The Leading Difference

Laura Yecies | CEO, Bone Health Technologies | Osteoporosis, Fostering Better Patient Support, & Leadership Lessons

Laura Yecies, CEO of Bone Health Technologies, shares her journey from a tech and marketing background to leading a company that's revolutionizing the treatment of osteoporosis with Osteoboost, a wearable device using NASA-proven vibration technology. Laura's diverse professional experiences highlights her personal motivation to improve people's lives. Her story illustrates a passionate commitment to developing non-pharmacological treatments and fostering better patient support, emphasizing the significance of technology in advancing healthcare.
Guest links: www.bonehealthtech.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 DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 026 - Laura Yecies
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] 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.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guests today, Laura Yecies. Laura is the CEO of Bone Health Technologies, makers of Osteoboost, which is the first clinically proven, safe and effective non-pharmacological treatment for low bone density. Osteoboost puts NASA proven vibration in a wearable, comfortable, convenient belt form factor. Laura, thank you so much for being here today. I'm so excited to chat with you.
[00:01:23] Laura Yecies: Me too. Really happy to be here.
[00:01:25] Lindsey Dinneen: Wonderful. I would love, if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry.
[00:01:35] Laura Yecies: Sure. My background's in business and tech primarily. I went to college on the east coast and after business school, in 1988, I came to California. I grew up in New York, but my husband was from California and so we decided to give it a shot out here for a little bit. And I started working in tech doing marketing, first in enterprise software, relational databases, and developer tools. And then I moved into consumer softwares, started off at Netscape. And when I was at Netscape, I took on larger roles and responsibilities. I was Vice President of the browser division, managing a group of over 200 engineers, and we were responsible for Netscape 6.1 and 7.0 and the Mozilla spin out. I then led the mail team at Yahoo, when we were sort of the number one email provider.
[00:02:30] And then I also worked at a tech startup and spent some time at Checkpoint, which is a large internet security company heading up marketing there as well. And then I was CEO of two different tech startups, Sugar Sink, which is a sink and share company, and that's now owned by J2 Global. And then I became CEO of a small company called Catch. We had a note taking app and we were able to sell that company to Apple and the Catch team became the core part of the Apple Watch team. So that was very exciting.
[00:03:03] And after that when I was thinking about what I wanted to do next, I worked on some ideas for my own startup with some colleagues and, some things that happened in my life that really drew my attention to healthcare. And also I grew up in a family of doctors, both my parents, two of my siblings. And then at that point, my two older sons were in medicine, and I'd always been interested in that and had a bit of flexibility because of this exit and decided that, I'm gonna, I'm gonna make a pivot. And so I switched and started looking for roles in the healthcare area.
[00:03:40] And everyone sort of wanted me to work in more of the pure software side of healthcare more of the billing and receiving and revenue cycle management and staffing and logistics. And that's interesting and important. But I found that I really wanted to work on something that had directly a health or therapeutic or diagnostic benefit for patients. And so I started consulting. I consulted with companies in the genomics field, MS. And then I was lucky to get my first CEO role at a concussion diagnostic company. And that company, now called NeuroSync had great science. I think they went on to get an FDA clearance for diagnosing concussions. But after a couple years, the board and I had different ideas of what to do. It sometimes happens.
[00:04:26] And so I left, I spent a year consulting at Achille Interactive and at Fabric Genomics and a couple of other companies while I was looking for my next CEO role, and I was really excited to have the opportunity, just over three years ago, to join Bone Health Technologies. I knew a marketing consultant that had been there and was connected to the company, and as soon as I saw what they were trying to work on and solve and have, frankly really make a dent in this issue of osteoporosis, I was interested.
[00:05:01] I mentioned that my parents were doctors. My dad had been Medical Director of a nursing home, and I worked a couple of summers during college as a nurse's assistant. And people seemed, my recollection was that they were in the nursing home typically for one of two reasons: Alzheimer's, or they broke their hip. And, my grandmother had osteoporosis. I'm a small person. It certainly runs in my family. And so I recognized that it was an important problem, a big problem, an unsolved problem.
[00:05:30] And so my really, my only question for the company was, does it work? We had this innovative treatment for osteoporosis and the founders shared the data with me. It was not a sure thing, but I found the data to be very compelling and so I joined and we're three years down the line from that point in time. And one of the most important things that's happened is we finished our pivotal trial and we got the results. Now it takes a while to do a trial for osteoporosis, but we had excellent results from the treatment.
[00:06:03] Lindsey Dinneen: Yeah. First of all, thank you so much for telling us a little bit about your background. You have such an incredibly diverse background. So many questions just emerge from that, but I would love to hear about your current device and the way that it works and whatnot.
[00:06:18] Laura Yecies: Sure. So it's a wearable treatment. It's a belt that has a vibration pack that you wear over your lumbar spine, specifically at the sacrum. And so we're applying vibration to the hips and lower back, and those are to the key areas that experience fractures from osteoporosis. So hip fractures are very life impacting, deadly for almost 30% of people. Spine fractures, you can imagine, are very painful and debilitating. And so we're focusing vibration, which has been proven to improve bone density on the vulnerable anatomy. And, there's a body of evidence from NASA where they did whole body vibration to try to reduce bone loss for astronauts.
[00:07:05] So when astronauts spend time in space, they lose bone. And what they proved was that standing on a whole body vibration platform can improve bone density. But those companies that make these platforms, they have very good products. I'm a believer in the science, but those products haven't gone mainstream. They're people that tend to not comply very well with them, and the good ones are expensive. And so we're aiming to take this proven science-- and by the way, before NASA did the whole body vibration studies, there's a lot of studies in animals and cellular research showing the same thing. There's really a lot of science to support this.
[00:07:45] But our device, we aim to solve the ease of use challenge by making it something wearable. And then most importantly, the vibration is applied locally to the vulnerable anatomy. So that's what we do. And what we showed in our pivotal trial is that we reduced bone loss by over 80%. So we measured the lumbar vertebra with a CT scan at baseline in one year. And the patients who were on the active treatment lost about a half a percent of their bone strength. And those on the placebo or sham treatment lost just under 3%. Our patients, we kept them clinically, essentially stable and slow this bone loss so you don't outlive your bones.
[00:08:29] Lindsey Dinneen: Wow. That's incredible. I am. . I . I say this a lot and I know it's used as sort of a more tongue in cheek manner, but for real, what a time to be alive. That is so cool how so much innovation is just constantly coming through and the, there's this, people like you are doing this incredible work to bring new devices that are really impacting patients' lives. So that sounds like incredible results. You guys must have been thrilled with those numbers
[00:09:03] Laura Yecies: Yes. And this was really our first attempt. We had done a pilot study, but this was our first one year study and we just applied for a grant to do another study with in basically a longer treatment duration, essentially a higher dose of vibration. So from my point of view, this is a great result, but this is like the beginning.
[00:09:26] Lindsey Dinneen: Yeah. Yes, which is so exciting too, because it just leaves room for so much more as you continue to go down this path. So that is exciting. And so that's your next step. I'm imagining, is this, next level of treatment and what do you envision the company to, to do or be doing in say, three, five years from now?
[00:09:50] Laura Yecies: So in three to five years, my goal is first of all, that we have this device very widely used in the market or with patients. So there's 52 million patients with osteopenia and other 12 million with osteoporosis. Our trial was for patients with osteopenia, and so there are a lot of patients out there who I think would benefit from this device. We also want to start to develop a relationship with those patients. Not just sell them a device, but support them in their overall bone health optimization. So we today have created an OsteoBoost application. So we help patients remember and comply and we remind them and give them encouragement to use the device. We help them get the optimum amount of calcium by tracking that exercise.
[00:10:41] And then, our vision is to add community and other elements of optimizing bone health and potentially to have other services. We never wanna get in the way of a patient's relationship with their doctor. So if their personal physician is supporting their treatment of their bone density issues, that's great. But in many cases they're not. And so we wanna have services available for that as well. And it's interesting if you look in the app store or look at a lot of startup activity, there's many companies doing these kinds of solutions for diabetes or cardiovascular disease or asthma or depression, but there's really not much out there for bone health. And yet it's really a key part of staying well and independent and living, living healthily, and it's such a common problem. So we're excited, that we have something unique, yet very much needed and not in a, in a small group it's not a rare thing. It's very common.
[00:11:46] Lindsey Dinneen: Yes. Yes, absolutely. And is your plan to sell directly to the consumers or will you be going through, insurance companies, doctors, whatnot, or do have you gotten that far yet?
[00:12:00] Laura Yecies: We haven't finalized the details of that. So we're not ready to share them. But but what I will say that I think we are quite certain about is first of all, it is a prescription device, so there will be a doctor involved to write prescription and some of the details, and we will certainly have a way where the personal physician can write that prescription. We may have some other options for patients, but a doctor's involved, which is appropriate because they have a condition that puts them at risk of fractures and other health issues.
[00:12:34] But the other thing that I am confident about is that we are going to want to appeal to patients to generate interest. We have seen tremendous inbound interest into the company with not a lot of marketing. I mean, I've done things like this podcast and I speak at conferences, but we have not spent money on advertising or things like that because the product's not on the market yet. And I hear from patients all the time, they are searching for an innovative treatment. They're searching for ways safely to slow their bone loss. I, I'm a member of a number of Facebook groups for osteoporosis and hear how patients talk about this, and so I believe there's tremendous interest by patients and that we wanna tap into that to build the business.
[00:13:24] Lindsey Dinneen: Yeah. Yes. And part of the reason I brought it up, the question in the first place was exactly for that reason. I was thinking there's gotta be so many people who are searching for a solution and yours is so innovative and accessible. I'm so excited to see where it leads. Yeah, that's gonna be incredible. And it really struck me, you talked about your background being heavily in marketing back in the day and so obviously those skills are still very present today. So it's fun to see how, elements of things that you've done throughout your life will lead to this success, in this next endeavor.
[00:14:01] And I'm actually very curious also. yoU talked about some really amazing positions that you had, and then those led you to have these CEO roles. So I'm curious, how was that transition for you stepping into your first CEO opportunity? Was that exciting, daunting, energizing? How are you feeling in those moments?
[00:14:25] Laura Yecies: Those, you captured many of the feelings. So you know, a bit of context. So it was the very end of 2008. And so the world from a financial markets point of view was kind of falling apart. I had led large groups. I had been a general manager, but I'd not been CEO. I had never raised money before, and so I stepped into a company that had been through some trauma. They were supposed to be acquired. The acquisition, the plug got pulled out because of the markets collapsing. The founder had left before I got there. So it was, the company was really in a crisis, I would say. The employees were very afraid for their jobs. We didn't have money and, the financial markets were terrible. It was really challenging to go in and stabilize things and kind of pull the team together and then, build the business in a challenging environment.
[00:15:23] Existing investors gave us some runway, but it was limited. They had already kind of been in investing quite a while, and so I had to find outside money, which in 2009 was challenging. But it was exciting. I loved the product that I was working on. I had been a user of it. It was something that was in my wheelhouse of, I had worked quite a bit on productivity tools for workers and business people and consumers. And, and I, we had great technology. So it was exciting. But it was It was intense. But we built that business. When I joined we had essentially zero revenue and we got to essentially in the 20 million run rate in four years.
[00:16:07] Lindsey Dinneen: Wow.
[00:16:08] Laura Yecies: That was great.
[00:16:09] Lindsey Dinneen: Yes. That is great. That is kudos to you and your leadership for being able to step into such a challenging situation and it around. Yeah.
[00:16:19] Laura Yecies: You know, one thing I learned then, because we did have all these challenges, but we also had a market where the latent demand and need was growing. It was a rising tide. Just to be specific a bit-- and then I'm gonna give an analogy to bone health technologies. So at that time we had a sink and share solution. We were a little bit more niche, but you could think of it as it was quite similar to a Dropbox or a box.box, what was then box.net, and that was also the time that iPhone sales, laptop, Netbook sales were growing very quickly, and so the need to get your data into the cloud was I mean, you could argue that it was always useful to be able to access your data remotely. And there, there were always kind of some niche solutions like, Go To My PC.
[00:17:12] But suddenly, because the environment was changing where people were having these devices the market demand and the market opportunity was growing. Okay, so fast forward, oh, 14 years, 13 years, and osteoporosis and osteopenia is growing. But the other thing that's growing is awareness. And our target demographic, postmenopausal women, I'd say our typical patients are in their sixties. I don't know, what's the joke? Sixties is the new fifties or the new forties. Like these are women who wanna stay active, right? They may be still working if they're not working. They're very involved in the community, they're very involved with their family. They may have, they may be at a point where they've educated their children, they've saved some money, so they have disposable income that they want to take care of their health. And so it's a demographic that spends money on their health. They also are very social and community minded.
[00:18:16] Let's imagine a six year old woman with osteopenia and she's going on a hike or a walk with her girlfriends. What are the chances that her female friends also have osteopenia That's probably 80%, right? If similar in age, and so I see this set of patients and who we're going after as being very interested in safe non-pharmacological solutions that are easy to access. You can call it the Amazon effect. They're used to things being convenient and seamless. And they, they want this type of solution to help them stay kind of active and healthy and be in a way preventative of the need for medication. So I see this as in a very different way than Sugar Sink, still a rising tide market.
[00:19:08] And oh, by the way, at the same time talking about health concerns related to menopause is suddenly, and as it should be not just socially acceptable. It's a hot topic, right? Oprah, Michelle Obama, Gwyneth Paltrow, they're all talking about menopause symptoms. And by the way, osteopenia is very much a result of menopause. You're losing bone density slowly typically starting your thirties, but in the five years after menopause, there's rapid bone loss, and that's typically when women get into that osteopenia stage.
[00:19:44] Lindsey Dinneen: Yeah, absolutely.
[00:19:46] Laura Yecies: Oh, by the way the women who are in their sixties today, when they were going through menopause 10 years ago, or 12 years ago, or 15 years ago, they were told no. Hormone replacement therapy unless you're completely miserable because of findings in the Women's Health Initiative. And that pendulum has now swung back to a more moderate position. But today's 60 somethings are less likely to be on HRT or to have even been on HRT, so they're more likely to have bone loss.
[00:20:21] Lindsey Dinneen: . Yeah. And. Speaking of this, and you were talking about thankfully, there's much more awareness, there's much more conversation happening about women and menopause and going through symptoms and whatnot. I've just been reading lately how much it is still a struggle despite that for women founders, especially of medtech companies to get the funding that they need. And I'm curious, what was your experience when you were fundraising, what were your challenges? What were your triumphs and maybe even suggestions for other women founders who are gonna be going through this soon too?
[00:21:01] Laura Yecies: There's no controlled experiments on these questions, right? So if my fundraise on a difficulty from zero to 10 was a seven. Right? Would it have been easier or harder if I were a man? I really don't know. I know that women, there's less funding going to women, but I have felt that, at least for this company, I don't have any reason to assume that to be the case. If anything. I believe that investors, many of them, they even talk about this, they're looking for founder product or founder market fit. And I'm not the founder of the company. I was brought in as CEO after it started, but I feel like a founder. I operate that way. This is my adopted child. And I love it no less than if...
[00:21:56] Lindsey Dinneen: Yeah, of course.
[00:21:58] Laura Yecies: ...if I gave birth to it.
[00:21:59] Lindsey Dinneen: Right, right.
[00:22:00] Laura Yecies: I am a user of our product, right? And I empathize with very deeply and connect with our patients. And I think if a, a 25 year old man were sitting in my shoes trying to raise money, maybe he would've even had a harder time. So I, I know. I don't know. Women's health has been under invested in, I believe it still is under invested in. And why is that? It's very hard to tell. I will also say that devices are a harder field to raise money for, independent of gender. There's more investors investing in digital solutions or pharma than devices for a variety of reasons. The size of the device investor market has shrunk.
[00:22:51] And I think that's unfortunate and because I think there are a lot of solutions that are less invasive, less systemically invasive. Osteoporosis or osteopenia is one example. But we see devices for other women's health areas like pelvic prolapse or stress urinary incontinence, or a number of things that are of concern to women, but also things that affect everyone like migraine and these device solutions are very safe. They don't completely replace pharmacological solutions, but I think it's really important to have other options and so I do think it has been challenging, especially in the early stages in that field.
[00:23:37] Lindsey Dinneen: Yes, exactly. Yeah. But I thank you for your perspective too. It is, I think quite refreshing to hear from somebody who was a woman who went through this raising capital and actually did have a really good experience, 'cause you hear so many of the opposite, so sometimes it's easy to go, "oh gosh, it's not changing fast enough." But it is so encouraging to hear from somebody who has had a really good experience, so I appreciate your telling me about that.
[00:24:03] Laura Yecies: Yeah. And for women's health if most of the investors are men, a good investor should be able to appreciate concerns outside of their personal experience. But I think human nature is such that we tend to connect with problems that we've had. And so the fact that most of the VCs and investors are men makes the whole women's health field, I think, more challenging for fundraising. But we'll see. That's changing too.
[00:24:35] Lindsey Dinneen: Yeah. Absolutely. Yeah. . So what are some things that you are excited about, either personally or professionally in the coming, coming couple of years? What are, what's gonna, what's gonna get you up and ready to just tackle the day?
[00:24:52] Laura Yecies: Yeah. It kind of goes back to what we were talking about before that most of my career I've spent more on the commercial and marketing and sales side. And since I've been at BHT, we've been very much in sort of science and research mode, which has been very interesting, fascinating. I've enjoyed it, but I'm really looking forward to this next phase where we can get the product on the market. I mean, I hear from patients multiple times per week. "When is this gonna be available?" And I don't like saying "it's not available today."
[00:25:27] Lindsey Dinneen: Yeah. . Yeah.
[00:25:29] Laura Yecies: I wanna say today, and that feels tantalizingly close. I'm very much looking forward to that. And, first doing it at a small scale, we have a waiting list of patients. And I wanna, kind of put a shout out on that. We will first go to the waiting list. To make the product available and people can sign up at bonehealthtech.com and the front of the line are the patients who, the citizen scientists who participated in our pivotal trial, and they're, we have another trial going on. They're first in line. They have contributed so much and did it really out of a total generosity of spirit. They had minimal compensation. And then of course to get to the next level of, hitting the gas and growing the availability and distribution of the product. I'm imagining, I talked about hiking before and that's because I love to hike and I'm imagining, osteo boosting hiking groups or something like that. I know that sounded corny, but.
[00:26:27] Lindsey Dinneen: Oh, I love it. . No, it's fun. And that is so exciting. I am really cheering you on as this next phase comes to reality. That's, yeah. That's incredible. Pivoting just for fun, imagine you were to be offered an opportunity to teach a masterclass on any subject you want. It doesn't have to be in your industry, but it can be, and you'd get a million dollars for doing so. What would you choose to teach and why?
[00:27:00] Laura Yecies: I think I would want to teach around marketing and commercialization, sort of product management, and then really the full life cycle of bringing products to market. I've been doing it for 35 years. I hate to say that. Sounds like a long time in various formats. I mean, I've, some of it has leaned heavily on the digital marketing. Some of it has been more B2B sales, business development. So I feel like I've spent a lot of time in that area and I have lessons learned to share. I actually enjoy teaching. I spent some time, when I first came out to the Bay Area, I taught marketing at Santa Clara Business School. I enjoyed it, but I enjoyed working in the marketing field more, and I had young kids, and so between a full-time job and kids, there wasn't also time for teaching. But I would love to get back and do more teaching. And I do executive coaching and I informally coach and that's a very rewarding part of my job.
[00:28:07] Lindsey Dinneen: Yeah, absolutely. That sounds like a great masterclass and very needed. So we would sign up for that one.
[00:28:13] Laura Yecies: Thank you.
[00:28:15] Lindsey Dinneen: And how do you wish to be remembered after you leave this world?
[00:28:22] Laura Yecies: Oh I mean, I'm a family first person and I am lucky to have great husband, four kids and today's six grandchildren. And the first thing that goes through my mind when you ask that question is, to have had just a really positive impact on them and the other family members and friends in my life. And then, work-wise if this device or our solution is effective it provoke small changes, but in our field, small changes over time can have big results. And, if we've prevented fractures and help people, I would be really honored to be able to be known for that.
[00:29:00] Lindsey Dinneen: Yeah, of course. And final question. What is one thing that makes you smile every time you see or think about it?
[00:29:10] Laura Yecies: My grandchildren getting to play with 'em when they want, when they come through the door every Friday.
[00:29:16] Lindsey Dinneen: Aw.
[00:29:17] Laura Yecies: We have a family dinner almost every Friday night. And I look forward to it all week and when they walk through the door. So that's my mental image and I for sure smile with that one.
[00:29:29] Lindsey Dinneen: Oh, I love that . What a great tradition. And I, it's so lovely that all your families, or at least some of your family, is close enough to be able to do that. How fun.
[00:29:40] Laura Yecies: Yes, it's really fun. It's fun. And I grew up with that so I'm trying to continue, with the next generation.
[00:29:47] Lindsey Dinneen: Yeah. Yes. That's fantastic. Laura, thank you so much for joining us and sharing about yourself, your background, and the incredible work that you and your company are doing. I'm so excited to see it come to market and just really impact lives. Thank you for the work you're doing.
[00:30:06] Laura Yecies: Oh, my pleasure. And thanks for the chance to share it with people and for inviting me onto your show.
[00:30:11] Lindsey Dinneen: Of course, and we're so 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 wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world.
[00:30:40] Laura Yecies: Thank you very much.
[00:30:41] Lindsey Dinneen: 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.
[00:30:55] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Richard "RJ" Kedziora | Co-Founder, Estenda Solutions | Digital Health Solutions, Bettering Lives, & People-First Cultures

Richard "RJ" Kedziora, co-founder of Estenda Solutions, dives into the inspiring world of digital health solutions, where innovative minds are not just developing technology, but also saving and improving lives. RJ shares his journey from early software development days to creating impactful healthcare technologies, highlighting the importance of understanding patient and provider needs. With a focus on people and process management, RJ's story is a testament to the power of technology in making a tangible difference in healthcare through human compassion and the drive to better lives.
Guest links: https://www.linkedin.com/in/rjkedziora/ | https://estenda.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 DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 025 - Richard "RJ" Kedziora
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] 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.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to welcome as my guest today, Richard "RJ" Kedziora, co-founder of Estenda Solutions, focusing on people and process management which also provides strategic technical direction, guidance, and innovative insights, creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient provider satisfaction. RJ received an MBA from Westchester University and a BS in Computer Science from Duquesne University, where he received the excellence in computer science award. RJ is a frequent podcast guest, has spoken at numerous technology and healthcare conferences, and has coauthored articles in technology and peer reviewed clinical journals.
[00:01:37] Welcome to the Leading Difference, RJ. And RJ, I would love if you would start by telling us just a little bit about yourself and your background.
[00:01:46] RJ Kedziora: Yeah, Lindsey, thanks for having me. It's a pleasure. I look forward to our conversation. My background is through software development. Graduated with a computer science degree back in, in the early nineties before web and mobile and internet. So crazy days. And came up through those software development racks. Started out programming, got into requirements analysis, understanding what a solution is about, project management, general management. And then in 2003, with a good friend, we were working with together at a large consulting company in the pharmaceutical space, we went off and started our own company called as Estenda Solutions and remain there today. We just hit our 20th anniversary, which is always crazy when I can talk about decades, but it has definitely been an interesting journey. So my day to day is, I think of it as a digital solution architect. So helping a mix of large companies and small companies, startups develop tools, technologies, algorithms, better ways of looking and dealing, handling data, to make a difference in the lives of people.
[00:02:56] Lindsey Dinneen: Wonderful. That's incredible. So 20 years. Congratulations. That's no small task. . So I commend you for that. That's really exciting. I. Yeah. So how did the idea to start your own company come into being? Did you identify a gap basically in the market?
[00:03:15] RJ Kedziora: It's something probably even early on as I was graduating from college, always in, in the back of my mind to make a difference, to go off and try something new and really drive what I wanted to do. Even before starting my own company, as I worked in various different roles, I'd be hired by a company, I'd come in with a defined role, and then I'd always just find a niche. They'd be like, "okay, where does this company need help? Where can I make the biggest impact?"
[00:03:40] And that's how I went from software development into like more of the analysis and project management , 'cause I quickly realized software development, developing a digital product, it, you know, technology is important and you have to understand how to program and how to test, but it's very much about the people, the process, understanding what they're going through, and realizing those things. It was sort of a natural evolution of like, "okay, I need to strike off on my own and really drive projects and things like that with my talents and capabilities and now our team's talents and capabilities."
[00:04:17] We were fortunate in those early stages to have a Congressional grant for the development of a diabetes disease management application for military healthcare. That's how we got our start. So we worked with people like Walter Reed Army Medical Center, the Boston VA, the Indian Health Services, which is responsible for the Native American population here in the United States. Still working with 'em 20 years later, which is crazy that we have 20 year clients-- bunch of other clients that we've been working with, 10, 11, 12 years a across the board. So, it's been enjoyable from that perspective.
[00:04:53] And I always talk about, I've developed accounting systems, I've developed inventory management systems. And even a railroad car scheduling system, it's like, "Hey, great. We need to get that railroad from here to here. It's important!" You know, it's essential and the economy's important. But healthcare, there's that sense of giving back, of making a difference.
[00:05:16] Lindsey Dinneen: Yes. Absolutely. Yeah, I, that is one of the things that I really enjoy about being in this industry is you're right all of those things matter that you could do with your skills, because obviously you have those skills and can use them in all sorts of capacities but in healthcare and med tech, it's this really great extra layer of feeling like you really are able to impact people's lives directly. And it, it just, it has a different sort of feel to it.
[00:05:46] RJ Kedziora: Yeah. And our projects are typically on the R&D side, work, working with the R&Ds, working with academic medical centers, work with PhDs, with doctors, where they'll have an idea. It's like, okay, here's a different way of treating a patient with diabetes. A different way of looking at the data that you can collect around diabetes or other chronic conditions. I, I wear the Aura ring. It's there's a lot of data that's available there now. And so as we develop those solutions, it's one thing for us and the doctors, the PhDs, the corporations we work with to say, "okay, yes, this really works." But they, you know, they have to go to clinical trial. They have to go and do, they work in the real world. So we also have a couple PhDs on staff to help drive those discussions and do the planning around those clinical trials.
[00:06:34] And ultimately, in certain situations, things then have to go to the FDA to be approved and validated. These days, there's a new terminology called digital therapeutics that we're getting heavily involved with. It's a relatively new term, probably 2017, 2018 that came around. And if there's probably 300,000 digital health applications out there. Systems, you know, some of which we've helped create over the years. But there isn't extensive clinical evidence that they work. There's some, but not extensive, and I think of it as the difference between, supplements and prescribed medications. And so there's lots of supplements out there. You can go to your CVS, your Rite Aid and pick them off the shelf, and there's some evidence they might work, but the evidence isn't exactly clear.
[00:07:25] But then you go to prescribed medications, go through a very extensive, rigorous process of development of clinical trials, and then the FDA or other global regulatory bodies look at these and say, "okay, yes, this does make a difference." And that's the idea of digital therapeutics today is there are lots of digital health applications out there, but now people are taking these digital therapeutic applications: evidence-based, clinically validated, approved by regulatory bodies that can be prescribed by your doctor, by your provider. And more importantly than reimbursed by the insurance company. So making a difference.
[00:08:05] You know, and we talk about health, healthcare, and being able to make a difference. There's not enough healthcare professionals out there, particularly in mental health. There's a mental health crisis in the United States. We just can't train enough people fast enough. Digital health is a way to approach that, to scale, to increase access and equity to these systems, to the care and treatment people deserve, and so that's the idea of digital therapeutics. They can get out there, provide this treatment, share the information with your provider, and make a difference.
[00:08:38] Lindsey Dinneen: Yeah, absolutely. So what does it look like when somebody comes to you and says, "Hey, I have this idea for this app, for this software, whatever." And then how does it work when they start approaching you, and this is a brand new, never before , you know, project and you step alongside them. How does that work?
[00:09:00] RJ Kedziora: Yeah, it is. It is a great question. And we work with a mix of Fortune 50 clients, so big customers, global customers, lots of people, processes, technology. We do happen to be ISO 1345 certified, which quite simply means we have a, well-developed quality management process of how we do software development, very template driven, process driven. It's like, here's how we're going to do it, and then we demonstrate that we do it. We get audited regularly by external third parties, by our clients.
[00:09:32] But then we also work with startups who, in some cases don't really understand software and don't understand regulations and what's required to create one of those digital therapeutic applications. So when a customer does come to us in the, in those early stages, it's very exploratory. It starts out with prototyping understanding the problem in the domain space. One of the things that differentiates Estenda from a lot of other companies is we are going to provide the entire development team, software developers, QA from the ground up, educational training, medication training. So if you're working in diabetes or congestive heart failure or lupus, multiple sclerosis, the better the entire team can understand the condition, have empathy for the patient, can understand the provider, the care professional's journey about what they're dealing with and how they can care and treat that patient, the better off they're gonna be.
[00:10:27] So it's those early stages of experimenting and playing and we start with, you know, black and white wire frame diagrams and really get those going and gradually build them up. And I think about it as you, you have a problem and you want to get across town as fast as you can from one end to the other, and you can walk. Great. Okay. But it's not very fast. Okay? I have this idea for a car. I can get across town really fast, but it's gonna take a long time to build that car and realize value. So, let's first build a skateboard. Very simple, can do it very quickly, provide value, get feedback, from the stakeholders, from the customers, from the patients, from the doctors, the nurses, whoever we're developing that application for.
[00:11:15] And so you figure out the unknowns, you know, so what, aren't we sure? What areas are showing promise? So we build that skateboard and then it becomes a scooter with a handlebar, you know, okay, I'm getting across town faster. It's not the ultimate goal. But I can get there. And then you can build a simple motor on it,, and then you build a body around it and you progress gradually until you get to that car. But along the way, you're adding value very quickly, which is important.
[00:11:47] Lindsey Dinneen: Absolutely. Yeah, that sounds like a really good process to work through. And I love your illustration. That's such a great way of capturing the essence of the process and the way that you go through all of that. So, I'm curious, have you always had an interest in and passion for computers, technology, software development, or is this something that evolved over time?
[00:12:08] RJ Kedziora: Yeah, I was very fortunate. My parents were able to buy an IBM PC Junior when I was in probably seventh grade in the mid eighties. I went to a local parochial school. They had a computer lab, you know, as one computer in the classroom. But, for the eighties, that was phenomenal. And so I knew going into college that I wanted to do software development. A good friend had a Commodore 64, which is typically a gaming, and so I'd be over there and it's like, "okay, games are fun, but what can we make the computer do?" You know? So I was very early driven by what can I do and the possibilities of digital everything.
[00:12:49] College, I really thought I was gonna go and get the PhD in artificial intelligence. Very much enamored with that idea. Ultimately as I got ready to graduate, I got offered a job and was like, huh, money and so that, that turned my, you know, immediate trajectory there. You know, I did start working in programming kind of thing, but always followed AI and things and applied those ideas and principles and what AI is, has evolved a lot over the years. We've developed some AI systems in the past, but you know, now when you look at them, they're really like rules engines, and think things of that nature. And they were considered AI at the time, but nowadays it's like, "okay, that really wasn't AI."
[00:13:36] But you know, the idea is, and the principals were there, and one of my senior thesis projects was genetic algorithms and how do you apply the idea of genetic algorithms to solving computer problems? And that was at the early stages of the internet kind of thing, just as a browser were coming out. So that made research interesting 'cause you could even at that early stage reach out globally to people and seek ideas and thoughts and stuff like that which led me down that road. But fast forward 30 years now and AI is everywhere. It's all that, that the media can talk about these days. Rightfully so.
[00:14:15] Lindsey Dinneen: Yeah, and actually that brings up a great question that I had for you, because I did notice on your LinkedIn, you do share a lot of articles about AI, and you're obviously very involved in that. How have those tools helped your work or how has it changed your work or whatnot? How do you feel about all of that?
[00:14:33]
[00:14:33] RJ Kedziora: It really comes down to data. That's the core of AI. In the past and today, you need data to be able to train the AI systems to do what they're capable of. And it's interesting, our journey as Estenda is, as I've been reflecting on it was one of data scarcity. You know, 20 years ago, getting data was the difficult challenge. In diabetes, it was typically finger sticks, and people would, you know, do it a couple times a day and EMRs were there. They existed. We were lucky working with government organizations that had them, the military, the VA had them. Now it's, you know, fast forward 20 years later, there's an overwhelming amount of data. So early on it was like, how do you make decisions with limited data? Now it's like, okay, how do you use all of this data and pick out the important, salient things to be able to make decisions on and drive recommendations,
[00:15:29] And the same thing is true with AI today. As you're developing a system, you need a robust set of data to train the AI systems. The broader data that you have, the better off you're gonna be. Day-to-day. I think today, generative AI, you know, the Chat GPTs, the Bards, what everybody's really, the media is talking about are amazing. You need to know and understand how to use these tools today. And it's not so much where they are today because there are challenges, there are problems, you know, they make up stuff. It's called hallucinations. And so you do have to fact check what they do. It was interesting is I was sharing, we do a monthly all staff meeting kind of thing, and I was sharing my experience with chat GBT and one of the people on the call sort of googled, like, tell me about Estenda. And it made him the president of the organization kind of thing. It was like, he's a great guy, does amazing work us, he's not the person. And it was just one of the odds of that, in that moment, kind thing. It was like, yeah, that's not true.
[00:16:34] Lindsey Dinneen: Right.
[00:16:34] RJ Kedziora: So you do have to fact check it. But that's today and where we are. And so imagine where we're gonna be 10 years down the road. And Bill Gates said a long time ago, "Humanity overestimate what technology will be capable of in, in the 18 months, two years, underestimate where it's gonna be in 10 years." And I think about Estenda, if the iPhone didn't exist, Facebook didn't, Instagram, Twitter, X, none of these things existed when we started, and here we are a short 20 years later and the world's changing. In terms of AI now it's really an efficiency thing. And it's like, "okay, I need to do some blog posts." And yeah, I can sit there and come up with the blog, post ideas, but it's like "Hey, ChatGPT, gimme 10 ideas for blog posts," you know, and I might not like four of 'em. Okay, "gimme four more." I don't like this. "Gimme four more."
[00:17:29] You know, and it's just, it's an efficiency thing. Even in healthcare, that's what we're seeing. So there are, a lot of, I think it's over 400 now, approved, FDA approved AI algorithms very much in the idea in the area of radiology and looking at images. That's by far the biggest use of . Today, if you have those images, you can train systems to recognize certain things, you know, whether it's breast cancer or diabetic retinopathy. You can train systems to recognize what you need to see in those images instead of a person looking at them all the time. So, again, you can scale much more effectively, which is nice. But in, in healthcare it's very much, it's that efficiency question.
[00:18:09] Lindsey Dinneen: Yeah.
[00:18:10] RJ Kedziora: It's like, okay, I know how to write a prior off letter for this patient, but that takes time. So have ChatGPT write the prior off letter. And then you as the physician, the trained professional, have to look at that and evaluate. And you can't just send it off. You do have to look at it, but you know, EMRs, there's a plethora of data in the EMR. Let the AI systems...
[00:18:35] Lindsey Dinneen: Yeah.
[00:18:35] RJ Kedziora: ...you know, surface what is important, is a challenge. EMRs is a general idea, are very much around capturing data for billing, not the best, usable experience. If you can use AI that's just listening in the room to then document that encounter, that provider's now not heads down on the computer typing, trying to make sure they get everything in and not looking at the patient and not paying attention to the patient.
[00:19:02] Lindsey Dinneen: Right.
[00:19:03] RJ Kedziora: It can reverse this kind of thing. It's like, okay, the doctor can now pay attention to the patient and look at that person and really understand their situation better and pick up on those cues of just their body language kind of thing, and not have to worry about typing away at the computer. And then there's a lot of duplication in clinical records. So it's like, let the AI systems get rid of that duplication, make it better. And then just, you know, enhance. And I saw an article, I think I posted about it, the idea of collaborative intelligence, but a lot of people are asking is, AI going to replace Doctors, software programmers, software developers, insert profession X, is AI gonna replace it? And then people are like, "AI is not quite there. AI makes mistakes. It has biases. AI Hallucinates."
[00:19:50] I love my doctor, but my father has said over the years, " the doctor that graduates last in his medical school, what do they call him? Doctor!" You know, they're human. That, and that's what it amounts to. It's, they provide a great service, but they're human too. And they might not recognize everything. And so if we work collaboratively with the AI to balance that out we can improve overall care and treatment. So.
[00:20:18] Lindsey Dinneen: Yeah, so a lot of potential for it, and I love your idea of using it for some of those more tedious, time consuming tasks and just giving you your first draft because it's not, like you said, it's not gonna replace the human. Let's look through this. But it can help. And if you're using it appropriately, there's a lot of good uses for it too. So, yeah. So, you know, there's a couple of things that I noticed from your LinkedIn profile I'd love to chat with you about. One of the things that stood out to me was in your headline, you mentioned Chief People Officer as being most important. So I would love if you would speak a little bit to that and why you feel that way.
[00:21:00] RJ Kedziora: I can do a lot, but I can't do everything. So I, the people that work for us are very important. I can make an impact. A team can make a much bigger impact. A company can make an even a bigger impact. So that is, that's why they are important. I talk about family first a lot. And, we provide fully paid healthcare benefits for you and your family. You want to have that sense of safety, want people to feel that they can take risks, and do their best work kind of thing. And the better they feel, that emotional safety, that the better off we're gonna be as an organization. They'll be able to provide more value to that customer, be more productive, 'cause ultimately that's what it amounts to is we need to get software out the door. We have customers and clients that have needs and demands and we have to meet those, but you know, you have to balance that with life. So.
[00:22:02] Lindsey Dinneen: Yeah, absolutely. And I love the emphasis on people first, and I'm, I'm wondering if that's something that, is that an ethos that developed over time for you as well as how did your leadership skills evolve? Because going from starting a business to then and then growing it, I mean, it's a whole thing. So, yeah, I'd love to hear a little bit about that.
[00:22:24] RJ Kedziora: Yeah, it definitely has grown and evolved o, over the years. It there, there's this concept of being a 10x software developer, one person making the impact of 10 people. And that's somewhat of a myth, but there are people that are more productive than others. And the idea of empathy and understanding that other person's perspective and experience is what's driving to that next level to become that 10x developer. You're not developing for yourself. You're developing for the end user, but we embody it in, we have a professional development process, and the idea of helping others is embedded in that.
[00:23:01] You'll see that we do one-on-ones, not as great, as frequently, as I would like. But we try and do those. But as part of our structured plan, we do a self-assessment and we ask everybody that question, "how have you helped other people?" as part of the goal process, "how are you helping others?" But even as you're developing in that day to day when you're writing code, "how is it helping you in the future understand what you're doing? How does it help the tester better test that software? How does it help the support person provide better support?"
[00:23:37] So it's really thinking about how you're helping others along the way. And ultimately the whole company is driven by that of working in healthcare. But it starts at that bottom of every person. It's like, "how, what you're doing, helping the next thing?" So we try and constantly reemphasize that when we can.
[00:23:54] Lindsey Dinneen: Yeah, that's a great approach. And so, and because that is so much the heart of your company and your people, I'm curious if there's any particular moment that stands out to you as you've gone along this journey, that kind of really reinforced, yes, this is why I am here doing this work. Is there anything that, or a series of moments, just things that really stand out as being a very sure "yes, this is correct" for you?
[00:24:20] I
[00:24:21] RJ Kedziora: Yeah. It, I would say it's more a series of moments, because as we've developed software and then it's used by the care providers or patients, we've constantly over the years, hear those anecdotal stories of "Hey, I was using your software, what you developed for us, and found this and helped this patient." There's a series of those, but then it even goes up, it bubbles up that we do those clinical trials and we've done five year NIH funded National Institutes of Health funded RO one study. So it's like a five year study to then demonstrate that the software we produced does make an impact kind of thing.
[00:25:00] But even more importantly, as we're part of that process, we've had several customers put our names, our developers' names on patents, or as those articles have gone to clinical journals, peer review journals that our software developers and QA, other staff have been authors on those. That, that's just rewarding where, okay, yes, we are helping people, but then our customers are also recognizing how much of a part of this journey we are. You know, if you really know what you wanna do and have it, here's my 10 requirements kind of thing. We're probably not the company for you. Let's explore and create something together.
[00:25:38] Lindsey Dinneen: That's really cool. So it's always a collaboration it sounds like with your clients. It's not just a one way or the other, them dictating to you or you dictating to them. It's this, let's figure out the best way for us to work together.
[00:25:50] RJ Kedziora: Yeah, it says how do we add value? How are we, you know, we want to contribute.
[00:25:56] Lindsey Dinneen: Yeah. That's amazing. Yeah. So, one other kind of random question. Based on your LinkedIn profile, when's your next triathlon?
[00:26:04] RJ Kedziora: How much time do you have?
[00:26:06] Lindsey Dinneen: Yeah.
[00:26:06] RJ Kedziora: I, yeah, that's a whole 'nother podcast.
[00:26:08] Lindsey Dinneen: Yeah, sure.
[00:26:09] RJ Kedziora: I think I'm, I think I'm, I think I'm done for this year. I live in the Philadelphia area, the temperature's getting, yeah, temperature's getting a little colder and that type of thing. But, you know, take a little rest for a month or two before I get back into training. And, but there are definitely ones I do every year. There's one escape from Cape May, Cape May, New Jersey. You jump off the back of a boat, the ferry, into the ocean and swim to shore. I did escape from Alcatraz two years ago, which is interesting because they take you out in a boat, in, into the. And jump off the boat from Alcatraz and swim to shore. Always interesting kind of thing to, to do those, but it's very much-- it's interesting because my day-to-day at Estenda, my own company, and how I get involved in projects is 'cause I enjoy the challenge of it.
[00:27:00] And in triathlon, yes, there, there's a definitely a physical aspect of training and, but it is also very mental to, and that's really what I think drives me in the sport of triathlon. It's like, "okay, I need to get up at 4:30 and go jump on the pool and swim for 45 minutes and then hop on a bike" time and time again. And I thoroughly enjoy it. But yeah, it is that mental challenge. I've done just pure marathons in the past and it's like, "okay, get to the next telephone pole. Get to that next half pot." It's that mental, keep pushing kind of thing is drives me.
[00:27:34] Lindsey Dinneen: That's incredible. It just reminds me-- tangent very quickly-- it reminds me, I remember I was running a 10k with my husband and I'm not a runner, I don't claim to be, but I was doing this challenge for myself, and I just remember we, we were getting close and I was so exhausted and, you know, kind of miserable at that point. And he was like, "it's all downhill from here. It's all downhill." And I was like, "it's literally sloping up!"
[00:28:00] RJ Kedziora: Yeah, but it's, you know, it's like, yes, for me, try, it's hard. It's difficult kind of thing. but I'm also good enough that I'm not out there it's like, for a a marathon, I can-- in the past it was like 3:20 for a marathon.
[00:28:16] Lindsey Dinneen: Wow.
[00:28:17] RJ Kedziora: But there are people out there that are five hours, six hours. I think that is so much harder, so much dedication for that individual to be out there for five hours. It's kudos to you for being out there for, you know, it's like, yeah. I'm not saying I, I have an easy time of it by any means, but I'm not out there for five hours and they did it. So I just, I'm astounded by those people and they're not on the couch. And I know I, I look to have a long lifespan and a long healthspan. I want to hit a hundred years, but with a good quality of life. And I have a couple friends that are in, still out doing that 5k at 70 years old, and they're like, "I won my age group! I was the only one in my age group..." but you weren't on the couch! Like you did it! And that's motivation to, to keep going out there as well. So hopefully I'll be that person.
[00:29:10] Lindsey Dinneen: I love it. That's brilliant. Excellent. So, pivoting just for fun, but imagine you were to be offered 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?
[00:29:29] RJ Kedziora: Oh wow. It would probably be about health.
[00:29:34] Lindsey Dinneen: Okay.
[00:29:35] RJ Kedziora: Which, which combines sort of everything I do. The triathlon, the training, the fact that I'm in software development in the health field. It brings all of those things together. And just a lot of people don't know what they don't know. And so if I could impart that knowledge on more and more people, I think that would make an impact that would make a difference. So yes, I could teach a software development course on cybersecurity. Interesting.. I could teach one on AI. Yes, interesting. But if it, if you really just focused around the idea of eating better, moving. You don't have to do a triathlon, you don't have to do a 5k. And it's like park a little further away from the supermarket and walk. You're gonna be better off, have that longer lifespan, longer health span. So yeah, it's, if I have that million dollars and it is probably health in in general, which encompasses a lot. But yeah, it would be health.
[00:30:37] Lindsey Dinneen: Yeah, absolutely. Yeah. And then, how would you like to be remembered after you leave this world?
[00:30:44] RJ Kedziora: Huh. Wow. Then I've made an impact and I've made a difference in, in some small way. I don't have to win the lottery, I don't have to be the billionaire kind of thing, but that, that I've made a small impact and, the lives of the people around me and hopefully a bigger audience through the work that I've done, that our company's done. And yeah, I've made a small difference and made a few people laugh.
[00:31:12] Lindsey Dinneen: Yeah. Yeah. I mean, I've already laughed today. So , you're succeeding. Excellent. And then final question, what is one thing that makes you smile every time you see or think about it.
[00:31:26] RJ Kedziora: Family, I, that's, you know, wife. I have two daughters, 24 and 21, doing very well. Yeah, any chance I get to see them? Family.
[00:31:36] Lindsey Dinneen: Yeah.
[00:31:36] RJ Kedziora: And oldest of six. So you get to see them and their family kind of thing. Family's important, yeah. Yeah.
[00:31:43] Lindsey Dinneen: Yeah. And you've mentioned that several times: family first and people first. So it's a running theme. . That's great. RJ, this has been so much fun. I really appreciate your time today and just thank you so much for joining us. We are so 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. So, thank you so much for picking that, that organization to support and we just wish you continued success as you work to change lives for a better world.
[00:32:24] RJ Kedziora: Thank you very much. This was a great interview. Thank you.
[00:32:27] Lindsey Dinneen: Excellent, excellent, and thank you so much to our listeners for tuning in and if your feeling is inspired as I am right now, I'd love if you'd share this with a friend or two and we will catch you next time.
[00:32:38] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Scott Bertrand | AllCore360 | Spinal Injuries, Core Stability, & Changing the World Through Medtech

Dr. Scott Bertrand, the inventor of the AllCore360 therapy optimization platform, shares his journey, beginning with two significant spinal injuries that led him to question conventional physical therapy methods and ultimately steer his career towards chiropractic care and MedTech innovation. He discusses his invention, which revolutionizes core training by focusing on isometric exercises, benefiting a wide range of individuals, from spinal injury patients to elite athletes. Scott's personal experiences and challenges fuel his passion for MedTech and his desire to impact lives positively. His story is one of perseverance, innovation, and the power of using personal challenges as catalysts for creating solutions that can change the world.
Guest links: www.allcore360.com
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com. 
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 024 - Dr. Scott Bertrand
[00:00:00] Lindsey Dinneen: ​
[00:00:05] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:14] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:20] 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.
[00:00:33] 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.
[00:00:43] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:47] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:55] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Dr. Scott Bertrand. Scott is the inventor of the AllCore360 therapy optimization platform, and currently the chief research officer with AllCore360 America. He is retired after 35 years of caring for the chiropractic needs of a wonderful community in south Atlanta. He is a proud a 101st Airborne veteran and honored member of Mensa, but most importantly he's married to his wonderful wife, Lori, has two incredible children, Stephanie and Luke, who have blessed him forever with five precious grandchildren. Thank you so much for joining us today, Scott. I'm so excited to have you on the show and hear from you.
[00:01:40] Dr. Scott Bertrand: I appreciate the opportunity to speak with your audience and to you.
[00:01:45] Lindsey Dinneen: Excellent. I would love, if you wouldn't mind starting off by telling me just a little bit about yourself and your background, and let's start there and then we'll get into some of the other fun things.
[00:01:58] Dr. Scott Bertrand: Let's go back to where probably my medtech life started. I had two separate spinal injuries that kind of thrust me into the healthcare world. One when I was 19 years old and I had a fracture in my lumbar spine, and when I was 19, I was brought up in a blue collar, middle income family and my parents, you know, believed that medical providers were set next to the Pope. I, it was whatever they said, whatever they did, that's how we looked at it. And I thought, I felt no other way. I had, I'd injured my spine and fortunately I wasn't paralyzed at all, but I was definitely beat up and pretty painful.
[00:02:36] But I went into the therapy process at that time just excited to recover. In my mind, the medical doctor would fix me. That's all. I mean, I knew I was broke, but that was his job, and I believed that's what he would do. He goes on and, you know, I'm not putting fingers at anybody. I realize that he was doing the best he could with what he had at the time he had. So I, I'm not, this isn't anything negative, but he refers me to a physical therapist, of course, which he would. I excitedly go to my physical therapist and instantly he requests me to do things that were incredibly uncomfortable, very painful. And I remember kind of leaning back and going, "whoa, wait a minute, that this problem isn't a good thing. This is quite similar to the trauma. Let's probably not do that." But, you know, he kept insisting that I needed to do these movements, and these movements were brutal.
[00:03:30] I was 19. I was an athlete. I had been in the 101st Airborne. I was a, I guess you could quote, kind of a tough guy, but, you know, this was incredibly uncomfortable. And I, I finally, after several visits going back and forth with him and complaining that this was obviously not the right approach, he just looks at me and says, "Hey, you know what, Scott, what you need to do is suck it up." And, you know, this really wasn't a suck it up thing. I mean, I know what suck it up is,
[00:03:57] Lindsey Dinneen: Yeah.
[00:03:58] Dr. Scott Bertrand: That really wasn't it. And I was incredibly disappointed and everything just kind of fell into my like, oh my gosh, maybe they don't know everything. It was kind of a, oh my gosh moment for me, but I ended up going, you know, this isn't gonna work for me. I'm gonna have to, I'm gonna have to quit.
[00:04:14] And so I look over at him and he takes a stamp and puts "non-compliant patient" stamp on my file. I remember going, wait a minute, I'm not "non-compliant." There's nobody that wants to get healthier than I do. He released me and that's how I was. That's my name. I'm a noncompliant patient. So I was really frustrated at that time and I thought, this is really not right. I, but what it did do though, is it focused me in healthcare. You know, I'm a young man and I'm not sure what my career is gonna be. I don't know what I want to do in life exactly. But I went, oh my gosh, some missing links here. And I, at least I need to know more about it for my own self, you know, my own health.
[00:04:54] So I started pursuing a career in health, and I ended up going into the chiropractic profession because I had injured my spine. And these people seem to be the ones that were the spinal professionals. So I go to school I'm going through this process. I'm learning about the spine and the body, the miracle machine we drive, which these are the first kind of early things that are going off in my mind going, oh my gosh. We're blessed with a miracle and we're just trying to learn how to take care of it.
[00:05:23] I'm getting ready to graduate from chiropractic school. I'm at my brother's wedding. I dive off the high dive. I shouldn't have been up there to begin with. I hit somebody in the pool and I break my neck. Okay? It's like, oh my gosh. Here we are again. I'm thrust into this space again. I'm not paralyzed,
[00:05:38] Lindsey Dinneen: Oh
[00:05:39] Dr. Scott Bertrand: and I say that because I've treated and worked with so many people who are...
[00:05:42] Lindsey Dinneen: Yeah.
[00:05:43] Dr. Scott Bertrand: That I don't wanna put myself in that basket. I wasn't, but I was, you know, it was a shocking experience to say the least, and incredibly uncomfortable, and it took a long time to heal, but it's been a good eight, nine years since the first trauma, and now I'm almost a chiropractor. I'm graduating from chiropractic school. So I've got a really strong background, at least anatomy and physiology and how the body works, and excitedly. I go off to therapy again, and I look across the table and he asked me to do the same movement again that they recommended 10 years ago.
[00:06:13] I'm like "whoa, wait minute. I know that doesn't work. Let's not do that. What else do you have?" " No, that's what we do." And I go, " no." And we went back and forth. And then he said to me, Scott, "you need to suck it up." The second "suck it up" got me to walk out of there and say, "look, there's something massively wrong with how we're treating this. I don't know what it is yet, but there's something wrong and it needs to be corrected."
[00:06:36] Medtech is coming up with some innovation that addresses a concern in the medical world that hadn't been addressed that way before. So there's a long process between "I have a problem and I'm trying to figure it out," and "I come up with a solution." I don't wanna underestimate the time that requires. There's a long gap of time in there, but then, okay, now we have a solution. And I guess really, Lindsey, that's kinda where it starts. I invent the AllCore360. That's an interesting conversation if you wanna go into that. But that's what threw me into the MedTech industry.
[00:07:10] And that's where I realized that, when you come up with something in MedTech industry, it's not like a better windshield wiper, which Lord knows we might need better windshield wipers, and that's good. But when you're impacting people's lives and the way that we got to do that, and it's a global reach. It's not just like across the street, across the neighborhood. When you can impact a human being, there's a strong possibility you can impact us all. The awareness of knowing that I can help the world was the motivation in everything. That really was, I think, that's what drives everybody in the medtech industry.
[00:07:44] It's an innovation that can impact society in a way that it needs, but it can do it on such a grand scale and it's not . I know you have a lot of medtech industry, so I know I'm preaching to the choir, but it's not about money. You'll be rewarded certainly, but you'll spend your money, but I'll never be able to spend the hug from the mother who I took care of their daughter and help her to walk. Not only does, I can never spend that, that just gets interest. That just gets better and better, and then they tell somebody else and it grows and it's, it's a, it's just a wonderful industry to be in. Tough, hard, really hard, but oh my gosh, are the rewards amazing.
[00:08:24] Just anybody in that space and is struggling and Lord knows I know how hard that is, please don't give up. It's so worth it. You know, we all say if we could just take care of one person. Back to what I said, if you can take care of one person, you can probably take care of 'em all. And that's, that is pretty exciting. And I've been able to do that. That's where we're at now. I've, you know, it's taken my whole life to get here and decades, but, you know, we're here now and we're really, I'm really proud and I could not be more happy with what the company and our team has been able to do.
[00:08:57] Lindsey Dinneen: That was fantastic. I loved hearing it. I love hearing your background and what motivated you to get into this field, so thank you for sharing, especially some of those really personal stories of challenges that you had to overcome, which ended up being the catalyst for. This new stage. So I wouldn't, I certainly wouldn't wish those injuries upon you by any means, but I am, I want to recognize and thank you for taking those kinds of really challenging periods of your life, but using them as catalysts for good. I think that is very commendable and not easy.
[00:09:34] Dr. Scott Bertrand: No, and I appreciate you saying that. And I kind of joke, but only a little joke that this kind came to me. This invention came to me after months and months of studying on all the issues I was trying to resolve in that kind of hypnagogic state. You know, that's that dream state. It actually came to me in a dream, and when I realized what it was, I realized that was a gift. I'm giving this gift, and now the job is to share that gift. You know, in medtech it's a lot easier said than done, but that's kind of the next step. And they know we've been able to do that. We finally have and it's been a blessing that I've thoroughly enjoyed.
[00:10:14] squadcaster-bf62_2_10-20-2023_140435: Yes. Yes, absolutely. And like I said, thank you so much for sharing about that. And there's so many questions that I have that popped up from it. But I'll start with, I would just love to hear more about your company now and your incredible device and how it works and how it's changing lives.
[00:10:32] Dr. Scott Bertrand: Oh, wow. Thank you for even giving me the opportunity to share that because that's unique and that's why, I guess it's an invention. It's not been out there before. So to do this real quickly, the, the design of the device is to train the core. And when I started, the core was an apple core. People didn't know what cores were. We used to call it the trunk, but anyway, it was, it's the core. And so what we're gonna call "the core" is from the base of your skull to your pelvic floor, that tube of muscles that is who you are. We plug arms and legs into it, and if you're an animal of flippers or fins or wings or whatever, but we're all just this tube of muscles that is that core.
[00:11:12] And so the design of our, my device is to train that core. And so the, here's how we do it contemporarily. We take the core instead of, you know, really realizing we're a tube, we're a round tube. We call ourselves a box. I'm not sure where we came up with that, but now we say our tube has its front and a back, and a right and a left when tubes don't have front and back and right and left. But for some reason we called ourselves a square and then, and that was our first mistake, but we just all just accepted that like, "okay, um, our eyes are pointing forward, so let's make our box pointing that way." So what we did is we took this square, we decided what the square could do.
[00:11:54] The square could bend forward at the waist. It can bend backward at the waist. It can bend to the right at the waist. It can bend to the left at the waist, and we're gonna challenge it that way to make it better. You know, I think what happened was people did that and they got better. There were, it does that kind of works. It wasn't a horrible thought. It was just a, an incomplete thought. So what the AllCore does is it takes this 360 degree machine, it's really a 360 degree machine that can go in any direction. It can bend and twist in any direction, and it takes it and challenges it in every direction. If we took our box example and we bend forward, bend backward, bend right, and bend left, that's four degrees. That's four separate degrees of movement.
[00:12:40] We've only left out 356. What about all those other movements we just left out? And I'll tell you where one of the lights went off that I, this is kind of what makes it so unique, I believe. We are, we train the core isotonically, and by isotonically, I mean, we bend and twist and move. So right now, 99% of the people that run down to their local workout gymnasium center, they go in to do their core and they bend in half. Let's call it like a sit-up. They do sit-ups. When I was like 15, we were doing sit-ups, so you know, that's not anything new. Okay. And then they, we got really clever and we started calling our sit-ups "crunches." That's the same thing. A crunch is a sit-up, but we somehow thought that was even better. And then we went we can make a machine to do that. And then we had a crunch machine. But what we have, it's the same concept. It's bending in the middle of our bodies.
[00:13:40] This was one of the, oh my gosh moments. They, one of these things that eureka moments, if you will. I walked out of the gym one day and I'm a gym rat. I live there. I, that's what I did. And I realized that . If for some reason I'd never walked into the gym, I would've never done a sit-up in my life. Sit-ups are not things we do. These are not positions we get our bodies into. There's no sport where everybody lays on the ground and bends it half 50 times. I started to go, "why in the world are we working so hard to do this one movement when we never ever do that movement?"
[00:14:19] And I thought, "oh my gosh." My next Eureka moment comes in. Now I'm outta chiropractic school and I'm working really hard and I realize we're working with this miracle machine body and I, all of a sudden, I had to start laughing at the way we treat the body 'cause I was reading old medical journals and old history medical journals. I mean, there was a time when they thought smoking cigarettes made you a criminal. I mean, I know that medicine only took what we could take and we believed it and we taught it and we treated it. But what I really realized now, the things we think are true now may not be true in the future, unfortunately, but what I realized, what medical providers and medtech providers really need to do this to me became the bottom line.
[00:15:02] We were blessed with this incredible healing miracle machine. To ever think that somehow our brain that read that book knew better than our body did on how to take care of our body was ludicrous. Our body knows how to do everything. We're the best survival machine on the planet. This machine knows how to heal. It knows how to do everything. In fact, it's a lot better if we just stay the heck outta the way. The more we get involved, the more we screw it up. So here's what I think physicians really need to do, and this is what I kind of decided to do at the medtech, is realize what the body does to survive.
[00:15:43] Because that's really all it's about. It's about survival. There's no extra parts on the body. I mean, everything on the body has a survival value. And if you want to improve the body, you help the body in its ability to survive. So what I did was I looked at the core, and this is, these are these eureka moments. I looked at the core and I said, "what really is the survival value of the core? Why am, why do I have a core? I mean, what do I do with it that helps me survive?"
[00:16:12] It dawned on me almost immediately. The core, as much as we think the core is designed for movement, there's not a lot of survival value to movement. I'll take that back and say, if a rhinoceros was coming after me, I need to step outta the way. So I understand there is a survival, I gotta move, but let's say I didn't move when the rhino hit me. How was I damaged? I was damaged by being bent around the rhino's head. My body went beyond its normal range of motion. So what really is the core designed for?
[00:16:48] And here's the key. It's designed to isometrically maintain your posture in the most efficient, safe position possible. Your perfect posture is so perfect. It's almost hard to get damaged where you're in that perfect posture. When you bend to the left and pick up a weight, you took yourself out of the perfect posture and oh my goodness, he blew a disc. You know, you took your posture, got it out of position, and then challenged it. So that's not how you should challenge your posture. You should take your posture, put it in a perfect position, and then isometrically challenge it because that's how we use it: isometrically in the 360 degrees of its potentiality.
[00:17:31] It needs to be able to do all those things isometrically, and at the end of the day, the AllCore360 takes your body, your only athletic ability has to have the ability to sit. You know, sometimes you go to the gym, you look across the floor and you go, "oh, that looks like a great exercise, but I know I can't do that." The AllCore, all you gotta do is sit and what that does is that adds everybody on the planet. That's your senior citizens. That's people in wheelchairs, that's people that don't have legs. It addresses so many people in the population. All you have to be able to do is sit and we can make your core better.
[00:18:10] At the end of the day, like I said, the core is everything. So what's the survival value of the core? It's not to bend. It's to stop from bending too far, 'cause if you bend too far, something breaks. So what you do is you stop it from bending and you stop it from bending in every direction, and you do that isometrically. That's how you need to challenge the core in the way it was designed to perform. Once you do that, once you develop a very balanced, coordinated strong core, that core can go hit golf balls and baseballs and do anything it wants, but you can't train a core by hitting golf balls and baseballs and all those things.
[00:18:49] You train the core the way it's designed to perform. You make it efficient and strong and high endurance and balanced. What you're really doing is taking your God-given miracle machine and making it the best it can be. As opposed to what most of us do is we take this incredible miracle machine and we beat it up until we kill it. So it's a better way to look at it. We really should take care of it. But yeah, so it allows most of the population, and 99.95% of the population treat their core in a balanced, optimal fashion and it only takes 10 minutes, three times a week.
[00:19:29] One of the problems with therapy, and one of the problems with fitness is always I don't have the time. I don't have the time. My goodness. 10 minutes. It takes you longer to put your gym shorts on. All you gotta do on this machine for 10 minutes. That's how it works. And because of that, people really -- they're compliant. Back to my non-compliant patient status, if it's only 10 minutes, you can kick people to come and do 10 minutes.
[00:19:56] Lindsey Dinneen: Yeah.
[00:19:56] Dr. Scott Bertrand: To have someone come in and do an hour and a half, and now they need all kind of other things in their life that they can use for excuses.
[00:20:02] Lindsey Dinneen: Right.
[00:20:02] Dr. Scott Bertrand: 10 minutes isn't a big commitment for the remarkable, miraculous results it gets for some people. That's kind of how it works. And it's, like I said, it's a it's a blessing, and it started in this spinal cord injury space because what it did for people who only have their cores, I mean, this is what they have. They don't sometimes have arms and legs. This is what they have. So it started in that space, but when those patients and clients started sporting six packs and losing 10 pounds, all of a sudden, everybody wanted it. Everybody wants a six pack, everybody wants to lose 10 pounds. And that's great.
[00:20:39] So we definitely are in this spinal cord injury space, this extreme rehab space, this weekend warrior rehab space. But we're also in that elite athlete space. We're at a lot of colleges, university, sporting clubs. They're seeing that, it's much better to prevent injury than always trying to fix it. Doctors go into the world praying that they get to take care of people and they teach 'em how not to get hurt. But really what they do, they get thrown into this world of broken bodies, the people that don't take care of their bodies and they don't listen to you and you never get a chance to teach them even how to take care of it. Right? So it was an opportunity for us to really impact lives. We don't need a lot of time, we just need you to show up and this, and it works that way.
[00:21:21] Lindsey Dinneen: Wow, that is incredible. And yeah no, it is incredible, and I love that there are two extremely important case uses for-- more than two-- but I was thinking about it in terms of, like you said, injury prevention, just in general, health, wellbeing, physical optimization, versus also, then you have the Yeah, versus also, then you also have treating,
[00:21:47] Dr. Scott Bertrand: Right.
[00:21:48] Lindsey Dinneen: Right. Yeah. So I think it's incredible
[00:21:51] Dr. Scott Bertrand: That opens up such a big market.
[00:21:53] Lindsey Dinneen: It could exactly right because everybody could benefit from this. This is literally something that could impact everybody's life who participates. Holy mackerel.
[00:22:02] Dr. Scott Bertrand: And the nice thing was, it's if you knew where there was one or you used one, I. What I get to do every day, although oftentimes it's cry because these stories are so overwhelmingly wonderful, but I get to hear on a daily basis almost about these recovery stories and it's because we weren't doing it right. It's not that-- I mean, I appreciate the fact the AllCore is the, it's my device and our device, and it's doing what we said it would do-- but it's the body. The body-- if you treat the body right, it just does the right things. It just needs someone to kind of just help it a little bit. It's a miracle. We just need to kinda encourage it sometimes, and that's what this really does.
[00:22:43] And the, again, because it's the results and the responses are so rapid, people enjoy maintaining the schedule. And the longer you maintain the schedule, the more and more of those results improve. And once you finally develop a balanced core, like I said, I've been an athlete my whole life. But I didn't have a balanced core. I thought I did, but I didn't. And when I developed a balanced core, I was, I'm overwhelmed and I can, I can't tell you how many athletes that are starting to experience those same things. You would think an athlete would come in and get on our device and max it out, you know, show me something that, wow, only an Olympic athlete can do. But I can have an Olympic athlete come in and when they get on the machine, I can say to them straight to their face, "I've got a woman in a wheelchair that can make you look horrible." And that is the honest to goodness truth. What the core actually can do when it's taken care of is an amazing thing.
[00:23:43] I wanna make this one really quick story. So I had a beautiful woman come in that was, had been in a wheelchair for decades. And we had to transfer her from her wheelchair to our chair. It's just a matter of lifting her and setting her down here. And I don't wanna sound negative when I say this, but when I lifted her up the first time, she was soft, you know, fluffy, kind of, you know, 'cause she couldn't, she didn't have a lot of muscle tone and Lord knows, how could she? She spent her life in this wheelchair. So I, it didn't surprise me. I would put her in the wheelchair or we put her in the machine.
[00:24:19] Lindsey, I will say probably in three months, maybe, when I would reach over to help her, instead of reaching around somebody that was fluffy, I was reaching around somebody that felt like a granite statue. She was solid rock, and I saw that happen and I saw what that did for her life. She could get in and on and off the commode on her own now. She could get in outta the car. These things that make a difference with independence, these things that are so important that we take for granted.
[00:24:49] Lindsey Dinneen: Yeah.
[00:24:49] Dr. Scott Bertrand: I saw these incredible recoveries and I knew then that I was absolutely on the right path. It wasn't about our six packs and our low back pain. It was about these people that had been almost forgotten and deserved so much, and now they're having an opportunity with hope and getting some great results. So that's the reward of MedTech. That's why, and all your listeners, hang on. It's worth hanging on. It's taken me three decades. I mean, you can't expect to go out and be tampering with people's lives and not expect it to take a long time to get there. People aren't just gonna let you start messing with them until you can prove you're doing the right thing. But it's so, but don't give up. Do the research, keep doing it. And that one person that you help, maybe you'll be a million.
[00:25:33] Lindsey Dinneen: Yeah.
[00:25:34] Dr. Scott Bertrand: I know that's what's gonna be happening to us.
[00:25:37] Lindsey Dinneen: Yeah. Oh, yes. And thank you for that encouragement because I, like you said, it's a long road. So it's helpful to have people on the other side of it going, "Yes, it's possible. It's absolutely it. It'll take time, but you can do it." yeah. So, looking back ?Over your life, I'm just always curious about this, you know, do you think, is there any way that six year old Scott could have possibly had an inkling of what was to come in the future? What your path may have turned out to be?
[00:26:09] Dr. Scott Bertrand: I, you know what's funny? I'm so that, that's such an interesting question. I'm writing a book and the book is, you know, it kind of goes through some of my life and I was just doing this the other day and, yeah, there was a six year old Scott that had an occurrence that happened to him that made him stop and think and go, "my God, I'm driving a miracle." and I was only six. And I remember it like it was yesterday, and it stuck with me. Long story short I was, I shouldn't probably be alive, but due to just natural reflexes, I got outta the way of something. And what I had to say, and I realized is I moved on from that potential horrible trauma that my body moved me out of the way.
[00:26:50] Scott didn't, little six year old Scott wasn't smart enough. My body pulled me outta the way. And that reflexive action, that right there is what the AllCore relies on. So I don't know if that was the very first little thing, the very, you know, the little spark that said, Hey this machine you're driving is not just a bucket of bolts. You know, this is pretty impressive. And I got to, I still get to see that miracle every day. It's amazing.
[00:27:17] Lindsey Dinneen: Yeah. Yes, it is amazing. Yeah, thank you for sharing that story. That's pretty, pretty interesting how that ended up being a, you know, of course, like, like you said, six year old Scott wouldn't have known where that would've led, but hey, It's, it's just, it's cool to see those threads looking back.
[00:27:35] Dr. Scott Bertrand: Yeah. That's what they're the little seeds that found some fertile ground somewhere down the road that'll let 'em grow. But they, it's all those little things. And I can go through my life and point out about a dozen of those and that. You know, you go through life with all kinds of paths that present themselves, and you right or left. And where you are today is dependent on all those choices you made. But I can go back and look at so many of those and go, "thank God I turned that way because that allowed me to get here." And
[00:28:05] Lindsey Dinneen: Yeah.
[00:28:06] Dr. Scott Bertrand: That's almost pure luck. I don't know. So,
[00:28:09] Lindsey Dinneen: Or Destiny or both?
[00:28:12] Dr. Scott Bertrand: You know, I prefer to say that too. I think we're all put on this world for a reason. I think one of the things I say to people all the time, and the two biggest moments or greatest things in your life is the day you were born and the day you realize why you were born. And that, I realized that day, when it finally came to my mind why I was here that my job on this planet was to make sure that people knew that there was an alternative, and just make sure it happened before I died. You know, I just I remember one time sitting on a couch and all of a sudden realizing that if I don't do this, it might not get done. That was a frightening place, it really, it scared me. I was kind of thinking in my mind that someone else will come up with it, and I was okay if somebody else did. I just knew it needed to happen, but all of a sudden I realized maybe somebody else isn't going to, and I knew it was my job, so.
[00:29:09] Lindsey Dinneen: Yeah. Yeah, that, that brings up an interesting point. I mean, my initial thought was that quote from Spider-Man where there's the whole " with great power comes to great responsibility." And, you know, and it's not exactly applicable here, but the idea of when you've been presented with a series of challenges that have led you to a possible solution. Yes, I think there is some sort of feeling of I have this responsibility to, to help because this isn't just about me anymore. This is about the planet. Who else could I impact if I can bring this successfully? And there are, and that's probably something really helpful because, I'm sure as a founder and you know, and you're leading your company, there are days where it's tough and you have to go back to your why of, you know, why are we here? Why are we, you know, going to all this effort and expense and whatnot.
[00:30:12] Dr. Scott Bertrand: Right, right, right. You know? Yeah, exactly. It's every company, and I think a lot of people have, we all have dreams, you know, we have dreams, we wanna do this and do that, and dreams and goals, and those things and they all drive us forward, and they're good motivation. But when it goes to a mission, when it goes from a dream to a mission, it's a total different thing. It's a mission is one of those things that you think about it when you go to sleep, but it wakes you up in the morning and starts beating you on the back until you go ahead and get it done. I was almost fearful of if I didn't do it, God was gonna throw me off another roof and break something else. I needed to get this done.
[00:30:50] Lindsey Dinneen: Oh no.
[00:30:51] Dr. Scott Bertrand: Hit me twice. He told me what to do. He's like, pay attention here, gotta get this together. So, but anyway, I did. It took me a little while, but you hit me in the head a few times. I'll wake up . so, we did, and here we are.
[00:31:06] Lindsey Dinneen: I love your honesty. That's fantastic. In the end, you followed that calling or leading or whatever you wanna call it. So go. This is so much fun just to hear all of your stories and whatnot, but I wanna pivot and take it in a slightly different direction completely for fun. If you were given the opportunity to teach a masterclass on anything that you want, it can be within your industry, but it doesn't have to be. You get paid a million dollars for this. What would you choose to teach and why?
[00:31:40] Dr. Scott Bertrand: I'd listened to the offer. What I've learned, and I could probably share better than most things would be, how important perseverance is at the end of the day. It's the ability to focus and not give up. It's that day to day responsibilities that lead to the final goal. It's, I just know, like I said before, it's not going to be easy. So if you want something easy, you need to pick something else. I would think I would just explain to people not only how to persevere, and by that I mean sticking to a recipe, maintain your vision and your passion because you are the one who has to protect that vision. And then do everything you can again, I guess, to make it happen. But that it's, you just don't give up. No one said it'd be easy and, you know, you gotta do it again tomorrow. But it's there. It's there. It's there. There is a ladder and the rungs are hard, but one step up is one more than yesterday, and I'll take that.
[00:32:40] Lindsey Dinneen: Yeah. That sounds like a fantastic masterclass. So yes. How would you like to be remembered after you leave this world?
[00:32:48] Dr. Scott Bertrand: You know, this is a powerful thing that we're doing here with the AllCore360 and to possibly able to be the inventor of a device that can really impact millions upon millions of lives. I don't think there's any legacy anybody could ever ask for that could be greater than that, but I think what's every bit is important and I think in medtech and all these innovative companies, I really know that-- it took me a while to realize this-- but you can't do big projects alone. You can't take on gigantic projects of changing the world by yourself. So you really need to develop a really good team. And I took a little too long to develop that good team. But the legacy I would like to leave, not just for the device and my name, this group took on that mission of changing lives just like I did. And they've invested their energy just like I did. So my legacy needs to include their legacy. They need to be just as proud of changing the world 'cause they have, and I could not have done it without the help. So it's that it's all of us, you know, it's that legacy. You know, two generations from now, their granddaughter needs to say, "daddy, you worked on that, didn't you?" "Yes, I did." And I want them to have that pride. I really do. That'd be a great legacy. I could wouldn't ask for more than that, you know.
[00:34:16] Lindsey Dinneen: Yeah. Yeah. That is a great legacy. Absolutely. And final question, what is one thing that makes you smile every time you see or think about it?
[00:34:28] Dr. Scott Bertrand: Gosh, there's several of those. You obviously can go to the birth of children and grandchildren. Those are hard to beat, but I, in, in, if not down that line. Yeah. Yeah. I'm a, I'll tell you a really quick story that, and I'll try not make it too long, but it was one of these individuals that had been in a wheelchair and were working with me on the device. And like I said, these things are always so rewarding and I love them so dearly, and I have many memories, but one that I will always smile. The girl's name was Lori, and like I said, I love Lori.
[00:34:59] But so, you know, it's hard to explain, but the device is a, it's a challenging device, and so, I could put it at a certain angle and it would be more difficult than maybe the angle you did got on. So we could compete, you know, I could do more than you, or you could do more than me. So I was using the device, obviously myself, and so I had a certain range that I went to that I was proud of. In fact, I, you know, I'm pretty tough. I'm down here. I'm doing a really good job. Here comes this gal on the wheelchair, by the way, the gal I'm talking about that turned into a granite statue. It's that gal. But so we start out, and I am way ahead of her, you know, and I am, I'm way ahead of her. Of course I am. But then like a two weeks later, she's gaining on me and three weeks later she's gaining on me and six weeks later she's on my rear end and I'm going, oh my gosh. I finally had, I stopped one day and I just had to look at her and I said, "Lori, How in the world are you doing this?" Because you know, I knew where I was at and she took her finger and put it in my face and went, "how are you not?"
[00:36:07] And I will never quit smiling on that day because she struck me to the ground and basically said, "here I am sitting in a wheelchair and I'm kicking your rear end. What is your excuse?" I mean, she brought me to my knees and I will never forget that. And I'll smile because that showed me power that I've never seen. And I only pray I can be as motivated as she is someday, you know? But I will always smile. It was a wonderful day.
[00:36:36] Lindsey Dinneen: That is incredible. I love that story and I also love the fact that that makes you smile that sort of Very much, you know, confrontation. And this is, she's gonna speak her truth to you. And you know, you took that as a good thing, as a challenge to keep, you know, doing what more of what you can do. And I,
[00:36:56] Dr. Scott Bertrand: She was right. Yeah, she was right. She hit me right where I live and I thought, you know, I don't think there've been many people on the planet that would even do that or even try that, you know? Yeah. It was came right at me.
[00:37:10] Lindsey Dinneen: I, love her boldness.
[00:37:11] Dr. Scott Bertrand: Love her dearly for it.
[00:37:12] Lindsey Dinneen: That's fantastic. Oh my goodness, this has been so much fun. You are incredibly inspiring. I love hearing what you're doing to really make a difference. I'm so thankful it has made a huge difference for you personally. But then, like you said, all of the ripple effects and all the lives you're touching, I think it's absolutely incredible. So I just wanna really, you know, basically say thank you. Thank you for the way that you are choosing to lead your life, and thanks for joining us today.
[00:37:43] Dr. Scott Bertrand: No, that's I really appreciate it and I hope in the time we spent, I could leave your listeners with maybe there is some hope for some of the people that mo so many people I know, people have had a stroke or in a wheelchair and loved ones that could, there's, I just want them to know that, hey, reach out, look around. We're growing as fast as I can grow it, but there may be one close by and I would like to at least try because it's for some, it's remarkable and I appreciate you giving the opportunity to share that.
[00:38:09] Lindsey Dinneen: Yeah. Yes, of course. We are also so honored to be making a donation on your behalf as a thank you for your time today to Sleep in Heavenly Peace, which is an organization that provides beds for children who don't have any in the United States. And so just thank you for choosing that one in particular to support, and we just wish you continued success as you work to change lives for a better world.
[00:38:35] Dr. Scott Bertrand: Lindsey, I so much wish that and to you. I've enjoyed your podcast. I know you're gonna do wonderfully well as you do more and more. Keep me in the loop and I'll look forward to talking with you next time.
[00:38:45] Lindsey Dinneen: Sounds great 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.
[00:38:59] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Marina Daineko | Biocompatibility Consultant | Regulatory Compliance, QMS, & Women's Representation in Medtech

Marina Daineko, a biocompatibility expert with a background in analytical chemistry, shares her journey from a research assistant in physical chemical problems to a prominent figure in the medtech industry. Marina discusses her passion for understanding the regulatory compliance and quality management systems in medical devices, reflecting on her curiosity and desire to make a difference in people's lives. She also shares her commitment to increasing women's representation in the medtech field.
Guest links: https://www.linkedin.com/in/marinadaineko | https://www.intrinsicmedicalgroup.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 DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 023 - Marina Daineko
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] 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.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:52] Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I'm excited to introduce you to my guest today, Marina Daineko. Marina, a certified biocompatibility subject matter expert with an MSc in analytical chemistry, shines as a dynamic figure at the intersection of medtech and chemistry. Her knack for seamlessly bridging biocompatibility, regulatory compliance and materials science, sets her apart. Marina's captivating presentations at conferences, including the prestigious Women in Tech Global Conference 2023, underscores her multifaceted expertise in the medtech industry.
[00:01:31] Welcome. Thank you so much for joining us. I'm so excited to have you here today.
[00:01:36] Marina Daineko: Hello, Lindsey. Nice to meet you. Thank you very much.
[00:01:40] Lindsey Dinneen: Yes, absolutely. I was wondering if we could start off by you just sharing a little bit about your background and yourself and how you got into the medtech industry.
[00:01:51] Marina Daineko: Oh, yeah, absolutely. Actually, it's very interesting story because I have started with medical device industry, not from the very beginning. But since I was young, I have always had a keen interest in learning more about the properties and different forms of matters and understanding how this undergo changes. So all in all, I fell in love with chemistry while I was in high school, and knew that I need to proceed with chemistry in my adult life. So anything that can be touched, tasted, smelled, seen, or felt is made of chemicals. And I was inspired by this fact and yeah, so I decided to connect my life with it.
[00:02:36] And it's interesting because I started my career as a research assistant in the Research Institute for Physical Chemical Problems. And here I had a really scientific background because I published several articles, put my hands into patent work, and so on and so forth. And everything related to non resist photocatalytic lithography and nanoelectronics. So far away from medtech industry. And yeah, but it was interesting for me. And it was sometime after that it was time of self discovery through challenges, because I wanted to do something in my career that is challenging, interesting, and makes a difference in people's lives on a daily basis.
[00:03:23] And actually around this time, I found out that my ancestor, Vladimir Galalyev, was a researcher in medicine and published academic papers dedicated to rheumatism and the morphology of allergy. So, I found it interesting and I decided that I might delve into this area, into this domain. So all in all, I started look for opportunities and found out RNC position. And that's why I joined MedTech industry as R&D and my background in chemistry and material of science helped me a lot here. And I'm a curious person, so when I was working as R&D, I also was trying to understand, "Okay, what are the sources of different requirements?" What are these come from, what are all these regulations that some people are talking from time to time.
[00:04:20] And as a result, yeah, that was really interesting for me. Okay, I need to understand the source. I need to understand the matter, what I'm doing, why I'm doing. So, and as a result, I started to look into regulatory compliance area and overall, like, quality management system, just understand how the things work and to understand medical devices from different areas, right? Because it can have very different requirements depending on what aspect you're looking from, right?
[00:04:51] So I was really fascinated and thankfully I had the chance to, to join biocompatibility and biological evaluation team as R&D also understands the requirements with chemical background in chemistry. So I started to look into biological evaluation to, because it's so interesting for me, look here, it's mixture of science, also medical device, and additionally some investigation, some topics that are not discovered or something like this. So it's really nice. And also next step I decided, okay, I'm pretty aware like what are things with medical devices that contain hardware for instance, but how make this medical device life. Because it's really interesting and fascinating to see how their lives can be changed.
[00:05:45] So that's bring me to software in the medical devices. So software and firmware is something that could help to make medical devices live so they can be used in some analysis, predictions, and so on and so forth. And that's why I'm here in the medical device industry, really enjoying what I'm doing and understanding the medical device from different perspectives.
[00:06:10] Lindsey Dinneen: Yeah, that's wonderful. Thank you so much for sharing your background too. It's so fun for me to hear about how you go from so many different, yeah, because you're so multi talented, and you're so interested in so many things, and I love hearing that. I love hearing about your background in chemistry and then you went into R&D and now you're doing software and firmware. Oh my goodness, you are a lifelong learner!
[00:06:38] Marina Daineko: Yeah, I believe it's very important because we are living in book of world. It means that, there are a lot of changes around us. And additionally, for me, it's really interesting. I'm really fascinated to see is a medical device from different sites. Okay, we have compliance. Compliance means like this requirements, right? We have R&D and product quality and biological relations and those requirements may be applied, and when touching one topic, it's very interesting to see what is beyond this topic. For instance, as I said, okay, R&D requirements, design input, design verification activities, and so on, according to, for instance, ISO 13485 or CFR part 820. But what about regulatory, right? What about FERS?
[00:07:27] Moreover, it's also, yeah, one thing that I'm proud right now is that this year I took a very bold choice to become a student one more time and I selected a program that focused on the medical sterilization engineer. So I believe it helps me to understand medical device even deeper because biocompatibility and sterilization are things that lay near each other. So just to deep my knowledge in the sterilization and disinfection areas, I picked this program. So I'm a student again. It's a very nice feeling.
[00:08:09] Lindsey Dinneen: Oh good, yeah. I love how you said that, it's a nice feeling.
[00:08:15] Marina Daineko: Like back to school, yeah!
[00:08:17] Lindsey Dinneen: Yes, that is ,incredible though and it is so Interesting to hear how you just keep developing your skills, and like you said, you're a curious person, so you're going continue to explore different ways and help the industry move forward. So, good for you.
[00:08:35] Marina Daineko: New choices for industry,
[00:08:36] Lindsey Dinneen: Nice. Nice. Okay. So, I know that you also are an advocate for women in medtech, and I would love if you would share a little bit more about that and your involvement. How did all that get started, and what are you optimistic about with that?
[00:08:56] Marina Daineko: Oh yeah, it's great questions. Thank you very much for asking it. So it has started actually recently when I was invited to speak at Women in Tech conference. So I was really excited here because in my experience, I-- all right, some time ago, long, long time ago, I don't remember even how many years it was-- I tried to start a business as a woman and unfortunately, I have got quite a lot of pushbacks with said words, like for instance, "okay, you need to sit down at home and growing up children and I don't know, cooking," and for me it was like a question, "okay, I can do it truly, but I have like other perspective and other ambitions and willing motivation to grow like a professional, like an expert." So for me it's very important to show an example for other people, women said, "okay, we can, surely we can grow up children. Surely we can take care of some other people and cooking and cleaning, like this man."
[00:10:09] So it's very important to show an example that I can do it. So everyone can do it. Everyone has own voice and this voice shall be heard. It's very important. So it started quite innocent for me, just invitation to, to talk at the conference, but I was so proud of it. And I shared this news with my colleagues, with my family, friends like with everyone, I believe, and trying to support this.
[00:10:39] Moreover, recently I has been nominated for Women in Tech nomination. So, and I'm so excited of it because my presentation, I was talking about Internet of Medical Things actually, and compliance and risk aspects within IoMT. So, my, my talk as a speaker and I was congratulated with this nomination, so I'm so proud to, to show again other people that, "okay, look it start, it has started really innocently, but where I am now."
[00:11:13] I'm nominated and I am growing awareness regarding women in tech and asking for collaboration here as a women to join this network because I could see a lot of opportunities with it like to support each other, to help each other to grow together, because when we are sharing our expertise, when we are given advices, when we are providing areas for improvements, it is really also very important, actually, our points of growth here. So I believe it's very valuable network and really could see a lot of improvements while taking part in this Women Tech Network.
[00:11:54] Lindsey Dinneen: That's incredible. And first of all, congratulations on that nomination!
[00:11:59] Marina Daineko: Thank you. Thank you so much.
[00:12:01] Lindsey Dinneen: That's incredible. Yeah, I'm so excited to see where that leads, but in general, I
[00:12:06] Marina Daineko: Yeah.
[00:12:08] Lindsey Dinneen: Yeah! And you're like, oh my goodness, "yes, me too!" Ha Yeah, but I just I love the fact that, it started off with an ask of you do this talk, and then you just said, "okay, and I'm diving into this too." So,
[00:12:25] Marina Daineko: It's exactly how it works with me.
[00:12:26] Lindsey Dinneen: Okay. Excellent. Yeah. And, I know from being connected with you on LinkedIn that you are very passionate about helping to spread knowledge about the industry. Yeah, and so you do this Mondays, you do like a coffee chat or coffee talk. Yeah. Can you tell us a little bit more about that?
[00:12:50] Marina Daineko: Absolutely. So it's again interesting story because sometime ago, actually I have started to be pretty active on my LinkedIn, like just around the year or so. And how I, why I decided to be active and why, how it's actually started. It started because I felt like I'm so full of expertise, knowledge, advice that I can't just hold them with myself so I need to somehow to share them and I found LinkedIn platform very useful and comfortable for such knowledge sharing because here there is a community of different experts and that's why we can share opinions, advices, comments, because it's also valuable to see from some things from our perspective, right?
[00:13:43] And on Mondays, I'm doing like Monday news. And I remember when I'm using actually my own picture. I took this picture when I had a coffee and croissant, like dreaming, "okay, what would I like to read on Mondays?" And for me, it was kind of a digest of important things. And I usually connect in this important available things around biological evaluation, because I could see quite a lot of information regarding compliance, quality management system, risk management clinical evaluation, like really ocean of news and updates and knowledge sharing regarding clinical evaluation.
[00:14:24] But for some reasons, I saw that biological evaluation is kind of underestimated, meaning that-- and it's quite, it's not too easy to find some valuable information or clarify something or, to make it transparent and traceable why we need to go like this direction or this direction, and what are updates in the industry and so on so forth. And I know that quite a lot of people are too shy to ask directly or they simply don't know whom to ask, right? Because if you are known as a subject matter expert in this domain, nobody would ask you even if you are right.
[00:15:03] So, and it helped me to understand like, okay, maybe I could put myself in this niche and provide some updates like I'm doing here on Mondays, like taking one topic and provide small basic, maybe basic, maybe not too basic things, around this topic. Like for instance, biological evolution, but inside of biological evolution, we have a lot of things to talk. And to be honest, I can talk about a biocompatibility like all days and nights. It can be unstoppable. So, yeah.
[00:15:42] Lindsey Dinneen: Okay, so you have lots of things in the works and you're a student still. What is coming up for you? What is next that you're particularly excited about either personally or professionally or whatever you want to talk about.
[00:15:55] Excellent
[00:15:56] about
[00:15:56] marina_1_10-18-2023_190318: My God, I swear a lot of things, to be honest. Yeah. First of all, maybe from professional side, I'm really excited to take part in the MedTech Summit. Flying to the United States, and I'm really excited because there would be a lot of professionals and subject matter experts within the summit like from biological evaluation, as well as regulatory affairs. So I'm very interested to make like connection in real life, not only like online, looking at people's heads and that's it.
[00:16:34] Lindsey Dinneen: Right?
[00:16:37] Marina Daineko: So, I'm really excited of it. Also I will have panel session about post market surveillance. And it's very interesting, actually, format because it would be different experts here at this panel, like from regulatory, clinical, risk management. And I will represent biological evaluation aspect. So, and we would be talking about post market surveillance for medical devices. It's also hot topic and I'm excited because in such format is it, that would be my first time in such format with other experts, but I find it really valuable because this cross functional team usually, it's like kind of brainstorming, negotiation, discussion. So I expect like a vivid discussion around this topic and again I believe that would be very interesting insights here during this panel. Yeah.
[00:17:34] Lindsey Dinneen: Yeah. Yeah. And, speaking to that, when you are involved in these these panel discussions or conversations or things where you might, where like you said, you're going to be surrounded by experts and you have your area of expertise too and whatnot and you're sort of all collaborating, is there ever a moment where, does it ever feel overwhelming when you're just " oh, I don't know enough about this topic?" I'm just curious because I know sometimes we have those moments as humans. We go into this situation that's not 100 percent our realm, and I'm just curious how you handle those moments of " how can I contribute to this conversation?"
[00:18:13] Marina Daineko: Yeah, that's a great question because I wouldn't be honest if I say that I don't have such moments. Surely I have and as I'm quite active as a speaker in different conferences. So surely I have such moments in my life. And yeah, so, how I deal, I'm trying to be logical, first of all, and structured. Actually, I'm a super structured person. I have folder and folder, all the reminders and so on. Organized and structured. But, yeah, so I'm trying to think in this way, "Okay, here is the question. How can I decompose it for the parts that I can understand, right?", And I can provide some feedback, insight or advice, for instance, right? Because usually a person who is asking a question, this person usually has some background or circumstances or conditions why this question is asked. So I'm trying to decompose this question if it's still unclear. So I'm trying, I'm asking to ask maybe in a different way. It gives me additional time to think actually, so well, right?
[00:19:19] So, and in that for, I would say for 100% cases with this decomposition or, and for instance, asking to reward the question, I can answer it because it gives me time to think the decomposition can gives me the base, " okay, we are talking about XYZ or ABC or what we are talking about, right? What area from what perspective?" So all the things help me to answer, but usually, yeah decomposition and additional time to think helped me each time.
[00:19:57] Lindsey Dinneen: Yeah, and thank you for your honesty, because I really love listening to other people's strategies, because I think we all have those moments sometimes, right?
[00:20:04] Marina Daineko: Absolutely. It's very nice because I also can understand, okay, what are my weakness? What my, what are my areas for improvement? Maybe I need to dive deeper into this topic. But, I am, I consider myself brave enough to say, I don't know if I really don't know something, right? Not to, not to make a not proper conclusions, for instance, or advices and so on, so forth, because it's very important to, to say such things because we are talking about medical devices. Medical devices are used when people are in need some help. It might be even the question of life and death so it's very important to say if I don't know so I'm saying I don't know, please ask this I need additional time to investigate. So I need to so I need this additional time, right?
[00:20:56] And also what is very important for me as again as a woman and as immigrant, right? Not to be shy, but to talk, to speak up because yeah, I can be, I am an expert. And I need to show my expertise to others because others, other people can, for instance, they just simply maybe not aware that I'm expert, right? So it's very important to speak up and to be brave here.
[00:21:26] Lindsey Dinneen: Yes, a hundred percent. And I kept thinking about that when you've been telling us about your life and your trajectory and how curious you are. And I was going to say that bravery is such a strong theme. I, it really is though, because it is hard sometimes to be willing to speak up and say, "I don't know, or I let me go back and research or whatever." And so I really, I think that's really powerful what you said, and I appreciate your candor there. And I'm, I am also curious myself, so if, let's say that you are in a sort of mentorship position. What kind of advice would you give somebody, maybe especially a woman or, somebody who is coming from a different background who may not have the same access basically, how would you advise that person to participate and to keep moving forward with their own career, even if they're feeling a little uncertain or they don't fit in.
[00:22:30] Marina Daineko: Oh, yeah. No, I love this question. Thank you for asking it. So, I believe that we are living in such a world where hard skills shall be complemented with soft skills. And as far as I could see, listening is very important. Listening and communicating properly. And listening, I believe that listening to others is a part of communication. So, regarding listening, it's very important to listen,: like kind of correctly what I mean on this is for instance, not multitasking when someone is listening to another person, right? Because sometimes we are doing something and listening not attentively. And we, for instance, can mix up topics or don't understand something or just don't miss some part of, conversation. And that's why it's very important to, to listen attentively, really deep really diving into the topic and understanding what is going to be, like, what we are talking about, what is the topic, what is the ask. Maybe something is hidden between rows, so it's very important.
[00:23:44] Sometimes we are listening with a goal in mind. What it means? We have we are talking to each other, right? But I have my goal in, into my mind, so it doesn't matter actually what you are talking about. So. I have something and that's it. I don't care. So it doesn't work. It doesn't work actually. So especially for leadership, but not only for leadership, it's just for, for real life. It doesn't work. We need to listen and trying to understand what another person is trying to say here.
[00:24:20] And one more, maybe things that I noticed is judging. So when something, when someone is saying something, so we are judging. We are like, okay, there is just black and white and that's it. But fortunately, no, we have different colors, so like rainbow colors, there is no black and white, so we don't, we should, we shall not judge, we need to listen attentively, accurately, and trying to get rid of maybe some negativity when talking to a person, so it's very important because collaborating with different people may be challenging, especially in these cross functional teams because I could see more and more that we are working in remote world.
[00:25:08] So I'm from Poland, you're from the United States. Someone is from the United Kingdom, someone from Australia and it's really amazing and I love it. But people are from different cultures. People have different, I don't know, mood, time zones, different things in their private life. So it's very important to switch off this as, as much as possible, this emotional thing and don't judge, just take the information as it is. And actually it helps me also a lot when I'm doing internal audits. So as it's written, I could see, and I could just, yeah, ask for some evidence as it's written not judging here.
[00:25:50] And maybe one more topic here I would like to raise, it's about preparing your response. So when, for instance, my colleague is talking to me and I just codes the first sentence, for instance, right? And I'm answering to this sentence, not to whole speech or whole things that this person is trying to say, but to this sentence . Please don't prepare your response and improve your listening skills. I believe that this listening skills, first of all, when we are collaborating with other colleagues from other, I don't know, departments, for instance, like product quality or clinical affairs, regulatory affairs, R&D manufacturing, so it's very good, marketing, some other. So it's very important to listen and to listen to the messages because there are a lot of valuable information. It shall be filtered accordingly and taken into account for, taken for consideration.
[00:26:51] And when we have like good listening skills, we can proceed with improving our communication because I believe that communication is just powerful tools that can resolve any, simply any issue, challenge, whatever, if we can communicate effectively so it helps. It helps a lot in professional life, in not only professional , so it's very important to work on this.
[00:27:17] But coming back to your question, I believe that any person can entry medical device industry because there are a lot of directions here. This directions depends on people background. So here we need like mechanical engineers to be able to prepare drawings and actually work on new product development or modifications of existing medical devices, for instance, right? Someone with a chemistry, biology background needed for like specific things like biological evaluation, clinical evaluation, right?
[00:27:49] But even people without technical background, someone who is like a good communicator is very nice. It's very valuable person in the project because such person can help with communication between different departments, because someone needs to orchestrate all this work for medical device. So don't be afraid, listen carefully, and improve your communication skill. And I believe, yeah, it would help in any industry, including medical devices.
[00:28:21] Lindsey Dinneen: Yes, that's great advice and thank you for sharing that. I think you're right that in many aspects, so one of them,
[00:28:29] Marina Daineko: Thank
[00:28:30] Lindsey Dinneen: I just want to clarify, agree with you, one thing that stood out to me is, you said that it, It is definitely possible for people to come into the medical device industry. And I think you're absolutely right. There are lots of avenues within the industry. So if your background is in engineering, there's plenty of places for you to go, but if your background is in marketing and sales, I mean, people have to know your device exists in purchase it. So all of the roles are are useful. So I think you're absolutely right in finding the area where you fit in. But the industry is really friendly, is what I have, yeah.
[00:29:12] Marina Daineko: Absolutely. Because if I can, yeah, add here, for instance, for marketing and sales, so, I love these people because they help me a lot. Why? Because I am doing, for instance, biological evaluation, I need, this is my documentation, I need to explain other people from notified bodies who, for instance,. Can audit this documentation how this medical device works. And what happened here? Look, I need these people from notified bodies or like from like auditors, right? They can have really different background. They can have background in clinical or they may not have this background. They may just have, I don't know, absolutely different background, right? They are not familiar with this specific medical device.
[00:30:01] So, and within my biological evolution, I need to explain how this medical device works. And it's known fact that a lot of people can consume the information with their eyes. So it's visual. So it means that the information shall be visualized, and visualization is the best tool to explain some things to people. That's why I love marketing, people from marketing and sales, because they can prepare these great pictures of medical device, how it works, for instance, on YouTube, like video or whatever, right? As well as, yeah, to make it understandable for everyone. It's simple, not with all these tons of words. But usually it, it shall be described as well, right? But visualization as well. So, that's why, yeah, I triggered so much when you mentioned marketing and sales, because yeah, it's really important to explain complex things in pictures.
[00:31:02] Lindsey Dinneen: Yes. Indeed. Yes. And I'm glad to have an advocate for that.
[00:31:12] Marina Daineko: Absolutely. Yeah. Yeah.
[00:31:13] Lindsey Dinneen: Yeah, absolutely. Pivoting the conversation just a little for fun. Imagine you were to be offered a chance to teach a masterclass on any subject that you want to. You would be paid a million dollars to do so. It can be about your industry, but it doesn't have to be. What would you choose to teach and why?
[00:31:35] Marina Daineko: As I said, I can talk days and nights about biological evaluation. So maybe it would be the simplest answer because it really, it really works for me. I mean, like I can talk about biocompatibility a lot and I am more than happy to share some insight with people, especially taking into account that this buzz and noise regarding biological evaluation recently, and I could see a lot of people that are coming in this aspect, this domain, I mean, in biological evaluation in medical devices, so I would be more than happy even be paid properly for this.
[00:32:18] Lindsey Dinneen: There you go.
[00:32:20] Marina Daineko: Yeah.
[00:32:22] Lindsey Dinneen: You could put the million dollars to, your research or something fun, so.
[00:32:27] Marina Daineko: Yeah. No, absolutely. When I was younger, I had actually a dream to organize a kind of, research center and to have some equipment, to have some databases, and so on for scientists who can, for instance, like scientists, startups, and so on so forth who can actually try, say, ideas on this on this research center. So if you, for instance, I don't know, invented something, you can go to my research center and I, we can first of all, test it and also provide like scientific background if required to help with patents and so on and so forth. So I believe this million dollars can be used for this goal.
[00:33:12] Lindsey Dinneen: Ooh, I like it. Okay. Excellent. All right. And how do you wish to be remembered after you leave this world?
[00:33:24] Marina Daineko: This is important question and I'm thinking from time to time exactly on it. So, it's very personal for me because it's also a funny story. When I was a student at the university, I was, I have been providing kind of mentorship for people who would like to study chemistry. So, and usually I was working with, mentorship, blaming the fire for chemistry. So showing that chemistry is not just something boring, boring science, but also very interesting and it can be kind of fun. So, I had a case when one boy he needed he needed improve his knowledge for chemistry just for his marks because he intended to, to get in British College. And, we were having the studies with him. I was explaining things and providing real life examples where and how chemistry can be utilized and improved. And in the end, this boy decided to utilize chemistry in his life, so he switched from math as well as physics to chemistry and connected his life with chemistry.
[00:34:40] And for me, it was like, "Oh my God, it seems like I changed someone's life." And it was so, so inspiring for me that I decided for myself that I would like to proceed with it, that I like how I can make this connection to show people the beauty of different things, like for instance chemistry to this boy. And yeah, I believe that I'm pretty successful in such things, so I would say that I would like to be remembered as a person who can connect people with beautiful and inspiring things, changing lives in this matter.
[00:35:26] Lindsey Dinneen: Ooh, that is a beautiful goal. I love it. That just gave me chills.
[00:35:33] you
[00:35:34] Marina Daineko: Yeah, no, I feel the same, actually, because for me, this boy, it was like a changing moment for me. Yeah, it's very powerful. Even this even this memory is very powerful for me.
[00:35:47] Lindsey Dinneen: Yes. Thank you for sharing that story. It's a fantastic story, and I love that because it's so, that just speaks to you and your willingness to, to help somebody understand something that doesn't come naturally or maybe easily to them. And what a difference you made in that person's life, so, yes, I think that's incredible and a beautiful life goal of yours.
[00:36:11] Marina Daineko: Thank Thank you, Lindsey. Oh yeah. To explain like complex things into simple, understandable steps is my favorite entertainment, I would say
[00:36:21] Lindsey Dinneen: Ah, okay, I love it, alright. What is one thing that makes you smile every time you see or think about it?
[00:36:32] Marina Daineko: Oh, I believe it's my dog. I have pitbull, but she reminds me a cat, mostly, because, yeah, no, really, because, for instance, when I have a door opened to join other room, to go into other room, for instance, but when I close the door she needs to come back immediately. And it makes me smile because it's behavior of a cat and also yeah she's sleeping and she is snoring from time to time and when I have a meeting for instance with my colleagues So I am asked all the time "Marina, please don't sleep." Yeah. So, yeah it's funny and I adore her. I am working with her, actually, I like, I love walking like 10 kilometers or so. She's not happy with this distance, but she has just simply no choice with it. Yeah. So, yeah, no, believe useful for her heart, so that's my, yeah.
[00:37:35] Lindsey Dinneen: Mutually beneficial for both of you.
[00:37:37] Marina Daineko: Yeah.
[00:37:38] Lindsey Dinneen: Yeah. Very good. Oh my goodness. That's fantastic. Yeah. This has been so much fun. Thank you so very much for joining us today. I'm just so thrilled to have you and you're so inspirational. So thank you for doing what you're doing and how you're continuing to learn and evolve with the industry, but evolve your own skills too. Yeah. And we're,
[00:38:05] Marina Daineko: Thank you.
[00:38:06] Lindsey Dinneen: Of course. And we're so 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 thank you for choosing that organization to ,support and we just wish you continued success as you work to change lives for a better world.
[00:38:30] Marina Daineko: Thank you. Thank you so much, Lindsey. It was a pleasure. I really enjoyed our conversation, a lot of, love and insight. So thank you very much for invitation and yeah I'm really happy to meet you.
[00:38:45] Lindsey Dinneen: You too. 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 will catch you next time.
[00:38:58]
[00:38:59] Ben Trombold: The leading difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Ken Hoyme | Medical Device Cybersecurity Expert | The FDA's New Guidance, Safety-Critical Systems, & Pipe Organs

In this episode, Ken Hoyme, a semi-retired product security expert, talks in-depth about his 40-year career focusing on safety-critical systems, which spanned across commercial aviation, aerospace, and medical devices, with a particular focus on medical device security. Ken reflects on the personal impact of his work, and also talks about his continued involvement in the field through consulting, teaching, and volunteering post-retirement. He also discusses troubleshooting solutions, his pride for his family, and his passion for pipe organs.
Guest links: https://www.linkedin.com/in/kenhoyme/
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 DinneenEditing: Marketing WiseProducer: Velentium
 
EPISODE TRANSCRIPT
Episode 022 - Ken Hoyme
[00:00:00] Lindsey Dinneen:
[00:00:01] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:08] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:13] 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.
[00:00:27] 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.
[00:00:37] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:41] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:47] Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Ken Hoyme. Ken is the semi retired former Director of Product security at Boston Scientific. His 40 year career spanned commercial aviation and aerospace and medical devices with specific emphasis on medical device security. In retirement, Ken continues to consult, teach, and volunteer. Welcome, Ken. Thank you so much for joining us today. I'm so excited that you're here.
[00:01:20] Ken Hoyme: Thanks, Lindsey I'm happy to be here.
[00:01:22] Lindsey Dinneen: Wonderful. If you wouldn't mind just starting off by telling us a little bit about yourself and your background, I would love to hear more about you.
[00:01:31] Ken Hoyme: Sure, I'd be happy to. Being semi retired, I have had a career that spans close to 40 years, or actually I think I just passed 40 years about a month ago from when I started working. So I went to grad school, did four years of grad school at the same time my wife was in vet school, so four years of marriage that we were both studying like crazy. I never finished my dissertation on a PhD, so I'm the classic PhD, ADD person. Pretty much my entire career has been spent in safety critical, life critical systems, which has been a fascinating area. You gotta do the right job or people might die.
[00:02:08] I started, split 50 /50. My first 18 years was at Honeywell Corporate Research Labs, where I ended up working on various things between integrated circuit projects, but a lot of it was focused on control systems for commercial aircraft, and so building safety critical systems that made the pilot interface to the airplane was fascinating, tough, but interesting problems.
[00:02:32] Touched a bit on industrial controls and automotive controls, and then mid career, I got recruited away by former Honeywell folks who had gone to Guidant, medical device company at the time, that was later purchased by Boston Scientific, and where I ended up working initially on cardiac pacemakers and defibrillators and then shifted into remote patient monitoring, and that kind of evolved into more detailed interactions with how security can impact patient safety.
[00:03:02] So a large fraction of the last 12, 15 years has been in medical device cybersecurity. Did a brief stint, three and a half years, at a small R&D company doing research on medical device cybersecurity, and then returned to Boston Scientific in 2016 to lead the product security program at Boston Scientific, which is what I was doing when I officially retired.
[00:03:25] Lindsey Dinneen: Nice. Okay. So lots of cool twists and turns throughout your career. I wanted to touch on a couple things. The first is, you've actually talked about how one of the running themes was safety and safety critical systems and whatnot. And I'm curious, have you always had an interest or a passion in safety and security. Where did that come from?
[00:03:49] Ken Hoyme: Given some of my behavior as a kid, you wouldn't think so. I certainly did my share of foolish things as you grew up. My, my interest in grad school was in computer architecture, kind of a foot between hardware and software, though I was in electrical engineering as a degree. So as I ended up at Honeywell, Honeywell was at that time focused on control systems. And control systems are cyber physical systems, they are computers touching the real world physically. And almost all aspects of cyber physical systems-- which are pervasive and now what's viewed as US critical infrastructure-- there's a safety aspect of whether you're talking about nuclear power plants or oil refining and things that can explode to commercial aviation, automotive. All of those things, if they don't work correctly, the people that are interacting with them that run the risk of being harmed.
[00:04:44] So it really was that culture at the original research center of thinking about how you interact with the physical world. And so that really grew that interest. And that was the skill set in doing safety analysis that drew guidance to recruit me because it really was obviously another safety critical environment in cardiac devices. So it was a an early budding interest that was really nurtured by the projects and things that worked on for Honeywell.
[00:05:14] Lindsey Dinneen: Yeah, absolutely. And then you obviously continued to grow in your career, you continue to be involved in safety and security. And then you had your stint at Boston Scientific. And I wonder if you could share a little bit more about some of the projects that you worked on that were particularly impactful or just moments that stand out perhaps.
[00:05:36] Ken Hoyme: My first project, I knew nothing about things that bled. I had avoided them. In junior high, I had to dissect a frog, I really didn't like it. And so in high school, when you needed to have some science stuff, and I knew I was planning on going toward electrical engineering, I skipped biology and took chemistry and physics. And by working on cyber physical systems, aircraft and automotive and industrial controls, nothing bled, but I also had no pets growing up.
[00:06:09] And when I started dating my now wife of 44 years, she had a quarter horse, 4 Shetland ponies, a dog and two cats at a 10 acre hobby farm she had talked her parents into buying so that she could have horses. And as a veterinarian, everything in her life bled, so we really had this difference in backgrounds, but interest in learning from each other.
[00:06:35] And so when I first went to Guidant, the company recognized I didn't have that domain knowledge. And so I ended up being put on projects specifically with the goal of rapidly bringing me up to speed. I went to various classes on how the heart works, how you pace it, all the various different things. And I can tell you that the dinner conversation changed considerably as I was starting to learn these things and my wife knew these things. So it was kind of an exhilarating mid career change because of having to learn the domain.
[00:07:05] So, because of my safety background, Guidant was working on a new architecture for their pacemakers and defibrillators. And I got put on the redundant safety core, which was a redundant hardware pacemaker and defibrillator. If anything failed in the rest of the device, the hardware would kick in and keep the patient pink. And so I got to work on that, and I ended up with several patents.
[00:07:30] And so in 2006 or 7, I believe, my brother in law, my wife's brother, ended up with a viral cardiomyopathy and his ejection fraction was down at 15%. It's normally in a healthy human should be up around 70. He ended up getting a resynchronization defibrillator that I had worked on, as well as being put on the home patient monitor that I had been the lead system engineer in developing. And so that was that first family connection of recognizing that what you're doing is personal.
[00:08:04] And a few years back, my now 95 year old mother in law has a pacemaker in her and I have four patents on the technology. So you're recognizing that people that you love and care for are using these things. And the people who get these things are loved and cared for by somebody, so it really becomes a passion of building something that works correctly and is safe. Those kind of things stand out in terms of things that are meaningful.
[00:08:29] Lindsey Dinneen: Yeah, of course. Yeah, because when you are able to see the results in real time in real life, by people who you know personally who are affected by it, that's such a full circle moment of just recognizing that what you do isn't confined to this silo. It actually does impact lives. And that's a pretty cool thing to be a part of.
[00:08:52] Ken Hoyme: And I crossed over into security. I can recommend the devices that I was involved in developing because I am personally familiar with the level of detail that had been done in terms of securing them. So I don't have fears that my family members or others are going to have hackers going after them, which is a paranoia in the industry. The idea of hacking pacemakers became, as Dr. Kevin said, " sucks the oxygen out of the room." It's theoretically possible, but very difficult to do, compared to devices that might be connected to a hospital network, which are exposed to more.
[00:09:24] Lindsey Dinneen: And to that point, if you don't mind sharing a little bit more about how you were able to develop those skills and awareness of the importance of medical device security. I know that you are an expert in this field and there is a lot more education and knowledge these days, but it still seems like something every once in a while that you have to remind people, this is actually a critical thing. Do you mind speaking a bit to that?
[00:09:52] Ken Hoyme: I started out as an electrical engineer, but evolved to a systems engineer, particularly working in aviation. I worked on the design of the flight deck of the Boeing 777. And Boeing is the-- at least they used to be, they've lost some of the secret sauce-- but they were the premier system engineering organization in the world. And working on a critical system for an aircraft with the master of system engineering, you start learning the techniques. So my, my evolution into system engineering was very much on the job training, certainly a lot of reading and things that went on at the same time, but it was also interacting with experts.
[00:10:31] Similar thing happened when security came along is, I got recruited into Guident because of my safety skills. And then within the first year of being there, Guident was putting a remote patient management system together, which was a bedside monitor for every patient with the radio links to the device links up to a server that would analyze all the data for potential alerts that the physician should know.
[00:10:56] The system has more than a million patients on it. So it's a scalable protected health information, all of that. Program Manager on that project understood the importance of the various ilities that sit around system engineering and deal with the development. So he hired in a PhD psychologist to do human centered design and machine interface, he had been dealing with all of those issues. And in the medical device world, user interfaces also touch safety, because if you have confusion and a physician or patient makes a mistake in using something, harm can happen. So it's another branch of safety. And he recognized the security implications of what we were doing and hired in security experts.
[00:11:43] And so we had this old grizzled, bearded, absolutely canonical look of a computer geek that had been a chief architect at a company called Secure Computing and had been security. And he was titled our Security Curmudgeon and as Lead System Engineer, I worked with these various groups as we balance the design. And it really was interacting with real experts in this field who had no compunction about correcting me whenever I said anything that was inaccurate.
[00:12:15] In that environment, I started absorbing. The methods of doing security and the importance of it and what those kind of, so it really was one of those cool opportunities in your career where you get to a Vulcan mind meld with experts and absorb the information and integrate it with what you know.
[00:12:32] Lindsey Dinneen: Yeah, absolutely. And at the time of this recording the FDA has finalized their guidance and I'm curious to know what your thoughts are on that and how you feel it's going to affect everybody moving forward.
[00:12:50] Ken Hoyme: It's interesting because both the original pre market guidance and the post market guidance came out relatively quickly. The time between the draft pre market and the issuance of it, I think was just less than a year, which everyone who were involved with guidance has said was light speed for the FDA. And the post market was similar, but they've done a couple of iterations in 2018 and 2022 of drafts. And, was in a meeting earlier today where two of the FDA people who had been working on that were mentioning that in both cases, they got more than 100, 000 comments back to the FDA related to it.
[00:13:28] You know, the push by Congress to have it out by October 1st really pushed, I don't think anybody thought that it would be feasible to get it done. And yet they did it. It seems like they have clarified many of the concerns that were still in the 2022 draft, had some clear definitions about things like exploitability. So I think it really will anchor, and everyone is scrambling this week to read it and adapt to what's in there. But, the good news is it's not a giant leap from what they issued in 2022. So it's not going to have everyone doing a 90 or 180 degree turn on what they've already assumed it was heading for. So it's just good to have that out in its definitive form.
[00:14:14] Lindsey Dinneen: Yeah, absolutely. And it'll be exciting to see how the industry adapts.
[00:14:19] Ken Hoyme: As one example, the Health Sector Coordinating Council had published in 2018, I believe it was, their joint security plan, because the non formal standard, but kind of a guide, particularly helpful for smaller companies for what they need to do, incorporate cybersecurity into their quality system and their development. And a lot has changed, and so we have been working since middle of 2022, this is one of my retirement volunteer efforts that I'm involved in, to bring it up to date.
[00:14:54] And there was a real goal for the JSB version 2 to be out by the end of this year. And we were worried about the race condition with the FDA getting their final set pre market guidance out. And so one of the activities now is adapting what we've written in the joint security plan to make sure that it is in sync and in line with the finalized guidance. By getting it out now, we have time over the next couple of months to make whatever changes we need to based on that change. Which will be good, it means when that guide is updated, it will not be anchored in an old guidance, but will properly reflect the new update from the FDA. So it's really great to see them do that.
[00:15:38] Lindsey Dinneen: Yeah, absolutely. So circling back to something you mentioned, because I'm curious how you were able to overcome it. You mentioned you hadn't dealt early on in your career with anything blood related and you didn't necessarily want to go after that when you were in college. So how are you able to overcome that and say, "No, this is fine. I'm gonna, I'm gonna make it happen."
[00:16:05] Ken Hoyme: Thankfully, I didn't have to personally do any implants. Okay. I didn't have to handle a knife or deal with that and get flashbacks of my frog experience. When I left Honeywell, I thought I was going to retire out of the company. I was in an absolutely great position at the research center. I was invited to the strategic planning sessions for the entire aviation business as a technical expert. Honeywell was bought by Allied Signal, which was quite a culture shift. They were far more prescriptive. You're telling research center, here's what you're going to do rather than asking you to partner with the businesses, determine how to best apply the skills. And the other aspect is because I had become an expert in commercial aviation, I was not learning at the rate that you used to. It's like, you know, a lot of things, you're doing more mentoring than individual personal learning. So when I shifted domains and got hired in because I was a senior fellow at Honeywell, they hired me in at the top technical rank that Guidant had at the time to be competitive. I felt a huge obligation to learn the domain as quick as possible.
[00:17:19] I needed to feel like I was providing value. It's just not a good feeling to feel like you're taking a paycheck and not providing something for that. It's just not the way I was raised. And so I really took it on that I needed to learn this domain. And the reality, all kidding aside, is the work in understanding the physiology and the behavior of cardiac devices is really more about electrochemistry and how the muscles work and how arrhythmias occur and how they can be cleared. And so it was more of a learning a new technical domain than really dealing with the bleeding side of it.
[00:17:57] Yes, when I was at Honeywell, we had a program where if we were working in the commercial aviation side, we had, it was pre 9/ 11, we had jump seat privileges. So I got to be in the jump seat of aircraft so that you could see how the pilots who use the systems you develop, how they interact with them, just as an experience base. And one of my cool things, just as an aside to talk about, along with the family members using cardiac devices is, I got to jump seat a 777 from Dulles to Frankfort, and that's the aircraft that I did a fundamental invention to enable how the flight deck works. So that was cool to actually see the pilots interact with what you did.
[00:18:39] The same thing happened in the cardiac world is you got the opportunity to go and experience implants and see the doctors using and interacting with the devices. Again, part of that system's knowledge of how does the end person, the actual user, use those devices and how do you use that knowledge to get better. So the closest thing you get to bleeding is to watch somebody else do one but I never had to actually directly deal with blood.
[00:19:10] Lindsey Dinneen: Okay. That's fair. That's a really good hybrid situation right there. Well, nowadays I understand that you are quote unquote retired, however, you are still quite active. So I would love to hear about your current initiatives and frankly, if you don't mind sharing, why you're still so involved, obviously you care, but I'd love to hear it from your perspective.
[00:19:35] Ken Hoyme: So I've always been a bit of a workaholic. I gained a lot of my intellectual stimulation through the people I interact with. When I started a corperate research center, it was 25% PhDs, 50% master. It's a great learning environment because there were brilliant people are all around you.
[00:19:52] One of my career advices I've given to the young people is go to a place where you are not the smartest person in the room, surround yourself with people you can learn from. Now you want to have your niche. You want to have something that you feel is your area of expertise that you build, but being or thinking you're the best person in the room isn't necessarily a good learning experience. So, I've always enjoyed interacting with people at various stages in their career.
[00:20:20] So when I retired, I don't know how many different serious and semi serious reach outs I had from people asking what I was up to and what I was interested in. It was a dozen or something, but I had been interacting for several years at the company called MedCrypt out of San Diego, a company that focuses on initially tools to help secure medical devices, comes out of the medical device world and tools for software build of materials, things of that nature. And while I'm not a software engineer developing tools, they were also starting to build a service business to work with clients on how to improve their quality system.
[00:20:59] When I was at Adventium Labs, that three and a half year stint I did between my two Boston Scientific experiences, along with doing government funded research on medical device security, I also did consulting with companies, and so I had formed a reasonably strong opinion about how you can best organize cybersecurity into a quality management system in a medical device company. And so being able to apply those skills, very lightweight, I've tried to keep my consulting to no more than one day a week so that I still can do some retirement activities.
[00:21:36] And Mike Kijewski, who's the CEO of that, I've interacted with him for many years and he had been pursuing me before I retired. So they have some people on staff, two of them are ex FDA. One of their FDA people, Seth Carmody, had written the post market cybersecurity for the FDA and I think he did the first draft of the updated cybersecurity pre market. And then they have another gentleman, Axel Wirth, who I've interacted with for a decade and has written textbooks in the space. And so it was a way to continue where you got to really work with smart people and continue to have that intellectual stimulation that watching TV or picking up whittling doesn't give you.
[00:22:16] Lindsey Dinneen: Fair, but those two activities on occasion could be good for your mental health, which we were talking about. So you can have both. You can have both.
[00:22:26] Ken Hoyme: So my eldest daughter, when she was going through undergrad, wanted to take a class. She went to Luther College in Iowa, which was a very Scandinavian Norwegian school, and there was a class on Scandinavian whittling. And she really wanted to take it, and she did, but she was going into dental school, and so there was this paranoia about her slicing something important in her hand when she was whittling. She whittled with Kevlar gloves on!
[00:22:54] Lindsey Dinneen: Oh!
[00:22:55] Ken Hoyme: So there's a certain amount of connection, potentially, between whittling as a hobby and that blood thing that I didn't like, so that hasn't necessarily attracted me retirement hobby.
[00:23:04] Lindsey Dinneen: That's a fantastic story. I love that. I wonder, you know, with her whittling skills, did those help her in her dental practice?
[00:23:12] Ken Hoyme: She stopped it after undergrad. She also no longer plays the oboe, though she had an oboe scholarship along with her sciences because the finger stretching on the oboe ,she has all of the finger exercises she gets at work and doesn't really think she should be taking the risk of fatiguing it more. And so yeah, being safe in that environment has been important. So I think the thing that actually did the best for her is playing video games. She played things like Mario World, where you're having to constantly in your brain translate going around sphere things and jumping. And that's when you're looking through a mirror and drilling in the back of the mouth, you're constantly doing these translations. And so I'm convinced that all the video games she played growing up really gave her the spatial skills that help, particularly as she took the exams to get in, they do try to assess whether somebody is capable of that before you get into dental school, because you don't want to get in there and start getting into drilling and having somebody who just can't make their brain do that.
[00:24:17] Lindsey Dinneen: Thank goodness.
[00:24:19] Ken Hoyme: Exactly.
[00:24:20] Lindsey Dinneen: That's fantastic.
[00:24:21] Ken Hoyme: No wonder why people are afraid of the dentist. Maybe they had one of the bad ones.
[00:24:25] Lindsey Dinneen: Right. Yeah, exactly. Oh, my goodness. Oh.
[00:24:28] Ken Hoyme: And then I had already alluded to the fact that I'm, I'm doing volunteer work at HSCC on the joint security plan. And then the other thing that I did this last winter, and we'll be repeating this, is I had developed and taught a master's level class in medical device cybersecurity through the University of Minnesota's Technological Leadership Institute. And so after giving it once, they decided to make it a core curriculum for their medical device innovation. So it will be scheduled to be given annually. Things like the FDA keep coming out with new guidances, even while we were giving it last winter, one of the things that would happen each week is, this week, this got replaced. It's kind of this constantly changing environment that happens in this space.
[00:25:13] Lindsey Dinneen: It keeps you on your toes and it keeps you learning and growing. I guess that's a great thing.
[00:25:18] Ken Hoyme: I can't claim I've been bored.
[00:25:22] Lindsey Dinneen: Brilliant. All right. Pivoting 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?
[00:25:37] Ken Hoyme: My first thought might be a master class in how to hide out with somebody's million dollars and not get caught. Being realistic, if I was teaching in my domain, I would probably want to expand out things related to security and safety and how that really is my technical expertise. If I was going to jump out of domain, you know, just something that, might seem off the wall would be a masterclass on the design and physics of the pipe organ.
[00:26:09] Lindsey Dinneen: Oh, tell me more.
[00:26:12] Ken Hoyme: When I was growing up, I studied the classical organ and sang in choir, was in the all state choir in high school and came out of high school thinking, music major, engineering, music, and I ultimately decided I could do music on an engineer's salary a lot easier than the other way around. And so I had twice been on pipe organ projects at churches I've attended where they brought in and bid and had a pipe organ builder install. So I've been close to that process. When I've been over in Europe, I seek organ recitals. So I've gotten to hear many instruments in Europe that are older than the United States.
[00:27:00] And so, yeah, that's always been a passion and fascination of mine because there's such a engineering aspect of that and yet so much of it is musicality. And I've learned a lot interacting and talking with these builders. If I had a million bucks, I would be able to dive deeply into the topic and try to flesh out something that would actually be more comprehensive.
[00:27:23] Lindsey Dinneen: Amazing. Okay. So I have to ask you, since you are a pipe organ enthusiast, how do you feel about the fact that there's quite a lot in pop culture of, it's being a vilified instrument, you know, you have the Phantom of the Opera, and there's like a Disney something that has a pipe organ that's a bad character. And how do you feel about the fact that pipe organs are used as villains?
[00:27:48] Ken Hoyme: It's always an interesting thing when popular culture adapts something that is so much deeper. As a totally different but slight example, the accordion has always made fun of it. I don't remember how I tripped across it, but there is a very famous organ work by Olivier Messiaen, a French composer, which is-- I think it translates from French to English, "The Epiphany of the Lord." It is a multi-part work related to the Christmas story, and it is incredibly complex, somewhat challenging to listen to, you have to be quite into it. But there is a movement called Du Parmanu, which is, " God Descends and Becomes Us." And it is one of the most bombastic, just these big, huge chords. It's just exciting to hear.
[00:28:40] And back 20 years ago, I heard or saw something about a Russian woman who had recorded the entire suite on accordion. And here in the Twin Cities, and it's nationally distributed, but I don't know how many different places, there's a gentleman by the name of Michael Barone who works for Minnesota Public Radio, who for 30 years plus has produced a weekly radio program called Pipe Dreams, all about the pipe organ and that.
[00:29:10] So I ended up ordering, because I had a friend who was Russian and was only available on a Russian Amazon kind of equivalent, copies of it and sent a copy to Michael Barone and he actually played an excerpt. I think he did the Du Parmenu section on his radio program. And it's in countries like Russia, the accordion is treated very much differently than in Western countries, where it's more of a polka accompaniment. And so it's different instruments have the different faces, depending on how they're viewed and who's viewing them. So I just tend to look at the mass media view of it as the unwashed heathen.
[00:29:48] That said, there is a woman who is bursting onto the scene, she's 26, I think, British, name is Anna Hapwood, and she has been making TikTok videos of her playing the organ, including at the, the Albert Great Hall that they do the BBC proms, and she is popularizing the instrument through her TikTok videos. I think it was CBS Sunday Morning, I saw her interviewed about how she's popularizing the instrument. You never know with the modern media and music distribution, how somebody might reinvigorate interest in something that was viewed as old fashioned before.
[00:30:26] Lindsey Dinneen: Yeah, I love that. I love that. And I think it always depends on context. All sorts of instruments, for instance, could be used to be very light hearted and fun or very serious and mysterious. And part of it is just, yeah, are you playing in the major or minor keys? And, all the things that go into it. But anyway, it's just funny because pipe organ, I feel is one of those instruments that is a little polarizing
[00:30:50] Ken Hoyme: I understand that. I was warped as a child and the interesting merging there is my father was a serial hobbyist. And when he went into a hobby, he went in 110%. And when I was growing up in my formative years, he was into gardening and breeding his own Asiatic lily types. And we had flowers everywhere and garden clubs would come through and tour the garden.
[00:31:23] Then he went cold turkey on it and decided to build him an electronic organ in the basement and he built it from initially a kit and then through other designs that he did. And so I was in fifth or sixth grade with the soldering iron in my hand, helping build this electronic organ. And it was, part of what I view, my dad, his dad died in the Great Depression. He came out of World War II and really had to support his mother and sister, and never really had the money for college-- he would have been a great engineer-- but instead he manipulated my brother and I to both become electrical engineers, and part of it was by these, so part of my interest in organ was also my father's manipulation of getting my brother and I both interested in electrical engineering.
[00:32:11] Lindsey Dinneen: Hey, it worked out. I love it. Okay.
[00:32:14] Ken Hoyme: My brother has a church organ in his basement, so it took a little heavier with him than it did with me. I enjoy it being played but I don't play it myself anymore
[00:32:22] Lindsey Dinneen: Ah, understandable. Well, what is one thing you wish to be remembered for after you leave this world?
[00:32:24] Ken Hoyme: Number one would be that I didn't overstay my welcome. I would hope to be remembered that I made lives better, I made lives safer. That attention to detail matter and I worked on things that were significant, that actually had meaning for people's lives. When I moved from Honeywell to Guidant, I said, I used to be worrying on things that if they failed, people might die, 375 people at a time. And then you get into medical devices and now you're working to save their lives, one at a time. I would hope to be remembered that I worked to make a difference and had positive impact on people's lives.
[00:33:03] Lindsey Dinneen: Yeah. Of course. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:33:14] Ken Hoyme: I would have to say my children. Yep. I'm incredibly proud of them. They're both, both professionals, a dentist and an audiologist, they have remarkably snarky sense of humor that I presume they got from their mother. My story on that one was, I was telling my eldest one time, she said something snarky and I said, "Kirsten, you are the queen of snark." And her instant response was, "Yep, broke it, you bought it." But yeah, as you think about what you leave behind in the world, and I'm incredibly proud of them and the things that they've learned. They both secure, use individual passwords on every website and deal with the internet with the sufficient paranoia that they should, so I'm proud of that as well, but yeah.
[00:33:57] Lindsey Dinneen: Excellent. Well, It sounds like you raised them right.
[00:34:01] Ken Hoyme: They're great kids. They had to live with growing up with their dad being an engineer.
[00:34:06] Lindsey Dinneen: Yeah. But it looks like it all worked out beautifully. So I'm very glad to hear all that. Ken, this has been so much fun. I really appreciate you joining me today. It was great to hear about your background and your advice, and I loved especially hearing about some of the little nuances that I wouldn't have gotten to otherwise, like pipe organ interests. So that's fantastic. We are so 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. So thanks so much for choosing that organization to support. And we just wish you continued success as you work to change lives for a better world.
[00:34:54] Ken Hoyme: Thanks, Lindsey. I really enjoyed chatting with you.
[00:34:57] Lindsey Dinneen: Yeah, same. And thank you 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 will catch you next time.
[00:35:10] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

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.
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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.
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