scoliosis. Rebecca also shares personal insights, including her love for travel and the daily ritual of morning lattes with her husband, emphasizing the importance of finding joy in everyday moments.
Guest links: https://www.zimvie.com/en 
Charity supported: Opportunity International 
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 018 - Rebecca Whitney
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to the Leading Difference podcast. I'm your host Lindsey, and I am excited to introduce you to my guest today, Rebecca Whitney. Rebecca is a tenacious and passionate business leader with over 20 years of experience leading both large and small organizations in the MedTech space. As ZimVie Spine Global President, Rebecca leads a team that designs, develops, and commercializes spinal implants to treat patients with spine related disabilities. ZimVie is the market leader in motion preserving solutions for the spine, and Rebecca and her team are passionate about expanding patient access to these innovative technologies. Hello. Welcome to the show, Rebecca. I'm so glad to have you here.
Rebecca Whitney: Thank you, Lindsey. I'm really looking forward to this.
Lindsey Dinneen: Absolutely. I would love, if you don't mind starting off by telling us just a little bit about yourself and your background and how you got into MedTech.
Rebecca Whitney: Sure. So I grew up in a suburb of Salt Lake City, Utah. I'm the oldest of three children and have always been kind of inherently pretty driven. And so what happened is, just because of my age and a bunch of AP credits, I was done with college at the University of Utah at age 20 and realized that was too young for me to jump into the workforce. And so I went straight into grad school to get an MBA. And while I was there, I took a summer internship with BD Medical that turned into a full year opportunity and it was really great. I learned a ton about product management, the medical device industry, and when I was in the final spring of my MBA, they actually offered me a full-time position. And so, I jumped right into it and didn't realize at the time just how fortunate I was to launch this career into medtech. But I've always felt very fortunate to have found a career in an industry that I enjoy so much. It's been love at first sight, and I've never left the medtech space since. So, professionally it's been just a great run.
And then personally, I live in Boulder, Colorado with my husband James, and we definitely embrace a work hard, play hard approach. We love the outdoors, we love adventure travel, and are always looking to find ways to optimize our life to the fullest. So, we actually met a guy on a backpacking, hiking trip about three or four years ago in Escalante National Park. And this has always stuck with me because he said to us "Every day, do something that makes you feel more alive." And that resonated with me because we've always tried to live our life that way. And so, it's been really great. So my job is a huge part of who I am. But also I like to have as much fun as possible, as many adventures as possible when I'm not working.
Lindsey Dinneen: Yeah. Oh, I love that. Yeah. Feel more alive. That's such a great way of capturing it. I've heard variations on that. One of my favorites is " do something every day that inspires your soul." I love that too, of the feel alive, because there are some days too where you might not be feeling super inspired by whatever your circumstances happened to be at the time, but the "feeling more alive" seems very attainable because you could just go out into nature if that's something you very much enjoy, or maybe you put on some of your favorite music and you just let that absorb. Okay, I'm getting carried away. But I love that.
Rebecca Whitney: No, I agree. And to your point, it can be five minutes, it can be, you know, a huge adventure. But I think just that mentality, and it stuck with me, I think about it every day. So anyway, it's just a nice reminder that life is short and take advantage while we can.
Lindsey Dinneen: Yeah. So looking back at growing up-- and obviously I love the fact that you dove kind of straight into the medtech world and that sounds like a happy coincidence, so to speak. But looking back, would you have ever anticipated that's a field you might end up in, or was it kind of a surprise?
Rebecca Whitney: No, it was totally a surprise, a very happy, lucky one. I have always said my life and my career has followed a series of happy accidents, if you will. And so this was one of those where I was getting my MBA, I actually thought I was going to go into finance and I had interned at Merrill Lynch and so had full intentions of going down the finance path. And when I took this internship in marketing, I realized that, okay, there are a couple things about this that are really clicking for me. One, marketing brought that data and analytical elements together with the commercial and strategic elements that I love. And so I kind of found a sweet spot in product marketing at a very early age.
And in the medtech space, I remember the boss that hired me, he said medical devices are recession proof. And while that's not always the case-- especially when it comes to elective surgeries in times of COVID-- for the most part, that's been true. And so, I kind of fell into the industry, but feel so very fortunate that I hopefully am helping to impact patient lives at the other end of all this. So, I never looked back and never, ever even thought about making a switch.
Lindsey Dinneen: Yeah. Yeah. So what exactly does your role entail these days? How are you combining some of those interests and your passion for this particular industry?
Rebecca Whitney: So what I'm doing now is I lead our global spine organization and we make and manufacture, produce spinal implants. And so we help people with back pain or related pain to any type of back or spinal cord injury. And I love the global responsibility. I can get into that a little later. But international travel has always been a passion of mine, and so being able to work internationally is just fantastic because I think it brings just a whole different perspective to healthcare and patient needs and some of those variable aspects as you work throughout the globe.
And I also love leading teams, and so having this cross-functional responsibility to, to set the strategy and then mobilize the various functions and team members to get behind the strategy and execute is just really great. I've been in all different parts of medtech throughout my career. I will say that working in the spine space has been one of the most rewarding, just because you are able to see firsthand that the impact that these products are having on patients' lives and whether it's alleviating pain or getting their lifestyle back. It's just very rewarding when we hear from patients who benefits from the products and the solutions that we've been able to bring to market.
Lindsey Dinneen: Yeah, I can only imagine. Are there any particular moments that stand out to you as clearly confirming that this was the right choice of industry for you? I know you're so passionate about the space and the spinal aspect in general. So I'm curious what kind of moments have you had where you thought, oh my word, I know why I'm here.
Rebecca Whitney: Yeah, it's a great question and I will tell you that in this particular job, in this industry, there is a product that, that we have brought to market that is unique and it treats pediatric scoliosis. So these kids that are coming in and are needing basically to be addressed because they've got a curve in their back, the traditional standard of care is to put a bunch of rods and screws up and down their back and then fuse their spine into alignment. And while that clinically solves the problem in most instances, we have developed, an innovative way to, to basically provide the same procedure for these patients that are properly indicated. But we do it without fusing their back. And so we have this product called The Tether that we brought to market in 2019. And leading up to 2019, we partnered with thought leading surgeons, the FDA, parent advocates, and a whole slew of others to advocate to bring this technology to market.
And when we hear from these kids who have had the surgery and they're back to gymnastics and cheerleading and horseback riding, skiing, snowboarding, when we hear from these kids and their parents, it is such a wonderful endorsement. And, I can't take the credit for the innovation. Those are our very talented engineers and researchers. But to know I've had a small hand and our company has had a hand in helping change the trajectory of these kids' lives, it is truly inspiring. And we bring in patients all the time to speak to our internal team members. And it just really kind of puts the context behind all the hard work, whether it's the engineers or the shipping and operations teams who are making sure the product gets to the right spot, the salespeople who are out selling it. It's just really impactful. So I would say that's probably the clearest example of every time I hear from a patient, it is just another reinforcement that I made the right choice and that there's something really special about this medical device industry when you can see how it helps patients.
Lindsey Dinneen: Oh my goodness. Yes. As an adult, I'm sure that kind of an operation or procedure would be just as impactful. But I got a little choked up thinking about a child who has this condition that maybe is inhibiting their dreams of becoming a gymnast or even just as a hobby, but something that they love. And then to have that hope restored again, that's that's, immeasurable. That impact is immeasurable.
Rebecca Whitney: You know, it, it really is, and I say this all the time, this is a true passion project for so many of us. And internally we have a team saying, and kind of a mantra, if you will. It's "having the courage to do things that haven't been done before." And we all kind of got behind this starting several years ago to say this is the right thing to do and we're gonna keep advocating to, to get this technology to market because no one's done it before. We were the very first. And to be able to actually see this materialize in the lives of these kids-- yeah, to your point, it's just, it's very inspiring for all of us that have worked on it and we're not gonna stop. We really are very passionate about continuing to develop this space.
Lindsey Dinneen: That is wonderful. Well, I know that you are also really passionate about leadership and leading teams. I know that's an aspect of your job that is enjoyable to you. And I wonder if you wouldn't mind sharing a little bit about how you got into that leadership role and a little bit about your philosophy towards leading and managing teams.
Rebecca Whitney: Yeah, so I'll start with my philosophy. I think everyone has a slightly different take on what does leadership mean to them, and to me, first of all, I've always felt very humbled and honored to be in a leadership role and I take that responsibility very seriously. As I've worked throughout my career and observed leaders, I have found that the most effective and the most admirable leaders are those that take a true interest in the individual. Because at the end of the day, we're all people, and I personally believe that the basic principles of healthy and strong relationships are the same, whether it's a sibling, a spouse, a friend, a colleague, a boss, or an employee. And so I think that you've got to start with two basic principles. For me, trust and mutual respect. And it's very important to me that I build and establish and maintain trust with the teams I lead, as well as my colleagues and my leaders. And so that's kind of number one. Those are table stakes for me.
I think too, I have learned over the years that leadership does not necessarily mean being liked all the time. And early on when I was starting out, that was difficult for me to learn. And it was hard. And I remember it was about six months into my career and at Becton Dickinson, BD Medical, we'd just gone through a pretty major layoff and I was eating lunch in the cafeteria and the division president came and joined my colleague and me, which was intimidating 'cause I was fresh into the role. And he was just making conversation with us and asked how we were feeling about these layoffs that had just happened. And I said to him, "Yeah, I dunno how you do it. I can't imagine having to lay off all these people." And I'll never forget this. He looked at me and he said, "You know, you really can't call yourself a leader until you've hired and fired. You have to be able to make the tough decisions." and as a young 22 year old product manager, I remember sitting there thinking, "Wow. I can't imagine what that must feel like." But he wasn't wrong.
And I think what I've learned over the years is, if you can operate with those principles of mutual trust and mutual respect, it builds up that bank account with these individual relationships that you have as a leader. And so when you have to make the tough calls and you have to make the unpopular decisions, hopefully, if you can at least help people understand the "why" behind some of these decisions. I've seen people do this really well and I've seen people do it very poorly. And I am by no means perfect at it, but I'm constantly striving to be as transparent as possible. So that people at least understand the "why."
And then finally I would say, leadership is so much about creating the right environment for healthy teamwork. And so for me, I always love it when I start to see my various leaders on a team click and start to build those connection points without me in the middle of it. Because to me, that is an indicator that this team is starting to really work together in a high performing, high trust fashion. And that is the secret sauce behind every team I've ever led is creating that environment, getting the right chemistry between the various team members in the group, and then watching those connection points really take hold. To me that's where the magic happens, and I think that's what makes it all worth it.
Lindsey Dinneen: Yeah. Yeah. So you've obviously had a really lovely career so far, and I'm sure will just continue. But you know, one interesting element is it sounds like you had opportunities to lead fairly young into your career, and I'm wondering how you approached perhaps teams that had a diversity in terms of ages. And was that ever intimidating to you if maybe you were coming in as a younger leader than some of your followers? Was that ever a challenge or how did you handle that?
Rebecca Whitney: You know, it was, and that absolutely happened. I was probably 26 years old when I started managing people that were older than I was. And the whole team was, it wasn't just one or two. And initially I was extremely intimidated because I felt I had that imposter syndrome, you know, what right do I have? And it did take me a little bit to, to feel comfortable. I think for me, I just told myself, "Look, somebody had confidence in me and somebody put me in this role for a reason. I have to trust myself and I'm going to prove to my team through my actions and earn their trust and show that they're in good hands with me."
And luckily I had a team that was very receptive, and I think when they saw how I approached it and what I brought to the table, they were very supportive. But yeah, initially I had to get over my own internal talk track that said, "You know, this doesn't make any sense. Why in the role would somebody take direction from me when I'm 10, 20, 30 years younger than they are?" But it was a great learning opportunity and frankly, it continued for, not so much now 'cause I'm a little further on in my career, but that was the case for at least the first decade of my leadership opportunities and so it was important for me to learn that early on.
Lindsey Dinneen: Yeah, absolutely. As a woman leader in a field that isn't predominantly women led usually, what are some of the pros and cons you've seen? What are some of the exciting elements about that? And then what are some of the opportunities for growth as the industry continues to evolve and change over time?
Rebecca Whitney: That is a great question, especially in the orthopedic spine world. It's extremely male dominated, at least historically it has been. And just like managing team members that were older than I was, I had to learn very early on that, especially when I started out, I was likely going to be one of, if not the only females in the room. And I had a boss fairly early on that, that gave me some great advice because, by default, I remember-- first of all, I have horrible handwriting. I'm probably the worst scribe you could ever pick out of a group. I've just never, ever had good penmanship and I was constantly being asked to take notes on flip charts. And I was doing it, and my male boss pulled me aside and he said, "You know, we teach people how to treat us." And he said, "I know that you're just being collaborative and helpful, but you've been taking notes for the last six times we've been in a group." He said, "The next time you're asked to take notes, say no." And that seems like a little thing, but I did, and not because I was refusing to take notes, but I just was making sure I was a little more balanced of an approach.
That's a silly example. But I think that for me, I had to learn early on that there was nothing wrong with me being one of, or the only woman in a room, just like there was nothing wrong with me being on the younger side of people in the room. And again, there's that imposter syndrome. But I think having confidence in my abilities and recognizing that the more I could be comfortable in my own skin, that was what would enable me to bring probably a different and unique perspective.
I was told in my twenties that I should dress in subtle tones and black and gray and navy blue suits. This was from kinda a leadership coach, and I remember thinking about that, and I thought, "I don't want to wear black and gray and navy blue suits." And so I've always tried to keep my own brand and my own authenticity while at the same time recognizing that it is difficult to kind of be the one outlier of a group.
I will say that as time has gone on, I'm very pleased that the workforce is starting to better reflect our society. And I think that, that gender diversity certainly is expanding, which is nice. But my advice for anybody out there, regardless of gender or ethnicity or even just diversity of thought, is recognize that we are put into these roles because of what people see in us, our abilities and our potential. And if we stifle that in any way, shape, or form, the company and our teams and our customers are not getting what we have to offer. And I think the more comfortable I got with that, the more effective I've been able to be.
Lindsey Dinneen: Oh my goodness. That is excellent advice. Really, thank you for sharing that, that really hit home. I appreciate that perspective that you've had. You've had such an opportunity to really grow in your role and I just love seeing that progression. So yeah, thank you for that advice. That was really good. I'm curious, how do you, these days, continue prioritizing your own learning and growth as a leader? Are there still things that you keep doing in order to sharpen those skills? What does it look like now for you?
Rebecca Whitney: Yeah, so I'll start with something that probably is an obvious answer that most people give you. But podcasts are amazing and I'm probably a little late to the party on this because I didn't start listening to podcasts until Covid. But I have found that is a fantastic way-- I mentioned-- I live in Colorado. I will spend Saturdays and Sundays out on very long walks, either around Boulder where I live, or even up in the mountains. And I will just binge listen to podcasts on all different types of topics: leadership, business, life skills, you name it. And they're not all work oriented, but I have found that to be a really good way to just get a sampling of advice, opinion, and learnings from a wide variety of people. So that's one. And I think for me, being able to do that on the weekend, disconnect a little bit and really dig into these podcasts that I compile and save up. It, it's just it's a major reset for me in a very good way. I'm sure I drive my team crazy 'cause I'm constantly sending them these podcasts over the weekend as I listen to them as well as my family. But that's been really great for me.
I would say the second major thing is, I love to travel. My husband and I look to enhance our lives any way we can, and I have found that one way that helps me learn is looking for those connection points between my personal life and my professional life. And what I mean by that is I try to be very authentic and consistent. So whether I'm in the workplace or at home with my family or on my own, the more consistent I can be is a healthier place for me, because you're not having to put on one persona versus the next. And so the more I can find those connection points, meaning if I learn something in my personal life, I can apply it into my professional life.
And to me, that's where I get a lot of my continuous growth and development. So if it's tackling a big aggressive hike I haven't done before, I find myself, while I'm training for that and doing the hike, I find myself thinking about ways I can push the team at work or push myself. So strangely, as I've continued to grow in these roles and in my personal life, that balance between work and life has blurred, but I think that's been to my benefit, both personally and professionally. So I'm always looking for opportunities to enrich my personal life, because I do think that transfers back into the workforce as well.
Lindsey Dinneen: Yeah. So what are you looking forward to next in terms of maybe both personally, professionally, and as your company continues to innovate and develop new things, what are you excited about these days?
Rebecca Whitney: So our company, ZimVie, is relatively new. We were spun out from Zimmer Biomed, our former parent company, not even 18 months ago, and it's been really fun to help shape this new identity and this new culture. And talking about this tethering device I mentioned earlier, we have another device that allows us to treat cervical neck issues with a disc replacement which, long story short, means we're able to preserve motion for these adults who are looking to have their pain addressed.
And so, what we're trying to do, and we do have a mission: we've got a number of patients that we're trying to treat in 2023 for both this cervical disc replacement device, which we call Mobi-C, as well as this tethering device for pediatric scoliosis patients. And so, what's next for us is continuing to develop these markets and make sure that we bring these amazing solutions to every patient who is indicated to receive it. And so, that's gonna keep us busy for quite some time. I'm sure we have work to do beyond that, but we're just also passionate about it. That's definitely what's next for us, at least professionally, is continuing to carry that forward.
And then personally, it's always about the next adventure to, to push ourselves. So, we're actually headed to the Grand Canyon in December, my husband and I are, with my sister and brother and their spouses, and we're going to do a multi-day hike backpacking trip. So really looking forward to that and just looking forward to being outdoors with my favorite people, doing something that challenges us physically and spending a lot of good quality time together as well.
Lindsey Dinneen: Oh, that sounds so exciting. Both the company's trajectory and then your upcoming adventure, that all sounds really fun. So I'm sure that will be a lot to look forward to.
Rebecca Whitney: It's busy, but that's the way we like it.
Lindsey Dinneen: Absolutely. Oh, I would always rather be busy than bored. Well, pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry, but it could be. What would you choose to teach and why?
Rebecca Whitney: So, I will say that my dream job, if I weren't doing my current dream job has always been to be a travel writer. I would love to travel the world and then write about my experiences. And so if I could do that and then teach a masterclass on it, to me that would just be the most amazing opportunity. I am driven by two things. One is influence or language and ideas. I love to communicate and I love to inspire others by speaking and sharing, whether that's talking or writing. And so to me, to share that know-how and knowledge and passion about travel-- and not just the regular beaten path, but having these adventures that are off the beaten path and the food and the culture and the people and the adventures-- I would love to, to master that and then teach people how to go tackle that so that others can share in that passion and see what the world has to offer. So, that to me just sounds like a dream come true. I would love to do that.
Lindsey Dinneen: Yes. Yes. That sounds like an amazing masterclass and yes another dream job for sure. I'm just curious because I completely agree with you that in traveling internationally is such such a gift and it is so important if you can do it in terms of broadening your horizons. But I'm curious, what do you think are the main one or two things that, that you find are the most important elements of traveling abroad?
Rebecca Whitney: So I would say the first thing is don't be afraid to say yes. My oldest nephew just graduated from high school and in my letter that I wrote him, as part of his graduation gift, I said, " Bias yourself towards saying yes when you're out on these trips and these adventures." And I think that when you're on an international trip, it can be really easy to just stay in your comfort zone. I'll give you an example. My brother and I were traveling in Africa several years ago and we had a driver pick us up when we landed in, where were we? It was off the coast of Tanzania. And it just happened to be the last day of Ramadan and he invited us back to his home-- we never met this man before-- to break fast after 30 days of Ramadan. And I think if we had been less open to trying new experiences, we both would've said "no way." But we said yes, and we had the most incredible experience that enriched our whole time. It was Zanzibar, that's where we were, and it was just one of the most incredible travel days of our lives. And so I think the first thing is being open to the experiences and biasing yourself towards saying yes, whether it's a dish or a food that looks terrifying to, to try. Or seeking something out that enriches the experience. I think that's one.
And then two is staying flexible because travel these days, especially international, it's going to be fraught with setbacks, whether it's a train strike or a ferry schedule. So just being very flexible to kind of roll with it. Because I've seen, myself included, too many instances where some of those glitches can unfortunately ruin the experience. And so, being open to the new experiences and saying yes-- and then staying flexible to just roll with it, and take the trip as it comes, and let it go down whatever path presents itself-- I think are two really important ingredients for maximizing a global travel experience.
Lindsey Dinneen: Could not agree more. Yes. Okay. What is one thing you wish to be remembered for after you leave this world?
Rebecca Whitney: So this is probably a very cliche answer, but it's really true. I, I've thought about this and I do want to be remembered for the way I make people feel. And I say that because speaking about the job first, I feel like people have a choice. And any job that we take has the day-to-day tasks and requirements. But when I look back on my career, by far the most rewarding and the most challenging elements have involved people. And so I think whether it's a tough situation or a very successful celebratory situation, I want to be remembered for how I made people feel, and hopefully that's a positive thing.
And that translates outside of work too: my nephews, for example, and my nieces. I want to be remembered for enriching their lives and giving them new experiences, but I also want them to know that I was there for them and the people that matter most to me. I think it's just very important. It's that old cliche saying, "people won't remember what you said, but they will remember how you made them feel." So, to me, if I'm doing my job right, inside and outside of work, hopefully people's impression after I'm gone is net positive in terms of how I made them feel.
Lindsey Dinneen: Yes. And that ties right into your discussion earlier about leadership and having that bank, right? And putting in those credits and and so when things do get a little difficult sometimes you have had a net positive in the end.
Rebecca Whitney: Yes. Yeah, that's right. Yes, exactly.
Lindsey Dinneen: Yeah. And then final question, what is one thing that makes you smile every time you see or think about it?
Rebecca Whitney: So I am a big believer that yes, we all have these milestone events and these big trips and things that come up, but I really look for the little things that bring joy on a daily basis. And when I took this role about two and a half years ago, my husband and I said, "Okay, we, we've got to find a way to stay connected because my days get busy." Even evenings are not that predictable. And so we've started getting up very early, which isn't as awful as I thought it would be. So we're typically up by about 4:30 in the morning. And one of the reasons we do this is because we have this daily ritual now where my husband makes the lattes, he's much better than I am. And we just sit together for about 30 minutes every morning.
And if I'm on the road, we do it through FaceTime and it's just this dedicated little moment of time before the day gets crazy and busy where we connect, we have our coffee, we watch the sunrise and we talk. And I look forward to it when I open my eyes in the morning and throughout a busy, stressful day or trip, knowing that we have that daily touchpoint to kind of anchor with both always puts a smile on my face and it just starts the day off on the perfect tone. And I look forward to it all the time and it definitely makes me smile.
Lindsey Dinneen: Yeah. Oh my goodness. That sounds like such a lovely time set aside to prioritize your relationship and get that special connection time. And of course a good latte never hurts.
Rebecca Whitney: That's right.
Lindsey Dinneen: That's amazing. Well, Rebecca, thank you so very much for joining us today. I really appreciate your perspective and your advice, especially for those who might be younger in leadership roles, maybe women who are coming into the medtech world, so thank you for that. And we are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers and scales innovative financial solutions that helps families living in extreme poverty, build sustainable livelihoods, and access quality education for their children. So thank you for choosing that as the organization, and we just wish you the most continued success as you work to change lives for a better world.
Rebecca Whitney: Thank you so much, Lindsey. I so appreciate the opportunity.
Lindsey Dinneen: Yes, my absolute pleasure, and thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a friend or two and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Dr. Kyle Flanigan | CEO of US Specialty Formulations | Kinder Vaccines, Commercialization, & Innovation

Dr. Kyle Flanigan is the co-founder and CEO of US Specialty Formulations. In this episode, Dr. Flanigan discusses the importance of providing specialized formulations that aren't typically addressed by larger pharmaceutical companies, shares about the company's focus on developing a unique oral vaccine platform called Kinder, and expresses his passion for leadership and innovation. 
Guest links: https://ussfgmp.com/ 
Charity supported: Equal Justice Initiative 
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 015 - Dr. Kyle Flanigan
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Dr. Kyle Flanigan. With more than 25 years of experience, Dr. Kyle Flanigan, co-founder and CEO of US Specialty Formulations, LLC is an expert in pharmaceutical and medical performance materials development stages. He consults with companies providing robust, stable solutions and services for formulation, scale-up technology, contingency planning, supply chain issues, quality systems implementation, and new facility design. He brings this knowledge and guidance to his company's clients and their pharmaceutical and medical developments on the best path to market. Thank you so very much for being here, Kyle. I'm so excited to speak with you today.
Kyle Flanigan: Yes, thanks for having me. It's a pleasure.
Lindsey Dinneen: Yeah, absolutely. I would love, if you wouldn't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are.
Kyle Flanigan: Sure. I'm Kyle Flanigan, CEO of US Specialty Formulations. I'm a co-founder with my business partner, Gary Moorefield. The two of us founded US Specialty Formulations with the idea of being able to provide specialized formulations to the public at large. So formulations that aren't typically picked up by the larger pharmaceutical manufacturing companies. And being able to provide those to, to patients or to doctors who are treating patients with compounds and formulations that they otherwise wouldn't be able to get ahold of. And that's kinda what started US Specialty Formulations.
In addition to that, both of us have deep foundational knowledge in specialty materials processing, pharmaceuticals processing, clean room operations, SOPs, setting up and building groups that work on a variety of different types of technologies like this. So we also looked at how do we further a vaccine project that my co-founder had going. And in doing that, we just, we decided to set up this company and make this service available to other people.
In addition to providing just your standard formulations used to treat certain diseases out there, we also provide a service for producing investigational drugs that new inventors may come to us and ask us to make, to deliver a high quality, clean, sterile high quality product into their investigations so they can continue with their clinical trials. So that's kind of where we are. And then out of that, we developed a vaccine platform, Kinder, which is the oral vaccine platform which we just got into, we just finished up its clinical trial out of New Zealand. And we got some awesome results out of because we adapted the platform from its original intended purpose, which was strep, and into a COVID 19 targeted vaccine.
And this oral vaccine actually shows improvement over the existing mRNA vaccines that are out there as far as protection capability. It operates on a slightly different regime. It's a mucosal vaccine, which is really interesting and part of a new wave of vaccines that are gonna start showing up in the next decade. And also, it's really easy to take. It's so great because this allows treatments without needing to stab someone with a needle. That's as simple as it gets. It's you don't need to have a needle to, to administer a therapeutic.
Lindsey Dinneen: Wow. That is very exciting for somebody like me who hates needles.
Kyle Flanigan: Yes. Both of us. I hate needles. Also, it's, that's part of the reason I got into this was to avoid-- when I was little, getting a battery of boosters and that was such an unpleasant experience. Part of the kinder thought process, and the reason we call it Kinder is because it's a "kinder" way to administer a vaccine. It's a much more pleasant patient experience.
Lindsey Dinneen: Yeah, absolutely. Backing up just a little bit, you mentioned founding the company, but I would love to hear the inception story of, how did you get connected with your co-founder, and then how did you guys come up with " this is what we want to do with our careers"?
Kyle Flanigan: Right. So Gary and I met through our daughters and we're in gymnastics and they're on the same gymnastics team. Anyone listening who is from a gymnastics family will know this very well. And what happens is, the person doing the gymnastics is maybe performing for a whole 30 minutes, maybe 50 minutes total time on the floor. But at a gymnastics event, typically with all the teams and everything out goes on for easily four to six hours. And so Gary had his other company that he was working with, I was employed by another company. But we were both very interested in technology . And so while we sat in the stands trying to be supportive of our daughters as they're doing these crazy death defying moves, to kind of pass the time we would just talk shop sometimes.
And, over the course of a couple of seasons, we recognize that one, we got along, but two, we both had very strong and clear ideas of how to do a variety of things. So that's key. And our vision and our goals kind of align with, "Hey, if I had the ability to do this, this is what I would do and here's how I'd run it." And as we work through those casual conversations, we recognized that we were aligned in kind of our thinking of what we wanted to do with our careers. And an opportunity came up so that I was able to leave what I was doing and devote some time to some business planning, business modeling and things like that. We developed the model and then incept the business in 2013. And bring it up and just begin to build our clean rooms and things like that. We built everything by hand at first. Just the two of us again.
With such intimate knowledge of the space, the operational side, as well as the development side, as well as the business side from our past lives, the two of us were able to do what typically you would expect a high powered team of, 10 to 12 people to do, just to start the company up and running. So we were able to do that, and that was, that's really what started, USSF off in this pharmaceutical space. It's really a cool story. I think our first clean room looked a little-- you could tell it was hand-built-- but it was very functional. It worked very well. Our next set of clean rooms is a lot better, and then our third set that we're still in the planning stages for our expansion, those look much more much more we'll say professionally built.
Lindsey Dinneen: That's amazing.
Kyle Flanigan: It was a good story because, again it's kinda like the two of us had the vision, put a business model together. And we've worked through it and surprisingly from our original business model, the environment and everything else hasn't changed all that much. So our model has held consistent through the test of time over these past what is it, 10 years? 10 years now.
Lindsey Dinneen: Great. Wow. Yeah that's amazing. I love those kinds of stories where it's just a person or a couple of people with big dreams and big goals, and they just set out to do what they know that they were meant to do. And sure, sometimes it looks a little wonky at the beginning, but it works.
Kyle Flanigan: Yes, we were very happy. The first formulation we had for sale was a very celebratory day. I think it was just, I think our first product was saline. We had saline for injection and it was a monumentous day when we got it packed and ready to ship to a customer.
Lindsey Dinneen: Oh, yeah. I can only imagine. That's so exciting. I love those moments. So I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career for you? Now, that's a broad question. So it could be related to your experience in the industry as a whole, or it could be specific to your company. But in general, is there a moment or a series of moments that just said, "yes, this is it."
Kyle Flanigan: Yeah. I think, one of them actually happened fairly recently. We made an investigational drug for a customer. And they used it. And this particular one was made to enhance the survivability of organs during transplant. From that, you know, it's still in development and it's still being going through its processes. But we had to refine the formulation, develop the formulation really quickly to get it available for a-- I think they were going for a compassionate care use, I'm not entirely certain-- but you know, we were able to get the team trained and ready to go and we were able to get this formulation out the door to the customer.
And we received a note later that was forwarded from their CEO to us, and it was, " Hey, you just wanna let the team know that because of your diligence and capability this, this was used and we applied it to an organ. And the surgeon let us know that the organ would not have been viable if not for the additive that you guys supplied to us and the transplant was successful because of what you provided." Otherwise, I think it was a girl of like 17 or something, she would not have made it if it, if they had not used this.
I did not think it would have such a big impact in my thought process, and then after it, as it kind of sunk in what we were able to accomplish. This really is one of the satisfying things about what we do. We were able to successfully get this out. We were able to produce a high quality thing and it saved someone's life. That makes the entire team as you're going through it, it focuses you and allows you to say, "Hey, this is the goal, this is why we do this. This is why this is important." And the results are very tangible at the end.
And that just affirmed that, so it was, it was awesome. But I would say that's the moment that was, you know, a couple years ago, but it let me know that, "okay, you're in the right field. This is what I like doing." You know, putting a team together that can do that. Having, the technology and the bits and parts that all come together to culminate in being able to provide that lifesaving action is really important.
Lindsey Dinneen: Yeah. It is so important. And I can only imagine too, being a father yourself and realizing, you have a daughter too, and that like connection-- yeah-- of, of this is so impactful to somebody. And it could be somebody that you know personally in the future, who knows, but the point is you're making a difference. And that's-- ugh. Yeah. That's a good feeling.
Kyle Flanigan: Right, it's one of the feelings-- when we thought about why does USSF exist? And that's one of the things is we handle a lot of the formulations that the big companies don't handle. For a variety of business reasons, they don't. But really, when it comes down to it, when you're a patient sick and your physician prescribed a certain medication, if that medication's not available, then it's effectively you don't have any healthcare, right? That's the problem. That's one of the reasons USSF is here, is to be able to provide, certain medications or vaccine technology, so that we are able to provide this healthcare when the larger companies have passed on providing for that.
Lindsey Dinneen: Yeah. Yeah. That's great. So growing up, was medicine always of interest to you or chemical formulas or whatever, like was that always of an interest or is that something you kind of developed?
Kyle Flanigan: It was always an interest. It was always, we'll say an ancillary interest. Truth be told, I'm a pilot and I love flying and anything aviation or space related. So I always wanted to go into space to do pharmaceutical research on the space station or zero G or microgravity type stuff. So , chemistry has always been a part of my training and my background. Both my parents are chemists. My dad was big pharma, my mom was analytical lab chemist, so, so it's always been there. My training is as a chemist.
But I think, I always want to do from the beginning is, it's that explore and build kind of drive in me. Go into unchartered territory where I am the first, or only among the very few, that actually have blazed the way down a certain technology path or being able to introduce new things to the market. And I think that drive is one of the things that influenced my spin up into deciding to found effectively a startup, and then grow it into a much larger entity.
And it's not for the faint of heart, right? As we discussed earlier, this is extraordinarily challenging. You need the technology, you need the chemistry chops, you need the science chops. But there's also more, you also need a energy and an underlying drive in order to really do this. It's that goal to explore, create, and bring people up behind me as I keep charting a path. And that's kinda the drive that's pointed me in this direction and laser focused me in this direction.
Lindsey Dinneen: Absolutely. Yeah. And I love your idea that you brought up of exploring and creation and sort of being the first to go into some uncharted territory. I think that's a common theme I've noticed in this industry of people who are curious and they're interested in learning and they're interested in growing not only themselves and their own abilities, but also the industry as a whole, pushing it forward and whatnot.
Kyle Flanigan: I was gonna say it's that, read everything. I think when I was growing up, the net was still-- it wasn't the net that we know now. But, reading The American Scientific or whatever business journals my dad brought home from the office. But just picking up those magazines and devouring them and reading, even though I didn't have the background in training for them, I would still read them and pick up little bits of knowledge here and there. And even today, I think one of the things that separates the kind of people on our team that do really well are those that if they don't know something or there's a meeting where there's some bit of information that they don't know offhand, the behavior that I see that really makes me proud is, they'll just go look it up.
Yeah.
No one goes, "Oh, I dunno," and then move on. No, you've got three or four people go look it up and like, "Oh, okay, here's what it is, now we understand it, let's proceed with this new knowledge." Those are the kinds of people that enable technology to grow rapidly because, to commercialize any technology, it's not a one man show. You might come up with certain things, but once you try to commercialize it or bring it into production or run it through a regulatory process, it becomes a major team effort, and the curious make that effort much easier than if you just have people who just do exactly what they're told all the time. That works for very large kinda sustaining type companies. But for these, the leading edge-- although as they say, the bleeding edge-- of technology, it's those kinds of people that is what's required for companies to be successful.
Lindsey Dinneen: Yeah, absolutely. I'm curious how your own leadership abilities have evolved over time and how would you define leadership or what does it mean to you?
Kyle Flanigan: You know, initially when we first found it, it was the two of us, then three of us, then five, and now we hover around between 13 and 16 at any given time. And I think it's gone from, initially when you first found, you're a doer, a planner, but you're focused on daily ops with a little bit of strategic stuff in there. And now it's shifted with more of a team. What has shifted is into being able to lay out a roadmap for people so that the team leaders understand where we're going.
And, I'm not, and Gary's not focused on, explaining to people how to do a certain task. It's more of a "Here's where we're going, here's the task that you need to accomplish. You guys know how to do it. We've trained you how to do it, or you've got the training on how to do it now, just execute to your training, but here's where we're trying to go." So that's how it's shifted. It's shifted from the tactical to the strategic.
I think for me, a leader is a person who can identify the strategic direction that the team should go. And usually that's getting input from a lot of people, not just in the company, but you know, knowing the lay of the land, right? Being out in the industry, taking in the voice of the customer, all that great stuff, and then saying, "Here's the direction this company should go. Here's what's required for us to go there, and here's what I need each of you to do to get us there." And being able to lay that out. That's kind of the strategic side.
The other side as a leader is to be able to remove roadblocks from your team, meaning reading the team, how does this particular team member operate? What are their buttons? What is preventing them from accelerating and providing that feedback to them. And if it's something that you can address, addressing it. So, removing roadblocks. Again, as I say to my logistics person when he says, " We can't get this our, our supplier doesn't have this anymore." Then it's working with him and saying, "Okay, let's work through this and find some alternates and we'll work through our process for identifying alternates and picking new ones."
That's a basic one, but you know, it could be as simple as, "Hey, my childcare person just quit." Right? "I have no one to babysit my child and so I can't do what we're doing." Okay, let's figure out how you can still do what I need you to do, but also your home stuff is taken care of so that you can focus, you're not worried about that while you're executing your other duties. And I think a leader has to be aware of the different challenges their team members are facing and be able to, one, create an environment to make it pleasurable to work. But two, help them overcome those different things. And so I call it just removing roadblocks, whether that's on the business side or the personal side. What are the roadblocks that I need to assist with?
And sometimes you just can't do anything, right? And you have to say that. But if there's things within your power to, to help with, then I believe a leader should do that. So set the direction strategically. Empower the people to do what you're asking them to do, right? Don't tell someone to do something and then give them no power to do it or authority to do it, right? That's pretty poor leadership. And then remove any roadblocks that are coming, whether it's professional or personal, if you can help with that.
Lindsey Dinneen: Yeah. That's great. Thank you so much for that advice. I think that's really important to have all those components, like you said, because people are multidimensional, so it can't just be one thing that you're trying to help manage, say. So it's not just the strategic side as a good leader, although that's extremely important. But like you said, the roadblock, I really like that analogy of helping someone to do their very best. And that could be through the work. It could be through the personal lives or whatever, but since people, it's all intertwined for us, it's so helpful to have a leader who understands that and can put it all together. So I really like your 360 approach to that for sure.
Kyle Flanigan: Ah, thanks. And again, both Gary and I come from large corporate environments. So we know how not to manage people.
Lindsey Dinneen: Yeah. I hear ya.
Kyle Flanigan: We've both experienced that. Yeah.
Lindsey Dinneen: Yep. That is sometimes not a lesson that you would prefer to learn that way, but it is a good teacher. Yeah, absolutely. Pivoting just a little bit. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?
Kyle Flanigan: Oh, I think, yeah, for me it would be how to commercialize a product. And I say that because a lot of the world, when you hear notes about technology and the challenges associated with just being a human today, right? You'll have people say, "Oh, well someone invented X, Y, and Z." Okay. And then you have a large company, many years ago that will say, "All right, we produced 80 million of these widgets a year, and we're providing them to, to these people to make their lives better." Okay. That's two ends of a very long spectrum. Very few people are familiar with what has to happen between the person in the lab saying, "Yes, I now have a working model of what we're going to ultimately produce" to when you can go buy it on a shelf somewhere, right?
And here's an example. I think, during Covid, a lot of people were saying, "Oh, we're gonna throw all this money at this problem. And we should be able to then have it go away." And it's that in between having something in the lab to having it on a shelf ready to use, that's a very long time period or a very complex period. Not necessarily long, but complex period. In some cases it is actually a fixed amount of time between certain steps in that, that have to occur, and no amount of money that you throw into it is going to speed that up.
So I see this a lot in the investor discussions and other types of discussions with politicians and things where, okay, if you throw a million dollars at a given problem, it doesn't mean it's gonna be fixed tomorrow or in six months. And so teaching that class of what are the things that actually have to happen at the high level. For instance, I talked a lot about teams and building and things like that. If you were to throw up a new facility, you have to staff it. That takes time. You have to find these people. Even then, once you have the people, you have to train them on all the new equipment you put in the facility, right? So all that takes time. And that could be six months, it could be a year. The team has to get comfortable working well together, so they're probably gonna take another eight months before of actually doing it, before everyone knows what each person's supposed to do. So now you're in a, a 24 month time period from someone just throwing a lot of money at something.
So, I would love to teach a, a masterclass on when we say we're gonna commercialize and start up as an entrepreneur or something like that, here's what that involves, right? Here are all the considerations that, that are gonna go into this, and these are the choices you're gonna have to make. Some, you can make early on to make your life easier on the backend. Some, you won't be able to make until the day or the month you actually have to make that decision. Some are instantaneous. But these are the kinds of things that you have to consider while going through.
While I was at grad school, actually took an entrepreneur course. We used Guy Kawasaki's book. But it talks about that, that beginning cycle. How do you pick what you're gonna do? But the commercialization side, I think a lot of people who are in the field, looking at it as industry specific. But I think it could be taught a lot broader. That would be my, my thing.
But how do you, commercialize looking at supply chains? We saw a perfect example of broken supply chains, right? So how do you design for those? And these concepts have been around for a long time. Certain industries are better at it than others, but it's not something that is ubiquitous in the industry. It's not a regular thought process for people. And I think in a masterclass set up, those are the things that, that if they're called out and actually focused on with a little bit more attention on stabilizing, or teaching people these considerations, it'll go a long way to mitigating those scale up risks in the future for all the other really cool inventions and technologies that are out there. But, everyone depends on a supply chain. So that's what I would teach, I would devote some serious time in examples into trying to teach people about that.
Lindsey Dinneen: Yeah, that's a great subject and very important, so that would be a great class to take. What is one thing you wish to be remembered for after you leave this world?
Kyle Flanigan: Yeah, again, we go back to having daughters and things like that, but as I look at them growing up and maturing, I think it's really having left the world, let's say, a better place. And by being in a better place, meaning the human condition is a lot more pleasant than it was when I entered the world. And I contributed to that. So again, vaccinations, you don't need to get stabbed every time you get vaccinated. I just hate needles. But, you know, that goes a long way at making the deliverance of healthcare process more pleasant, and making it more available to people who otherwise would not have access to it in using conventional methods. So I think that is improving the human condition considerably. And enabling a lot better care and opportunities for people throughout the world.
Lindsey Dinneen: Yeah. I love that. Yeah. And I love that you're actually living what you are passionate about and so you're building your legacy as you go. So, final question. What is one thing that makes you smile every time you see or think about it?
Kyle Flanigan: So many things. I'll give you two things I can't decide between them.
Lindsey Dinneen: Sure.
Kyle Flanigan: One is both my daughters are competitive in their sports. So one is a cyclist. And when I see her racing around the track on her bicycle, winning or placing and medaling, I am thoroughly thoroughly proud of that. And the other daughter is a gymnast, like I said. And when I see her out competing and again, medaling and things like that, I'm just immensely proud of their dedication and focus that allows them to do that. And I would say at least I married someone who was able to teach that to them probably. So I smile whenever I think of the two of them.
And then drone drops, drone dropping of medications and essential supplies to the outback, places where there are no roads and things like that. I think that's just awesome. It's the combination of multiple technologies to again, improve people's lives and it's gonna be the start of something. Right now we're talking about little packages, right, for those things. But as the tech gets better and people get more and more comfortable with trusting the robots. Again, that has some science fiction implications, but I think as people get more familiar with the technology and work some of the bugs out of it, more and more things will begin to be employed that way.
And it makes me smile because it is reducing the risk for people living out there and for the delivery people who have to deliver that stuff. You know, all around it's a risk reduction exercise. And it embodies everything I love about technology, aerospace, pharmaceuticals, and drones and logistics. So it's just awesome. So, I do smile when I think about drone dropping of stuff.
Lindsey Dinneen: I love that. What a great answer. So relevant to what you do, but also just such a unique answer. That's fantastic. Kyle, this has been so much fun. I really appreciate you joining me today and sharing your story and your insights. So, thank you just for the time that you spent and we're honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. Thank you for choosing that. And again, just thank you for being here. We wish you continued success as you work to change lives for a better world.
Kyle Flanigan: Okay, thank you. Thanks, Lindsey, for having me. And I appreciate it. I'm honored to always be asked to speak about various topics.
Lindsey Dinneen: Absolutely. Yeah, of course. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Dr. Ben Freedman & Dr. David Wu | Limax Biosciences | Innovation, Collaboration, & ”Snail Man”

Dr. Ben Freedman and Dr. David Wu are the founder and advisor of Limax Biosciences, respectively. In this episode, they discuss their breakthrough innovation of novel biomaterials to transform healthcare, why collaboration and mentorship are so important, and how slugs inspired their work to the point of Ben being featured in a German TV show as the superhero Snail Man. 
Guest links: https://www.limaxbiosciences.com/ 
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
SHOW NOTES
Episode 016 - Dr. Ben Freedman & Dr. David Wu
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am very excited to introduce you to my guests today. They are Dr. Ben Freedman. He is the founder of Limax Biosciences, and along with him I am honored to have Dr. David Wu, who is an advisor for Limax Biosciences. Gentlemen, thank you so very much for joining me. I am so delighted that you're here. Thank you for being here.
Dr. Ben Freedman: Thanks so much for having us. It's great to speak with you today.
Lindsey Dinneen: Absolutely.
Dr. David Wu: Thank you for having us.
Lindsey Dinneen: Yeah, absolutely. Well, I would love if you all wouldn't mind starting by sharing just a little bit about yourself, some of your background, how you got into the industry, and what you're excited about right now. Maybe we can start with Ben, and then David, I'll turn it over to you after that.
Dr. Ben Freedman: That sounds great. Yeah, so for me, I was always interested in science and technology in high school and prior to that point in time, and when I was looking at opportunities for what to major in as an undergrad, I came across bio-medical engineering, which at the time was really an emerging field that kind of blended a lot of the interests that I had between medicine and engineering and technology. And I got involved with a number of different courses. Had a number of different research experiences as an undergraduate and a lot of really fantastic dedicated research mentors that really pushed me to start to explore so many different areas within the field and industry and get a sense for all the different neat and exciting activities that were going on. And I really enjoyed research at the time, in the bioengineering space that led me to do a PhD in Bioengineering at the University of Pennsylvania where I was asking a little bit more basic science questions but had really strong interest in translation, in developing new therapies.
So, after that point in time, I continued to do a postdoc at Harvard and the Wyss Institute where we started kind of combining a lot of my interests from my PhD in soft tissue biomechanics with developing new therapies to try to improve the healing process. And one of those therapies that we came across very early is that we realized that for material to deliver something, whether that be a some cells or other type of drug therapy, two tissues. It really needed to be coupled to tissues locally. So we started exploring this area bioadhesive, quickly realized that this was a really exciting area, not for just areas within the orthopedic space, but really many different types of diseases throughout the body. And it basically led us to kind of explore not only the academic path, but also a lot of the translational paths as well. That's really what's brought us here today.
Lindsey Dinneen: Amazing. Thank you. David?
Dr. David Wu: Hi everyone. So, I am right now a clinician scientist at Harvard University and what got me interested in the space, so during high school and an earlier part of undergrad, I was really fascinated by this idea of biotechnology and the fusion between the biomedical engineering, biology, as well as healthcare. So I did my undergraduate training in anatomy and cell biology at McGill University in Montreal. And during that experience, being fascinated as a student to learn more about research, I was involved in several different aspects of research, including stem cell biology, tissue engineering and immunology. Wanted to explore a little bit more about how these things were intertwined together. At the same time, through working with the local community on certain humanitarian initiatives and community initiatives, I got exposed to the field of dental medicine actually because I was interested in having a very direct impact on each individual patient's lives, on a daily basis, as well as learning more about research and how to advance the field. As a scientist, I managed to combine both. So during my dental school at McGill University, as well, I was involved in a project in stem cell biology and regenerative medicine, looking at how we use bone marrow cell extract to help patients who have oral cancer and have undergone a radiation therapy. So as a result of these type of radiation therapy, patients would have their salivary gland destroyed, and that could lead to a lot of oral complications, including rampant caries, different types of infections, so making these patients lives very difficult. And exploring different regenerative therapies, and that introduced me to the field of tissue engineering.
So, fast forward a couple of years in terms of graduation from dental school, I had the option of pursuing specialty training to become a specialist. And the specialty that I chose was the field of periodontology or periodontics. And for those of you who don't know what that entails, periodontology is basically a specialty treating gum diseases and building a good foundation of supporting structure, supporting your teeth. So your jawbone, your mandible, your gum. And right now what we do is a series of plastic surgery, a reconstructive surgery, to help patients with severe disease to build them back to a health condition to allow them to smile and chew. And part of that involves regenerative medicine and tissue engineering.
So when I started at Harvard University, I had the privilege of meeting professor David Mooney, who was a world expert in tissue engineering and bio materials, and decided to start my doctoral thesis at the lab. And at the same time, that's how I met Benjamin Freedman, who was postdoc at the lab at the time, and we started collaborating on these projects, exploring the application of bio adhesives in different indications. And one of the indications we're exploring has to do with the cranial facial complex. So that kind of attracted me to the MedTech industry as well.
Lindsey Dinneen: Wonderful. Yeah. And so I would love to hear then more about Limax?
Dr. Ben Freedman: Yeah. A number of existing topical adhesives such as the super glues, the cyanoacrylate-based adhesives that are used commonly for superficial wound closure actually don't perform very well once you start using them in any sort of wet or actively bleeding environment that those types of glues become very rigid and don't bond well to the underlying tissue surface. A lot of existing tissue pieces are very weak. They're brittle upon any interaction with dynamically moving tissues or organs, compression, which is very common inside the body where a lot of these materials simply crumble upon any sort of mechanical stimulus that you place on them. That is coupled with a lot of the complications and challenges with the human body. There's a lot of wet tissues, a lot of tissues that are bleeding or exuding other fluids. And while these materials are really designed to try to prevent leaks and things like that, when they actually don't perform very well once they start to interact with wet surfaces.
So for all these reasons they certainly demand for new materials. There's also, of course, a number of complications that have been reported for other types of bio adhesives, depending on their cross-linking mechanisms that include areas where they're toxic to underlying tissues. They can create all sorts of catastrophic embolization events and many other areas which are reported in the literature, which has really driven a big demand for developing new materials. But there's been a limitation in the field and kind of a breakthrough that we had made a number of years ago before I had started working in the lab with Dave Mooney at Harvard and the Wyss Institute. There was a discovery that was made for generating materials with really unique mechanical properties. And this was actually something that we didn't realize was gonna be as important for adhesives until recently. Because the reason why existing adhesives fail is that there's been a huge amount of efforts placed on generating strong adhesion to underlying tissue surfaces. But there has not been as big of an emphasis on generating materials that have strong cohesion such that the materials may be sticking strongly, but they have such weak matrix properties that they will fracture upon any sort of mechanical stimulus.
And it turns out that you actually need really strong, cohesive properties first before you can generate really strong adhesive properties. So it turns out that a number of years ago, about 10 years ago at this point there was a discovery made at Harvard University where a new form of hydrogel was created. So hydrogel is a swollen polymer network. It's about 90% water, and It was discovered that if you created a dual interpenetrating network of two different types of polymers, one that dissipates energy and another that has high elasticity, that either one alone has relatively weak mechanical properties, but if you couple the two together, they interact synergistically to create a material with very high what we call material toughness.
And these tough hydrogels have really enabled us to reimagine what we can do with a biomedical tissue. This same high toughness principle was later applied in around the year timeframe of 2016, 2017, when the bioadhesive were first developed in the Mooney group by a very talented postdoc, genuinely, who was now faculty at McGill. And this is around the time that I was starting in the lab and since then we've been working to, to create new versions within materials that have really interesting new properties, but it's really the synergistic interactions between this interpenetrating network with high toughness that's then added, coated with an adhesive layer that allows us to generate strong adhesion. And where all this came from is we were inspired by nature. We are coming from the Wyss Institute for Biologically Inspired Engineering at Harvard where we tried to turn to nature for new ideas to create new materials that have unique properties.
So here we actually turned to the slug. And when slugs feel threatened, they secret a very sticky mucus that prevents 'em from being taken away by a predator. If you analyze the composition of this mucus, there's a whole series of slug slime researchers out there who have done a fantastic job quantifying some of the compositional and mechanical properties of this mucus, that it has actually very tough mechanical properties. You can stretch slug slime about 10 to 15 times its initial length without breaking, and if you analyze the composition of that same slime, it's about 90% water. It's a hydrogel, and it has a dual interpenetrating network of ions, proteins, and sugars that give it its unique mechanical properties. So, once we started realizing this, it, became clear that, hey, we have actually a material already in the lab that has really high material toughness, our tough hydrogel. Maybe we could actually couple that to tissues by applying some of the same principles of this interpenetrating network with a very amine rich bridging polymer, which we try to recapitulate in the lab.
So we don't use any slug components. Full disclosure, no slug components. It's inspired by slugs and actually, Limax is Latin for "slug." So we have kept the slug theme all the way up to the creation of this entity. So it's something that we, hold very closely near and dear to our hearts. And something that we think has a really unique strategy to solve a very pressing, unmet clinical need.
Lindsey Dinneen: Well that is amazing and I love the story behind it. And so I just have to ask, are you ever gonna have a snail mascot or is that a thing?
Dr. Ben Freedman: That's a great question. That's a great question. But before we all laugh, we do integrate a little bit of the slug with our logo. So if you go back and look at the logo now, you'll probably notice there's a little component that does have some slug- like characteristics. And actually for fun back in 2017, a TV show based in Germany, which is essentially the Discovery Channel of Germany, came by to do a segment on our materials and they actually turned me into a snail superhero that they coined Snail Man. So, that is online someplace. But it's a fantastic snippet of what our materials can do and how they may have a, what we hope a great impact on healthcare.
Lindsey Dinneen: That's amazing. I love that and I am definitely gonna have to Google that later because that's pretty fantastic. Well, I'm curious for both of you, are there any particular moments or a moment that really stands out to you as something that reinforced the idea to you that this is the right industry for you?
Dr. David Wu: I think I can get started on this one. So my interest to get into the medtech industry is as a clinician, as a surgeon, you are doing a lot of surgery. You see a lot of different cases where you need a certain technology to make a treatment available to the patient in order to obtain the best results. But sometimes these treatment modalities or these technologies are not yet available. There's some maybe basic science research that demonstrated certain effects that are promising for clinical application, but in clinic, there's no such thing available. So my goal as a clinician, as a scientist, and entrepreneur is basically bridging the gap between benchtop research as well as clinic. And in order to translate this technology, I think the involvement of the medtech industry is so critical because it's a long, arduous journey to translate a basic science discovery all the way to benefit each individual patients. It involves a regulatory process. It involves manufacturing, design, marketing, so many different steps. So that was the main catalyst and my mission that drives me to not only doing these translational type of research, but also to building a strong line of, of products, of technologies to change how we treat patients and how patients benefit from these type of treatment in terms of quality of life, as well as successful outcome.
Lindsey Dinneen: Yeah, that's great, Ben?
Dr. Ben Freedman: And for me it was, I don't know, going back to when I was really young. When I was in fourth grade, I think I, I had a kind of this toy robot that I was trying to build and the instructions kind of had a relatively basic design of the wrist of the robot. So it was pretty much fully rigid. The hand could open and close, but it couldn't exhibit the other types of range of motion that our human wrist could have. So I added some other motors and gadgets and things like that to kind of re-engineer the wrist. I think maybe that was an early sign that I was I was going to be a bioengineer cuz I was kind of curious to innovate, curious to try to develop new solutions that could better represent the actual human condition. And through that in a number of different projects that had been going on for a number of years, well before PhD undergrad projects, early on I took a technical entrepreneurship course. Kind of got involved with what would go into a business plan relatively early, got the chance to enter some competitions very early, which were great learning experiences and kind of left me hungry for more. And I think all these experiences, have kind of added up where, I definitely wanna be an innovator. I want to inspire new scientists, train new students, and develop new solutions for really pressing unmet needs that exist. I think, talking to so many folks, clinicians in this space, having family members that have also experienced a number of these terrible diseases and disorders that there's certainly so much work that still needs to be done and not enough folks out there developing new solutions here as we're running out of time to, to do all these things. So, certainly feel kind of the time pressure to develop new and an important solutions. And really to try to think big. I think that's really the most exciting part is to have a problem and really develop a solution that can really address that, that specific problem in the best possible way.
Lindsey Dinneen: Yeah. Yeah. Absolutely. So both of you have had really interesting career paths that have led you to where you are today, and it sounds like leadership has been a winding thread through various different avenues for you both. So, I'm curious, two things. One is what does leadership mean to you? And then the second thing would be what advice would you have for someone who might be interested in doing something similar to what you're doing or is looking for a leadership role within the medtech industry? So whoever would love to take that, I'd just be curious to know your thoughts.
Dr. David Wu: Yeah, I can start. I think the most important part of leadership is finding a common mission and enabling people on your team to achieve that common mission together, whether it is teaching them the skills to do so or encouraging them. I think just bring everybody to achieve a same mission, the common mission, the common goal. For example, in the MedTech industry, it could be developing a new biomedical device to, to solve a particular technical or surgical issue in order to improve treatment outcome for a specific population. It could even be broader, right? Tackle aging or tackle specific type of cancer. So, having the ability to really gathering the team and to inspiring every individual team member, who are from different backgrounds, who have different priorities and different level of life experiences and skills. And how do you find the common denominator and how do you motivate them? I think that's the key to success to leadership.
Dr. Ben Freedman: And I think just to add to that, there's certainly different types of leaders, different types of leadership positions, even within a single organization. I think just finding the right people that can help build that positive work environment, that can help motivate a group and inspire group to go after a common goal. And I think if you can get everybody on board with not only the mission, but but really have the drive to where it doesn't necessarily feel like work. It feels like everybody's going after something that's gonna be extremely impactful. You know, award credit when credit is due. All these things are really important characteristics of what I think goes into making somebody be a good leader. Certainly lots of things that you could learn in a class, but also a lot of it is practice and learning how to manage a lot of things going on at the same time, communicating really effectively, really recognizing accomplishments and achievements for those in the team. And being organized and focused to define goals that are within reach are all the different kind of important qualities that will go into being a successful leader. I think, we're relatively both early in our careers. So I think we're still trying to learn some of the key things here and in talking to some of our mentors about how they may handle situations and learning from others. There's always things to learn in this space to further advance our own careers.
Lindsey Dinneen: Of course. And what about any advice you might have for somebody who's interested in, again, either doing something similar or obtaining a leadership role, just maybe somebody who's even earlier on in their career. What would you say to them?
Dr. Ben Freedman: So, I mean, I think there's a number of things here. A number of different little key bits of advice. Certainly, people will say that you need a lot of grit, you need to work hard, you need to be determined. It's easy to say those things, but it's also, you have to practice going through those different things too, where not every day's going to be winning a competition, where there's gonna be a lot of failure. There's gonna be a lot of unanswered questions. There's gonna be a lot of things where it may not feel like you're making a huge amount of progress. You might be making a little bit of progress. You might be taking steps forward, you might be taking steps backward. But hopefully, you just have to keep your eye on the goal. And I think a lot of these skill sets with grit and determination and, not just working hard but working smart. Being really efficient with hours and time are some of the things that we've developed during this postgraduate, graduate training which, I think has been helpful probably for us as young, aspiring scientists and entrepreneurs to really have an eye on where things can go. Appreciate that it's not necessarily a straight line and things can go in all sorts of directions.
But just to, try to keep a focus and we heard an analogy last night, we were at the Resolve Mass Challenge event and taking place in Boston. One of the keynotes was talking about thinking about approaching problems with kind of a bandpass filter. Filtering out the really good things and how that might affect you and the really bad. So just to keep kind of a more moderate response to a lot of the different things that are coming. And I think, part of that is true. Keep a steady pace and surround yourself with folks that, that share in your, mission and that can hear your stresses and successes and you know, just surround yourself with the people, great people and that can push you to do new things. And I think that's really an important part for folks in this industry and other industries. Where you're not doing this in a silo. I heard once that, the hardest job of somebody in these, top leadership positions, whether that be CEO or academic professors is not necessarily the company, or the lab or the whatever. It's managing your own mental health. And I think, that's certainly, an important part and something that we all have to work toward. And I think if you do that in addition to doing really good science and really good in innovative technology development, hopefully that will be something that leads to success, but it's not an easy path. It's a lot of factors that can be out of your control as well, depending on industry dynamics and people, et cetera. But until that point we're certainly in this interesting phase of great determination and surrounding ourselves with fantastic people that, that share in our vision.
Lindsey Dinneen: Absolutely. David, anything to add to that?
Dr. David Wu: Yes, I think one of the advice to, to any young folks either in the industry, in academia or in clinical practice is be open-minded. There's a lot of things we currently don't know. So having the foresight to network within your own industry, but also in adjacent industries. And really exploring what are the different innovations, the different discoveries going on, and how to cross pollinate and how to collaborate with each other because we have to acknowledge that we only have so much time and so much expertise in, in our domain. So having the opportunity to collaborate with people outside of our immediate field, that could be really beneficial.
A second point I'd like to touch on is a mentorship. As young, aspiring leaders and inventors in the industry, entrepreneurs, it's important to seek mentorship and to learn from those veterans who have been there, done that. They have a lot of advice to share. How did they start their own journey? So by talking to these different mentors and really building your core group of mentors, or for example, there's one particular term in the literature I'd like to refer to as your "personal board advisors." So identify these people that play a certain role in your own growth, in your own development that could really expand your horizons in terms of knowledge as well as network.
And the third point I'd like to touch about is dream big and also act on it. And recently, I heard somebody in my network talk about this concept. When opportunities come knocking on your door, you gotta be ready and you gotta be there to open that door. So, when you have a dream, you're not gonna be able to foresee what's gonna be coming towards you next year or the year after. But what you can do is to build a set of skill, to build a network within the industry and to understand what are some key areas of opportunity and aligning yourself up for that. And when you're presented with these opportunities, see those opportunities.
Lindsey Dinneen: Absolutely. Yeah, that is great advice. Thank you very much both of you for that. I think you've touched on something that is really important and kind of a running theme of the interviews I've done so far is the concept that there are many avenues to a dream, and if you're open and you're willing to explore the opportunities that come your way, whether or not you initially thought that's how it would work out, I mean it leads people to some pretty amazing opportunities and experiences if you're willing to be open and you're willing to be humble enough to know that you're gonna be learning and growing your whole life.
Well, on a different note, for both of you, just a fun question. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry, but it could. What would you choose to teach and why?
Dr. David Wu: If I were offered an opportunity to teach a masterclass, and this might be coming from a totally different angle, but I would teach the art of Japanese sushi and sashimi making. And part of the reason why is first, it's full of art and history. And as the culinary arts is embedded in history. There's also a lot of knowledge you need to know and a lot of training. So just out of interest, for background knowledge, a Japanese chef for a Japanese sushi chef, when they undergo through training, it takes them about three years just preparing the rice for the sushi. And that is the amount of detail, technical knowledge, repetition, and perseverance. And once they're passed onto that stage, they move on to, to teach 'em how to make it a piece of omelet or egg. And that process also takes years. So to really become a master and to hone your skill to reach that level of master sushi chef it takes, 20, 30, even 40 years. And one of the most famous chef in Japan actually is well into his eighties and still perfecting his craft. And that is an analogy to my specialty, which is periodontal surgery. We do a lot of plastic surgery and a lot of the techniques in plastic surgery is very refined. You need to have fine control of the surgical blade. You need to master different levels and tiers of techniques. So that's kind of in parallel to, to the art of sushi making. So if I was offered a million dollars, I will definitely teach a class on these different aspects.
Lindsey Dinneen: I love it. Ben?
Dr. Ben Freedman: Yeah. So before I was-- I guess in parallel, actually, while I was doing science, I had a side job of teaching sailing. I grew up doing some water sports and got really passionate about teaching sailing and not just competitive sailboat racing, but I just loved the whole concept of working with somebody that's never been on the water, may have just learned how to swim and teaching them an entirely different skillset. It's not necessarily like walking or riding a bike, it's something where there's a lot of controls. You're on a boat that's floating and, and the ocean, there's lines to pull, there's ways you have to maintain your balance. All these things that, that go into place so that the boat goes forward, doesn't go in circles and you don't flip the thing over. And I've had such an enjoyable time working with younger students, adults. I volunteered for a number of years for the Sailing Special Olympics, working with athletes of all different backgrounds that, I would, in a heartbeat, love to build a, a whole career out of sailing. Probably not even pay me to do it. I would, certainly do it for free just because it's been such a strong passion of mine over the years. I think there's a lot of similarities to sailing a boat and doing a lot of things in life, whether that be entrepreneurship or learning a new skill or working harder in a class or doing a PhD, et cetera. A lot of times with sailing, it's not like driving a motor boat where you can go from point A to point B, you have to zigzag through the wind. You have waves, you have unintended obstacles that you'll hit, and you have to sometimes adapt on the fly. You can't predict what the weather is going to be or what might be out on the water. And I think that certainly resonates closely with me and the different activities that I'm doing in academia and the industry. And something which I think is true for a lot of us in life. So, without a doubt, I would teach a masterclass in sailing and I would do it for free.
Lindsey Dinneen: Well, we could put the million dollars towards your business. How about that?
Dr. Ben Freedman: Sounds good.
Lindsey Dinneen: Or a cause that you care about? One of the two.
Dr. Ben Freedman: Perfect.
Lindsey Dinneen: Oh, amazing. That is awesome. Thank you both for that. What is one thing that you wish to be remembered for after you leave this world?
Dr. Ben Freedman: I think certainly, we're in this area because we certainly wanna make a difference and we don't wanna necessarily have any regrets of not going after something that could be, a chance to improve healthcare, improve our environment, improve world peace, et cetera. So, I think that we wanna be remembered as or at least I want be remembered as something that goes after challenging problems that are facing the world, going after them in ways that are, of course ethical and, creating a great community and, and group along the way. I'm also really passionate about training folks and enabling them to be successful at whatever they do and solve other really important pressing problems that we're facing. Hoping to make a mark in many different areas I'm gonna hopefully be remembered for those things and hopefully they do result in some new novel device. But if they don't, the way that we're going about it, just wanting to do that in the best possible way that enables others to have a great impact on the world.
Dr. David Wu: And as for me in terms of one thing I wanna be remembered for, as a clinician and a scientist, and I teach a lot students along the way, and I had a lot of mentors who have played this role in my life. I want to be remembered as somebody who really encouraged people to pursue their dreams and provided them with concrete advice, resources, and opportunities so they can find a fulfilling career-- whether it is in the medtech industry developing new devices to help patients, or whether it is to become a scientist to advance their research project or become becoming a clinicians to treat patients-- to help these trainees and students find the ideal career path and the ideal sense of fulfillment for themselves. So as a mentor and as a leader, that's one thing I wanna be remembered for.
Lindsey Dinneen: Yeah. Those are great answers. Thank you. And then my final question is, what is one thing that makes you smile every time you see or think about it?
Dr. Ben Freedman: Oh, right now the number one thing that makes me smile-- we just had a our first child a few months ago. And seeing our baby smiling or crying makes me smile every single time.
Lindsey Dinneen: Aw, congratulations. That's wonderful.
Dr. David Wu: And for me, also in terms of you were talking about personal milestones. So this past summer I just got married to my wife. We've been dating for almost 11 years now. So it's a long time coming. And just being able to spend time together, whether talking about our future or going on new adventures, exploring different parts of the world, that's something that makes me smile.
Lindsey Dinneen: Those are great answers. Well and clearly, great reasons to smile, so I'm so glad to hear about those things.
Dr. David Wu: I'm smiling right now.
Lindsey Dinneen: I love it. Well, I just wanna thank you both so, so very much for your time today. We are very honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. I am truly inspired by what you all are doing and the different solutions that you are developing for a whole variety of different uses. And thank you for your passion and your drive to change lives for a better world. I just wish you both massive, continued success as you go along your paths, and thank you, thank you for being here. And thank you so much to our listeners for tuning in and if you're feeling as inspired as I am right now, I love it if you'd share this episode with a colleague or two and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Haven Tyler | Boston Engineering | Women’s Health, Mentorship, & A Horror Film

Haven Tyler is a Senior Client Relations Executive in medical device development at Boston Engineering and an aspiring interior designer in her spare time. In this episode, she discusses her innate curiosity about the world, why she decided to focus primarily on the medtech industry, her passion for furthering women's health, the power of mentorship, and the time she starred in a horror film.
Guest links: https://www.boston-engineering.com/industries/medical/ | https://www.linkedin.com/in/haventyler/
Charity supported: Polaris Project
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
SHOW NOTES
Episode 015 - Haven Tyler
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guest today, Haven Tyler. Haven is a senior client relations executive at Boston Engineering, a consulting and technology development firm based in Boston. Haven brings over 30 years of a consulting experience to her clients and she has worked with such consulting firms as IDEO and Continuum. Haven appreciates the variety in her work, especially the broad range of technical business and regulatory challenges her clients face. In her varied career she made the personal professional shift eight years ago to focus on medical device development because of the impact her teams have on improving patients' lives. The path her current role has not been traditional. Haven has a BA from Sarah Lawrence College, studied history of art and fashion, and is an aspiring interior designer in her spare time. Along the way, she also had a short-lived acting career and starred in a horror film in her senior year in college. What knits it all together is an innate curiosity in the world around her and solving tough problems. Well, hello, Haven. Thank you so very much for joining us today. I am so excited to learn more about you. Thanks for being here.
Haven Tyler: Oh, Lindsey, thank you for inviting me. I'm excited to go through this with you.
Lindsey Dinneen: Yeah, absolutely. Well, I was wondering if you wouldn't mind starting by just telling us a little bit about yourself and your background and maybe how you got into the industry.
Haven Tyler: Oh, sure, I'd be happy to. So I have to say, in perfect honesty and transparency, my path to where I am has not been a straight one. So it's quite varied. I started out by going to college in New York. I went to a small liberal arts school called Sarah Lawrence. And I studied art history actually. But I think that the thing that education, and also in my family, that was instilled was the sort of innate sense of curiosity. So I think that's a thread that runs throughout my career. I ended up in the Boston area and started actually working for an industrial design firm and learned about industrial design, which is something that was totally new for me.
So I'm clearly more of a visual sort of design person, but I've appreciated the sort of messiness of the creative process and the complexity of problems and I've really always loved that kind of, there's a problem and everyone's brainstorming and coming up to a solution as a group. So that's always been something that I've really enjoyed and I learned a lot from an industrial design perspective. And I was really lucky I got to work at some pretty amazing places. I was able to work at IDEO as their Head of Business Development on the East coast in what I would consider the halcyon days, if you will, of design and design thinking and innovation. And, you know, a lot of those words are buzzwords now, but we were actually living them, you know, back in the day. And that was just such an exciting sort of heady time . And it really just opened up my eyes to how our work could make a difference in the world.
And at that point I was professionally focusing on a range of products including consumer products as well as some medical. But then during the course of basically 30 years, at some point, maybe about eight or nine years ago, I had reached a sort of apex in my career and in my life and just really thinking about what my-- "legacy" is a big word and it's not exactly how I was thinking about it. I don't know what the correct word is, but I was thinking about what difference I could make in the world. And that's when I made the professional and personal decision to shift to focus just on developing medical devices.
And at Boston Engineering, I've been able to do that, which has just been a great privilege to be on the team. And I've loved the complexities of the problems we face and our clients face on a daily basis. I have things that come across my desk that are fascinating and they're disease states that you didn't know about, and understanding about that and sort of diving into what those patients experience, what the doctor's experience, what the hospital's experience in terms of purchasing equipment, what our clients experience in terms of their business needs and their regulatory hurdles and reimbursement hurdles, and the challenges are really complex. And that's what I love is cuz then you have lots of different people with lots of different areas of expertise contributing. I hope that helps answer the question. That was a long-winded, long-winded answer, I apologize.
Lindsey Dinneen: No, I love it. I love that your story is not linear and that you have so many different really interesting twists and turns in your path. I think that's really exciting. And then, I really appreciated the sort of theme of curiosity is being what kind of ties it all together and I'm sure keeps you interested and motivated every day.
Haven Tyler: It does. And you know, it's interesting because in preparation for this, I've been thinking about how I ended up where I am. And I grew up in an academic family in New Haven, Connecticut, and my parents were-- their upbringing, they were born after World War II, so it was like forties and fifties. So their upbringing was very strict and restricted. And then when it came to their own children, it was the seventies and the eighties, so it was hands off parenting. It was very different than it is today. But it was also explore your bliss, like find your passion. There was never a sense of you're gonna have to pay the rent or have a career. There was no thing involved.
Lindsey Dinneen: So, so that was a wonderful thing growing up and maybe a slightly rude awakening as an adult, or were you prepared?
Haven Tyler: Well I think I was prepared in the sense that they instilled a sense of, "you can figure it out." You have the tools to figure anything out, no matter what it is. And it was a question of perseverance and grit and, all of those things. So, I think that it was definitely a little bit of a rude awakening, but you could figure your way out of it.
Lindsey Dinneen: That's fair. I think no matter how prepared you think you are, you're not, anyway, you know, it's always a learning curve, but that's what keeps life interesting.
Haven Tyler: Exactly. Yeah. It's interesting too because I love the fact that if you had asked me at 20 or 21, when I was graduating school, where do you think you'd be? This is not what I would've predicted at all. And I'm also grateful for that because I've ended up in a place that's really great and I, I couldn't have made that up. I couldn't have fantasized that. So, I think that the fact that I get to go to work every day and feel like possibly I'm being helpful to the planet or the world, and maybe we can make a difference in people's lives. And I work for a company that has a ton of integrity and they believe that, they really do. It's not just some kind of byline. It's something that the whole group lives and breathes and that's pretty incredible to be able to say that, right? So, I feel lucky to have landed in a place that feels authentic, you know?
Lindsey Dinneen: Yes. I completely agree. That's one of my very favorite parts about being in the industry is knowing that even if your role is a little bit on the fringes, perhaps it's not the actual engineering of the product, but you're still helping to talk about the product and introduce it to the world, or however you fit into it, you're still making a difference. And I think that's a really powerful motivator and makes it fun to come to work every day because you just know inherently that you're doing good. So that's really special.
Haven Tyler: It is special and I don't think everybody gets to say that, you know? And I have friends who do a variety of different things and I have friends I've known since I was a kid and they're scratching their head going, "you do what for who," you know? How did you get there? And I was like, "I know it doesn't really make a ton of sense, but it's really where I should be." And I don't know if everyone gets to say that.
Lindsey Dinneen: Yeah. It's a special situation when you do, for sure. And especially if you've been through other seasons of your life when perhaps you didn't feel quite as connected to what you were doing. All work is valuable, but sometimes, your personal connection, if it's not there, makes it a little bit harder to be excited about getting up every day and going to work.
Haven Tyler: Yeah. And there was a large part of my career where there was a a focus on really sexy products, if you will. But they were more based in the consumer realm. I loved being a part of that. And it was really cool. And it definitely had its attractions. But at the end of the day, I was like, I'll be walking down the aisle in Target or whatever with my kids going, "Yeah, I helped make that," and I just, I don't know, it wasn't moving the needle or helping the way I wanted to help. So I think that kind of spurred me on to look at medical a little bit more closely.
Lindsey Dinneen: Yeah, absolutely. Is there a particular moment or series of moments that stand out to you because it clearly confirmed that this was the right next career choice for you?
Haven Tyler: Yeah, I think you're right-- the word "series" is probably the best. It's a lifetime of experience, and I can say this now cause I'm getting towards the tail end of my career. I had some health concerns in my own family that we had to address and I think my gratitude for the help that we got living in the Boston area-- I mean-- how fortunate are we to live in that area? You know? So I have access to some of the best minds and medical community. And I grew up in a medically privileged environment. My stepfather is a medical doctor. And our pediatrician was Uncle Sid and Uncle Sid would just like come on over to the house, and it was just amazing that you had access like that. And anyway, my, my appreciation and my gratitude for the people who are helping me and helping my family through a couple of different medical things was really profound, and it gave me a new line of sight into how complex that world was and how complex it was to get to the point where you were able to receive that kinda help. So I think that was definitely an aspect of things.
I think that also having certain people put into my life. So certainly working with my colleague, Paul O'Connor, who heads the medical business unit at Boston Engineering, that has been a really wonderful partnership, and I appreciate working with him. And he's, he has much more experience and depth in the medical arena than I do. But I think that we have a skillset that really complements each other and I rely heavily on him for aspects of building our business. And I hope that, I hope the inverse is true.
So, I think, having a combination of those types of things. I think one thing I wish that I had, and this is something that I talk to my own children about, is finding a mentor. And I didn't have that. So everything I did was really either sort of self-guided and I was just following my curiosity. Or something got put in front of me, and maybe it was fate, maybe it was, who knows? Something was in front of me. I think that large part of that was the product of my upbringing, of the sort of "follow your passion" kind of thing versus the " I'm trying to find a different kind of balance for my own children" and thinking about it with them as they're embarking on their careers. And maybe there could be a little bit more planning involved than there was in my career. Yeah, so I think the value of having mentors in your life, professional mentors, is something that could really be a great tool.
Lindsey Dinneen: Yeah. Oh, a hundred percent agree. And that brings me to-- I'd love to hear some of your advice for perhaps somebody who is interested in coming into the medtech field. Maybe as a, either a young career person who would be interested in growing into a leadership role or somebody who is switching careers. Is there any advice that you would relate to that person to help them as they begin that process?
Haven Tyler: Yeah, I think, the notion of a mentor is really the strongest drum I would beat in that regard. I may not also be the best person to ask that question just because I've always been on the consulting side of things. I have not been a part of a larger corporation, like a big med device firm. So I don't really have that perspective necessarily. I do know what I hear at conferences. I do think, and I'm gonna really stress this, that we need more women. I think that the more women we can have in medtech leadership, the better. I've been going to a number of conferences and doing my own research and women's health has been sorely underrepresented for a long time. I think we're getting slightly better and I think we're talking about women's health in a different kind of way, which is fantastic. But the numbers of research and development dollars that are spent globally on women's health is very low. I mean, I think the percentage is about 2%, which somebody said at a conference is a rounding error.
I would love to see that change with the next wave of leadership and I would love to see more women writing checks and making those decisions to expand those conversations and learn more about the different phases of women's health that we go through cuz there are topics that we talk about and there are topics we don't, and I think there's been a decent amount of conversation around women's health, particularly around childbearing years. But, the topic of, let's just say menopause, is one that's very complicated and I think it's a potentially huge market.
So from a business perspective, I think big companies should perk up about that. But I think we need to know more because I think that we don't know enough about that. It's not necessarily a disease state, if you will, but there are lots of varied symptoms with that phase of life and it can be quite confusing. So, I'd love to see that improve. So I guess, mentorship. If you're a younger person, maybe be a little bit more strategic with the help of someone who can guide you through so that you can attain the goals that you, you want to achieve.
Lindsey Dinneen: Yeah, absolutely. Mentorship is such a wonderful gift when you find a good match and are able to learn from that person and benefit basically from their own experiences and things that they would've done differently looking back or whatnot. You know, you talked a little bit about how-- because you didn't have a mentor-- you were self-taught and self-motivated or whatnot. And I'm curious: you have such a interesting eclectic background and you've had lots of different experiences. So how do you personally prioritize your own continued learning and growing, cuz obviously that's just been part of your life along with your curiosity, but I'm just curious how you prioritize it.
Haven Tyler: Oh, it's such a funny question because it's, it's not even a question of prioritization. It just happens. I'm just a curious person. I mean, I'm constantly taking classes that may have nothing to do with my professional life. I think I mentioned I'm pursuing a certificate in interior design because I like it. It's just interesting to me. Color and how colors relate to each other, and color theory. I go down these little rabbit holes that I think are very interesting and I go from there. I love architecture, I love gardening. It's never a dull moment, unfortunately for my family. But yeah, I mean, it's always been that way. It's definitely fun.
So I know a little bit about a lot of things which I think has actually served me well in my particular role, because my role at Boston Engineering is to identify where opportunities might be, develop the appropriate program, and I get engineers to help me with that. And that's creative in a way 'cause if you're looking for an opportunity, I'm looking for the negative space, right? I'm looking for where the hole is and, can I go in there and, is there a problem there we can help solve? And so, as I said, it's messy, but it, it ends up being not messy once you find the solution, if that makes any sense. So no, I don't really have any sort of prioritization.
The one thing that I have gotten better at though is, and I think Covid taught us all a lot, but it's just personally that I've gotten better at is boundaries. So, I start my workday at a specific time. I end my workday at a specific time. And so that allows me to have the space to do the other things I get curious about. So, during Covid, I personally found it a little hard because I think like a lot of us, there was a lot of fear. We didn't know what was coming around the corner from a health perspective, from an economic perspective. It was just scary for everybody. And so I was just very driven. And I think that while it's great to be driven, it can also be unhealthy. So, yeah.
Lindsey Dinneen: I'm just chuckling because I relate to that so much.
Haven Tyler: Yeah, exactly. And you can burn out and burnout's not good. I have a 18 year old who is going to be a college freshman, and she's incredibly driven. And she's just a good student. I've never had to check her homework. I've never had to do anything. And she can burn out. And I, I see this cycle in her and I think she's getting much better at having a balance, but I think left to her own instincts, that's where she goes. And so while that's a great thing in a lot of ways, how do you temper that, so, yeah.
Lindsey Dinneen: Yeah. And that is a really hard balance. But like you said, trying to put in some specific boundaries really does help. It sounds like you are boxing yourself in, but it's actually a freedom generating exercise.
Haven Tyler: Absolutely. I do think that one of the things that I've learned over life is that because I have three children and I, I've been a single parent for most of my children's lives, and taking care of myself was something that I didn't do very well for a long time. And making that a priority is really important. And that can come in many different forms. That can come with, I need to get enough sleep, I need to drink enough water, I need to exercise, I need to make time to walk the dog or sit outside in the woods or whatever it is that I need to do, to be able to do everything else effectively.
It's like that analogy where they give you the instructions on the airplane. And it never made sense to me that you would put the air mask on yourself first before the child. And I always thought that was just the complete opposite. I was like, "this is crazy." And then the reality is no, if you can't breathe, you can't take care of your child. So if you're a crazy person and you haven't slept and you're not eating well and you're not exercising, then you're not gonna be able to take care of anyone else. So, that's been something that has been a priority for a number of years for me. And like finding those balances and saying to people who need my time, like, "Yes, I really want to talk to you. That is very important. I have to get back to you in an hour." Or whatever that is. " But I can't have that conversation right now. I want to have that conversation, but let's do it in a little bit." And creating those guardrails has been helpful.
Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. Yeah. And not to pivot too dramatically, but I really do have to ask you about your short-lived acting career. Okay. First of all, how did this even come about? And second of all, what was that experience like?
Haven Tyler: Yeah. So it's, it was a little surreal, but yes. So I, as a part of my schooling, I took my senior year in Italy for art history. It was just an amazing experience. And that's one thing I encourage everyone to do. Try and study abroad if you can, or live abroad for a little bit. Anyway, while I was there, I was doing a lot of, and I had been doing while I was in school in New York, a bunch of kind of modeling and that was a great way to make money, but it was painfully boring. So I wanted to get out of that, but I still needed to figure out a way to support myself.
So, an American woman, who I met in Rome through a friend, was a casting agent, and she said, "You know, let me send you on a few things." And she sent me on one audition and it was funny because my mother, who is a dean of a college at Yale, she's like a serious person. She had flown in, we were gonna spend two weeks together and she had flown in and I said, "Oh, before we go, I have to go on this audition." And she is looking at me with her blue eyes going, "What the heck is this?" And I said "No, no, no, it's fine."
And we went into this place that kinda looked like a dentist office, but it had these big posters with monsters. And these guys come out and they don't speak any English and they say, "Come with me." And so I go back there and all I had to do was scream. So my poor mother was waiting in the lobby and all she hears is me scream. And so, I got the part. But I think that largely had to do with the fact that I had red hair and freckles and Sigourney Weaver was a thing at the time and the movie was a very specific genre. It was sort of a mashup, which was common then. It was a mashup between sort of "Aliens" and "Terminator." Anyway, it was just an absolute blast. I'm so grateful I had the experience. I am a horrible actress. But it was just really fun. And we spent two months filming in abandoned nuclear power plants. We spent a week in Venice filming overnight. I mean, it was just incredible.
Lindsey Dinneen: Yeah. Oh my gosh. Thank you for sharing about that, because that is an amazing story and such a unique opportunity. I love that you did that.
Haven Tyler: It was very fun. And I think two years ago, it was the 30th anniversary or something of the film release, and it has this unusual kind of, but very fun, cult following cuz it's this bad, bad horror movies. It was a part of a big drive-in movie theater movie festival up in upstate New York. So we all went, my family all went, we had our beach chairs and we got to watch it. And we had posters and signing autographs. It was just, it was very funny.
Lindsey Dinneen: That is amazing. I love it. I love it. Well, okay. That is fantastic. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry or related to your education, but doesn't have to be. What would you choose to teach and why?
Haven Tyler: That's a really fun question, and it's a big question. I think it would be a combination of teaching people to be their authentic self, and curiosity and creativity, all jumbled up together. And how to explore those and find them in yourself.
Lindsey Dinneen: Yeah. So when you say finding your authentic self, is there a specific thing that you would highlight? Or how would you talk more about that? Because I think that's an important thing that, that isn't always talked about as much.
Haven Tyler: Yeah, I think that I'm fortunate to have landed in a place professionally where I feel comfortable being myself. I think that when you're starting out your career, there's this feeling that you might misstep or you might make a mistake, and you clam up, you don't speak up, because you are concerned that you might say something wrong or you might embarrass yourself. Or you know, I mean, and I was guilty of this too. I'm not saying this with any judgment. I just think that it's, it's a natural thing. But to encourage people to feel, especially younger folks, to feel more confident in sharing because like 99.9% of the time us old folks in the room, we wanna hear what you have to say. But to let go of that fear to allow yourself to, to shine, whatever the topic is.
Lindsey Dinneen: Yeah, absolutely. Yeah. And I think that's especially something-- in fact, I was just having a conversation about this yesterday of the tendency and I think-- maybe not all women, but a lot of times for women-- especially the tendency to shrink and not show up as your full, authentic self. Not because you don't want to, but because you're not sure if you're gonna be accepted or if your opinion's gonna matter or count or any of those things that, that kind of keep you a little bit more quiet when actually you have a voice. You have things to say. And your contribution matters.
Haven Tyler: Yeah, it absolutely matters. And I've had the privilege of having younger folks on our teams and having these conversations with them and then once they start to feel encouraged and more supported, the solutions and the things that the ideas they have are just fantastic, really great stuff. And I see this with my own children as well. I love talking to my adult children. I'm like, "Wow, that's really interesting that you thought about it that way." Or they'll know something profoundly different than I do. And I think it's fascinating. So I would encourage people to find a place where you feel safe enough to be able to express yourself that way.
Lindsey Dinneen: Yeah, and I absolutely agree with you. And conversely, I think that's a good reminder also for leaders to, to provide that space, to provide that encouragement for especially younger folks to speak up and that it's safe, it's accepted. So kind of on both sides, like yes, encourage the younger career folks to, to speak up more and also encourage those who do have the privilege of being in leadership to do their part to foster that environment too?
Haven Tyler: Absolutely. And I think it's our responsibility to do that, actually.
Lindsey Dinneen: Yeah. Well, you know, you mentioned legacy a little bit earlier and that ties in very well to one of my questions, and that is, what is the one thing you wish to be remembered for after you leave this world?
Haven Tyler: So again, a very big question. I think I would really appreciate if people could think of it as like, "Oh, she was helpful." I don't need to be a rock star. I don't need to be a shining star. I just wanna be helpful.
Lindsey Dinneen: Yeah. Love that. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it?
Haven Tyler: Oh, my dog. A hundred percent.
Lindsey Dinneen: Okay. Tell us about your dog, because I love dogs.
Haven Tyler: No, she's a total punk. I love her dearly but she hates people except for us. And she's just, yeah she's wonderful, little cuddle bug. But she's a Boston Terrier, but she's sort of the wrong colors. They're normally black and white and she's brown and white, and so she's a little offbeat, which makes me like her even more.
Lindsey Dinneen: I love it. She is her own dog.
Haven Tyler: Exactly.
Lindsey Dinneen: That's fantastic. Well, I love hearing your stories and your insights and your advice. Thank you just so very much for taking the time today to speak with me and for sharing just a little bit about yourself and what's important to you. I just really value that. So, so thank you.
Haven Tyler: Thank you, Lindsey. I appreciate this, and I appreciate before we jumped on the recording, you describing your motivation for starting this podcast. And I think that it's really important the work that you're doing, and I think that getting at the underlying motivations for people being in this industry is really interesting. I mean, yes, at the end of the day, it is a business and we do live in a capitalistic society. I mean, that's just like baseline. However, within that there's a lot of choice that people have to make, and how you go about achieving those goals can be very different. And I think that on our side of the fence, on the consulting side of the world, none of us are ever going to be the next Bill Gates. But it's such a motivator to think that, " Okay, this might make a difference in somebody's life." And it just gives me goosebumps to think about, like that we can say we helped make that. It's really pretty cool stuff, so I'm glad to talk about it.
Lindsey Dinneen: Yeah, absolutely. Well, we are honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non-governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support and really appreciate that, and we just wish you continued success as you work to change lives for a better world.
Haven Tyler: Thank you so much, Lindsey.
Lindsey Dinneen: Absolutely. And thank you also to our listeners for tuning in ,and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Alex Condon | COO at Galen Data | Working for Small Businesses, Networking, & ”Meerkat Moments”

Alex Condon is the COO and co-founder of Galen Data. In this episode, he discusses how his background working with small businesses prepared him to grow and scale Galen Data, why he occasionally looks outside of the medtech industry to gain inspiration and insight, and how showing up and being a good person will write your legacy for you.
Guest links: http://www.galendata.com
Charity supported: Opportunity International 
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
SHOW TRANSCRIPT
Episode 014 - Alex Condon
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guest today, Alex Condon. Alex is the COO and co-founder of Galen Data, a medical device cloud data platform. Prior to starting Galen, Alex was the Chief Strategy Officer at Tietronix Software, a longtime NASA contractor. Alex is originally from Scottsdale, Arizona, having attended Arizona State University, but now calls Houston home. Thank you so much for being here today, Alex. I am so excited that you're here and talking with me and welcome!
Alex Condon: No, thank you for the opportunity, Lindsey. Sincerely appreciate it.
Lindsey Dinneen: Absolutely. Well, if you don't mind starting off by just telling us a little bit about yourself and your background and maybe how you got into the medtech industry, I'd love to start there.
Alex Condon: Sure. So I'm originally from Scottsdale, Arizona. That's where I grew up. I went to school at the WP Carey School of Business at Arizona State University for finance. So something way outside of MedTech. When I was 19, I got hired at a private investment management firm that was there in Phoenix and worked there until I was about 27. And then parted ways and took a job at NASA, Johnson Space Center, working for a NASA contractor, Tietronix software. They've been around for a long time. I usually focused on advanced technology across a wide spectrum of use cases. Things from system modeling and system engineering, all the way to augmented reality and blockchain applications and things like this.
And one of the things that a lot of NASA related kind of space flight software companies do down in Houston where offices is, is they moonlight doing medical device software because the compliance rigor of NASA space flight software is very close to class three medical device. So, the NASA contractor was splitting maybe 50% NASA related work and 50% custom medical software. And from that we saw a pattern merge of companies that needed cloud connectivity as part of their medical device offering. And typically if you're going to engage in that kind of work, it tends to be very costly and take a lot of time to develop. But the requirements from project to project are very similar. Everyone needs a way of seeing their device data, showing it to stakeholders, whether that be patients or clinicians or maybe someone else in the value chain. They needed a way to run algorithms, create notifications against the data. And from there we saw the opportunity to create a product and that's where Galen Data got started. So, went from finance to working with a NASA contractor and now in MedTech.
Lindsey Dinneen: Wow. Oh my goodness. Yeah. So you have had quite the exciting background. When you first started, could you have imagined that you would be now a COO of a company that you helped get off the ground from the very beginning? I mean, was that ever an idea of yours or was this just a complete surprise?
Alex Condon: I've always worked for small companies. When I worked for the investment management firm, I was the first employee, it was a team of three. And then when I left, I wanna say we were somewhere north of about 30. I think that number sounds right. When I started working for the NASA contractor, they'd always been small by design, liking to take on projects that they could really dedicate a lot of time and focus to. And it was about, I wanna say 75 people. And when I entered, I was in a Director of Strategic Initiatives role, and then moved up into Director of Strategy role. So, always worked for small companies. When the opportunity to create Galen rolled around, it felt very comfortable. So, no real surprises. But the journey itself was the surprise.
Lindsey Dinneen: Right. Getting from point A to point B was the surprise. Very nice. Is there a particular moment that stands out to you that this was the right career for you specifically? It could be Galen Data specific, but just in general working within the medtech industry, are there any moments or a series of moments that stand out to you as just, "Yes, I'm in the right place?"
Alex Condon: I think that the product was launched out of a need that we saw out in the world. So I think that being able to analyze the gap and seeing that these medtech companies were having to take on a large burden when it came to their cloud software. So those companies would have to, like I said, put up a lot of money, a lot of time, but there's an operation side of kind of owning cloud infrastructure and medical device that a lot of them might not be able to wrap their heads around.
So when you have the software, that can connect your device to the cloud, you're responsible for all the data that ingests, so you're responsible for all of the privacy concerns, the regulatory concerns. On the IT side, you're responsible for things like cybersecurity. You're responsible for things like disaster recovery. And in all of those landscapes, things change all the time. There's new regulations. There's new cybersecurity threats and all of those things can tend to morph a medtech company into an IT company. And that seemed like kind of a growing risk concentration, especially as more medical devices started leveraging the cloud for whatever they needed.
So, seeing that gap and seeing that the team we put together the CEO, Chris DuPont, the CTO of Abbas Dhilawala, both of 'em have very deep industry experience and by the work we'd done together, working at the NASA contractor, we all came out of the same place. I believe the team had the ability to execute. So if you marry that idea of product that has a need could seriously help people get their device to market in a safe and de-risked way, and then also have the team to execute on it, that to me solidified this is something that I wanna do and I think that it benefits the greater good.
Lindsey Dinneen: Yeah, absolutely. So could you tell me a little bit about the history of starting the company and where you are now and where you're looking to be? I'm always curious of the evolution of a small business and how you can go from that very first idea to reality and beyond.
Alex Condon: So, Abbas Dhilawala, our CTO, had the idea of creating this platform. Chris DuPont, our CEO, he has always had an entrepreneurial bent, and so they both latched on this idea of this is something that they want to do. But there was no kind of execution arm to get it done. And that's when I entered in. So, far before we became an actual company. But this idea of, well, Alex has this background in helping companies grow and seeing how a company should come together at an early stage. So putting some kind of, some meat on the bones. From then, we registered the company. The name, Galen Data, it doesn't really mean anything and it was by design. We knew that it was going to be in medical device or healthcare. So we picked an ancient Greek physician, Galen, to tack onto the name and then data, because we knew we were gonna have big data in some respect. Took those ideas, made the name, and then when the product came around it seemed to fit fairly seamlessly: a medical device cloud product for kind of cloud data management.
So Abbas had the idea and then a lot of it existed in his head. So from the time that we started the company in terms of kind of filing all the documents, we raised some funding and then Abbas just hunkered down and it went radio silent for a long time pouring his evenings into making an MVP for us. And from then it was okay, now we have this product, now it's time to try to scale it a bit. So we brought in a VP of IT Ops and started trying to attract some kind of initial clients. And when you have a company like ours that's housing a lot of this medical device data and the medical device companies who are our clients are reliant on our ability to execute, our ability to persist as a company, you have to knock on a lot of doors to find early adopters. As a small company that's being entrusted with a huge piece of operational infrastructure for a medical device that might have raised tens of millions of dollars and employ dozens of people, it requires a tremendous amount of trust.
And one of the things that's not lost on me is the amount of trust that those early clients put in us. The idea was relatively new to the space. Connectivity as a platform idea was something relatively new. Prior to that, everything was like what we were doing, kind of built the spoke. So, I look back and I love all of our initial clients, do anything for them. But awed by the amount of risk they took on working with a startup. And actually, one of the greatest days of Galen's existence was when we finally looked at the books and realized that we could persist through time. And that you were making enough money to pay all the bills and it was a huge sigh of relief across the company. And that is a, a great day that I'll always remember.
Lindsey Dinneen: That is a great day. Oh I love hearing those stories because I know how hard it is to get a company up and running and to be profitable and actually viable. So, so kudos to you because that is no small feat. So I am curious, you come from a finance background and found your way into the medtech space, which I think is fantastic. Do you have advice for others who might be in a similar situation, come from a background that is different, maybe not engineering, but that might be interested in being a part of the industry? Do you have any advice for those kinds of folks who might wanna make that leap?
Alex Condon: I think that this is a small industry that is very welcoming. And they put a lot of emphasis on knowledge. And so I think that if you are looking at becoming a leader in the medtech space, understand where your niche is, right? Go deep in that area. Network. People will respect you for the depth of knowledge you have and whatever it is you choose to pursue. And I think that's an easy way of integrating into the greater ecosystem. I think that the medtech in general, it spans so many different facets, right? From the people who are going out there and creating the product or the scientists behind the reason for the products to exist all the way through things like quality, regulatory, in our case, software supply chain, all of these different things. And I think that as long as you can show that you know your stuff in where you fit in the greater big picture, that people will naturally gravitate towards you. And I think that if people naturally gravitate towards you, it's also a good sign of trust and I think that, you know, if you have trust and you have people who believe in you, that's what kind of takes you places in this industry.
Lindsey Dinneen: Yeah. That is really a great perspective, and I think that you're completely right in terms of, when you know your own area of expertise, it doesn't have to be the same as anyone else's. In fact, it's helpful to have a bunch of complementary skillsets. And you're right, I think this is a very welcoming, it's very respectful industry and sort of allowing each person to have their own area and own it and people are really friendly here.
Alex Condon: Agreed. And I think that it's one of those-- the kind of the beauty of the space is that, everybody is aligned towards inevitably the goal of helping people. Even if you work in some aspect of supply chain and you're far removed from maybe the doctor with an idea, everyone is moving in that same direction. And I think that when you have all of those people paddling the same direction, not only do you rely on each other, but you can also create a lot of momentum. And I think that momentum has a pervasive way of working into people and bringing people together.
Lindsey Dinneen: Yeah, absolutely. And you mentioned at the very beginning of answering that question, that knowledge is such an important component, and I couldn't agree with you more. And I'm curious how you as a leader in this space, and as somebody who has had a couple different iterations of your career so far, how do you prioritize your own learning and growing as a leader, as a individual, as a contributor to this field?
Alex Condon: So I think that again, kind of knowledge in the space being important. I always try to focus on, be the best that I can be in the space that I'm in, right? So we probably work right now with 20% of large companies, 80% kind of startup companies, and so understanding the value that we add in both places. Always trying to stay on top of new happenings that would affect either our company or kind of the state of the industry, both from the big company kind of perspective and also from the small company perspective. And always trying to take time to also study things on the periphery, right? How we can improve as a company. How I can be a better part of the greater team. And really keep the focus there.
And I think that a lot of my job also is going out and talking to different folks in both places, the small companies, the big companies, and trying to be an active listener. And understand what their pain points are. Pain points can evolve over time. And they're usually unique to each individual conversation, right? And then try to take those things and formulate them in a way that I can then better my own learning by turning actionable, right? Where are my gaps by listening to the outside world and trying to chase after that information or that answer, or try to seek out that key opinion leader or something like that who might be able to add more to to the story that I can ingest and then put into practice.
Lindsey Dinneen: Yeah. Great answer. I also think, sometimes it's helpful to look beyond your own industry's standards when it comes to any aspect of the business and to sometimes look at other industries and see how they're being successful in various ways and see if you can't grab some of those ideas and make them your own. And I'm curious if that's ever happened for you too, where you can get stuck in, "Oh, this is how everyone in the industry does it." But there's a lot of great resources outside too that can sometimes apply.
Alex Condon: Sure. Absolutely. I think that we are a SaaS product, right? Software as a service. And there isn't a lot of that in the medtech space, right? You have some quality management system companies that are doing things, maybe you have some supply chain platforms and things like this. But medical device in general has been a laggard when it comes to adopting new technology on the operational level. So when we first entered, you had to look around and see other areas where connectivity was more widespread. So, when I was looking at how my piece of Galen would form itself, I looked at the Internet of Things space. So looking at how companies had been successful in connecting devices in energy or in consumer devices in the home and things like that. And seeing how we could turn those ideas and those success stories and try to make them a part of our narrative with a MedTech flavor.
And it's been interesting. The perspective that you get today is based off a lot of success stories, right? So right now, when you look at how other people were successful, you have to remember that it's winners biased, right? You don't hear about the mistakes that companies made that no longer exist, right? And in our case, we were bringing a product that was new to the market. This idea of cloud data management for medical devices, a very compliance heavy industry, wasn't something that a lot of people had kinda pursued wholeheartedly. There might have been some fleeting attempts but not enough documentation to make something useful. So, looked in those areas and tried specifically to find why people failed. And why is it that some of these companies that were hot in the connected device industry didn't make a mark?
And then also I think that goes back to your question about kind of understanding your industry. Why, if at all, is MedTech different, right? And it is. The product life cycle is so long. The funding cycles for the startup companies, the decision cycles for the large companies. In both instances, the slightest hiccup can throw you off for months. So being able to appreciate the buying cycle, work it into kind of a greater business plan. And then making sure that we had realistic expectations heading into it was something that I think was critical that we learned as a result of both knowing our space, but also looking out and seeing where other people had success in aligned areas like IoT.
Lindsey Dinneen: Yeah. Yeah. That's great perspective and I really appreciate you sharing about that because, just in terms of what you were saying regarding winner's bias and things like that, where we have a tendency, even from an outside perspective, to only look at the wins or to only hear about the wins, right? And so I think it's really helpful to also be able to have those honest and transparent conversations, when appropriate, to say, "Yeah, we tried this and it flopped, and here's why. And that's okay cuz we learn from it."
Alex Condon: Absolutely. And I think that to your point about transparency, that's probably one of the most core pieces about Galen Data everywhere that I've ever worked has been a very transparent and flat kind of organization. And that's very much the culture that we have with Galen Data. Try to value everybody's opinion, always make them feel like they're a part of the team. Always allow ourselves to be open to criticism, even if it's from the lowest person on the org chart all the way up. And always think about the feedback that we get. And like you said, approaching problems with kind of introspection and brutal honesty.
Lindsey Dinneen: Yeah, that's just been a reoccurring theme that I, I keep hearing from folks that I've been talking to is that idea of curiosity being such an important component to not only your own personal learning and growth and whatnot, but also as an organization. And if you can stay curious, then you can stay teachable and you can stay humble too, actually, which is not a bad thing.
Alex Condon: No, I think that I kind of find myself to be a naturally curious person. And I think that everything amazes me. I'm one of those people. I have a million interests. Everything amazes me. And I think that if you can bring that to a job or to a company, whatever, that it'll really take you places because you get out of your own kind of mental trench, right? It's important to pop up and look around every once in a while. And I think just being a naturally curious person creates that naturally. If that makes sense.
Lindsey Dinneen: Absolutely. I will say, when you were talking about popping up and looking around for a minute, I had this instant vision of this meerkat, so we can have our meerkat moment, you know, where we pop up and look around...
Alex Condon: That is a perfect example. I'm a huge outdoorsy person and one of my favorite things to do is just go out and look at Prairie Dog Towns. And so, sometimes you're digging and you're digging and digging in the dark, and every once in a while it's important to pop up and see what's going on around you.
Lindsey Dinneen: I love it. Oh my gosh, that's amazing. Well, okay, pivoting just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be about something in your industry, but it doesn't have to be. What would you choose to teach and why?
Alex Condon: So I grew up-- my family, me, mom, my dad, and my sister-- we did road trips a lot to the national parks. And I've always been, like I mentioned, a huge fan of the outdoors. And so I think that if I were to teach a masterclass on anything, it would probably be maybe national parks and kind of conservation in general. And this is not just something that's talking about here domestically in the US, but you know, national parks exist everywhere and every national park has a narrative around it. And I think that also, the outdoors kind of needs to fit inside of that work-life balance. And so for me, one of the things that I'm passionate about, and I try to do as often as I can, is go see the national parks, get some fresh air, take in the beauty that's around us and try to exist in that moment. Try to kind of take things in for the wonder that they are before you go back to work or family life and things like that. So, I love telling or reading about the narratives behind some of the big national parks here, hearing stories about the ones that are overseas, and I think that if I can share that passion with other people and get them more outdoors and enjoying that side of life, that's something that I would do if I had my druthers.
Lindsey Dinneen: Yeah. Oh, I love that. And that would be a great masterclass because it seems like not a lot of people necessarily prioritize as much, but when you've had the privilege to grow up and visit those places and experience what it's like to be in nature, and like you said, just take a moment and slow down and just be present. That is so important. So yeah, I would attend that masterclass.
Alex Condon: Sure. No, absolutely. Knowing a bit about your travels, I'm sure that you feel the same. It's, it's an important part of of our short time here. And so, make the most out of it. See all the things, do all the cool stuff. Try to soak in as much as you can and at the same time, if you're passionate about something like I am about Galen Data, you can have your cake and eat it too.
Lindsey Dinneen: Yes. Amen to that. Well, what's one thing you wish to be remembered for after you leave this world?
Alex Condon: So this is not something that I think about too often. I think that, it would be great to be remembered by friends and family as just a good person. Again, I have a lot of interests and when you extrapolate out, if I could take my experience in the business world, or maybe socially, and apply them to all these various interests that you have, there's probably a narrative that gets left as a residual if you're able to pursue those paths, right? And so I think that if you show up and treat people well, the legacy will write itself.
And in our case, one thing that's not lost on me is our product, it's a great accelerant when it comes to medical devices coming to market. And when I think of medical devices-- we'll take a startup perspective-- there's a lot of education, a lot of late night working, investor money, time spent, creating these medical device products. And if we can help those companies get to where they need to go in a de-risked way, maybe they come to market far faster, that means that their impact can be by more people, right? More people sooner who need these kinds of products.
So in that vein, we're a small piece of the puzzle. But our kind of legacy I guess would probably live on through the devices that we service, right? So that's one thing that's extremely gratifying about the role, right? We have many devices, devices on four continents, dozens and dozens and dozens of companies that are using us. Being a piece of that narrative, even if the champion is the inventor, happy to carry them on our shoulders as best we can. And at the end of the day, we'll never really have an idea of the number of people that we help. But it's satisfying to know that we've been a piece of the process for so many device companies.
Lindsey Dinneen: Yes. Absolutely. Couldn't agree more. That's fantastic. And final question, what is one thing that makes you smile every time you see or think about it?
Alex Condon: I laugh as I say it because a lot of it has been talking through it with you is, how we end up where we are, right? So, from working in Phoenix, Arizona, and essentially a basement with two founders of a investment management firm, and grinding my teeth there for years. And then, working with astronauts as part of this NASA contractor and getting to meet a whole lot of interesting people. And now being surrounded by some of the brightest people in the medtech space. I'm always happy to be the dumbest guy in the room. And looking at that play out in your own life is something that I smile about.
And then, outside of that, for me again, hearing positive feedback from the companies that we help, where they tell me something that was tangible to them: "we were able to save this much time, money or whatever we were able to launch our product this much quicker," or something like that. Going back to the last answer, hearing the results of your work. Again, being able to pop up from being that prairie dog digging in the ground and looking around and hearing people have liked what you've put a lot of sweat equity into and hearing how it really helped 'em, that always brings a smile to face a hundred percent of the time.
Lindsey Dinneen: Yes. Oh yeah. That's a great answer. Well, thank you so very much for joining us, Alex. We are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers, and skills innovative financial solutions that help families living in extreme poverty build sustainable livelihoods and access quality education for their children. So, we appreciate you picking that organization to support and thank you again so very much for your time today and we just wish you continued success as you and Galen Data work to change lives for a better world.
Alex Condon: Thank you so much for having me. Yeah, I sincerely appreciated it.
Lindsey Dinneen: Oh, absolutely. Thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

Kevin Saem | Brand Leader, Zapyrus | Childhood Inspiration, Creating Impact, & Curiosity

Kevin Saem is a brand leader at Zapyrus, a lifelong learner, and a passionate problem solver. In this episode, he shares stories from his early childhood in Cambodia and how that inspired his interest in medtech and healthcare, why he's so passionate about creating impact wherever he goes, and why he places a high value on curiosity. 
Guest links: https://www.linkedin.com/in/kevin-saem/ | https://welcome.zapyrus.com/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
SHOW TRANSCRIPT
Episode 013 - Kevin Saem
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Kevin Saem. Kevin is a brand leader at Zapyrus, a lifelong learner, and a passionate problem solver. Having lived in Asia, North America and Europe, Kevin is a leader that values diversity and believes that the small differences are what give intrinsic value to an individual. Kevin, thank you so very much for being here. I'm just so excited to have you here and learn all about your background and what you're up to these days.
Kevin Saem: No problem, Lindsey. It's a pleasure to be here. Thanks for having me.
Lindsey Dinneen: Of course. I would love starting off by just sharing a little bit about your background. I know that, even from your bio, you have had such a cool life so far, all sorts of places that you've lived, and I'd just love to hear a little bit about that and maybe what brought you to where you are today.
Kevin Saem: Yeah, absolutely. How far do you wanna go back?
Lindsey Dinneen: Whatever would make sense in terms of inspiring you to do what you're doing now.
Kevin Saem: Yeah, absolutely. When I look back right in my life, I always think of it as like the movie Inception. I don't know, have you, if you've seen Inception?
Lindsey Dinneen: I love that movie, one of my favorites.
Kevin Saem: So it's like a, yeah, so it's like a dream within a dream. When I look back at my life, cuz I grew up in a third world country. I grew up in Cambodia and it's almost like a different life there. So I almost see like a life within a life when I made the transition over to Canada. I was born in Cambodia, lived there for 10 years, lived through the nineties. And during the nineties, Cambodia experienced a couple things. So in the early days in the seventies, eighties, we experienced the Khmer Rouge, the genocide which my parents and my grandparents lived through. And then right outta that, when I was growing up in the nineties, we experienced the HIV/AIDS epidemic, which was a delayed onset from what North Americans experienced in the eighties.
And so because of the whole genocide and internal warfare, the country was in already recovery while being compounded with a healthcare crisis, right? Super chaotic. Hospitals were not a thing at the time. There were like some, and I lived in the Capitol, and just seeing people that you knew, like neighbors or friends and family be affected by this disease. And nobody kind of knew what was going on until the UN stepped in and brought some aid and support through portable kind of diagnostic testing for this disease, which kind of helped brought the spread down and help control the spread of the disease. And seeing that impact of what healthcare technology, especially in the MedTech space, diagnostic specifically, could do to a small population in a third world country like that really stuck with me from the early days. So when I moved to Canada in 2000, started studying here, really gravitated to the STEM field.
So science engineering, was able to put my thinking cap on in that space, so to speak. So I went to university and studied chemistry. I went in with a life science background and then specialized in chemistry and decided to go to grad school and do my PhD in chemistry and infectious diseases specifically for diagnostics and medical devices, for testing of infectious diseases because I had that in the back of my mind growing up in Cambodia and seeing the impact that those technologies could make.
And I'm a firm believer in chasing impact and creating value at every stage of your life. Like within your inner circle, what value you could create before you move on, what long lasting impact that you could create. So from Cambodia to Canada to my graduate days I was fortunate enough to meet a bunch of intelligent people, be taken in by very talented researchers in the space. I did my studies in McMaster University, which has now become, I believe, the most research intensive university in Canada, if I'm not mistaken, a few years back. So I studied under professor Jose Moran-Mirabal and I had a bunch of other professors as mentors, and they were really great. I was able to touch a lot of different topics in research, which is unconventional from a graduate experience. Usually you're narrowed down into kind of one scope, but I was able to start with kind of material science, materials engineering, like making novel, conductive, stretchable, elastic materials. Moved from there to nanotechnology, biosensing, and then eventually closed off my graduate degree in doing some work on premature 3D printing and tissue engineering work to create synthetic scaffolds for testing or biomimicry, which that work has been able to mature over time.
So that's like my graduate experience. So when I was, I would say in the last year of my graduate study, again going back to the impact theme. I wanted to understand, what was the next step after a research paper. Like how do you go beyond just benchtop work into actually creating a product that could affect people's lives on a day-to-day? And I wasn't able to get that just being in research. And so that got me thinking about the startup path going into industry, you know, the typical challenges you come across as you're nearing your graduation, right? What is the next step? Do I pursue a career in academia, become a lifelong researcher, and just stick in that space? Or do I take a step out and look at the rest of the world and see what other cool things people are doing?
So putting on my curiosity cap again. Got a chance to network when I was doing a sabbatical research with my professor at the time, Dr. Jose Moran-Mirabal. He had a sabbatical in the south of France and he took me along. It was really great experience, right? We had a lot of great wine, traveled everywhere. So again, unconventional, I would say, graduate experience. So I was very lucky to have had all those sorts of experiences. And it was like a France/Canada collaborative research internship where we were starting kind of new project in tissue engineering and really novel biomaterials, right? And this was like at the very start of the early days of 3D printing for medical devices. And so, got a chance to meet a bunch of cool people.
And then one professor that sponsored us there started this liquid biopsy startup company out of the institute that we were working in. And so nearing my graduation, I was presented with an opportunity to be a part of that early day kind of startup life or this novel liquid biopsy startup company that was in the south of France. And so, I spent a bit of my time there again, wearing multiple hats, helping raise capital, managing R&D strategy, managing relationships with industry. So I did that for a little bit of time and got to know the medical device system from an OEM's perspective at an early stage and then the pandemic hit and it threw a wrench in everybody's plan, not just my own.
And so at that time, our Prime Minister gave out a signal to all foreign workers to come back home. So I had to come back home and it was another reset. And I was looking at kind of new opportunities in the space and I stumbled upon this local Toronto bootstrap SaaS company. At the time it was called Zymewire and I did a little bit of digging and found that it was bootstrapped by a couple of guys. The CEO, Pete Bastedo, he came from the pharmaceutical side of the business. And then the co-founder Ryan, the CTO, he had a technical background. So I was really fascinated by this kind of bootstrap company model. And I took a look at their site and fell in love with the culture that they represented. And it aligned really closely with the philosophy that I had as well. And so that got me even more interested and took me down a rabbit hole of like, all right, what are they about?
And so, I made the connection between Pete, the CEO, and a good friend of mine that came out of the same graduate program. And I pinged my friend Faheem. I was like, "do you know anything about this guy, Pete? How is he?" And then he gave me nothing but great reviews on Pete. He's a really intelligent guy, really smart, and he's doing cool, exciting things with the company, right? And so, eventually ended up speaking with both Pete and Ryan and they were telling me about their plans for the company and kinda where they wanna go. And given kinda my background in MedTech, they wanted to expand the product offerings beyond Biopharma and into MedTech. And that's how I came about into Zymewire at the time. But now we recently rebranded to Lumerate. And now Zapyrus was born just last year around this time as a premium MedTech business intelligence tool specifically for the MedTech industry. And so now we have that. Now it's real.
Lindsey Dinneen: Wow. Oh my gosh. That is amazing. First of all, your story is incredible. Thank you for sharing all of that, and it's so fascinating to me to learn about how someone's background and often childhood can really shape who they end up becoming. But it's interesting because for a lot of the guests that I've had so far, there's been something that says, " I wanna make a difference in this area." But then their career trajectory and their education has allowed them to sort of weave in and out of all sorts of avenues of pursuing their dreams in very interesting ways. So I just love hearing about that. So thank you so much for sharing and I would love to hear a little bit more about your company and how it helps MedTech companies now.
Kevin Saem: Yeah, absolutely. The industry is made up mainly of these small players. I would say 80, 85% of MedTech companies are small, medium size businesses, and then they eventually get acquired by the big ones, right? Basically, our platform helps to connect MedTech service providers with MedTech OEMs at the right stage and at the right time so that they can be supported to bring their lifesaving technology to market. And as you know, a lot of medical device companies come from maybe a doctor had an idea, right, that there's this unmet need and they need this device to come to market, but they don't have any business background or they don't know how to get device to market. And so there's a lot of mess that goes into the early days that a lot of service providers can't help these companies and get this medical technology to market and actually affect people's lives in a positive way.
And so for us, we wanted to humanize business development. We were seeing a trend where there's all these solutions that would give you lists of companies, lists of contacts, and then a way to just bulk email them or bulk spam them. And with a industry like MedTech and the community is so small, that doesn't really tend to work well, especially because you're talking to founders and CEOs that are passionate people that are looking to bring medical technology to help and enable patients and better their lives. So we wanted to create something that was a tool, yes, to help the salesperson and the marketing team in service provider companies to be able to identify the right companies to help at the right time. But we wanted a way for them to do it where it reflects the industry-wide belief of like, "hey, we're passionate people helping other people and that's our community." And so our tool was designed for that, right? That's what our philosophy is. That's how it was based around. We have this mission to bring humanity into MedTech business development. And we do so through suppliers.
Lindsey Dinneen: Love it. That's awesome. That is a very needed service that y'all provide, so I'm so glad that you are out there doing that work. And thank you for sharing about it because it's great to learn about the various resources that are available.
Kevin Saem: Yeah. Yeah, definitely.
Lindsey Dinneen: Well, I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career path for you?
Kevin Saem: That's, that's a very tough question, Lindsey. For me to pick a time point in my life, honestly, I keep thinking back to a theme. I don't know if there's a particular moment, but I think there is a theme where, for me, I'm always looking for a way to create impact whether it's big or small, whether it reaches globally or it reaches my inner circle. That's always been my driving force of how can I do something that would benefit others around me in a positive way, and that would be long lasting? If I was gonna build something, it should be the best thing and it should do good. It's not enough to just do well. I think we should also focus on doing good. And so that's been my primary driver.
And so a particular moment in my life that I remember, this was back in my Cambodia days, from a very young age, I was always interested in building new things. So if I was presented with some sort of toy I would be disengaged really quickly because the toy was already built. I'm just playing with something like a finished product. I gravitated more towards building new toys out of clay, that was more my style. And so that theme just recurred. Like through research I was building out new projects, new process, I was developing new things. In this role as well, bringing a brand to market, you have to build things. And so that I think is in my DNA, that theme of creating impact through building new things.
Lindsey Dinneen: I love that. Well, And I know you've talked quite a bit about the creating impact theme throughout your life, and I just love that. I think that has clearly shown throughout your career and the various different things that you've done. It seems like having that running theme is really helpful because it guides you as you maybe look towards the next thing or how do I go about this project? If your goal is creating impact, then you always have that guiding light and I think that's really valuable. So I'm curious, how has that affected your leadership philosophy, or is that part of the way that you interact with others including in a leadership capacity?
Kevin Saem: Yeah, that's a great question, Lindsey, and I think it, it does, it really does because in a leadership role I'm always looking to create positive, lasting impact as well for the people and for the business that I'm with. So it helps me to separate leadership from management in a way, if that makes sense.
Lindsey Dinneen: Yeah.
Kevin Saem: So for me, that helps me to put people at the heart of it all and then it manifests outside of that. So if you're leading a team of people you're constantly thinking and you got your worried hat on of like, "are these people being fulfilled? Is their work enriched? Are they doing well? Am I helping them unlock the next stages of their progression?" That type of stuff lives in my mind when I think about leadership. Essentially empowering people to do great things and helping them achieve their goals. I think that's what it's all about if you're serious about leadership.
Lindsey Dinneen: Oh, I love that. Oh, that's a great definition of leadership. Amazing. How do you prioritize your own continued learning and growing as a leader?
Kevin Saem: Yeah. That's also another great question. You're coming with the heavy hitters here. So, I just wanna take a step back. And I think two people that kind of help me understand what good leadership looks like. The first person was my PhD. supervisor professor, Jose Moran-Maribal. He had a way to approach leadership where it's like an extra layer of inclusion that he has in the back of his mind and his ability to help support his students was amazing. I learned passively just through watching. Another person that currently I report to actually, Pete, I respect as a leader and I emulate a lot of my thinking through these key figures and mentors. Throughout my career, I always have at every stage several mentors that I like to learn from, either passively or actively. And so I guess that's helped shape the meaning of what leadership looks like, and I use that to surround myself with those types of people.
Lindsey Dinneen: Yeah. And so emulating has been a huge component in your own growth as a leader. Do you find that there are other resources that have helped you or continue to help you, or is looking towards those models of great leadership, is that primarily your source?
Kevin Saem: My source is actually in the people that I surround myself with. It's silly to say, but I think throughout my graduate school days I've really finally learned how to learn or how to ask questions the right way. And I guess to summarize that, it's how to think versus what to think. Leading up all the way to graduate school, you're told you know what to think. This is right, this is wrong. And then throughout my graduate school experience, I really understood the mechanisms of how to think.
And for me, my philosophy at continuous learning for leadership is trying to be the dumbest person in the room. It helps to protect me in a sneaky way where if you're the dumbest person in the room, you know there's only one direction, it's up, and you just learn so much. You just absorb everything, you soak everything in like a sponge. I learn things every day from the intelligent people that I have the opportunity to work with. And so yeah, I take that dumbest person in the room approach and ask tons of questions. That's the only way, I think, to really learn. And leadership is a funny thing where it's almost like trial by fire and you have to just go through it. You can read a lot of stuff-- obviously, I do read stuff-- but you kind of have to go through it and experience it and figure it out as you go and continuous process improvement along the way.
Lindsey Dinneen: Yes, absolutely. Yep. Great advice. Okay, just for fun, imagine someone were to offer you a million dollars to teach ambassador class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?
Kevin Saem: Oh, there's so many bad answers to this and there's very few good answers to this question. I don't know if I am skilled enough to teach a quote unquote masterclass in anything, but if I were to pick one thing to teach, and this is probably another unconventional answer, it's probably the application of curiosity to fuel success in anything that you pursue. I think that's very underrated. As as a trait in people that are successful, I think they're intrinsically curious and they continue to be lifelong learners.
Lindsey Dinneen: I love that answer. Yeah I absolutely agree with you. I had the good fortune when I was young, I was very curious and I was asking a lot of questions all the time. And I had an adult one time say to me, " You know, it's so good that you ask questions because then you'll always keep learning, so don't be embarrassed about it. Always keep asking those questions." And I'm so glad that someone thought to acknowledge that and point it out because it helped me retain that curiosity and not be afraid to be, like you said, the dumbest person in a room so that I could keep learning. So I love your advice. Curiosity is underrated and it's hugely important.
Kevin Saem: Yeah, absolutely, and I think there was a drastic contrast when I was going to school in Cambodia and when the country was in recovery, it was very authoritative interaction between students and teachers. It was seen as like the teachers know all the answers and you should just be quiet, right? And just absorb knowledge from this beacon of wisdom, so to speak. And I would get in trouble in class all the time, I would be sent home with notes saying, " your son is just a troublemaker. He is asking too many questions in class. He, he is disruptive." And they don't like challenges to what they know in that kind of culture at the time. I'm sure it's changed a lot now, now that it's more modernized as a country. But when I came here, I was very surprised as to how much encouragement in Canada and in North America as a whole to like question ideas and question what's right and what's wrong. And always be very inquisitive and almost skeptical of what's presented in front of you. And I really appreciate that philosophy over in North America.
Lindsey Dinneen: Yeah. Yeah, and that's really interesting perspective to have experienced both, so you can contrast and compare. What is the one thing you wish to be remembered for after you leave this world? I think I have a pretty good idea of your answer, but I'd still love to hear it from you.
Kevin Saem: Oh my gosh. I'd love to hear you guess.
Lindsey Dinneen: Okay. I'm gonna guess that it has a lot to do with impact in the various areas, whether it's personal or professional. But I will let you go into detail.
Kevin Saem: You got it. I think you summarize it pretty well. You know, being remembered for having created something or opportunities or memories that has changed the lives of those around me in a positive way, I think that's enough for me. I don't need much more than that.
Lindsey Dinneen: I love that. Absolutely love it. Okay, final question. What is one thing that makes you smile every time you see or think about it?
Kevin Saem: Oh, that's a good question also, and it's a good one to end off on. There's one fond memory and like I said, it's like life-ception. It's like a life in a life. When I was living in Cambodia versus here, you had to really mature quickly when you're living in a developed country. As a young child, you'll understand kinda the risks when you take a step outside. There's dangers all around you. You learn to be quite self-aware at an early age. And I just remember there was a relative that came from France to visit the country and they brought a pair of roller skates back. And this was like a size 10 and we're like eight years old. And there's a group of just street kids playing around on the rooftops and stuff cuz we had concrete buildings with flat rooftops and that's where all the kids would hang out.
And there's like about 10 of us and we remember just, we had a pair of roller skates and we were just taking turns using one each, actually, cause we didn't know how to ride roller skates. We're each just taking turns using one roller skate and just having the best time of our lives. And that reminds me of this, I guess, mantra that I have in my mind of " it's not about what you have, it's about who you share it with" and it's like that part of my life, we didn't have much, but we were so happy. We didn't know that there was anything outside of that. And so it's all about perspective, I think, and that's the memory that comes back to me that makes me smile every time. And I don't think anything else matters once you have things like that, that type of experience.
Lindsey Dinneen: Yeah. Oh, I love that story that I'm just smiling thinking about it too. Thank you so much for joining us, Kevin. I just really appreciate your perspective and advice and bringing such a powerful background to the industry. I'm so thankful for the work that you do. We are honored to be making a donation on your behalf as a thank you for your time today to Save The Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. That was the organization that Kevin chose to support. So thank you so much for your time and thank you for all of your great quotable quotes.
Kevin Saem: Quotable. Yeah. No, thank you, Lindsey, for putting all this together. I think what you're doing is incredible. I think you're highlighting the other side of MedTech, right, that is probably less technical, but is just as important. And I think you'd know, as better as I know, that storytelling is a big part of passing on knowledge and sharing with the community. And our community is so small that I think this is gonna really help bring us all together, especially coming outside of a pandemic years. This is a great, refreshing podcast.
Lindsey Dinneen: Oh, thank you. I appreciate that feedback and yeah, that is the hope. It was so fun earlier when you were talking about bringing the humanity into MedTech, I just had to smile 'cause I was like, "there you go." We're very aligned.
Kevin Saem: Yeah, that's right. That's right. Yeah.
Lindsey Dinneen: Oh man. Again, thank you so very much. We just wish you continued success as you work to change lives for a better world. I know that impact is really important to you, and I know that you're gonna continue to make an impact on the world, so thank you. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.
 
rjwA2u2Sx2mukDo1jErj

Lindsey Jardine | FARAPULSE, Inc. | Clinical Trials, Lifelong Learning, & Academia to Industry

Lindsey Jardine is a Senior Clinical Research Associate at FARAPULSE, Inc. In this episode, she discusses her love of designing and organizing clinical trials, her zest for life and continual learning, and the very human moment in her career when she realized she had to make a major change from academia to industry. 
Guest links: https://www.linkedin.com/in/lindsey-jardine-5a0985103/
Charity supported: Opportunity International 
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
 
SHOW TRANSCRIPT
Episode 012 - Lindsey Jardine
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Lindsey Jardine. Lindsey is a clinical trial manager renowned for her exceptional leadership and groundbreaking achievements in the healthcare industry. With a passion for advancing medical technologies, Lindsey has successfully managed two breakthrough innovations: one at Farapulse Inc. which was acquired by Boston Scientific in 2022, and another at Shockwave Medical that went public in 2021. Her entrepreneurial spirit has also led her to contribute to the success of Cala Health, now commercially available. Lindsey has earned a reputation for excellence in leadership throughout her career in clinical research. Lindsey, thank you so very much for being here. I am so excited to have you as my guest and welcome.
Lindsey Jardine: Yeah, super excited to be here. Thank you so much for having me.
Lindsey Dinneen: Yes, absolutely. I would love if you don't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are.
Lindsey Jardine: Oh yeah. I work in medical device. I work in clinical research. So the story of me, it's a long and twisty one, but I'm currently the Clinical Trial Manager at Boston Scientific in the electrophysiology division. So in electrophysiology, you kinda split in between cardio and neuro. So I've worked in both cardio and neuro. But yeah, just closed out my study for a atherectomyectomy device.
Lindsey Dinneen: Yeah, that's great. I'd love to hear how you either intentionally explored the medical device industry or whether you meandered in, either way I just love hearing the background of what got you to where you are.
Lindsey Jardine: Yeah. So my background was originally in biochemistry. So I went to school to get a degree in biochemistry, and in biochem there's only basically two ways that you can go in any kind of industry. So you can go into academia and do a PhD, or you can go into medicine. So in a PhD you'd usually go into genetics, which is a fascinating topic. Genetics is super fun. So I did work in a genetics lab after I graduated college, but with the intention of going into medicine, so while I was working in the lab doing a lot of like really interesting genetics work at UCSD, I was also studying for my MCAT, which did well, got into med school. While I was filling out the financial paperwork, I looked around and I was like, "everyone in medicine is miserable." And then I had this moment where I was just like, "you know what? I don't know if this is what I want."
Because in medicine you have this grind and it's like the glory is in the grind. And you sacrifice, and then eventually maybe you'll save some lives and your time on this earth will be worth it. But that seemed like a really bad idea because I love being outside. I love my family. I love my friends. I wanted to love life in a very profound way, so I decided that sacrificing everything for maybe some kind of hope that I'm going to further the human race was probably not best served in a hospital.
So I got very lost for a long time. Continued working in the lab doing genetics. I was like, "okay, maybe I can help figure out some cures. Maybe I can figure out some other way to help humanity at not costing me my life." So started working in research, decided that I was not a lab person, not because I don't love the problem solving of the lab, it's just more of a very isolated not as personal. So, I was at lunch one day and somebody who works in clinical research at UCSD, she's "oh, why don't you come into our office and our clinic and figure out what clinical research is all about?"
I was like, "Oh. That's a thing. Clinical research, I don't even know what that means." That's not really a degree that you can have in undergrad. It's not really something that you really hear about. At least when I was in college or immediately after post college, that's not really something that was, I'd never even heard of before. So, I started working at the Chelie Eye Institute, which was also like, not to get into too many too much detail, but a lot of genetic abnormalities present in the eye. So there was like a really strong genetic component. But also I got to work with patients in clinic, which was really fun. So on the hospital side, you get to implement a lot of other people's research and you get to interact with people and you get to see the benefits of research on a daily basis.
So I fell in love with clinical research. Then eventually I was recruited to work on a project at Stanford. So then I moved from San Diego up to the Bay area, started working on the baseline project at Stanford, which was a collaboration with Google and Duke University. So, that was a lot of fun. That was a lot of logistics that project was logistically super complicated, which was fun. I love that. That one was trying to figure out how all the puzzle pieces fit together and then also getting a really good deep dive into like data science. So that was my first like foray into like data science which was really fun. And then also I got to see what industry is like.
So from up until that point, my entire career was in academia. And I did like academia, but it was definitely still that grind that no matter what you do, it's never really gonna matter. You might serve somebody at some point in some time and then your life's gonna be worth it. It's like this noble sacrifice basically. But so then I got to see what industry is like and how innovative it can be, and like that really tickled my creative process and that was something that I really fell in love with was being able to move really fast, help a whole lot of people, and be creative in the process. And you get to put together all these like logistics puzzle pieces and understanding the science and really deep diving into something that gets noticed and that helps people in the immediate.
So that's that juxtaposition with academia and industry is-- academia you grind forever and then maybe someday you'll get a card saying, "You saved my life 10 years ago and my grandkids are now amazing people and it never would've been possible without you." But in industry you get that immediate kind of reward, like you see it come to market and you see your project. All that sacrifice, all that immediate hard work that you put into something, you see it come to market. And it's really fun and it's really great and you get to see it from not that 10,000 foot view where we're all contributing in the greater scheme of things. It's-- you get to see it, like you run a study of 20 people and you see the immediate effect of those 20 people. So that's why I chose MedTech specifically.
But yeah, so, after Stanford, I moved into the startup space. I started working at Cala Health which was neuro. So, that was my first transition into the electrophysiology, neuro cardio kind of space. For anybody listening who doesn't understand what electrophysiology is, it's basically understanding the way electricity governs your body, which is a really fascinating topic to me 'cause I'm a physics nerd. I love physics. So, being able to take all of my physics information, all my physics, like chemistry background, and then getting to split that time between the brain and the nervous system and, and the heart was really interesting. So that's when I fell in love with the heart and the brain.
But yeah, so Cala Health is doing really great. They're commercialized. I was part of the team that put together some of their early feasibility trials and also their pivotal trial, which was a lot of fun to work with them. And then almost immediately after that they got commercialization and being able to understand and talk through or hear the leadership team strategize for something like that was really interesting. And that was a whole new thing that I had never even seen before. Like, how do you bring a product to market and what capacity, who are we gonna reach? Who is this best suited for? So listening to all that strategy was really fun.
And then after that I worked for a company called Shockwave Medical, which is an atherectomyectomy device. So that's a cardio. So electrophysiology in the heart space. And that was a super fun, that was a breakthrough IDE/PMA trial. So it was huge. It was global. It was a lot of moving pieces that, all those logistics that I loved with the electrophysiology portion of it and I got to work with great leaders, and that's one thing that I find like really consistent about when I'm choosing my next job or my next project. I look at the leadership team and I get to see how they approach problems and that is how I make my decision of who I wanna work for, is if you approach problems in a methodical and innovative way, I love seeing that. I love being inspired by that. Those are the kind of leaders that I look up to is how well they approach problems in their thought process and their ability to innovate in a space that's either new or has been done a thousand times, either one.
But yeah, so worked at Shockwave, we were able to go IPO, the company went public and then we closed our trial. We started moving into the post-market trials, and I just still have that adrenaline high from the breakthrough study. We can get into this a little bit later, but those breakthrough PMA/ IDE trials are huge and they are a lot of logistics. It's very intense. It's a lot. It's a lot. And it's a grind, but in a fun way. For me, I love this. I love. So yeah, the thing that attracted me to medicine also attracted me to the breakthrough kinda trials, those breakthrough pivotal trials.
And so after that I was like, " I need another one." So I started looking. I got approached by a recruiter and this recruiter sent me a bunch of stuff and then I saw the Farapulse offer come across saying that they were looking for a clinical trial manager for their pivotal breakthrough trial. And I was like "That company looks like it's gonna change the game." Same thing with Shockwave, also changed the game. So I got on board with Farapulse which is another cardio EP, electrophysiology technology. And it was magic from the very beginning. And we just closed our trial-- which that trial had its own complications. It was a blinded trial and all the sites and like trying to figure out how to do all that through Covid, through all the things. So that's how I got to where I am now. Eventually, last year we were acquired by Boston Scientific. So, yeah, that's the very short background of how I got here, and now moving on to my next adventure, which is gonna be back in the neuro space.
Lindsey Dinneen: Nice. Oh, that's so exciting. That is something that kept resonating with me as you were talking, was just your enthusiasm and passion for this particular industry and for your role within it. And it's just so much fun to hear how all of your different interests and passions are coming together in a way that, it sounds like just keeps you constantly engaged with the process, and you know that you're making a difference as you get to see it right in front of you. It sounds fabulous.
Lindsey Jardine: Yeah, it is. It is. I really do enjoy my job, even like the daily logistics, and not every day is magic. Some days are just the grind, but then two days later or a week later, you're back inspired. So I do love what I do and I love the pace in which the trials that I do sign up for go and it's really fun.
Lindsey Dinneen: Yeah. So, in your role as manager for someone who doesn't know what a typical clinical trial might look like. How does it work? Is there like a typical process or it, I'm sure it varies per trial, but I'd just love to hear a little bit more about how you go about even organizing it to start with.
Lindsey Jardine: Yeah. Oh man. Oh, that's a good question. So there is, the FDA does have a reasonably prescribed way to put together a trial. So, when you're working in the startup space, what happens is you have somebody with a great idea. That person usually doesn't know how to build it. They usually don't know how to commercialize it. They usually don't know how to run a trial with it. So they have this great idea and then they go about trying to build this leadership team. So you'll try and find a CEO, you're gonna find funding, you're gonna start like prototyping some stuff. And then once you get to a point where you think that what you're building is viable, you bring on some engineers that work in the space, that are professional, they work in the startup space, kind of the same way I work in clinical trials. There's definitely people who work specifically in startups to engineer and build stuff like this.
So you bring on an engineering team, they build it, they test it, and then once they've gotten it to a point where, It's a viable product in a lab they usually bring on somebody like me, clinical trial manager, preclinical trial expert to start testing it in larger animals before we go into humans. So then you start putting together your preclinical data. And a lot of the times that's where somebody like me would jump in as a clinical trial manager or a clinical trial expert in some way. So it's usually not necessarily a clinical trial manager, but a clinical trial expert. In the service space, it's a fluid term. You could call 'em clinical trial specialist, whatever you want, but again, it's just somebody who has the expertise of bringing something from an engineering perspective all the way through market.
So, in that process, I get to build the protocols. I get to ask the questions. I get to set up the preclinical work so I can inform my clinical work, if that makes sense. So when we're putting together the preclinical work, you're putting together the studies, you're understanding the device, you're understanding the product, you're understanding the demographic that you're going after. So, the disease space basically. So that's one thing about clinical research, as somebody who specializes in clinical research, is the disease space changes with the technology. So I've worked in electrophysiology and neurology, so, atherectomy, ablation, therapy, neuromodulation.
So the disease space changes, the technologies change, but how you think about your job and how you approach things should be consistent, so it's that innovation. I think that's really what the difference is when you go into academia is you focus on as a very specific disease space and you focus on one very specific and you get into the minutiae of one specific thing. So if you're going into medicine you specialize, you subspecialize, and then you really understand that one protein of that one gene.
So, coming back to where I am now, I don't necessarily understand one specific disease, I have the opportunity and the privilege to work with a lot of different disease spaces. There's a lot of different products and I get to understand and innovate and build my knowledge as I move through my career. So I've worked in a lot of different types of medical devices and it's really fun being able to learn from the engineers and learn from the physicians, and learn from all of my colleagues as I go through my career. So I'm building my knowledge as I go along. So my specialty is building clinical trials. So to answer your question, there is a reasonably prescribed way to do it, but that prescribed way is driven a lot by your logic.
The FDA is your partner in all of this. So they have regulations that you have to follow. So as you're going through and you're building this process, as you're building these clinical trials, you have to make sure that you're adhering to all of the regulations that the FDA has set forward. So that's everything from building your internal standard operating procedures at your company to making sure that all of your regulatory documentation is above board and your operations, all of that stuff. So the FDA's your partner through all of this and making sure you're putting together a clinical plan and/ or protocol that is safe, effective, gets at the correct end points, targets the right demographic of people, disease state, and making sure it's safe and effective as you go through all of these steps from preclinical all the way through clinical.
Lindsey Dinneen: Yeah. And that actually brings up a question that I had, and that is, have there been any moments that have been scary in clinical trials because part of it from my understanding, please correct me if I'm wrong, is that you are trying to establish, not only does this product work as intended, but is it safe? And of course you hope you've done enough pre-work with that to have a solid idea. But are there moments where you've just been like, whew, that did not go as planned?
Lindsey Jardine: We have a term for that. It's unexpected adverse events or unexpected device malfunctions, but that's a good question. So it's yes and no. To be clear: one, you want to make sure that you study your device in the preclinical setting as thoroughly as possible. So that's your engineers. And your engineers are also going to the FDA for pre-submission and the FDA's double checking everything. But with that being said, that's why we do so much diligent testing before we put it in humans in order to make sure that once we get into clinical trials, it is absolutely safe.
So, protocols, they test out for years after a procedure. But to make sure that we have all of our ducks in a row, all of our T's crossed and I's dotted, we're not gonna hurt anybody. I've never been a part of a product that I was ever afraid was going to hurt somebody. That being said, there are definitely times in lab where just " Oh, that happened." So there's definitely times where you're just like, "Oh my God, how did that happen?" In a lab setting, but never in a clinical setting to be very clear, I've never been a part of that. So in a startup, you'll have like your engineering on one side of the building and your operations or something on the other side. But when you're going through user testing or trying to design user interface, the engineering department will bring somebody in you're like, "Hey. I'm gonna teach you how to use this. Let me know if this makes sense to somebody who doesn't build it." So, I've definitely been in a few situations where I was using something and something unexpected happened. I was like, "What was that?" They're like, "Oh, we found a bug!"
So, stuff like that definitely happens, but I've never been clinically in fear of any of the devices that I've worked with. But I also work with really amazing engineers and really amazing physicians. So that's another really great part about what I get to do is I get to collaborate with physicians who do this for a living, who do that very specific, very granular work in one very specific disease state. So they also inform and help, and it's ultimately their responsibility to make sure that whatever they're using on their patients is safe and effective. So that's why we work really closely with all of our physician surgeon collaborators to make sure that we aren't doing anything that could hurt anybody, cuz that's obviously, that's the opposite of what we wanna do. So yeah, that's another thing that I love about my job is the collaboration.
Lindsey Dinneen: Yes, it does seem the more that you've talked, the more I can sense how much you enjoy working with people and having that collaboration, that problem solving, we're in this together trying to make a difference. That's really cool. Another thing that you brought up that I really liked and something that I tend to ask my guests is about how you as a leader in the industry continue to prioritize your own learning and growing. And it sounds, because you get to work on so many different devices and with so many different indications, you really have this opportunity. It's almost built into your job. And then it just sounds like you as an individual are just a really curious person. So you're probably getting to learn and grow all the time. There's no stopping it.
Lindsey Jardine: Yeah, that's true. It's true. There is no stopping it. Honestly, that's why I chose the space that I'm in is I love learning. It's one of my favorite things in life is just expanding my knowledge base, learning fun new things. And even in my personal life, I'm always going out exploring, doing new things like learning and absorbing the world that we live in. And that's one consistent theme of my life is I just want to love the life that we have right now. And so learning and exploring and doing and driving yourself to, to a point of excellence is something that I truly enjoy doing. But yes, that learning is my job. And if I ever stop learning, I think that I would stop being good at my job. And hopefully by that time I can retire and learn something new, learn something that I haven't learned or even attempted to learn before. So, to answer your question, learning is definitively what I get paid to do.
Lindsey Dinneen: I love it. I love that. That is fantastic. Yeah. So is there a particular moment during your career that stands out to you as kind of a defining moment of "Yes, this is the right industry for me." Just confirmation that you really chose and that it was fulfilling some of those deep desires that you've had.
Lindsey Jardine: Yeah. That's a really good question. I can't say that there was ever one like lightning moment that told me that I was on the right path, but I do recall one specific moment where I knew I was on the wrong one. I think that the consistent feedback that I get throughout my career now is a continuing affirmation that I've chosen the right path and the fact that my personal happiness gets more-- like I, I gain more and more happiness with every passing day of my job. Not to say that you have to be happy every single day. I think that there is definitely something to be said with the highs and the lows in a moderated way, not the extreme highs and lows. But I consistently reaffirmed that I made the right decision.
But I remember probably the lowest point of my career that I had to take a step back and say, "This is not okay for me." I was working at that, the baseline project, and a lot of my mentors would call me probably more of a racehorse kind of personality, where I want to do stuff, I wanna improve, I wanna run it at full speed. And working on a project that was that logistically complicated with that many people and that many things, it was really fun. But, in the academic space, slow and the hierarchy, and it was definitely not my my favorite place because I remember there was this one instance where we had this intern and I was helping him and he and I were collaborating on a project and I was like, "Okay, this is how I'm gonna put all this stuff together."
And I have, like I'm known for my spreadsheets. I have this 80 tab spreadsheet and we're putting all together and we're putting all these formulas together. And he was helping me and it got to a point where I was like, "Man, I am super proud of this." I was really excited that I got to learn something about putting all of this stuff together. And I got to teach it as I was learning it. And I did it and then I got to teach it and then I got to see him like do some stuff and he felt very rewarded by it. And I felt very rewarded by that too. So that particular project had lots of different principal investigators. So we had four different principal investigators that I can remember.
And so we're in a room of 30 people. All of them are my superiors and obviously his superiors. But I'd found out that he had taken my work and he had presented it to my boss's boss as his own. And I had no idea that this was happening. And so I'm sitting in this meeting and he's presenting my work and you can't really stand up and be like, "Hey, get outta here, that's mine. I taught you that." And I was just fuming in this meeting. And there's just so much bureaucracy in that context that even if I were to say something, it would've fallen on deaf ears. And I did say something to my supervisor and they're like "Sorry, it's for the greater good." So, oh no, and I was just furious. And so I talked to him after and I was like, "Hey, you just put your name on my work." And he's, " I've changed the color scheme." And I was like, "Did you now? That's so cute."
But there was like, there was no repercussion. There was no anything. So I probably did an immature thing and just stopped talking to him. And he didn't take that very, he was an intern. It's fine, but so I'm just like, I'm not working with you anymore. I can't trust you. So he brought me flowers and he put them on my desk and I threw them. And that was brought like, but I remember like taking these flowers and throwing 'em at a wall and I was like, "This is a bad spot. I should not be here. I'm setting myself up for failure." So, that's when I decided that I needed to leave.
So I moved into the private industry, which was much more intimate. Everybody saw everybody else's work. Everybody knew, everyone was all striving towards the same thing, and it was never an ego trip for anybody, if that makes sense. And there's always that greater good feeling like we're all trying towards the greater good, but you personally are not sacrificing for somebody else's glory. And that's the thing that really got me about academia and that kind of " grind until you die" space. I was like, but. I did that. I feel good about that. Not that person gets to present my work and they get to feel good about it. So, to answer your not question. That was the moment where I knew I was in the wrong place.
Lindsey Dinneen: Yeah. But those moments are just as important cuz they're teaching you what doesn't work and what does not align with who you want to be or, or how you wanna show up in the world. So I think actually, I really appreciate you sharing that story in that very just sort of human moment because I think it's so important to be honest about those kinds of moments that also are exactly what you said, " this is not the right path for me." And then it sounds because of that experience, you were able to go, okay. It's not like I have to get rid of the entire industry or anything like that. It was just, this isn't the right place for me and I'll find the right place for me. And I think that's really important too. So. Yeah.
Lindsey Jardine: Yeah. And I do get reaffirmed by my job every day, and I love that. So it wasn't some shock, like lightning bolt moment, like this is the one. It was a slow burn that keeps burning brighter over time for me.
Lindsey Dinneen: And I love that too, because how wonderful is that? It's not just this one flash of inspiration, which could be the catalyst to continue on the path and do something great and whatnot. But I love that you're in a position now where you can just be constantly, maybe in very tiny little ways, but just constantly reaffirming this is right. And that's special. That's really cool.
Lindsey Jardine: Yeah. That is special. It is. And being invited on a podcast like this, I'm like, "When did this happen? When did I become the leader?" Like yesterday I was throwing flowers at people in a violent way. And all of a sudden I've been getting interviewed for a leadership podcast. Yeah, there's definitely been some significant changes that, all of a sudden, you turn around and you're like, I am the person that I wanna be. I did get here. This is amazing.
Lindsey Dinneen: Yeah, absolutely. I worked hard for this and it is paying off. And yeah, I can change and grow. That's great. That's fantastic.
Lindsey Jardine: Yeah, it is. Yeah, it is very special. Yeah.
Lindsey Dinneen: Just for fun, I'm gonna take the interview in a slightly different direction, but imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?
Lindsey Jardine: Oh man, that is another really good question. You're making me think. I like it. I would say if I could teach a masterclass in anything, it would be confidence. When I was sitting there watching my work that I've been, the project that I've been working on for months, being presented by somebody else, and then my reaction to it, that was a deep feeling of insecurity. And I think building confidence is a very important thing and building the appropriate confidence is another very important thing. I mean, for many years I was a "fake it till you make it" person. But having all of that insecurity being presented and then having somebody else take credit for my work, and then everybody else saying " So what, who are you?" If I had more confidence in myself, I would've reacted differently. And if I would've had more confidence in my ability to figure out problems, I would have not put myself in that position. I would have figured out how to get out earlier or figured out that "grind until you die" was not the right path.
So if I could build a masterclass, if I could help people understand, knowing their own personalities and finding that confidence in themselves. And I think that is an invaluable skill in any industry is not that you don't have to be the person up on stage presenting the project. You can have your own confidence in building something and saying " that's mine" and owning it as opposed to having that insecurity and exploding all over everybody.
So I would say that, yeah, I think that is definitely something that we are facing in a society that is troubling to me is the we're gonna go meta completely away from my specific story, but I see so many people with anxiety, I see so many people with imposter syndrome. So many people that even like Instagram, all these like social media feeds, it feels like a very deep-seated insecurity. And I dislike that. I dislike how we have to look a certain way or have to act a certain way or like all of these different movements to make people be seen and understood. And if we could collaborate and if we could speak with confidence, if we could speak with understanding that everyone here has some issues and if we could speak confidently about what we know, if we could be confident about who we are, then I think we could solve a lot of problems and not erupt into this, this really controversial space.
So I know that having confidence also means having compassion and having that ability to reach out and say, "these are my flaws, but that doesn't mean I'm incompetent. I'm confident in myself. I'm confident that I know that this is the space that I don't know anything about and I need somebody to teach me, and that has so much confidence." And that's another thing that I've learned over my years of working in clinical research is there is no space, there's no time to fake information. You have to learn information and you have to have the confidence to say that, "I don't know this. I need to learn it." No matter how stupid that question is. "I need to learn that piece of information so I can do my job confidently and I can be confident in the product that I'm putting forward." So, if I was going to teach a masterclass, I choose confidence.
Lindsey Dinneen: Yeah. I love that. That was really insightful too. I appreciate your perspective on confidence and, like you alluded to, appropriate confidence too with empathy, with compassion, with collaboration.
Lindsey Jardine: You can't possibly know everything. But somebody else knows something. And if they don't know it, you have to have the confidence to be able to figure it out.
Lindsey Dinneen: Right. And that curiosity is a strength. Because you don't know everything. Like you are highly specialized in, in many different ways, and you have this fantastic capacity to learn, but it doesn't mean that you're necessarily an expert in every single thing you come across and so having the confidence to be curious and to say "I, I didn't know this. Tell me more." That's fantastic.
Lindsey Jardine: That's truly it. That really is the curiosity and the confidence . You said it really beautifully. Just tell me more. Teach me everything and then we can change the world together and we can be better people to each other.
Lindsey Dinneen: Yes. I love it. What is one thing that you wish to be remembered for after you leave this world?
Lindsey Jardine: Oh my goodness. That's a really good one. The one thing that I wanna be remembered for I would say, my confidence. Yeah, I would say my confidence. And that's my all-encompassing confidence, compassion, and curiosity, because I roll all of those things up into confidence, if that makes sense. So my confidence doesn't come from perceived understanding of myself, but it comes from the feedback that I get on a daily basis from my family, my friends. My confidence is something that I hope inspires and I hope that people remember me for the type of confidence that I have. How about that? The type of confidence.
Lindsey Dinneen: Yes. I like it. Awesome. Okay, final question. What is one thing that makes you smile every time you see or think about it?
Lindsey Jardine: Oh, man. Okay. The one thing that makes me smile. I would say, life. That's not too tacky. Yeah. Life makes me smile. I am continuously impressed by the world around me. And that comes with all of the changes that life brings, and it's not always pretty. It's not always great. I've definitely had some times where I didn't wanna do it anymore, and I want to encourage anybody who's listening, who does not have that passion for life to just wait cuz it does get better. Because I, I threw flowers at people, and not in a fun way, in a very violent way. There's definitely times where I was not happy or impressed with life and I didn't wanna do it anymore, and I just I didn't think the next thing was gonna be any better than the last. But I can honestly say right now, life makes me happy, not on a daily basis because I think it's a misconception that you have to be happy every single day because you don't really understand happiness and you don't really understand what life has a capacity for until you know what the bad looks like.
So having bad times is just as important as having good times and understanding that the next piece of your life has the potential to be the best, has potential to be better than anything you've been through so far. But it makes me smile every day knowing that I get to keep doing this in this space and time that we're in right now. And in the world right now, there's turmoil everywhere, but I am very encouraged about life and it makes me happy because I get to see how hard everybody works. I get to see that we are going through something very profound and I'm very confident in the future. And life makes me smile.
Lindsey Dinneen: Oh, I love that. That's the first time anyone has said that, so I love it. Beautiful answer.
Lindsey Jardine: Thanks. It's kinda meta, but that's the one thing, yeah I don't know. Boyfriends, girlfriends, family, the sunshine. All of it's nice. All of it's good. Life makes me smile even when it's making me cry. It's the pain and the struggle and the future that, that just inspires me. And I love that and that makes me happy.
Lindsey Dinneen: Absolutely. Lindsey, it has been an absolute pleasure to have you on the podcast. I just really appreciate you taking the time to join me today. We are really honored to be making a donation on your behalf as a thank you for your time to Opportunity International, which designs, delivers and scales innovative financial solutions that helps families living in extreme poverty build sustainable livelihoods and access quality education for their children. So thank you for choosing that organization to support, and seriously, thanks again for your time. I just wish you the most continued success as you work to change lives for a better world. I love the fact that you have such a passion for life and for your work, and I know what you're doing makes a difference, so thank you.
Lindsey Jardine: Thank you. I really appreciate you having me on. This was a lot of fun. All your questions were so good. I loved it.
Lindsey Dinneen: Good. Glad to hear that.
Lindsey Jardine: Thank you for doing this, for doing you. It's very inspiring.
Lindsey Dinneen: Appreciate that. I appreciate that. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we will catch you next time.
 The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.B5IkdlvEu8YlwXbE9H3a