A Medical Device-to-Market Journey

A Medical Device-to-Market Journey

In today’s Startup Hustle episode, Lauren Conaway and Bradford Holden, CEO of Resilient Lifescience, talk about a medical device-to-market journey. In this conversation, Lauren and Bradford discuss the opioid crisis and what Resilient Lifescience is doing to help curb it. Further, they talk about the challenges of bringing wearable medical devices to the market. Finally, they discuss why you should talk to customers and how it is to be a medical device founder.

Want to learn more about Bradford’s local startup scene? Check out our top Pittsburgh startup picks featured on Inc.com for 2024. Discover the most exciting startups in Pittsburg, including more on Resilient Lifescience!

Covered In This Episode

The opioid crisis is real, killing over 75,000 Americans in 2021, and approximately 70%  occur without anyone present. Resilient Lifescience designed a wearable medical device to prevent overdose-related deaths when no one else is around.

Listen to Lauren and Bradford discuss his path leading to life-saving wearable tech. He explains how the extent of the opioid crisis prompted him to explore his options for preventing it. Because he had previous experience with medical devices, he believed it would be the perfect solution. However, the medical device-to-market journey was not smooth sailing, despite the urgent need and receiving support from the Richard King Mellon Foundation.

Lauren and Bradford go through the unique challenges that medical device industry startups face. These include FDA approval and funding. The conversation winds down with advice to startup founders and a Q&A. 

Bringing a product to market involves many challenges. Tune in on the conversation in this Startup Hustle episode now.

Highlights

  • Bradford’s journey (1:09)
  • Opioid overdose prevention through wearable technology (4:07)
  • Developing a medical device for opioid overdose detection and treatment (11:08)
  • Medical device’s journey to market (17:80)
  • Feasibility study involving the target market (20:17)
  • Winning the Richard King Mellon Foundation (25:41)
  • The challenges of startups in the medical devices industry (28:12)
  • Have the confidence and can-do mentality that you can figure it out (33:44)
  • Quick and fun questions with Bradford (40:03)

 

Key Quotes

One of the key reasons that you do customer interviews is because you're going to think about things that aren't from your normal perspective. -- Bradford Holden

People who are actively in recovery and seeking treatment when they relapse are actually more likely to die from overdose than folks who have just been habitual, continuous users. And it's because often people overestimate, like, if they've been clean for, you know, weeks or months, their tolerance has dropped. So often, users overestimate their ability. They're using pre-rehab amounts of a drug. And so they tend to overdose more frequently. -- Lauren Conaway

The one thing that a lot of startups challenge or have a challenge with is, what is the most important thing I can be doing right now? Right? There's always like 50,000 things you can do. So, what is the most important thing for us? -- Bradford Holden

You don't need to have all the answers. You just need to be confident that you're going to be able to figure it out. I think that if you're gonna start a company, you know it's gonna be hard. And you also should know that, like, there's not a chance in hell that you're going to have it all figured out when you start the company. But just by being confident that you can solve the problems and having that kind of can-do mindset of like, yeah, I can handle this, we'll figure it out. -- Bradford Holden

Rough Transcript

Following is an auto-generated text transcript of this episode. Apologies for any errors!

Lauren Conaway  0:01 

And we're back. Thank you for joining us for yet another episode of the Startup Hustle podcast. I'm your host, Lauren Conaway, founder and CEO of InnovateHer KC. And I gotta tell you, friends, today's episode of Startup Hustle is powered by FullScale.io. Hiring software developers is difficult, but Full Scale can help you build a software team quickly and affordably. And they have the platform to help you manage that team. Visit FullScale.io or click the link in the show notes to learn more. All right, friends. So today, we have with us a guest who is doing work in a very, very important area of health and wellness. And some of you have heard me talk on the show about my previous struggles in this area. And so I am just so very honored and so excited to talk to Bradford Holden, CEO of Resilient Life Science. Bradford, Welcome to Startup Hustle.

 

Bradford Holden  0:58 

Thanks, Lauren. Thank you for having me on. I'm very happy to be here.

 

Lauren Conaway  1:01 

Awesome. Well, I got to ask the perennial question, my friend, tell us about your journey. Let's hear it. Bring it on.

 

Bradford Holden  1:09 

Yeah, great. So, where to start? I guess I'll start by saying I grew up pretty fascinated by medicine and engineering. So it was pretty natural that I ended up studying biomedical engineering as an undergrad. From there, I took a pretty hard pivot and joined the Marine Corps. So, I spent four years in the military as a company engineer officer and got out in 2015. Had a great experience and realized that I wanted to continue in this world of leadership after my time serving in the military and leading teams there. I entered the startup world. So I actually worked at a wearable medical device startup in Palo Alto, like a proper Silicon Valley garage startup. It was an amazing experience before going off to business school and getting my MBA. After getting my MBA, I went into the tech world and Silicon Valley and worked for AutoDesk as a problem Product Manager for AutoCAD. And then, I joined a company called Infinitus Systems, which was using, excuse me, using speech recognition and text-to-speech, speech-to-text to automate human phone calls for healthcare benefit verification, so had an awesome experience. They're growing the operations team. Then, COVID-19 happened in 2021 came around and in 2021, the news broke that the overdose death rate in the US crossed 100,000 annually. And that was just an astounding number to hear. It's the number one killer of Americans under 50. And 80% of those are from opioid overdose, specifically. And I had also recently lost a family member to health complications around opioid use and a combination of that and COVID, actually. That had the front of my mind for me. And I thought back to my experience working with wearable medical devices and thought to myself, wait a minute, why can't we take the sensors that I know work on patients in a home care continuous monitoring situation? You use those to detect an opioid overdose, and then combine that with an on-body drug delivery system, and use that to reverse somebody's overdose and save their life when no one else is around? So, started looking into it and realized there's real potential for this. There was actually some university research from some great universities that had looked at proof of concept for this. So, there was some scientific validity to the potential for this. And we said, okay, why is nobody commercializing this? And that kind of grew to a, okay, well, I guess it's gonna be up to us. So, I talked to my co-founder, Charlie Proctor, who worked with me at Infinitus. And we decided that this was absolutely worth pursuing. So, we decided to go full-time in April of 2022. That's when we started Resilient Lifescience.

 

Lauren Conaway  4:07 

Absolutely incredible. And I, again, as somebody who has kind of a, I actually don't know too many people in the states who have, who don't have an invested stake in the opioid crisis, as we commonly hear it called in the media. You know, I know so many people whose lives have been touched by opioid overdose abuse. It set the stage you've done it actually, you've done a beautiful job of setting the stage for us kind of talking about the the 10,000-foot view, this is a really big problem. But I want to talk about it in an individual level because one of the things that I know matriculating through rehabilitation, a rehabilitation program, is that when you are in the throes of an overdose time is of the essence, right?Like you do not have a very long period of time to stop As the I guess, the flow, and I don't know the science behind it, so forgive me. But you don't you don't have a lot of time to stop the overdose before it starts initializing things like organ failure. And if there's like deep, permanent damage that can be done at this point. And so the wearable technology with sensors that administrates, like, immediately administrates medication, that's it's such a game changer, you know, when you're out of it because you're in the throes of an overdose. What are you going to do, you have to, you have to depend on having somebody around, who knows how to administrate these medications, and somebody who can help. And because you're out of it, you're gone, you know. And so it's really, I almost feel as though it might be empowering for a user who is, you know, caught up in addiction, or maybe using a drug that they're not familiar with? I almost feel like it would be empowering to know that you have this safeguard in place. It's kind of like a Life Alert bracelet almost. Right? Is that kind of the feedback that you're hearing? Like, talk to us about that point in the experience for users?

 

Bradford Holden  6:06 

Yeah, so that awesome question. And you give me a ton of thoughts as you're talking, of course, good. Turns out I spend all my time thinking about this. Yeah, so first, as you're talking about, like the the kind of the physiology side of it, right, the the part that, and this is a little bit of a tangent, but the part that ends up killing people from opioids overdose, is that it stops your breathing, right? So the same thing that ends up killing someone is that they stopped breathing, which means that they're not getting oxygen to their lungs, not getting to their blood, oxygen saturation in their blood drops, and they end up dying of anoxic brain injury or hypoxia in general. And that same mechanism that kills them is actually what we use to detect an overdose, right? We can see that somebody stops breathing, we can see the drop in their oxygen saturation. And we say, okay, this person is overdosing. So that's how we think about this, from the real-time perspective is okay, the same thing that's risking your life is the exact same thing that we are measuring and then using to determine whether or not this person is at risk of dying from overdose, and that's when the device intervenes. To the other question you asked about, or the point you brought up about the the empowerment and the the the Life Alert style of this device, right? That's absolutely what we're trying to provide. Opioid use can be an isolating condition, people oftentimes use alone, there's a lot of stigma around opioid addiction in the US, and causes people to use it alone. And while Naloxone commonly known by the brand, Narcan is super effective at reversing an overdose, if it's given on time, the majority of these deaths happen without anybody around, oftentimes because people use it alone. So our device allows somebody to stay protected as if they were using with somebody else. When they're not with somebody else, right? And I shouldn't say we, our device is not on the market. So I can't make claims about a medical device, you know, legally, without saying, but we what we are developing intends to do that. So we are trying to provide that safety net. And whether that's for somebody who is in recovery, and suffered from a relapse and ended up using again, or they're not ready to recover. And they, you know, maybe even they want to recover, but there aren't beds available in any rehabilitation facilities, right, this can help keep somebody safe until that time is right for them, or during their journey of recovery. So what is that it is that safety net for somebody? Interestingly, that we have gotten questions about that being a enabler and actually having negative effects. I can talk about that too. But it is what we're trying to do is keep people safe throughout their journey.

 

Lauren Conaway  8:56 

Yeah. Well, I mean, it's the same kind of conversation that happens about like safe needle programs, you know, you have to, essentially, if you're coming at it through that lens, I feel like you have to view it as a lens of mitigating harm. Like the fact is, we know that this is a problem. We know that users are addicts, and oftentimes, especially when they get to points along the journey like that are further along. Like, they don't they have, they don't have the capacity, the ability. It's not it's no, this is no longer a question of I want to change, it's I can't change. And that's the feeling I think that addicts have when we reach the end of our journey. You know, I remember before I went into rehab, I was like, I am I am beholden to this drug, like, there is nothing. This is my life, you know, and you get kind of resigned and so I almost feel like I thought that I was gonna die, you know, and I almost feel like I had I had a security blanket. And I don't want to minimize what you're building at all, but like there is a component of comfort and knowing that all right, if I'm going to be alone, and if I have to do this thing that I am compelled to do, that's what addiction is, you know. If I'm going to do this thing, at least I can be safer while doing it, you know. So thank you, you know, for that work. And I'm sure that there's controversy. And there are people that are, you know, just telling you all of their opinions, but the fact is, you are the product that you're building has the potential to meaningfully change lives and has the potential to meaningfully help people along their, along their journey at whatever point they're at. And so I think that there's a lot to be said for that. Now, you said something really interesting. And I do want to drill down on it a little bit. But I'm very interested in your process. So you have this, you're building on technology that you're familiar with that is used to address other issues. Talk to us about what it looked like to think through the product itself. And then the first steps you had to take around that approval process? Because it's, it's pretty arduous from what I understand, right?

 

Bradford Holden  11:08 

So just to make sure I understood the question, it's like the first steps we thought about when determining the device that were

 

Lauren Conaway  11:17 

this technology is already in use, how can we apply it here? So So from from the epiphany point, what did the process look like?

 

Bradford Holden  11:29 

Yeah, so actually, the first thing I did was, texted my brother-in-law, who's a doctor and I said, Hey, can we use these like vital signs to detect overdose? And I think I mentioned like heart rate first, he said, No, well, no, actually, you're better off using respiratory rate, and oxygen saturation. I was like, Oh, great. We can do those too, right? So first, first thing was get a little scientific validity for the idea. And from there, a lot of it was in a huge challenge for building a successful device, especially in this space is going to be patient adoption, right? So adherence to medication in the US is terrible. It's like 50%, in general. And then you have a wearable device that that's also challenging, and then our target population, it's going to be a, again, adherence within that population can be challenging to to medications and interventions. So we have a situation where, okay, we really need to make sure that what whatever we build is going to be incredibly usable, and non-obstructive to daily life, right? So the first things we thought about were like, Okay, how do we how do we make this like the best possible product for the user, and in that way, be confident that as we bring it to market, and as we spend millions of dollars to get this through the FDA and to commercialize it, that it's actually going to be used bypeople need it. So we looked at form factors, we looked at options for wearable devices. And what we decided is that in order to be the best possible product is we should just build a single device, right? Not a bunch of devices that Bluetooth connect to the phone or you know, are linked together that have like several different components, one on different parts of the body, we just wanted the single thing that the person had to worry about not several things. And the advantage of that is also that now you're not risking somebody dying because a Bluetooth connection was lost between two devices or something like that, right? So we thought about the form factor and decided, okay, you know, what we're going to do is actually take inspiration from insulin pumps, which are now becoming more and more widely adopted a patch base insulin pump, wear it on the abdomen, it's a great location, because it's underneath the person's shirt. So no one's going to, you know, see it on their arm or shoulder and say, oh, you know, what's that? Tell me about it. Right? So it allows it to be discreet and avoid that stigma issue for opioid use. And from there, we said, Okay, well, let's, let's start building this, what does it look like and started playing it out. And building early prototypes of just the sensing technology ended up hacking of some medical devices together and building a full, functioning prototype that I wore, went through some breathing exercises and injected me with saline solution. This was about a year ago. So we're like, okay, hey, we made something work here. Now we need to build it out of real stuff and not not hack devices. So that was the very beginning. And he kind of validated that this approach was reasonable. I think, later on, you asked about how does this end up getting toward approval, right? So that is an arduous process. And a lot of that has

 

Lauren Conaway  14:34 

to do with but

 

Bradford Holden  14:35 

We should be careful about what we sell as medical equipment. And so what needs to happen now is first of all going from like these early prototypes that we have that are 3D printed and using a lot of off-the-shelf components, and building more and more to be to the exact specifications for the device, right. So that's probably Like development work that's partnering with industrial design and PCB manufacturing, and all of like all of the the real engineering work that needs to happen. And at the same time, we've had a few conversations with the FDA to date and saying, Okay, what is our regulatory pathway, right? How exactly is this going to be approved. And one thing that they pointed out is that, hey, you have a pretty complicated system here. Right? There's a overdose detection tool and there's also a drug delivery tool. And because of that, you're going to be regulated as this special kind of product called the combination device, we're actually going to be more of a drug than a device in the FDA is eyes. And we kind of established the pathway for what's going to need to happen in terms of product development. Then all the clinical research that we have to do, and then the the quality testing and documentation that needs to happen. So we've actually dialed back a little bit from there from there and said, Okay, you know, the first thing we should do is get a sensor through the market, right? So the half of the device is being able to detect an overdose with that having a cellular component that can call for the friend or family, or 911, depending on that user's choice to send a rescue team to them is the first step right. Then, the second step is combining that with the auto injector. So we realized we could parse those two things out from each other. And that would help us get something to people in need faster, and then have what we would call a predicate device for our final product that we can submit to the FDA. So that was probably a lot of follow up, pause and let you ask any further.

 

It's really, really interesting. And I think that you, you're actually so smart, and the way that you approached it, you know, let's kind of divide these divide and conquer, I guess I almost feel like I mean, we've talked to founders in the in the biosciences area, in the medical area, and every single time I talk to them, like talk to us about the approval process, they're just like, Ah, it's a beast. So, I commend you for for finding a way to kind of streamline the process a little bit. One of the thing I have you reached a point where you are doing clinical trials yet?

 

So, we just wrapped up our first feasibility study, right? So clinical trials, like there's a very specific like NIH definition of a clinical trial where you're measuring outcomes of a specific intervention against the control group, right? Based on that definition, we have not done a clinical trial, but we've done human research, wearing prototypes of our device. And what that was focused on first is just showing that our device is capable of measuring vital signs, right? Yeah. So if you think about it, like abstraction layers in a program or something, there's, there's the raw data coming from our sensors, then we have to interpret those to vital signs signals, right? So what is your heart rate? What is your breathing, right? What is your oxygen saturation? Then from there, there's the algorithm to say, is this person overdosing? And then from there, there's the actions that take place. Do you inject Naloxone? Do you call 911? Right? So the very first step is what we did in this last research study is just say, Hey, okay, look, we're measuring heart rate, our device effectively sits on the abdomen and measures heart rate, measures breathing rate measures, best CO2 levels. So I would say yes, we're doing our research studies in humans, which is really exciting. Great to get that milestone taken care of, I should say, but there's quite a bit more that we'll need to get before to FDA.

 

Lauren Conaway  18:41 

Well, and I gotta tell you, like I You said earlier that you were you were one of the first guinea pigs with that saline solution injection and I started I was like, you poor thing. How many times do you think you've tested this yourself? Just out of curiosity?

 

Bradford Holden  18:57 

You know, there was only that happened in like a, the actual full system we're testing with an injection system only, like only like a couple dozen, maybe maximum in rapid succession.

 

Lauren Conaway  19:12 

Like, no big thing. And I'm just like, yeah, here, you're definitely lifting to get my stuff I don't. That's still pretty impressive, man.

 

Bradford Holden  19:25 

The needles are really small.

 

Lauren Conaway  19:27 

Well, so one of the things that I'm super cute, actually, you know what, really quickly friends, I do need to remind you, I got so excited to ask the next question. But I have to remind you, finding expert software developers doesn't have to be difficult is that it's always really hard for me and now that Full Scale is around I feel so much better about it because you can visit FullScale.io and you can build a software team quickly and affordably. I love them so much. Use the Full Scale platform to define your technical needs and then see what available developers, testers, and leaders are ready to join your team. Visit FullScale.io or visit the show notes to learn more. All right, Bradford, I need to know. This is what I got so excited to ask about. So are you involving heavy opioid users in your, in your research and in your product design process?

 

Bradford Holden  20:17 

Yes, absolutely.

 

Lauren Conaway  20:19 

What are you hearing from them? Are they excited? Are they like, talk to us about their feelings on it? Because that's really what matters. Right? That's who you're designing for. Talk to us about that.

 

Bradford Holden  20:32 

Yeah, it's interesting because you mentioned earlier, the idea of having this, this being a really attractive thing to some people, it is to some people, there is a segment of opioid users who are less interested in this either because it's no, this is another thing I have to worry about. I'm worried about dosing Naloxone when I don't need it. So there's definitely people who are concerned about it. But in the market that we have identified as people who are receiving or seeking treatment while while actively using opioids or people who are living with family members who are helping support them and have a support network around them while actively using. We have 87% of the folks that we've talked to in that group. And we actually ran a survey to validate specifically this would be interested in this technology specifically for it for using it. So we have some concrete number validation saying, like, yes, we're looking at the right target market that we're trying to bring this to within the opioid use population. That's about 1.7 million Americans there. Yeah. We actually did our first research on with people doing interviews in in Kensington in Philadelphia, so on the streets of Philadelphia, talking to people using opioids there. And the feedback was a lot, I would say, a lot of excitement and hoping, oh, that's really cool. The form factor was the thing we asked about, right? Like, how would you want to wear this? And the big thing was like, Yeah, I want it. I don't want to have to explain this to a family member if I see them. We got an interesting one of like, Hey, don't make it too bulky because I don't want someone to think I'm wearing a gun in my waistband. Okay, yeah.

 

Lauren Conaway  22:12 

Multiple, multiple sources for your, your feasibility studies.

 

Bradford Holden  22:17 

And that's, that's good. So the that's something I would not have thought about. Right. But it's one of the one of the key reasons that you do customer interviews is because you're going to think about things that aren't from your normal perspective. In terms of actually the last study we did, and there's gonna be times where we're doing research with people that are using opioids, and in times where we're doing it with people that aren't using opioids. The last study we did was specifically just for like, Okay, can you measure somebody's heart rate? That was just general healthy population because it's a lower risk study to do, and it's actually faster to get approved. But essentially, all the research we will do with the device from now on, in addition to the market research is also going to be specifically with the population using opioids.

 

Lauren Conaway  23:02 

Yeah. Well, and you said something interesting, and it just reminded me, so I, I'm gonna apologize to the audience. I do not remember the specific, specific statistic. And Bradford, I bet you you might know it. But there is a, there's a little talked about problem within the addiction community. And that is people who are actually actively in recovery and seeking treatment, when they relapse, they are actually more likely to die from overdose than folks who have just been habitual, continuous users. And it's because often people overestimate, like, if they've been clean for, you know, weeks or months, their tolerance has dropped. So often users overestimate their ability. They're using like pre-rehab amounts of a drug. And so they tend to overdose more frequently. And I can't remember the exact statistic. But it's just something to keep in mind. So when you say that your users like often, they might even be in recovery. Really, you're creating a failsafe, like, if you relapse again, here's your safety blanket, like you know, go go forth, and good luck with your recovery. Right, like, yep, that's a really cool.

 

Bradford Holden  24:18 

And that was one of the things that we heard that this was something surprising from our customer interviews, too, was that when we talked to people that were in recovery, one of the interesting points someone brought up was like, Yeah, I actually liked this device too because it would remind me of where I am in this journey, too. Right. So it's not just a comfort blanket, but it's a reminder of my journey. Yeah, that's that was really interesting to me to hear as well. I don't know the statistic. Another common the scenario for this is leaving prison too, right? So people leaving prison. I believe there I saw it was like 127 times more likely to die from overdose in the first Just two weeks after leaving prison, yeah. Wow, that exact same thing. So generally, within any population, your risk of overdose is even for people that are actively using like you mentioned, it's not super high. But there are these critical points in people's journeys where it's super high. Right. So what is this right after leaving prison or right after leaving inpatient recovery? Right after somebody overdoses, and it seemed that the ER, there's a 25% chance that they'll be back within a month? Yeah. So right after an overdose, there's another case where we can really identify like, Okay, this is the time that you really should have this device on it and just to be safe in case of a relapse.

 

Lauren Conaway  25:41 

Yeah. Well, so I just wanted to kind of underscore the importance of the work that you're doing once again, and I do I just realized that I have been remiss, I owe you, I owe you a congratulations. Because you recently you made you made the Startup Hustle Top Pittsburgh Startups list and I forgot to commend you for that. But I also believe like you've won a couple other pitch competitions awards, social impact investment, that's what it was. Talks about a little bit about that, like you've been doing all of this work to develop this product and bring it to market. But talk about what that process on the on the business side has been like.

 

Bradford Holden  26:21 

Yeah. So I'll start by saying the, the venture investment or the social impact investment was the Richard King Mellon Foundation, which is a great Philips philanthropic organization.

 

Lauren Conaway  26:34 

Carnegie Mellon Mellon. Yes, have the

 

Bradford Holden  26:37 

Yes, of the same last name. That is the the RK Mellon Foundation. Yes. So they know they, they have a annual social impact venture competition, which we competed in last year, and actually around this time last year. And it is for companies that are looking to make a difference in the world. And we were one of I think, around 100 applicants and happen to win, which was super exciting for us. And that organization has been incredible to work with. Just a lot of great support from the team great publicity helping us get our name out there as an excellent. And being connected to Pittsburgh is also really important to us, too. Right? So we've, we found a great community there. And RJ Mellon has been very centric to that experience of building a startup in Pittsburgh, which is a great tech hub. And I would say is not maybe often talked about, but we've had a great experience, but so far.

 

Lauren Conaway  27:34 

Well, good. What are some of the other I mean, I feel like there are a lot of priorities that you're working on right now, you know, that that FDA approval thing, which you know, not insignificant? And you know, raising capital, like, how are you managing to juggle all of these things are demanding your attention, and all of them are crucial? Like, you're right now you're in a very, very important part in your company's journey. Let's but talk to us a have you been able to balance the business side with the medical side with the personal side? Like, is that been difficult for you to do?

 

Bradford Holden  28:12 

I think it's challenging for everybody, right? Or if you're starting a company, it is a ton to juggle. But yesterday, I was sitting in a call and we were negotiating a quote for pharmaceutical ingredient stability testing for Naloxone, right? And I'm sitting there and really focused on the line items on this quote, and how can we adjust this to make it meet the needs of what we're asking for right now. And I pause for a second and said, I have like the coolest job in the world right now. Like, one day I'm talking about like the or like on the whiteboard next to me, we have drawings, talking over signal processing, the algorithms for detecting the early, improving heart rate detection. And now I'm sitting down talking about pharmaceutical testing, and like, there's just so many cool things I get to do on a daily basis. It's really exciting. And I think that's what draws so many people to entrepreneurship in general. But, you know, obviously, there's challenges with it, too. It takes a lot of time. And it can be hard to I think the one thing that a lot of startups challenge or have a challenge with is like, what is the most important thing I can be doing right now? Right? There's always like 50,000 things you can do. So, what is the most important thing for us? Yeah. Since you mentioned, like the business side and the fundraising side, I would say the key challenge that we're working on, and it's it's somewhat unique in our world is proving that there's a market for this and being able to demonstrate that right before we have a product. So with medical devices and pharmaceuticals, generally, you can't sell it before it's FDA approved. So that's common across all FDA-regulated technology. So you have to have some faith that there really is a market there. And you can do some things to approximate the market. It's not like an app where you can launch a beta version and get a bunch of people using it. It's there's more complications. But then on top of it for our technology, it's also a unique distribution channel that we need to go through. Right, if we look at Narcan and the success of Narcan and how they commercialized as really a guide for how we should bring our product and technology to market. Most of that is through state programs that are funding harm reduction programs, funding community centers that are distributing harm reduction technology or Naloxone, safe needle exchanges, stuff like that, yeah. And that you're selling to different people than a lot of other medical devices. The funding is coming from a different source. And then you have this different interaction between the person providing the product and the user as well. So there's just different business model to prove out as we develop this technology. So that's one of the things we're really focused on right now is like, Okay, how do we show that this is a repeatable and scalable business model to sell this within states? And what we're working on to do that is building pilot programs to say, Okay, this state will fund a number of people to wear a investigational version of this device. And that shows that states will actually put their money where their mouth is, in terms of wanting a product like this. And then we can take that to investors and say, hey, look, we have success. People are wearing this in the pilot programs, people are paying for it to get to people. So that is a that is one of my key focuses right now is really kind of building a sales funnel for a investigational product. There's a piloting it.

 

Lauren Conaway  31:43 

So when you're ready, you can really be ready. That's, that's really powerful. So is there anything like you're very clear, like I one of the things I love about this interview is like you're very clear on like, this is what we're doing. This is why this is and this is the path forward. And I love that. But I'm curious, is there is there anything that must be or like, by the way, thank you for your service, it must be your marine background, like you have a very disciplined approach, I feel. But at any rate, is there anything that you wish you had done differently? Or that you wish you would change? If you could?

 

Bradford Holden  32:21 

Oh, my goodness, so much.

 

Lauren Conaway  32:25 

You yeah, there's always screeched through my head, because that's like every entrepreneur.

 

Bradford Holden  32:30 

And especially as a first I'm sure it happens to everybody and every time. But for first time entrepreneurs definitely like so much that you just don't know that you don't know. I think one thing early on is we we started before we built anything, we did a lot of what I'm doing right now and trying to sell the product wanting to feel good that there's really going to be a market. So that's what led us to do our research on the streets of Philadelphia. We talked to people and programs that would fund this device or to purchase a device not from the investment angle. We also talked to investors, of course and raised money. But I would say that I wish before if I were to do it again, I would go further down the sales pipeline before starting to build just to just to almost like learn more about how that works. I don't think we obviously we can't sell a product before having it but really getting as deep as possible into the sales. And really being able to say this is exactly like this is like all of the signatures that need to go on this page, when talking about the business model will be helpful. So that's something I'm really focused on now. And if I had done it a year ago, I would have been even better.

 

Lauren Conaway  33:44 

Yeah. Well, I certainly get that. But I think you're absolutely right. Like I have never met a founder who didn't have a million different ways that they had failed, or things that they haven't thought about where and it's, it's, I think it's actually one of the most frustrating and yet rewarding parts of entrepreneurship. Like we're in it, we're in this shit. And we're gonna do it. Even if we even if it doesn't look pretty all the time. So So I do I am curious for our listeners, you know, not everybody is going to focus on the opioid addiction. Not everybody is going to go into med tech. But what are some key pieces of advice that you would give to the entrepreneurs, the founders out there, maybe those who are thinking about becoming a founder?

 

Bradford Holden  34:30 

Yeah. Let's see, I would say and kind of related to the last point one of the pieces of advice that I got from my, my previous CEO, who's a brilliant CEO and entrepreneur Ankit Jain, the CEO of Infinitus, is in paraphrasing, you don't need to have all the answers. You just need to be confident that you're going to be able to figure it out, right? Like other people have said like, Oh, if I knew how hard this was gonna be, I never would have started that company, right? A lot of entrepreneurs will say that, I think that if you're gonna start a company, you know, it's gonna be hard. And you also should know that, like, there's not a chance in hell that you're going to have it all figured out when you start the company, right? But just being confident that you can solve the problems and having that kind of can do mindset of like, yeah, I can handle this, we'll figure it out. Yeah, that gave me that gave me a lot of confidence to start a company we don't get, I don't need to be the world's leading expert in every aspect of what we're doing here. I just need to be able to find the right people, figure out myself, and build the right team and expertise to do so. So that was a huge part of it. Another thing that I thought about was, especially for folks that are thinking about starting a company would be that there's never a right time to start a company or, and kind of found that it wasn't like when my wife and I like there's never like, there's never like the right time to have a kid. It's never it's never like an easy time to do something. So if you're thinking about it, like some there are some times it might be worse than ever others. But the framework I've thought about it is like, is there any reason to believe that this is gonna be easier to do in one year from now? Or two years from now? Right? And if the answer is no, then I think go ahead. And just as it just started ticking.

 

Lauren Conaway  36:22 

I mean, that's so clutch like, I, I have so many so many friends who are interested in starting companies, and they're like, Well, you know, we want to wait until the kids get there. And it's like, I understand that, like, we all have limitations, and we all have things in our lives. The fact is, it's never going to be easy. You know, there's this saying in the entrepreneurial community, like you have to jump off the cliff and build your wings on the way down late. And that's essentially what you're speaking to, like, you're gonna figure it out. You're probably gonna figure it out. But But yeah, like, I'm 100% with you, like if you're really called to do this, and you said something that I thought was hilarious, like thinking about the entrepreneurs who start companies because they think it's gonna be easier. They're like, Yeah, I don't want to have a boss. And it's like, actually, you have 1000 bosses, and they're called clients. So let's not, let's not, you know, soften the blow, like, it's gonna be hard. There are aspects of entrepreneurship that absolutely suck. But it is also one of the most glorious, most empowering, most like, it's one of the coolest things you can do in my humble opinion. Right? I mean, how do you feel about it?

 

Bradford Holden  37:33 

So I, like I said, my example from yesterday, didn't look, yeah, it was the coolest job I could imagine. It's great. And it's incredibly challenging. And there's a, you know, there's a high risk of failure in any venture that you start. So you're have that in the back of your mind. And there's a little, you know, persistent anxiety, I think, in any entrepreneur, right, but but you're working on, I feel like I'm working on one of the most important challenges in facing the US right now, facing the world right now. And I'm sure, there's nothing I'd rather be doing. I actually, not to take this on too far of a tangent. But when I left the Marine Corps, I stood in front of the team of junior officers and marines and said, hey, you know, I think that when I leave, I'm actually going to be able to do more good for the world as a civilian than I could leading troops in combat. And that was a, you know, sounded like a cool thing to say at that time. And I realized that that was a pretty damn high bar. So you know, I actually what I'm doing right now, I'm living up to this insane promise I made eight years ago. So

 

Lauren Conaway  38:45 

It's so interesting. As you're talking like, I'm like vibrating with recognition because we're not we're not addressing the same problems. But I'm just, I like, I love my work. And I don't always love my work, but I love what I do because it matters. And I'm passionate about it. I was I was at an event last week, really quick little story. But this 17-year-old kid came up to me. And I had just gotten done speaking about something and he was like, can you tell me how to make money? And I mean, first of all, like, hi, nice to meet you. Like, that was literally the first thing a he said to me. But I was like, Ah, I mean, yeah, probably like, I can probably tell you how to make money, but you're asking the wrong question. The question is what are you best better at than anybody else in the world? And what are you never gonna get sick of? Those are the questions to ask. And then if you can come to me with those answers. Yes, I can tell you how to make money. You know, like, that's what it's all about. So, I love that that's a part of your core. Now. I do have a human question for you. Are you ready?

 

Bradford Holden  39:47 

I'm ready.

 

Lauren Conaway  39:48 

I'm very very excited. Do you want the serious one or do you want the silly one?

 

Bradford Holden  39:56 

Oh, boy. Let's do silly. I have a fairly serious subject matter for the business so we can go to silly for this.

 

Lauren Conaway  40:04 

I mean, it's not it's not like super silly, but if you had to pick the worst television series ever made, what would win? That was the kind of silly one?

 

Bradford Holden  40:13 

Oh, boy. Okay.

 

Lauren Conaway  40:14 

Are you a TV watcher? I guess I should ask that first.

 

Bradford Holden  40:19 

Ah, not a little bit. Yeah, I watched some TV, but I don't spend much time on that DVD. That's,

 

Lauren Conaway  40:26 

I'll go to the next one. This is the kind of serious one. But if you could reverse the ongoing extinction of any animal now endangered, which animal would you choose to save?

 

Bradford Holden  40:38 

My goodness, and a brush up on my endangered animals.

 

Lauren Conaway  40:42 

I'm trying to think through like a date. So, like rhinos are in date. I'm like that for some reason. I'm thinking of the African Sahara. I'm like lions and tigers and bears.

 

Bradford Holden  40:55 

Manatees doing. I feel like when I was growing up, I was into manatees for some reason.

 

Lauren Conaway  41:02 

Well, the thing that breaks my heart about me is that it's a really great answer. And the thing that breaks my heart about manatees is that most of their extinction, like, in fact, from what I understand, almost all of their extinction, is human-based. It's people out joyriding in, you know, with boats and hitting them with propellers and setting them just like, can we stop? They are just so peaceful.

 

Bradford Holden  41:26 

At the risk of choosing an animal that might not be endangered anymore because I haven't looked at this in about 20 years. I'll say manatees and

 

Lauren Conaway  41:35 

I liked that. Beautiful sea cows.

 

That's a great answer. This was a great interview. And I got to thank you so much for taking the time to chat with us. And congratulations again on Top Pittsburgh Startups.

 

Bradford Holden  41:51 

But Lauren, thank you so much for having me on the show and for the great questions. I absolutely enjoyed this. And yeah, thanks again.

 

Lauren Conaway  41:58 

I am so glad to hear it, friends. Something else that I'm really glad about. I'm glad that Full Scale is around. Do you need to hire software engineers, testers, and leaders? Full Scale can help. They have the people in the platform to help you build and manage a team of experts. When you visit FullScale.io, all you need to do is answer a few questions and then let the platform match you up with fully vetted, highly experienced software engineers, testers, and leaders. At Full Scale, they specialize in building long-term teams that work only for you. Learn more when you visit FullScale.io or click the link down in the show notes. And, friends, I've kind of felt like a broken record. And it might be because I've done two recordings today, but I'm gonna say it again. We host here at Startup Hustle. We do this for you. We do this for founders. We are founders; we know how hard it can be. We want to share the stories of people doing really incredible work. And we want to talk to you about the topics that you want to hear about, so I'm gonna I have an ask, and my ask is to reach out to us. You can find us at StartupHustle.xyz, which is our website. You can find us on LinkedIn, Instagram, TikTok all of the socials. But reach out to us and let us know if you know of a founder who needs to have their story heard; we want to talk to them. If you have a topic that we haven't addressed or even one that you want us to address further, let us know. We are here for you. We are here to give you the content that you need to empower you to find amazing companies, and we hope that we can help you do that. We just want to hear from you. We are very grateful that you come back and listen to us week after week. We hope that you keep doing so, and we will catch you next time.

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