The Leading Difference

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.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.

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

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

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

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

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

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

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

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