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Daniel Powell | CEO of Spark Biomedical | The Sparrow Therapy System, Opioid Addiction, & Compassion

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Content provided by Velentium. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Velentium or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

Daniel Powell, a 20-year veteran in the medical device community, is the CEO and co-founder of Spark Biomedical and developer of the Sparrow Therapy System. In this episode, he shares about opioid addiction and how Spark's device helps alleviate withdrawal symptoms for those in recovery, his passion for deep brain stimulation, and how he almost gave up on entrepreneurship after his first small business venture ended.

Guest links: https://www.sparkbiomedical.com/

Charity supported: Threads of Love

Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.

PRODUCTION CREDITS
Host: Lindsey Dinneen
Editor: Tim Oliphant
Producer: Velentium

SHOW TRANSCRIPT

Episode 003 - Daniel Powell

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, Daniel Powell. Daniel, a 20 year veteran in the medical device community, is the CEO and co-founder of Spark Biomedical, and developer of the Sparrow Therapy System, which is an FDA cleared medical device that delivers non-invasive neurostimulation to alleviate opioid withdrawal. Daniel, thank you so very much for being here today. I am so delighted to have you.

Daniel Powell: Thank you, Lindsey. It's a pleasure to be here, too.

Lindsey Dinneen: Awesome. Well, I was wondering if you don't mind starting with just a little bit about your background. What's your career path been like? How did you get into this space?

Daniel Powell: That's a great question and I, I definitely do not have a typical path here. I took the scenic route, I would say, to MedTech. I graduated from Texas A&M with a business degree, and my first job was an accounts receivable at electronic data systems at Ross Perot's old company in Plano, Texas. I was very interested in technology and I kind of spent the first. 10 years of my career trying to figure out what career I wanted. So I bounced around. I had a great opportunity to be a consultant for KPMG. I did Y2K consulting, so we sat around telling everybody it was gonna be the end of the world and it wasn't. And then I got the crazy idea to start my own internet cafe for gamers because I really wanted to be self-employed and do my own thing. And I always say that was a fantastic way to lose a lot of money. And I swore I'd never be an entrepreneur again. I was like, I'm just gonna go to work, take a paycheck, keep my head down.

And my next job was at St. Jude Medical in the neurostimulation business. And so I got a great opportunity to go into the the engineering side of all things. Even though I had a business background, I was pretty good with soft, actually, I was mediocre with software. But I got an opportunity to do requirements analysis, so, what does the product need to do to meet the user's needs? And I was really good at that and it really started a fantastic career and I really didn't get how excited I would be about the medtech industry cuz I, really was just looking for a job to not be losing money as a self-employed game store owner.

And I remember going into training, they put me in sales training and they sat there and explained how putting electrical stimula on or near the spinal cord would alleviate pain in this world of neurostimulation. And I would say I fell in love with it immediately and could never get enough learning how the mechanism of action works, all the different modalities of this type of therapy. And it's set me now here for a 20 year run, where I'm just as in love with neurostimulation today as I was back then.

Lindsey Dinneen: Oh my goodness. Wow. Well, I love your story and I love the fact that you come at this from a very interesting background and, oh my goodness, your swearing off entrepreneurial endeavors and then of course-- "never say never," I guess. Right?

Daniel Powell: Well, when Spark came about, I'd actually gone to work for a startup that failed where I met my co-founders and I hadn't been paid in nine months. But I got along with my co-founder so well, and it was the worst time in the world to start a business. So you can imagine the conversation with my wife was like, "I know I haven't brought home a paycheck in nine months and I'm coming out of a failed startup. But what if we started our own company?" But we've never regretted it. It's just been an amazing four and a half years.

Lindsey Dinneen: Oh my gosh. That's amazing. Well, I would love, if you don't mind sharing about what you're up to now and this amazing new venture that you're on, and how has that all come about? I mean, obviously you must have had some highs and lows even there, so I'd love to hear the story of Spark.

Daniel Powell: Yeah. It's been quite a journey. So what was interesting is my two co-founders, Navid and Alejandro, were exploring how to do auricular nerve stim, so stimulating the cranial nerves around the ear. And we had a wide selection of different things we could go after. Navid's PhD work was in vagus nerves stim for stroke recovery, and we know vagus nerves stim works for depression and epilepsy and a wide range of disease states. But what really set us in motion as we saw another product, just by happenstance, a friend of mine was selling trans magnetic stim to a psychiatrist who had used acupuncture needles to alleviate withdrawal-- an an electrified acupuncture needle. So they were kind of creating a way of delivering electrical stim to the nervous system.

And they showed me a video of a young lady going through withdrawal and a time lapse over 30 to 60 minutes and this young lady went from clearly uncomfortable, snot running down her face, squirming in her chair. You can tell when someone's in absolute misery and she was an opioid withdrawal. And then 60 minutes later there's this beautiful young lady sitting in the chair laughing and having a conversation and there's a twinkle in her eye. And I was sold. I was like,, this is what we're gonna go after cuz our product doesn't use needles. I think we could build a better mouse trap. And then also kind of the concept was we know there's an FDA path and we know there's a clinical path and we know the technical path. So the big three pillars of building a medical device company were relatively low risk.

And so we talked about it and then we formed the company and we spent the next three months trying to kill it. " Does this make sense? Do we really want to do this?" And just every time we turn around, another door opened. Another opportunity presented itself. A clinical partner came online, somebody came to us and we just were continually encouraged to keep persevering. And we developed our first generation device, put it in clinical trials in Austin, Texas at Recovery Unplugged. Everything from building the quality management system to building the product-- everything we were doing for the first time. But you know we persevered through that. Everything took twice as much money and twice as long as we expected. All along the way, everything continues to take twice as long and twice as much money, at least.

And then when we finished, we took the product to the FDA. And then that's when the real challenges began. We did a pre-submission. So you go to the FDA ahead of time and you go, "we think this is all the things we should do, and if we do 'em, you'll approve the product." And the FDA then gives you feedback and you take that feedback and then you go execute. And when we showed back up at the FDA, they said no, "we changed our mind." And we're, just like we're outta money we're, betting on this working. We did everything right. We followed the directions. So we started throwing money at consultants and onboarding people, and we onboarded somebody who, as a consultant, had just come out of the neuro division to help us fight, and finally got the product approved six months later than it should have.

But that was an exciting day. Well, it wasn't a day, it was a night. The FDA has a clock and they have to deliver all their documents and their decisions and everything before the timer runs out. And the timer ran out Saturday night at 11 o'clock, January the 2nd. So a holiday weekend, and we got the approval about 30 minutes before the clock ran out, which means on a holiday weekend, in the evening, people at the FDA were having to route this thing around and, and sign off on documents. I was like, "thanks, guys."

Lindsey Dinneen: Oh my word. But what a brilliant way to start the new year?

Daniel Powell: Yes, it was, and that was two years ago. And we spent the first year really trying to test different business models. Well, really spent both the first and second year just figuring out the business model. And all of us, our entire careers we'd sold into doctors and neurologists and neurosurgeons and hospital systems. And selling into addiction rehabilitation is a very different animal. It's funny cuz I would have a neurosurgeon when I was doing deep brain stimulation with St. Jude Medical, " where's all your clinical evidence? I wanna see four or five, six papers" and "where's your proof?" And then we went into addiction, everybody was like, "yeah, I totally believe you, this works." We're like, "okay, well we do have clinical proof also," but they would hit the "I believe" button really quick.

But integrating it into the practice has been a real challenge. And it didn't help that we started selling right in the middle of Covid, so we couldn't get appointments. But importantly, what we saw in rehab was, rehab is a tough business and doesn't pay great. They run on rough margins, and in the middle of Covid, a nurse could work at a rehab facility or get a job at a hospital and make four or five times the hourly rate. So that they had staff turnover. So it's, it was a real tough time to launch a product into the rehabilitation space.

Our journey has brought us to now where we have our second generation product about to be approved by the FDA. Really just took all the lessons on usability, accessibility. Everything we saw with the first gen, and we really did have like kind of an MVP, a minimally viable product. So we took all of our lessons to really make a very much more consumer focused, industrial design on the case and everything, and then get our costs of the goods way down as we get ready to ramp. And we're really focused on bringing this to telehealth and so our journey from here, at the time of recording this with you, is Covid changed everything.

If I had a business model in 2019 that said "I'm going to deliver at-home detox services with telehealth support," it would've been ridiculous. And then two years later, it's "of course that's the way you're gonna do it." It's changed all the laws, changed reimbursement, changed acceptance. It really is a great opportunity to meet people where they want to detox. Nobody really wants to go into a center and be away from their family and the comforts of life and their dog and the pet and the kids for seven days. And for some people that's the best thing for them to do. But for a lot of other people, they want to get well-- and we can dig into the opioid epidemic and the realities of it as opposed to maybe what a lot of people's preconceptions are-- but most people really want to get off their dependence or addiction to opioids. But going through the detox process is the giant barrier. You're gonna go through seven days of absolute hell. And so being able to let people stay at home through that process, we think, is really the way to go for the future here. So we're betting a lot on it.

Lindsey Dinneen: Yeah. Well, there's a lot to unpack in that story. That is such a great story. Thank you for sharing that. So one thing that stands out, for sure, is you were saying that there is quite a bit of stigma around addiction and treatment. How do we get past that? How are you and Spark and the different products, how can that help alleviate some of the challenges with getting healthy again and overcoming that addiction?

Daniel Powell: Yeah, we definitely as a company want to actually not just alleviate withdrawal-- that's a minor piece-- but really be a solution for battling the opioid epidemic. So, the first step is to remove the stigma, stigmatization about it. At the RX Summit-- which is a big summit that has a lot of political leaders and industry leaders and pharmaceutical companies and everything that come together every year-- they put doctor's notes of patients with diabetes and then patients who had an assumed opioid overdose incident. And while the notes side by side were factually accurate, the tone of dismissal was just evident, you know, one was a bad patient and one was as patient you could have sympathy for. And it was really shocking to see that bias. I've heard the stories where the paramedics will use an extra large gauge needle to administer IV fluids on an overdose patient just so they hurt in the morning, just so that arm really hurts. And it's just, oh my gosh, you kind of back up and you go, "how inhumane? How inhumane is that?"

And so best I could do is I'll get on a podcasts like this and talk about it openly, but you know, in my own family, my nephew was addicted to heroin, this is my brother's kid. And I have permission to talk about it. In fact, now that he is in recovery, he talks about it all the time. So he said, absolutely I could reference him. And we didn't talk about it and he went to prison and I didn't ask about him and it was shameful, and my brother didn't want to talk about it and his wife didn't want to talk about it, because there's this failing of one of their children. And when I started this company, I actually called my brother one day and I said, how much had treatment cost him. Cause I was trying to get an idea of what to price this product at and would he buy it, and he had spent well over six figures.

And you realize families trying to save their loved ones were spending huge amounts of money and we just started talking and really formed a much closer bond and got really honest about everything. And it has brought us so much closer because there's no judgment. We're just really supportive of each other. And so from what I saw in my family is talking about it, hitting it head on, being honest and not throwing the person away is so important. And an opioid addiction-- we'll just talk about opioids-- opioids hijack the reward system in the brain so powerfully that you are not just being a bad actor, misbehaving, or just getting high. In my nephew's own words were, after six months or so, he never got high from heroin again. He was just running from withdrawal every four to six hours.

And then withdrawal is a complete fight or flight state of mind where you think you literally believe you're gonna die. And if I put you in a state of absolute fear and terror, and you believe your life is imminently gonna end, at the core of your being deep in the neurochemical structure of your brain, what are you gonna do? "I'm gonna have more willpower and I'm not gonna take these opioids." No, you're gonna do whatever it takes to make that go away and we're wired like that. So the more I've started to understand the neurochemical aspect of opioid addiction, and this translates to other addictions, but I specify this cuz this is what we have clearance for with the FDA. You go, "well, how important it is to remove that giant scary fight or flight, deep in the lizard brain part of our body, that primordial fear, to get somebody on a road to recovery." It's huge. It is the most important way to get them out of addiction. And so it's been really cool learning about this and really seeing how important this is to the journey of recovery.

Lindsey Dinneen: Absolutely. And is there any one story in particular-- I'm sure there are many-- but during these clinical trials, have certain stories emerged that are really particularly compelling to you as to how this device is making a difference in someone's life?

Daniel Powell: Yeah, there's a bunch. We always share stories of patients and all on our company chat. And I think someone always says, "I'm not crying. You're crying." So, I think that should be our company motto. We're adapting this for newborn babies too, so you wanna get everybody choked up, just go down that path. But I have two. One was, just a gentleman who has PTSD-- and we're not on label for PTSD, but PTSD was one of our secondary outcomes-- but PTSD is a constant state of fight or flight, which is what we're neuro modulating in the brain. But, he said, "I slept for the first time last night. I've never felt this peaceful in 10 years."

So that, that was one, but the other one was in our initial clinical trial and a young lady named Eliza had really fought addiction for years, had been in and out of rehab and came in, her dad made her go back in, I think she's 21, 22. And in her words, she was mad. She didn't wanna be there. She was gonna detox and then get the hell out of there and never come back like she was done. She didn't wanna get better. She just wanted to get through detox, which just meant she would've relapsed two days later after getting out. And about two, three days into the process to the five day process of her detoxing, she recognized she was clearheaded, feeling like her old self cuz she wasn't on any meds. She wasn't on meds to taper off the opioid. She was on our system and she made a life altering decision right there to continue therapy, which she vocally swore she wasn't gonna do. They put her in a 30 day program post detox. Then she went on and I've heard back from her and the family. A year later she went into a sober living facility and had reached over a year sober.

And her video and her story's on our website and you can watch it and I dare you not to tear up at the end. So the facility called us during the clinical trial and said, "this girl wants to do a testimonial." And so we piled in the camera equipment and drove from Houston to Austin as fast as possible and found a little room in the rehab facility, got some lighting up and just shot it on the spot. So it's not produced, it's just raw, and you just see the way she's beaming at how happy she was where she was in her life. And that was just on day five or six, that's before she went into long-term recovery. And we get those stories all the time. It's really exciting.

Lindsey Dinneen: That is amazing. The impact that makes on not just the individual who, of course, their life is dramatically changed as a result, but all of the people who love them. Oh my goodness. I am sure that it's extremely hard on the family and loved ones as well because they're watching somebody in a difficult place. And so, oh my gosh, just the ripple effects of what y'all do is really amazing.

Daniel Powell: Well, thank you, it's funny you said that. I was talking to somebody else yesterday and he goes, "have you thought of the legacy you're leaving?" He goes, "you're creating a legacy. They think of the families they're affecting and then the children that's gonna pass onto." And it, it got real humbling, real quick. I'm just fighting the FDA today for a second gen product and making sure our third party logistics is shipping. Stop and pull back and remember that we have a great culture here at Spark. Everybody knows they're part of something really important and come to work with that passion to make a difference in people's lives.

Lindsey Dinneen: Yeah, absolutely. Well, I know that you've had experience with other companies and then of course with your own, but is there any particular moment that stands out to you because it kind of clearly confirmed that the medtech industry was the right one for you?

Daniel Powell: Yeah, for sure. When I was at St. Jude Medical doing spinal cord stim and I got to go on a field ride and then talk to, I remember this old man had spinal cord stim, and he was in a follow-up visit and I was getting to do a ride along with the sales rep. And the man said, " a year ago, I I couldn't even get out of the chair without assistance and today I climbed a ladder" cuz of the pain relief he had from spinal cord stim. And just hearing those stories and this person telling you "this product made a difference in my life." But it then got really profound for me when I went to deep brain stimulation.

And so I had the privilege of being on the launch team for St. Jude's deep brain stimulation platform in Europe. And with deep brain stimulation, the patient is put under kind of twilight anesthesia, holes drilled in the head, wires put in the brain, but then you wake them back up and have them do motor tests cuz you're taking this little wire and you're pushing it into a 3D space. The brain's like a bowl of jello. So imagine you're pushing a wire into Jello shooting for 3D space that you can't see, the size of a pea. And so to make sure you're on target, you wake the patient up and have them like draw a circle or sign their name. And that whole experience when you're working with the physicians to actively use the product and being a subject matter expert during the surgeries in the early days. It was the most amazing thing to be in the brain surgery,. And then having the patient cry cuz they, their hands have been shaking so much, they haven't been able to sign their name in a decade and here they are able to sign their name while their brain's exposed and their skull's open. It's just, it was just such I, I look around, I'm like, "how did I get here? This is a amazing." So I have a special place in my heart for anything deep brain stimulation. That, that was truly just an amazing part of my career.

Lindsey Dinneen: Oh my goodness. So now you've come from a business background and so has that really helped your entrepreneurial journey and is that something that you felt like it did help prepare you for this particular company or is this a lot of learning on the way as well?

Daniel Powell: Yeah, no, that business background didn't do anything for me with the game store. So, clear, clearly, clearly, no. So what happened after the game stores and I went to work for St. Jude and then onto Cyberonics down in Houston, which is now LivaNova that does vagus nerve stim in the neck for epilepsy and depression is, I actually learned the business. We went through a warning letter, so I learned all about quality. We went through FDA submissions that I was part of the meetings and audits. And I spent the next 15 years actually learning a skillset in an industry versus meandering my way so that when the opportunity came to start my own company, I kind of looked around. I was like, "oh, I know what to do."

And what it was is respecting everything besides the business portion. So respecting that a quality system's important and you need a quality manager. And respecting that you need IP and respecting the engineering process has to happen and it's takes longer and it's messy. You're respecting that the legal stuff needs to be made, respecting and appreciating all that goes into running a clinical trial. And I say all that because I've been part of a company where the CEO just yelled at everybody to "get it done," but didn't really know what it took to get it done. And so I think that's what prepared me more was understanding and respecting all the various parts of the business. I don't have to totally understand it, but I have to be aware of its level of difficulty and the talent it takes to execute it properly. And I think that's really served to be successful.

The other opportunity that presented Spark uniquely is my two co-founders with me. Alejandro has his PhD in neuroengineering and he's our CTO and he is an absolute expert in that domain. And so we got the technicals covered by him. We got the business covered by me. And then Navid Khodaparast has his PhD in neurophysiology and is our chief science officer. And so when it comes to the clinical studies and the science and everything, while there's some overlap with him and Alejandro, he comprehensively covers the science. So we got engineering covered and patents, science and grants covered with Navid. And then the business side and sales and marketing covered with me. And it created a wonderful balance where we didn't have three scientists or three engineers, or three business guys stepping on each other, but three very complementary skill sets that we all brought to the table. And if somebody's starting a company, I would say " find partners that fill out other skill sets you're never gonna be able to master."

Lindsey Dinneen: Yeah. That's great advice. Surround yourself with good people that are complementary in their abilities and their knowledge. How do you personally prioritize your continued growth and learning as a leader?

Daniel Powell: Hmm, that's an interesting question. Ooh, I'll look back to the first time I was a manager and I've come a long ways. I, I think a couple things have affected that is there was a point in time where you realized that supporting your team and enabling their success versus controlling them. And I don't know where I've started seeing that. I remember specifically as a, a director at Cyberonics and we could get in front of the board room and I started reading books more on being a manager. There's something that tripped the realization that I needed to enhance that skillset. There's like a book, like the first 90 days or something like that when you're a new manager and you outline a plan, and so I, I embarked upon that. And I was moving down to Houston, joining this department. And I just really got real serious about not just meandering down and doing it, but really having a very specific plan.

And so I started to educate myself more and more, read books on leadership and think about it. And I made this change from needing to be seen and get the kudos. And it just dawned on me: if the people working for me, if I just said" it was because of them," I got all the credit, but then they got all the credit too. And you had a loyal team and they felt appreciated. So you could see a manager, a director gets into the boardroom and gets to present and shows everybody what he did when reality is his team did it behind him as opposed to a director or VP or that they'd have an opportunity to present to upper management. And when they go, "well, that's really good," you say, "ah, that was John. I couldn't have done it without him. This was all his research." "Oh, that was, Jane. She pulled this together, amazing talent on my team."

And once you flip over and start understanding that managing gets really easy. You start to be able to cultivate loyal teams. I had a manager tell me, he sent me an article. The article was, "Is Your Manager for You, for Themselves, or Against You?" And it said, "you know, managers look at their employees three ways." One is the majority of 'em are for themselves. Look, "I'll throw you under the bus if I have to to move my career forward. But otherwise I have no Ill intent towards you, but you know, this is about me." That's the majority of managers. On a rare occasion you get managers who are for you, they're like, "I want to make you succeed. I'm confident in where I am. If you move in front of me, it won't even hurt my feelings, but I'm invested in you." I had a manager at St. Jude like that, and he was fantastic and really was that example.

On the rare occasion you get somebody who's against you and they want you to fail. I also got that manager at a later point in time. And in the article and the wisdom said, "you run, leave the company. There is no surviving that and it's toxic and I'll tear you down." So I try to really be for my people's success. And then I think moving into the CEO role and starting the company really put the pressure on me. And then life had changed from books to this thing called YouTube. I could watch and so I just gobbled up videos by Simon Sinek and real thought leaders on, on how to lead and all these great voices that are out there. And we really try to adopt those styles of management and those philosophies into Spark. We spent a lot of time talking about culture and how we were gonna build a really good company that, that was great to work at in the early days.

Lindsey Dinneen: Yeah. That's great. And then that's great advice too in general for a leader or an aspiring leader. Appreciate your people, support your people, and it changes everything. As an employee, you feel appreciated and feel valued and feel like your contribution makes a difference, so, that's great advice. I like it. Well, on a lighter note, perhaps, imagine someone were to offer you a million dollars to teach a masterclass on anything you want, does not have to be in your industry. What would you choose to teach and why?

Daniel Powell: I like mentoring. I would love to teach, end to end, how do you bring a medical device to market. And, I think what I've done over the last four years, personally, my personal growth everywhere from raising money and the management of all these different processes. I love sharing that. I love being a resource to other, younger entrepreneurs on this journey, on that kind of stuff. So it would still be in this industry, I think, and I think it would reflect what I've learned and experienced and then been successful doing over the last four years.

Lindsey Dinneen: Excellent. Well, we definitely need a masterclass on that. That would be a great topic.

Daniel Powell: But I don't have the discipline to put a curriculum together. I'm telling you now. The question hurt, cuz in my mind I was like, "I don't have energy for that."

Lindsey Dinneen: That is fair, but also you are currently a little busy with your own company. So maybe this could be your retirement gig or something just for fun.

Daniel Powell: I'm a procrastinator and I wing stuff and I wouldn't prepare ahead of time. I would just say, I would just wing it.

Lindsey Dinneen: Ok. Ok.

Daniel Powell: It's horrible to say. I know.

Lindsey Dinneen: Okay. Well, we touched on legacy earlier, but I am curious, what is the one thing that you would wish to be remembered for after you leave this world?

Daniel Powell: I really hope what we're doing here, just two things. I hope the people I work with have good lives and got to go to work and not felt like somebody was against them. You see you're in these companies and the layoffs come and people get treated like numbers and we have had to have a layoff and there were people who were like, "this is not working for the business." But we try to be as humane and caring as possible when we're making tough decisions. So I'd like for the people who work for Spark, I hope this is an enriching part of their life, and that it allowed them to have a better family life. I mean, I just remember the stress of working for a company that's going through layoff after layoff, and you see bad managers treating people poorly and you sometimes get trapped there and you got nowhere to go. So I hope on one note for internally that I've made everybody who's part of this journey, their life better. And then I hope that we've really are gonna put some products into the world that, that had a legacy effect that saved families and brought 'em together. It's cool getting to work in medtech, right? We're not just making a widget, but this widget has real effects on lives. I'm lucky I get to work in this industry. It's really cool.

Lindsey Dinneen: Yeah, absolutely agree. Yeah. Well, and my final question is what is one thing that makes you smile every time you see or think about it?

Daniel Powell: I think our work in the neonatal space is just the most rewarding thing in the world. So these newborn babies born physically dependent on opioids. And that gets me up early every single day and keeps me motivated. We're not on market with the baby product yet, but we're in our big clinical trial and it's just cool. I always smile when I just even think the serendipity of how this happened. So I was on a flight to San Francisco to go to the Neurotech Reports conference, and I was putting my first investor PowerPoint together. And so I've got internet connection and I'm looking up, " how many people die of opioids and how many Americans are addicted" and putting all the numbers together.

And I come across neonatal opioid withdrawal syndrome and I start to read about it and how these babies are born and they just go through a horrible, excruciating first month of life. And, They had this like unnatural scream or cry and they don't feed, and I was like," oh my gosh. We have to do something about this." And so I sent an email to Navid and Alejandro and I'm like, "look at this article. We are gonna do this too, even if we don't make money." And by the time I landed, they both had replied, "we're all in." Like on that day we started the neonatal program and started researching.

The next day I went to the first session and the first panel was New Science Discoveries. And about the second presenter was Dr. Bashar Badran out of MUSC. And he was presenting his auricular vagus nerve stimulation results on newborn babies for stroke recovery for feeding. So in front of me was the only person in the world who had ever stimulated a baby's ear and had brand new breaking results. And I mean, I was " what are the chances 24 hours after we see this?" So he, he finished speech and got off the stage and I ran up like a crazy man and I'm like, "we're gonna work together" and he was like, like, "wow." I was just, it was just I and I--

Lindsey Dinneen: Wow.

Daniel Powell: My, my wife said several times "the universe conspires to make us successful." I think what we're doing is good and is noble. And things like that, I mean, and so it took him over two or three years to get his IRB approval to run his first baby study. We piggybacked on their IRB approval and had approval in 60 days. So I mean like probably shaved two years off getting this product to market. It's really amazing. So that makes all, that makes me smile every time.

Lindsey Dinneen: Oh yeah. And that's a fantastic story. Oh my goodness. Thank you for sharing that. Well, thank you, Daniel, so, so very much for joining me today. Thank you for all of your insights and your stories. I'm so inspired by what your company is doing, how it's helping-- just again, the ripple effects. I keep thinking about that and that's just that's really amazing. So, so thank you for what you all are doing to help change lives.

And we are honored to be making a donation on your behalf as a thank you for your time today to Threads of Love, which through the effort and support of many participants and chapters across the country, provides clothing, blankets, and other handmade articles for tiny, premature and sick infants.

And I just think, Daniel, that works so well with exactly what you were just talking about and your heart for others. So thank you for choosing that organization to support. Thank you again for your time. I just wish you continued success as you work to change lives for a better world.

Daniel Powell: Thank you so much. I appreciate the chance to tell the story.

Lindsey Dinneen: Yeah, absolutely. And thank you also to our listeners for tuning in and if you are feeling as inspired as I am right now, I would love if you would 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.

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Daniel Powell, a 20-year veteran in the medical device community, is the CEO and co-founder of Spark Biomedical and developer of the Sparrow Therapy System. In this episode, he shares about opioid addiction and how Spark's device helps alleviate withdrawal symptoms for those in recovery, his passion for deep brain stimulation, and how he almost gave up on entrepreneurship after his first small business venture ended.

Guest links: https://www.sparkbiomedical.com/

Charity supported: Threads of Love

Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.

PRODUCTION CREDITS
Host: Lindsey Dinneen
Editor: Tim Oliphant
Producer: Velentium

SHOW TRANSCRIPT

Episode 003 - Daniel Powell

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, Daniel Powell. Daniel, a 20 year veteran in the medical device community, is the CEO and co-founder of Spark Biomedical, and developer of the Sparrow Therapy System, which is an FDA cleared medical device that delivers non-invasive neurostimulation to alleviate opioid withdrawal. Daniel, thank you so very much for being here today. I am so delighted to have you.

Daniel Powell: Thank you, Lindsey. It's a pleasure to be here, too.

Lindsey Dinneen: Awesome. Well, I was wondering if you don't mind starting with just a little bit about your background. What's your career path been like? How did you get into this space?

Daniel Powell: That's a great question and I, I definitely do not have a typical path here. I took the scenic route, I would say, to MedTech. I graduated from Texas A&M with a business degree, and my first job was an accounts receivable at electronic data systems at Ross Perot's old company in Plano, Texas. I was very interested in technology and I kind of spent the first. 10 years of my career trying to figure out what career I wanted. So I bounced around. I had a great opportunity to be a consultant for KPMG. I did Y2K consulting, so we sat around telling everybody it was gonna be the end of the world and it wasn't. And then I got the crazy idea to start my own internet cafe for gamers because I really wanted to be self-employed and do my own thing. And I always say that was a fantastic way to lose a lot of money. And I swore I'd never be an entrepreneur again. I was like, I'm just gonna go to work, take a paycheck, keep my head down.

And my next job was at St. Jude Medical in the neurostimulation business. And so I got a great opportunity to go into the the engineering side of all things. Even though I had a business background, I was pretty good with soft, actually, I was mediocre with software. But I got an opportunity to do requirements analysis, so, what does the product need to do to meet the user's needs? And I was really good at that and it really started a fantastic career and I really didn't get how excited I would be about the medtech industry cuz I, really was just looking for a job to not be losing money as a self-employed game store owner.

And I remember going into training, they put me in sales training and they sat there and explained how putting electrical stimula on or near the spinal cord would alleviate pain in this world of neurostimulation. And I would say I fell in love with it immediately and could never get enough learning how the mechanism of action works, all the different modalities of this type of therapy. And it's set me now here for a 20 year run, where I'm just as in love with neurostimulation today as I was back then.

Lindsey Dinneen: Oh my goodness. Wow. Well, I love your story and I love the fact that you come at this from a very interesting background and, oh my goodness, your swearing off entrepreneurial endeavors and then of course-- "never say never," I guess. Right?

Daniel Powell: Well, when Spark came about, I'd actually gone to work for a startup that failed where I met my co-founders and I hadn't been paid in nine months. But I got along with my co-founder so well, and it was the worst time in the world to start a business. So you can imagine the conversation with my wife was like, "I know I haven't brought home a paycheck in nine months and I'm coming out of a failed startup. But what if we started our own company?" But we've never regretted it. It's just been an amazing four and a half years.

Lindsey Dinneen: Oh my gosh. That's amazing. Well, I would love, if you don't mind sharing about what you're up to now and this amazing new venture that you're on, and how has that all come about? I mean, obviously you must have had some highs and lows even there, so I'd love to hear the story of Spark.

Daniel Powell: Yeah. It's been quite a journey. So what was interesting is my two co-founders, Navid and Alejandro, were exploring how to do auricular nerve stim, so stimulating the cranial nerves around the ear. And we had a wide selection of different things we could go after. Navid's PhD work was in vagus nerves stim for stroke recovery, and we know vagus nerves stim works for depression and epilepsy and a wide range of disease states. But what really set us in motion as we saw another product, just by happenstance, a friend of mine was selling trans magnetic stim to a psychiatrist who had used acupuncture needles to alleviate withdrawal-- an an electrified acupuncture needle. So they were kind of creating a way of delivering electrical stim to the nervous system.

And they showed me a video of a young lady going through withdrawal and a time lapse over 30 to 60 minutes and this young lady went from clearly uncomfortable, snot running down her face, squirming in her chair. You can tell when someone's in absolute misery and she was an opioid withdrawal. And then 60 minutes later there's this beautiful young lady sitting in the chair laughing and having a conversation and there's a twinkle in her eye. And I was sold. I was like,, this is what we're gonna go after cuz our product doesn't use needles. I think we could build a better mouse trap. And then also kind of the concept was we know there's an FDA path and we know there's a clinical path and we know the technical path. So the big three pillars of building a medical device company were relatively low risk.

And so we talked about it and then we formed the company and we spent the next three months trying to kill it. " Does this make sense? Do we really want to do this?" And just every time we turn around, another door opened. Another opportunity presented itself. A clinical partner came online, somebody came to us and we just were continually encouraged to keep persevering. And we developed our first generation device, put it in clinical trials in Austin, Texas at Recovery Unplugged. Everything from building the quality management system to building the product-- everything we were doing for the first time. But you know we persevered through that. Everything took twice as much money and twice as long as we expected. All along the way, everything continues to take twice as long and twice as much money, at least.

And then when we finished, we took the product to the FDA. And then that's when the real challenges began. We did a pre-submission. So you go to the FDA ahead of time and you go, "we think this is all the things we should do, and if we do 'em, you'll approve the product." And the FDA then gives you feedback and you take that feedback and then you go execute. And when we showed back up at the FDA, they said no, "we changed our mind." And we're, just like we're outta money we're, betting on this working. We did everything right. We followed the directions. So we started throwing money at consultants and onboarding people, and we onboarded somebody who, as a consultant, had just come out of the neuro division to help us fight, and finally got the product approved six months later than it should have.

But that was an exciting day. Well, it wasn't a day, it was a night. The FDA has a clock and they have to deliver all their documents and their decisions and everything before the timer runs out. And the timer ran out Saturday night at 11 o'clock, January the 2nd. So a holiday weekend, and we got the approval about 30 minutes before the clock ran out, which means on a holiday weekend, in the evening, people at the FDA were having to route this thing around and, and sign off on documents. I was like, "thanks, guys."

Lindsey Dinneen: Oh my word. But what a brilliant way to start the new year?

Daniel Powell: Yes, it was, and that was two years ago. And we spent the first year really trying to test different business models. Well, really spent both the first and second year just figuring out the business model. And all of us, our entire careers we'd sold into doctors and neurologists and neurosurgeons and hospital systems. And selling into addiction rehabilitation is a very different animal. It's funny cuz I would have a neurosurgeon when I was doing deep brain stimulation with St. Jude Medical, " where's all your clinical evidence? I wanna see four or five, six papers" and "where's your proof?" And then we went into addiction, everybody was like, "yeah, I totally believe you, this works." We're like, "okay, well we do have clinical proof also," but they would hit the "I believe" button really quick.

But integrating it into the practice has been a real challenge. And it didn't help that we started selling right in the middle of Covid, so we couldn't get appointments. But importantly, what we saw in rehab was, rehab is a tough business and doesn't pay great. They run on rough margins, and in the middle of Covid, a nurse could work at a rehab facility or get a job at a hospital and make four or five times the hourly rate. So that they had staff turnover. So it's, it was a real tough time to launch a product into the rehabilitation space.

Our journey has brought us to now where we have our second generation product about to be approved by the FDA. Really just took all the lessons on usability, accessibility. Everything we saw with the first gen, and we really did have like kind of an MVP, a minimally viable product. So we took all of our lessons to really make a very much more consumer focused, industrial design on the case and everything, and then get our costs of the goods way down as we get ready to ramp. And we're really focused on bringing this to telehealth and so our journey from here, at the time of recording this with you, is Covid changed everything.

If I had a business model in 2019 that said "I'm going to deliver at-home detox services with telehealth support," it would've been ridiculous. And then two years later, it's "of course that's the way you're gonna do it." It's changed all the laws, changed reimbursement, changed acceptance. It really is a great opportunity to meet people where they want to detox. Nobody really wants to go into a center and be away from their family and the comforts of life and their dog and the pet and the kids for seven days. And for some people that's the best thing for them to do. But for a lot of other people, they want to get well-- and we can dig into the opioid epidemic and the realities of it as opposed to maybe what a lot of people's preconceptions are-- but most people really want to get off their dependence or addiction to opioids. But going through the detox process is the giant barrier. You're gonna go through seven days of absolute hell. And so being able to let people stay at home through that process, we think, is really the way to go for the future here. So we're betting a lot on it.

Lindsey Dinneen: Yeah. Well, there's a lot to unpack in that story. That is such a great story. Thank you for sharing that. So one thing that stands out, for sure, is you were saying that there is quite a bit of stigma around addiction and treatment. How do we get past that? How are you and Spark and the different products, how can that help alleviate some of the challenges with getting healthy again and overcoming that addiction?

Daniel Powell: Yeah, we definitely as a company want to actually not just alleviate withdrawal-- that's a minor piece-- but really be a solution for battling the opioid epidemic. So, the first step is to remove the stigma, stigmatization about it. At the RX Summit-- which is a big summit that has a lot of political leaders and industry leaders and pharmaceutical companies and everything that come together every year-- they put doctor's notes of patients with diabetes and then patients who had an assumed opioid overdose incident. And while the notes side by side were factually accurate, the tone of dismissal was just evident, you know, one was a bad patient and one was as patient you could have sympathy for. And it was really shocking to see that bias. I've heard the stories where the paramedics will use an extra large gauge needle to administer IV fluids on an overdose patient just so they hurt in the morning, just so that arm really hurts. And it's just, oh my gosh, you kind of back up and you go, "how inhumane? How inhumane is that?"

And so best I could do is I'll get on a podcasts like this and talk about it openly, but you know, in my own family, my nephew was addicted to heroin, this is my brother's kid. And I have permission to talk about it. In fact, now that he is in recovery, he talks about it all the time. So he said, absolutely I could reference him. And we didn't talk about it and he went to prison and I didn't ask about him and it was shameful, and my brother didn't want to talk about it and his wife didn't want to talk about it, because there's this failing of one of their children. And when I started this company, I actually called my brother one day and I said, how much had treatment cost him. Cause I was trying to get an idea of what to price this product at and would he buy it, and he had spent well over six figures.

And you realize families trying to save their loved ones were spending huge amounts of money and we just started talking and really formed a much closer bond and got really honest about everything. And it has brought us so much closer because there's no judgment. We're just really supportive of each other. And so from what I saw in my family is talking about it, hitting it head on, being honest and not throwing the person away is so important. And an opioid addiction-- we'll just talk about opioids-- opioids hijack the reward system in the brain so powerfully that you are not just being a bad actor, misbehaving, or just getting high. In my nephew's own words were, after six months or so, he never got high from heroin again. He was just running from withdrawal every four to six hours.

And then withdrawal is a complete fight or flight state of mind where you think you literally believe you're gonna die. And if I put you in a state of absolute fear and terror, and you believe your life is imminently gonna end, at the core of your being deep in the neurochemical structure of your brain, what are you gonna do? "I'm gonna have more willpower and I'm not gonna take these opioids." No, you're gonna do whatever it takes to make that go away and we're wired like that. So the more I've started to understand the neurochemical aspect of opioid addiction, and this translates to other addictions, but I specify this cuz this is what we have clearance for with the FDA. You go, "well, how important it is to remove that giant scary fight or flight, deep in the lizard brain part of our body, that primordial fear, to get somebody on a road to recovery." It's huge. It is the most important way to get them out of addiction. And so it's been really cool learning about this and really seeing how important this is to the journey of recovery.

Lindsey Dinneen: Absolutely. And is there any one story in particular-- I'm sure there are many-- but during these clinical trials, have certain stories emerged that are really particularly compelling to you as to how this device is making a difference in someone's life?

Daniel Powell: Yeah, there's a bunch. We always share stories of patients and all on our company chat. And I think someone always says, "I'm not crying. You're crying." So, I think that should be our company motto. We're adapting this for newborn babies too, so you wanna get everybody choked up, just go down that path. But I have two. One was, just a gentleman who has PTSD-- and we're not on label for PTSD, but PTSD was one of our secondary outcomes-- but PTSD is a constant state of fight or flight, which is what we're neuro modulating in the brain. But, he said, "I slept for the first time last night. I've never felt this peaceful in 10 years."

So that, that was one, but the other one was in our initial clinical trial and a young lady named Eliza had really fought addiction for years, had been in and out of rehab and came in, her dad made her go back in, I think she's 21, 22. And in her words, she was mad. She didn't wanna be there. She was gonna detox and then get the hell out of there and never come back like she was done. She didn't wanna get better. She just wanted to get through detox, which just meant she would've relapsed two days later after getting out. And about two, three days into the process to the five day process of her detoxing, she recognized she was clearheaded, feeling like her old self cuz she wasn't on any meds. She wasn't on meds to taper off the opioid. She was on our system and she made a life altering decision right there to continue therapy, which she vocally swore she wasn't gonna do. They put her in a 30 day program post detox. Then she went on and I've heard back from her and the family. A year later she went into a sober living facility and had reached over a year sober.

And her video and her story's on our website and you can watch it and I dare you not to tear up at the end. So the facility called us during the clinical trial and said, "this girl wants to do a testimonial." And so we piled in the camera equipment and drove from Houston to Austin as fast as possible and found a little room in the rehab facility, got some lighting up and just shot it on the spot. So it's not produced, it's just raw, and you just see the way she's beaming at how happy she was where she was in her life. And that was just on day five or six, that's before she went into long-term recovery. And we get those stories all the time. It's really exciting.

Lindsey Dinneen: That is amazing. The impact that makes on not just the individual who, of course, their life is dramatically changed as a result, but all of the people who love them. Oh my goodness. I am sure that it's extremely hard on the family and loved ones as well because they're watching somebody in a difficult place. And so, oh my gosh, just the ripple effects of what y'all do is really amazing.

Daniel Powell: Well, thank you, it's funny you said that. I was talking to somebody else yesterday and he goes, "have you thought of the legacy you're leaving?" He goes, "you're creating a legacy. They think of the families they're affecting and then the children that's gonna pass onto." And it, it got real humbling, real quick. I'm just fighting the FDA today for a second gen product and making sure our third party logistics is shipping. Stop and pull back and remember that we have a great culture here at Spark. Everybody knows they're part of something really important and come to work with that passion to make a difference in people's lives.

Lindsey Dinneen: Yeah, absolutely. Well, I know that you've had experience with other companies and then of course with your own, but is there any particular moment that stands out to you because it kind of clearly confirmed that the medtech industry was the right one for you?

Daniel Powell: Yeah, for sure. When I was at St. Jude Medical doing spinal cord stim and I got to go on a field ride and then talk to, I remember this old man had spinal cord stim, and he was in a follow-up visit and I was getting to do a ride along with the sales rep. And the man said, " a year ago, I I couldn't even get out of the chair without assistance and today I climbed a ladder" cuz of the pain relief he had from spinal cord stim. And just hearing those stories and this person telling you "this product made a difference in my life." But it then got really profound for me when I went to deep brain stimulation.

And so I had the privilege of being on the launch team for St. Jude's deep brain stimulation platform in Europe. And with deep brain stimulation, the patient is put under kind of twilight anesthesia, holes drilled in the head, wires put in the brain, but then you wake them back up and have them do motor tests cuz you're taking this little wire and you're pushing it into a 3D space. The brain's like a bowl of jello. So imagine you're pushing a wire into Jello shooting for 3D space that you can't see, the size of a pea. And so to make sure you're on target, you wake the patient up and have them like draw a circle or sign their name. And that whole experience when you're working with the physicians to actively use the product and being a subject matter expert during the surgeries in the early days. It was the most amazing thing to be in the brain surgery,. And then having the patient cry cuz they, their hands have been shaking so much, they haven't been able to sign their name in a decade and here they are able to sign their name while their brain's exposed and their skull's open. It's just, it was just such I, I look around, I'm like, "how did I get here? This is a amazing." So I have a special place in my heart for anything deep brain stimulation. That, that was truly just an amazing part of my career.

Lindsey Dinneen: Oh my goodness. So now you've come from a business background and so has that really helped your entrepreneurial journey and is that something that you felt like it did help prepare you for this particular company or is this a lot of learning on the way as well?

Daniel Powell: Yeah, no, that business background didn't do anything for me with the game store. So, clear, clearly, clearly, no. So what happened after the game stores and I went to work for St. Jude and then onto Cyberonics down in Houston, which is now LivaNova that does vagus nerve stim in the neck for epilepsy and depression is, I actually learned the business. We went through a warning letter, so I learned all about quality. We went through FDA submissions that I was part of the meetings and audits. And I spent the next 15 years actually learning a skillset in an industry versus meandering my way so that when the opportunity came to start my own company, I kind of looked around. I was like, "oh, I know what to do."

And what it was is respecting everything besides the business portion. So respecting that a quality system's important and you need a quality manager. And respecting that you need IP and respecting the engineering process has to happen and it's takes longer and it's messy. You're respecting that the legal stuff needs to be made, respecting and appreciating all that goes into running a clinical trial. And I say all that because I've been part of a company where the CEO just yelled at everybody to "get it done," but didn't really know what it took to get it done. And so I think that's what prepared me more was understanding and respecting all the various parts of the business. I don't have to totally understand it, but I have to be aware of its level of difficulty and the talent it takes to execute it properly. And I think that's really served to be successful.

The other opportunity that presented Spark uniquely is my two co-founders with me. Alejandro has his PhD in neuroengineering and he's our CTO and he is an absolute expert in that domain. And so we got the technicals covered by him. We got the business covered by me. And then Navid Khodaparast has his PhD in neurophysiology and is our chief science officer. And so when it comes to the clinical studies and the science and everything, while there's some overlap with him and Alejandro, he comprehensively covers the science. So we got engineering covered and patents, science and grants covered with Navid. And then the business side and sales and marketing covered with me. And it created a wonderful balance where we didn't have three scientists or three engineers, or three business guys stepping on each other, but three very complementary skill sets that we all brought to the table. And if somebody's starting a company, I would say " find partners that fill out other skill sets you're never gonna be able to master."

Lindsey Dinneen: Yeah. That's great advice. Surround yourself with good people that are complementary in their abilities and their knowledge. How do you personally prioritize your continued growth and learning as a leader?

Daniel Powell: Hmm, that's an interesting question. Ooh, I'll look back to the first time I was a manager and I've come a long ways. I, I think a couple things have affected that is there was a point in time where you realized that supporting your team and enabling their success versus controlling them. And I don't know where I've started seeing that. I remember specifically as a, a director at Cyberonics and we could get in front of the board room and I started reading books more on being a manager. There's something that tripped the realization that I needed to enhance that skillset. There's like a book, like the first 90 days or something like that when you're a new manager and you outline a plan, and so I, I embarked upon that. And I was moving down to Houston, joining this department. And I just really got real serious about not just meandering down and doing it, but really having a very specific plan.

And so I started to educate myself more and more, read books on leadership and think about it. And I made this change from needing to be seen and get the kudos. And it just dawned on me: if the people working for me, if I just said" it was because of them," I got all the credit, but then they got all the credit too. And you had a loyal team and they felt appreciated. So you could see a manager, a director gets into the boardroom and gets to present and shows everybody what he did when reality is his team did it behind him as opposed to a director or VP or that they'd have an opportunity to present to upper management. And when they go, "well, that's really good," you say, "ah, that was John. I couldn't have done it without him. This was all his research." "Oh, that was, Jane. She pulled this together, amazing talent on my team."

And once you flip over and start understanding that managing gets really easy. You start to be able to cultivate loyal teams. I had a manager tell me, he sent me an article. The article was, "Is Your Manager for You, for Themselves, or Against You?" And it said, "you know, managers look at their employees three ways." One is the majority of 'em are for themselves. Look, "I'll throw you under the bus if I have to to move my career forward. But otherwise I have no Ill intent towards you, but you know, this is about me." That's the majority of managers. On a rare occasion you get managers who are for you, they're like, "I want to make you succeed. I'm confident in where I am. If you move in front of me, it won't even hurt my feelings, but I'm invested in you." I had a manager at St. Jude like that, and he was fantastic and really was that example.

On the rare occasion you get somebody who's against you and they want you to fail. I also got that manager at a later point in time. And in the article and the wisdom said, "you run, leave the company. There is no surviving that and it's toxic and I'll tear you down." So I try to really be for my people's success. And then I think moving into the CEO role and starting the company really put the pressure on me. And then life had changed from books to this thing called YouTube. I could watch and so I just gobbled up videos by Simon Sinek and real thought leaders on, on how to lead and all these great voices that are out there. And we really try to adopt those styles of management and those philosophies into Spark. We spent a lot of time talking about culture and how we were gonna build a really good company that, that was great to work at in the early days.

Lindsey Dinneen: Yeah. That's great. And then that's great advice too in general for a leader or an aspiring leader. Appreciate your people, support your people, and it changes everything. As an employee, you feel appreciated and feel valued and feel like your contribution makes a difference, so, that's great advice. I like it. Well, on a lighter note, perhaps, imagine someone were to offer you a million dollars to teach a masterclass on anything you want, does not have to be in your industry. What would you choose to teach and why?

Daniel Powell: I like mentoring. I would love to teach, end to end, how do you bring a medical device to market. And, I think what I've done over the last four years, personally, my personal growth everywhere from raising money and the management of all these different processes. I love sharing that. I love being a resource to other, younger entrepreneurs on this journey, on that kind of stuff. So it would still be in this industry, I think, and I think it would reflect what I've learned and experienced and then been successful doing over the last four years.

Lindsey Dinneen: Excellent. Well, we definitely need a masterclass on that. That would be a great topic.

Daniel Powell: But I don't have the discipline to put a curriculum together. I'm telling you now. The question hurt, cuz in my mind I was like, "I don't have energy for that."

Lindsey Dinneen: That is fair, but also you are currently a little busy with your own company. So maybe this could be your retirement gig or something just for fun.

Daniel Powell: I'm a procrastinator and I wing stuff and I wouldn't prepare ahead of time. I would just say, I would just wing it.

Lindsey Dinneen: Ok. Ok.

Daniel Powell: It's horrible to say. I know.

Lindsey Dinneen: Okay. Well, we touched on legacy earlier, but I am curious, what is the one thing that you would wish to be remembered for after you leave this world?

Daniel Powell: I really hope what we're doing here, just two things. I hope the people I work with have good lives and got to go to work and not felt like somebody was against them. You see you're in these companies and the layoffs come and people get treated like numbers and we have had to have a layoff and there were people who were like, "this is not working for the business." But we try to be as humane and caring as possible when we're making tough decisions. So I'd like for the people who work for Spark, I hope this is an enriching part of their life, and that it allowed them to have a better family life. I mean, I just remember the stress of working for a company that's going through layoff after layoff, and you see bad managers treating people poorly and you sometimes get trapped there and you got nowhere to go. So I hope on one note for internally that I've made everybody who's part of this journey, their life better. And then I hope that we've really are gonna put some products into the world that, that had a legacy effect that saved families and brought 'em together. It's cool getting to work in medtech, right? We're not just making a widget, but this widget has real effects on lives. I'm lucky I get to work in this industry. It's really cool.

Lindsey Dinneen: Yeah, absolutely agree. Yeah. Well, and my final question is what is one thing that makes you smile every time you see or think about it?

Daniel Powell: I think our work in the neonatal space is just the most rewarding thing in the world. So these newborn babies born physically dependent on opioids. And that gets me up early every single day and keeps me motivated. We're not on market with the baby product yet, but we're in our big clinical trial and it's just cool. I always smile when I just even think the serendipity of how this happened. So I was on a flight to San Francisco to go to the Neurotech Reports conference, and I was putting my first investor PowerPoint together. And so I've got internet connection and I'm looking up, " how many people die of opioids and how many Americans are addicted" and putting all the numbers together.

And I come across neonatal opioid withdrawal syndrome and I start to read about it and how these babies are born and they just go through a horrible, excruciating first month of life. And, They had this like unnatural scream or cry and they don't feed, and I was like," oh my gosh. We have to do something about this." And so I sent an email to Navid and Alejandro and I'm like, "look at this article. We are gonna do this too, even if we don't make money." And by the time I landed, they both had replied, "we're all in." Like on that day we started the neonatal program and started researching.

The next day I went to the first session and the first panel was New Science Discoveries. And about the second presenter was Dr. Bashar Badran out of MUSC. And he was presenting his auricular vagus nerve stimulation results on newborn babies for stroke recovery for feeding. So in front of me was the only person in the world who had ever stimulated a baby's ear and had brand new breaking results. And I mean, I was " what are the chances 24 hours after we see this?" So he, he finished speech and got off the stage and I ran up like a crazy man and I'm like, "we're gonna work together" and he was like, like, "wow." I was just, it was just I and I--

Lindsey Dinneen: Wow.

Daniel Powell: My, my wife said several times "the universe conspires to make us successful." I think what we're doing is good and is noble. And things like that, I mean, and so it took him over two or three years to get his IRB approval to run his first baby study. We piggybacked on their IRB approval and had approval in 60 days. So I mean like probably shaved two years off getting this product to market. It's really amazing. So that makes all, that makes me smile every time.

Lindsey Dinneen: Oh yeah. And that's a fantastic story. Oh my goodness. Thank you for sharing that. Well, thank you, Daniel, so, so very much for joining me today. Thank you for all of your insights and your stories. I'm so inspired by what your company is doing, how it's helping-- just again, the ripple effects. I keep thinking about that and that's just that's really amazing. So, so thank you for what you all are doing to help change lives.

And we are honored to be making a donation on your behalf as a thank you for your time today to Threads of Love, which through the effort and support of many participants and chapters across the country, provides clothing, blankets, and other handmade articles for tiny, premature and sick infants.

And I just think, Daniel, that works so well with exactly what you were just talking about and your heart for others. So thank you for choosing that organization to support. Thank you again for your time. I just wish you continued success as you work to change lives for a better world.

Daniel Powell: Thank you so much. I appreciate the chance to tell the story.

Lindsey Dinneen: Yeah, absolutely. And thank you also to our listeners for tuning in and if you are feeling as inspired as I am right now, I would love if you would 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.

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