Can You Really Get FDA Clearance on a Budget?

[00:00:00] Jared: Hello everyone and welcome to the Med Design Podcast where we explore the journeys of medical innovators. Our guest today is Galen Robertson, principal of Vital Simplicity. He has a wealth of experience in the medical device industry having held various executive and product development roles throughout his career.

In a recent role, Galen was the chief operating officer of 410 Medical a company dedicated to developing innovative products that help emergency clinicians provide better care for critically ill patients. As the first employee of the company, Galen played a critical role in taking 410 Medical from pre-seed funding to the commercialization of LifeFlow, a product that enhances the speed and efficiency of fluid resuscitation, improving care for patients with life-threatening conditions like sepsis and shock.

Galen was instrumental in leading the company through the growth phase, building the team, and leading day-to-day operations. Prior to 410 Medical, Galen worked as the R & D director at TransEnterix, where he managed multiple R & D work groups and oversaw the development and system integration of multiple prototypes. With his vast experience in executive and product development roles

galen is an excellent fit for the Med Design podcast. Feel free to ask us any questions as we go along, and we're just excited to hear more about his journey. Welcome.

[00:01:11] Galen: Thanks. Thanks for having me. I'm excited to be here.

[00:01:14] Jared: Yes. We're happy to have you. Let's get started with a bit of your background in the medical device industry.

What motivated you to choose this as a direction for your life and how did you get started? And also maybe as a fun note how many patents do you have to your name, by the way?

[00:01:29] Galen: Cool. Yeah. So I got started in high school I liked physics, I liked the math stuff. And I liked medicine too, and I went back and forth on, do I wanna go to med school or do I wanna go to engineering?

And I decided to do engineering. But always found myself torn between the two. So I kept trying to pull back towards medicine and never decided to go to med school. In graduate school, I did research in the orthopedic bioengineering lab, and then I was able to find a job at J & J doing medical device design, which I thought was really cool and a nice mix of what I like to do.

So that's how I got into it. And then yeah, I just stayed there. I sometimes feel like, working with the FDA and working with all the requirements, it's like, why am I doing this? But then don't know. I would miss it. I like doing it, so I get stuck and I'm having fun though, so that's good.

And then, I've been fortunate to have a lot of support in my innovation. But with that support, I have gotten 85 patents over the years.

[00:02:25] Jared: That is, that's incredible. What an incredible career you've had already, and you're just getting started. You're in the middle of it all,

[00:02:30] Galen: yeah. Yeah. Not early anymore, but late. Yeah.

[00:02:34] Jared: I guess talking about earlyness the early part of your career, is spent as an R & D engineer in various capacities and, what is life like for an early in career R & D engineer, and how does that change as you step into the more senior roles like you're in now?

[00:02:48] Galen: Yeah. I think, starting on a team, working with a bunch of more experienced engineers, that's what I did. And that was an awesome learning experience. So just being able to learn from the other engineers that's how you start off, right? You don't know what you don't know but being able to be part of product development team and being able to see what happens. I always tell younger engineers now just go through the cycle, the product development cycle, as many times as you can find ways to get involved and be part of that cycle. You're first time through, you have no idea what's going on. And as you finish that first project and you see it go into the market you start to be like, oh, that design decision I made back there that I didn't understand or that the senior engineer made, like that's how that impacted. Now we have these complaints or that we don't have as many complaints, or, and you're like, ah, it starts to make sense just going through the cycle a couple times. So that's what I tell people starting off as like just soak it all in. You're not gonna know at all. It's imposs, just be a part of it and learn as much as you can as you go.

[00:03:49] Ty: Yeah. Galen, I remember seeing you do that directly with one of the projects we worked on together where you saw the complexity of one of the solutions we were looking at and you're like oh no.

We're gonna dial all of that back cuz it's gonna create so many downstream effects for us later for the falling in love with the Rube Goldberg device versus what are we actually gonna be able to build? So yeah you, I've seen you guide that and that expertise really shines through with a lot of like how you manage product development.

[00:04:14] Galen: Yeah. Yeah. And it helps cuz you can hear that and be like, oh, I know we're supposed to keep it simple. But then it honestly helps a whole lot to have had a complex mechanism that doesn't work so well and to deal with the pain of that. You learn more that way.

You were gonna get that at school. You just got that from like scars. Yeah, I got that from scars. And from working with other engineers too. I don't know how to avoid getting the scars, right? Everyone gets the scars.

You're like, no, this is a really good idea. And the older engineer would be like it's not gonna be a good idea. And you're like, ah, I'm sure it will be. And then to really learn it, you have to move it through the prototyping process and then hopefully it's not, having problems with customers and patients. You can get to the next phase of design and you do your suite of testing and it's now I see why they said, don't do that.

[00:04:55] Jared: Maybe some of those scars, lead to, better foresight and speaking of scars, one of the aspects of R & D that, comes with a territory is failure, right? And maybe it would be defined as success, to some people in some ways. And so how often does a product that you're developing end up being terminated and

do people really get tied emotionally to bringing a product to market? And, they're really impacted emotionally by the termination of their device. When that does happen, how do you in turn keep people motivated to continue working on the next product and still be great?

[00:05:25] Galen: Yeah that's a great question and I have a funny story that I started my career like I said, at Johnson and Johnson, and so I started my first day and when I did the HR paperwork and like all that, and so I joined the team. I got to the team at 10:00 AM or something like that. And then we were like, oh, we have a meeting at 11 with a bunch of people.

I'm like, okay, cool. Sounds good. So I'll come to that meeting. And then they're like, we're canceling this project. Was what they said at the meeting. And I was like do I have a job still? I didn't even do any work on this project yet. What does this mean?

Oh my gosh. So I had been assigned to a project and then I guess they assigned me and they didn't take me off of it and then they canceled it. I was not emotionally invested in that project at all. I was like, I don't even know what we're working on yet. Cause I haven't, no one's showed me the details of what we're working on.

So that taught me that, failure happens a lot, right away you learn failure happens. But I wasn't emotionally invested in that project. I didn't care as long as I still had a job. When it's your design and then when it's your thing, it's your idea and your design.

It's harder to take. And a lot of people have trouble, it may be the project's still going, but you're like, Hey, I came up with one way to solve this problem. It may be a design mechanism on a part, and you're like, this is a cool way and I def I'm sure it's the best way.

And then the team will be like, we're not doing that way, and people can get bent outta shape about that. As a manager, what I worry about is are they giving? They'll be like, no, this is the best one and here's the data to support it. You're always watching out for are they emotionally invested in it and they're shading how they're interpreting the data, or are they giving you honest feedback like it is the best one and this is why.

Overall it's always better. Like I've had a bunch of my, what I thought were for sure the best designs not used. And even as an executive like I'd still be like, this is the way we should do it. And my team would be like it's not gonna be the best way. To be a good leader you have to recognize that your team knows better than you a lot of times. And being able to recognize that and be like, yeah, they're giving me good reasons, right? Sometimes you can know something that they don't know. But everyone knows everything, right?

They're like, everyone understands all the reasons that they're giving me good reasons why this design that I thought was the bees knees is not good. And so you gotta move on. And it's not about the percent of your ideas that make it right, like everyone has a pretty low percent overall.

Like most of your ideas are not good ideas, right? It's knowing which ideas to hold onto. And which ideas to let go. That's the hard part. If you can do that, I think the percent ideas that I've had that are good is similar to other people's, overall percents.

But if you know which ones to hold onto, like your total number of winning ideas can be higher.

[00:08:01] Jared: It reminds me of if you are a musical artist, right? Or just artists in general, for example any pop artist you can imagine, they have a whole catalog.

Hundreds of songs have never been released, they get canned, right? And then the album is 10 songs long. There's a hundred songs they were working from, and I can imagine in, R & D it's probably even more than that, that don't get released. It comes down to also trying not to be so emotionally tied to that idea, because

you almost have to just become friends with rejection and become friends with failure and know that it's just part of your process, yeah.

[00:08:30] Galen: And as a leader of a company, you do what it recognize that there is that emotional, aspect. And when you do a big shift when the company needs to pivot, when the company needs to shift, like you need to give people time to come to terms with that, right?

So it's an important part of, having a good company culture. You don't just come in and be like, your ideas are terrible, we're not doing it. No feedback and we're next thing, right? You want that balance, right? You need to give people time and space to be comfortable with that.

There's never an easy playbook to just be like, here's how to do it. Each situation is unique and you have to walk through it, but you wanna be, at least I found it works well when you are, ruthless with ideas, right?

And if the idea's not good enough, you don't do it, but you don't wanna be ruthless with people, right? Like you want to give, I need time to come to terms with things. Like you want to do that, you wanna make sure you're doing that for everybody else too. And you give the organization time to understand why are we doing this, and why are we not going with this idea?

Yeah. I mean what you're describing there is that productive conflict that is natural to any team that's looking at a really hard problem. And different specialties are gonna come in and say it doesn't work for this direction, but then another specialty is gonna come in and that whole heartedly supports something that fits for their point of view.

[00:09:39] Ty: And it's that ability to have a respectful conversation and argue about it to get to something that's right. That's what's basically, anything that's innovation, anything that's new product, development you're doing something for the first time and so it takes lots of perspectives and you have to continue building consensus or effectively leading that transition.

Which I don't know if you can talk a little bit more about leading through a pivot, you've been through some really interesting challenges. I dunno if you can double down on that one a little bit more cuz that's fascinating.

[00:10:05] Galen: For R & D you're always like, you launch something and people are like, let's sell this. And you're like, yeah, definitely sell this, but I wanna work on the next thing too. Getting people, excited about the next thing.

And iterate an improvement to the product. Like Gen 1.1, you launched your first product. Now we've learned some things and we wanna launch Gen 1.1, right? And so I think figuring out, you can kind of see what people like, see what people don't like. And you gotta

keep people excited about the Gen 1.0 product, cuz that's what you're selling, right? Like you're selling Gen 1.0 but you're excited to launch Gen 1.1. Finding that balance right? And you have different talk tracks for, different folks too, like your customers. You wanna just talk about the benefits of the device and if they have a problem, you're like, we hear that problem and we're working on it.

And with investors, you're like, we have a great product and it's selling this much, but it would sell even more if we can, have this money to launch Gen 1.1. Or our next gen product. But I think really understanding it's all about value proposition, right? So understanding.

What matters to what person, right? Your investor wants to know why when you're doing this pivot for the company, like why this money will help have more sales in the future. Your customer wants to know, it's helpful to be able to tell them the benefits of the device and the customer wants to know that the problems that they're having, you've heard them right?

And they have to there's a certain amount of patients cuz you have to go back to the FDA on a lot of this stuff. So we heard you, we promise we're getting to it, but you have to stick with us. It won't be in two months that we will fix your problem. So just having a talk track that talks to the needs of the person you're talking to. When you go through that pivot, and it's not one talk track for everybody, right? You're like, okay, I'm talking to the design team now. Here is the benefits for them. I'm talking to investors. Here's what they are thinking and they want to hear.

So just knowing what's important to who you are talking to.

[00:11:53] Jared: Thank you for that. I want to dial it back and go back to the product development process. And, we were talking a lot about failure, right? And, how that feels, but there's also gratifying parts to it, right?

And so what are the most, personally, satisfying parts to the product development process that you look forward to personally?

[00:12:11] Galen: Yeah. What sticks out in my mind when you ask that question is my favorite memories are the first time that any product that I was responsible for was used.

And being able to be a part of that and hear how you touched a patient's life at that point. And those are always the most memorable experiences than ones I think back to, like, why did I do this? The first time at J & J, the first time I was lead design engineer.

I actually got to go to the surgery that they were using it for the first time. And being in the operating room was very exciting. I'm like, I'm gonna see something I designed, used on a surgery and that's the real person that's it's gonna be used on.

Super exciting. And also it flipped to super scary right as we got started. Cuz what if I screwed this up right? So you have that sort of highs and lows too. I remember very excited flying there and, getting ready for the surgery. And then right as we got started I was like, super nervous and oh God, something's gonna go wrong.

And it didn't, it was fine. That product, did really well. Then, for 410 medical the first use actually ended up being. I wasn't there. It's emergency medicine. It happens, you can't just hang out there, right? It'll be at three in the morning on some random morning that they use it for the first time.

But Dr. Mark Peele, who had the original idea for LifeFlow. He got the full story from the doctor who used it and he shared it with me and Albert. I always remember where in the house I was standing when I got the phone call and him describing it, but it was actually a pediatric patient.

Forget how old she was, but it was a young girl, I think around four, and she came into the hospital like in very bad shape. She was perfectly healthy, like a totally normal four-year-old just living her life. And then mom had got on a business trip the night before and then she woke up in the morning like vomiting blood, and not doing well at all.

The team was worried that they were gonna lose her in the next 15 minutes basically. And it's panic inducing for the clinicians too. It's a very intimidating situation. You only got 15, 20 minutes.

You have no idea what's wrong with this girl. , And I still get choked up talking about it. It's It's cool to have been a part of it, but they knew that she needed more fluids and that, she was in shock and she was crashing because she was in shock. So they're like, ah, we got this new thing.

We've never used it, but we're gonna try it. And so they did. And they put a bunch of fluids in quickly. And she like perked back up and became they say mentating, her brain turned back on basically and she was, interacting with the world again where she wasn't before.

So everyone calmed down cuz okay, when the patient's like this, they're still sick, right? But we have time, so they're able to take her to CT scan and they were like, oh, look, there's a section of bowel that's knotted on itself and dead. Like they could see that. And so she needs emergency surgery to fix this, but they had the time, right?

So they had the time for the CT scan, they had time to prep her for emergency surgery and they had time to do the surgery and get it out. And she walked out of the hospital a hundred percent fine. There's a lot of work with the FDA a lot of long nights getting stuff ready.

But in that one moment I was like, oh, all that's paid off, I'm good. That was worth it just for that one patient. That's my favorite patient story.

[00:15:13] Jared: So humanizing, when you talk about the work that you do and the devices that you create, and when you get to actually hear about the impact that it had on somebody's life, and now it continues to do it and you'll never hear those stories right?

And it just does what it's supposed to do every single day. You can only imagine the amount of lives that it's impacted.

[00:15:30] Galen: Yeah, it is. I will say, working with a clinician, that was nice to be able to get those stories a lot of times you don't get those stories on the company side.

So whenever you can get 'em, it is good to have them and it's good to share them with everybody on the team too.

[00:15:44] Jared: I can imagine. It's just inspires everyone to keep going. Keep going, keep doing the best work because that's exactly what can happen. Lives will be better, people will keep going,

[00:15:52] Galen: yeah.

[00:15:52] Jared: Man. Okay. We might have to make a pivot off of this one. Speaking of pivots some, something I did want to talk to you about or just ask you is, to you, what does commercialization mean to you? We've talked about it a little bit, it's just come up in the conversation and I've heard it talked about where people say, oh, it's when you reach a regional market.

It's when you get into your first hospital, it's when you take over a certain side of the country and now you've got partnerships all over side of the country. Like for you, what does commercialization mean?

[00:16:22] Galen: Yeah, I think for me, commercialization means and I'm maybe tough on myself, but commercialization means when you have a value proposition that resonates with, your customer and for medical device clinicians, right?

So when you have something and you have your device and you have it on the market, obviously getting through the FDA you can't commercialize anything without going through the FDA. But then you've got clinical studies, you've got data, you've got marketing material.

You got a story that you can tell clinicians and they're like, okay, I understand why I need that. And that they know why they need it and they see the value in purchasing it. And that can happen. You're always having to do a ton of work on the sales side, it's a tough haul, a long haul. And there's never a magic moment where it becomes easy. But having that where you can talk to clinicians and they start nodding their heads and they're like, yep, that makes sense. And then they're ordering it, right? That's what I look at as like the end game of commercialization.

[00:17:14] Jared: Talking about commercialization, maybe tell us about, the early stages of starting 410 Medical. What went into that decision of even going into and launching that company? Obviously you were the lone ranger in the beginning and, built it from there.

[00:17:28] Galen: Yeah like I said, Dr. Mark Peele, he's the one that had the original idea and he connected with Luke Roche, who I worked with at TransEnterix. And Luke was helping him from a business side. Luke had started a venture capital fund and was familiar with all that.

He knew that Mark could use my help. So he connected, the three of us. He explained his idea and it made sense to me. It seemed exciting and we just started working on it as the nights and weekends. It takes a long time to get ready, people don't always appreciate how much time and energy goes into even getting it to the point where you can raise money on it or you can get grant funding on it.

So those early days are about what can you make happen with the resources that you have and how do you build a team? An awesome part of 410 was in the very early days, there was Luke who understood the business side of it. There was Mark who understood the clinical side of it, and then myself who understood, the operation side of it.

And we all had our lane and we all used our strengths to help others. So getting that. Sometimes you can have a group of engineers that get together and no one really understands the business side or the clinical side, and you know that company, sometimes they're successful, but they can struggle a little bit more than if you're honest with yourself and be like, maybe I don't understand the clinical side that well, and I need a clinician, or maybe I'm not that good at business and I need somebody that understands that side of it a little bit more.

[00:18:49] Jared: And so you kind of mentioned this early stage and that, you're there nights and weekends basically, trying to make this thing happen. Even, before FDA clearance, all this stuff, like how long was it or how long were you working on this before you even got your pre seed funding, before you were even at that stage?

How long does that early, early startup stage last?

[00:19:08] Galen: Yeah, so I worked on it for around two years nights and weekends. But Dr. Peele, mark had worked on it for a while before that. So it depends, he'd worked on it for several years before I got involved. So it takes, when you're like, ah, that's a problem.

If you're at that stage, you're like, oh, that's a problem. And we could do this better. It's usually years. Not always, like sometimes people can move quickly, but a lot of times it's years to get to the point where you can raise money. And then in a regulated area, like medical devices, getting the final device design also takes years, right?

Like you have to have the finished design, it has to be passing all of its tests before you send that into the FDA. A lot of times people are like, oh yeah, it works. We have this one problem, but we know how to fix it, right? Like you have to fix that before you even send it to the FDA.

[00:19:55] Jared: And so even before you send to the fda, so this is all pre-funding. You're not funded by that point, really. This is all just everyone pulling their resources together essentially at that stage. Yes. Yeah.

[00:20:06] Galen: So in the pre-funding stages, what can you do? How can you make a simple prototype with the money you have on hand?

How can you demonstrate the concept? And so being creative at that stage is really important. Can you make a prototype yourself? A lot of times, you can't, right? So it's can I find the right team to help me make a prototype for a reasonable amount of money that that we can then show to people. So looking for those, you're always just scrounging, right? Like, how do we find somebody that's done this before that can help us pull this together? That's what you're doing in the early days.

[00:20:36] Jared: I know Ty has a whole speech, a whole lecture on lean prototyping, I don't know if you wants to dig into it today.

[00:20:42] Ty: A lot of what Galen talked about there about even just like versioning your product. Reinforces that your first product isn't perfect, even though you go through all of the iterations prior to that. I think it's a continual process of improvement and testing and iterating and doing scrappy low cost early iterations to build confidence to then have like enough of a case to make to investors of yeah, we've de-risked this a bit.

Not at the FDA level, but enough to make a good bet on this. And just like you talked about designing a for each of the different audiences you have.

[00:21:12] Galen: Yeah. Yeah. And what you what you mentioned is important too, like setting expectations, right? There will be a lot of it.

Like what is good enough to get early, early funding is nowhere close to what's good enough to go to the FDA. So you've gotta just set expectations with everyone that you work with. And Ty obviously knows the story well. You helped us with the early prototypes of LifeFlow.

[00:21:34] Ty: Yeah, I remember the first prototype, the requirement was it cannot fail in the investor's hands. And so it did not fail, but it was this massive object.

[00:21:44] Galen: It was a little big . It could have been smaller in hindsight,

[00:21:48] Ty: but you got it down the next one, but it did not fail.

[00:21:51] Galen: Yeah. It was actually funny cuz the next one.

So the first one was way too big cuz we 3D printed it and, and we like, make sure that there's enough material there that 3D printing stuff won't fall apart. And then the next one that we did, we made it like the right size and Dr. Peele, we were testing it at the kitchen sink is just him and I, so not too stressful, but he squeezed it one time and it just broke on the inside.

And we used the next, we had two prototypes. The next one I filled with epoxy, just to strengthen it, right? So I'm like, let's try, don't touch anything else. Let's fill it up with epoxy and maybe that one will survive. And it did and it worked. And then we kept going from there.

But that's another part of failure. It doesn't have to be like your whole idea fails but you're gonna be like, huh? Do I wish that we made a smaller prototype to show to investors like, yes, I do. That was, and that was my instruction, right? Make it big. It's gotta not fail. So I gave that input, and then it turned out too big.

And do I wish I had that back? Yes. But did we still raise the money? We did. And the next one broke, right? So we had to fill with epoxy. So we're like, all right well we learned from that and we went, so there's all kinds of different failures. Failures don't have to be like the project's terminated.

Failures can be like, yeah broke instantly when I got it back. And then that was expensive but we did it right. We failed the right way. So the investors saw something bigger than it needed to be, but it worked for them and they still invested. And then we had one break, but it was at a kitchen sink and it was only internal people, so we had time to fix it before we looked real bad in front of other people. So we failed, but we also didn't fail catastrophically.

[00:23:22] Ty: Which is such an interesting idea of failing the right way. So instead of it's safe to fail instead of fail safe.

So there's, I don't know if you have a way of thinking about that in terms of like, when is a bad failure versus a good failure?

[00:23:33] Galen: Yeah, I always I guess the other thing is I know there will always be failures, right? I try to cheat the failure in a direction that I know is okay.

We went too far with making it too big but knowing I'm doing an investor presentation, I only have one shot, right? And I am going to always modify those to be like, I'm gonna practice it ahead of time. I'm gonna be sure my prototype, I'm gonna be as confident as I possibly can, that my prototype will work in the way that I show the investor how it works.

So if I'm gonna fail, I'm gonna fail with not having features like not showing features or not having features with investors. And they can ask questions. They'll be like, oh yeah, we're working on that. We're gonna have it. And then, when I'm doing like my pre FDA testing the final testing you do is called verification and validation.

But when I'm doing like, oh, I have my alpha prototype, I'm gonna do all the testing, right? I lean the other way. Fail as hard as you can immediately, right? Because it's internal testing. And you wanna bring all those failures up to the surface. And if you have a failure, don't be like, oh, we know that's a failure.

We'll fix it later. Keep testing it. Can you find more failures after that failure? Because, they're all, there's hundreds of failures, all over the place. You think about the situation that you're going into and you modify what you're doing.

Is this showing to investors and it's gotta work? Or is this, uncover all the flaws as fast as you can and you'll do different things based on which situation you're in.

[00:24:58] Jared: I think another piece of maybe the failure process as well for a lot of startup companies is time. Time to get to market.

A lot of companies fail because, they didn't have enough runway for the funds. Did you ever feel like you were in a time crunch? We've talked to, other folks that have made devices, they're working on for 10 years in some cases, and a lot of times they're pulling in family funds, they're pulling in funds from their job, from elsewhere and whatnot. Just to try to get to the end of that runway. How did you guys make sure that you also made it to the end of your runway in time?

[00:25:28] Galen: Yeah, that's where experience kicks in, right? So knowing how complex it is and how much should it cost? How much should, how long should it take? That's important. And there'll always be some noise around that. I don't know anyone that finished early is gee, we have a million dollars left over.

But also if you're close, people wanna see the finish line, right? So what happens? If you're halfway there or not really close, you're supposed to be all the way there and you're three, two thirds of the way there. There's a big gap still.

And so having that experience and knowing okay, this is about what it's gonna take, and then does your, did the money and time that you asked for does that make sense from a market point of view? So if I'm asking for 50 million dollars in 5 years to do something, Investors will be excited if they believe I can do it, first of all.

And if they know that the market is gonna be there, like it's a huge market and, it'll be a 500 million annual sales if we're successful at this, it's a massive market, right? So they're happy to wait 10 years for that. And medicine takes a long time and there are those big, exciting projects that the investors will fund because the market is so big.

But you gotta know are you working on that or are you working on LifeFlow was a small disposable, right? So we used a small amount of money and went quickly cuz we had to, no one would ever spend a big chunk of money to launch a disposable that isn't a massive market.

So knowing the market and knowing what you're getting into and does your funding story make sense? That's what gives you the time. And investors know pretty well too. If you're like, yeah, we're gonna do this small disposable, it's all mechanical. There's no software, we need 10 million.

They're gonna be like, I've seen a bunch of these projects and that doesn't make sense.

[00:27:08] Ty: How much should it cost to get through FDA clearance in the market? Because so many times you're talking to somebody for the first time as like an entrepreneur and they just don't have a sense of what the range of costs could be to launch their enterprise.

Did you just touch on that a bit?

[00:27:23] Galen: Yeah. We got to for speaking from my experience the LifeFlow, we got on the market in a year and a half after we got seed funding and we had raised like 1.2 million and that is the absolute fastest and less least expensive FDA product that I have heard of.

And it was a simple device too, right? If it had been more complicated, it would've taken more money and more time. And I don't know if I could even do that again. Like I don't wanna promise people that. That was a while ago now.

There's inflation and everything else, right? For any product that's going through the FDA, it's millions of dollars, right? You're gonna need millions of dollars to get it there. And so yeah, you can raise the money, you don't have to have it in your pocket, right? But the market has to be there, to get your money back, right?

If you're gonna spend several million dollars launching this product, you wanna know that the market, not just the market, several million dollars, but the portion of the market that you'll be able to get to and your annual sales will be many millions. So doing that math and having that story together ahead of time is important.

And you can't do anything through the FDA for less than millions of dollars.

[00:28:32] Jared: Talking about money again, you. You raised a million dollars in seed capital or you said one point, 1.1, 1.2. In seed capital for a medical device.

I feel like it really forces you to stay lean and mean in the early stages. How'd you really navigate making the most out of just that million dollars? Obviously you raised more eventually, but, maybe you could tell us a little bit about that pathway as well.

[00:28:53] Galen: Yeah. So having a good team and having experienced people goes a long way, right? If you're a business person and you just have a idea and you don't have someone that's done it before, they always end up spending more money than they think they will.

Cuz they don't know where the failures are. They'll bumble into all the failures instead of missing half of them. And so building, I think, being lean is about building the right team. Have the right people on the team that can, you're absolutely gonna work with consultants because you'll need that.

It's spiky, right? Like you need a lot of design help and then you don't, right? And you don't want to hire a person to do that. But having someone on your team that knows the technical side. Having someone on your team that can talk to investors and raise that money. Having someone on your team that understands the clinical side, like you need all those people.

And I think to me that's the most important thing. Have a well-rounded team that can lead. A device through and then have good, strong partners that can help you because you need a million different things to make you go and you're lucky if you've got 10 things that are really covered well.

Geez. You're gonna pull in a good core team and you pull in strong people to help. With the parts that you cannot possibly cover. And then, and then you have to be smart and then you have to be lucky. That's what it takes. Gotta know your stuff.

[00:30:10] Jared: Speaking of knowing your stuff, and you talked a little bit about, FDA clearance already. But can you speak to the importance of having someone on the team or knowing somebody that can speak FDA and how long does that process usually take?

Just the FDA clearance alone, like what's that segment of this long product development cycle?

[00:30:29] Galen: Yeah, I don't know a single person ever who has inherently understood how to get a product through the FDA. It is a learned skill. You have to learn it.

And the other thing is the FDA process. Like when you submit your 510 K or submit your pma, or even if you're class one and it's exempt, right? You need to know what the FDA wants to see. And you need to build that into your design, right? So you need that early.

The first person I hired at 410 is actually Bob Titkemyer. He was a quality regulatory guy and he was able to work on it part-time. And I was like, awesome a part-time quality regulatory person who's taken a bunch of devices through the FDA. That was the first person. I'm like, yep, you're on the team.

And I learned, a boatload from him. He had a ton of, he'd just done it before. Being able to be shoulder, shoulder with him, you're able to learn it. And then when you do it again later on, you're like, oh I remember Bob said this and you do better.

So if you haven't gone through the FDA before, like you have to get somebody who has, and they have to be on your team. I've never seen it and I don't like to say never very often I've never seen it where're like, oh, we'll figure it out. You need someone that is guiding you and helping you and be like, this is what the FDA's gonna wanna see.

So document your design this way. And if you do that up front, it's a million times better than if you get to the end and you're like, oh yeah, what does the FDA want again? You're like, okay, we can pull it all together, but it's gonna be a while . And you're gonna have to redo stuff that you already did cuz it may all be in your head, but it's not on paper and the FDA needs it on paper.

[00:32:02] Ty: So one follow-up question to that is around the human factors and human factors guidance and all of that. Could you speak to that aspect of the FDA process?

[00:32:13] Galen: Yeah, the human factors is a huge deal and the FDA cares a ton about it. Because it's important. Like I care a lot about it too. I think they're right to care a lot about it.

The human factors is just for those that don't know, what the FDA wants you to do is you bring people, end users in, whether that's a patient or a clinician or whoever's gonna use your device. You bring them in, you give them an appropriate training, whatever training that you're going to be able to give in the real world, and then you usually have to wait for a while and they have to come back and they have to use your device without any input from you, like you cannot help them. And then you have to record everything that goes wrong. You set up whatever milestones, here's what the device should do, here's how it should work. Like it should push, a liter of saline into their venous system.

That was LifeFlow. The end result is we pushed saline from a bag into their venous system. And so did that happen? Did they violate aseptic technique and they were at risk of an infection or any of that? We did all of our testing in a sim lab.

So just getting that human factors set up in the end, that's what you're gonna have to do. You're gonna have to hand it to people. You're gonna have to give 'em a brief set of instructions, and they're gonna have to do okay with it.

And you're gonna have to document everything that's gonna happen. So the way that we do it in the early days is, give them your prototype, give them less instruction than you would with your actual device and see what they do. Because if you get to the end of human factors and that's the first time you're letting people loose in the wild with your device, you're gonna find new problems.

And that is the absolute worst time to find new problems. Cuz your device is already finalized, you've already started all your sterilization and biocompatibility and all this other ridiculously expensive testing and you may need to make a design change cuz everyone sees the off button and think that's good to press in the middle of the infusion, right?

Ooh, , I'm just making up stuff. But yeah, you want to have that. What will an actual person do? I see a lot of engineers that like, wanna sit next to them and oh, here's how it works. Lemme show you how it works. And Oh yeah, don't do that. Push this button. And oh, you're struggling with that.

Let me help you with it. If you're doing that in the early labs, oh, I see they're struggling. But let me just help tell you what to do now. You're papering over all the problems that the human brings to it, right? So your design needs to work, but the human needs to be able to interact with it.

Those pesky humans are hard to design for. Yeah yeah, I got my EMT certification a couple years ago and that was my biggest learning was human factors. So I went out and, there was a car wreck that happened right in front of us in the ambulance. We were going to another call and there was a car wreck and there was a bunch of people like in multiple cars.

They're like, yeah, just go over there, right? And see what's going on over there. So I'm walking over, I'm like, I don't even know what I'm doing here. And I'm walking over to a person that's in this wrecked car, airbags, broken glass I don't know what I'm gonna find. And I was scared, right? And when you're scared you can't do simple things.

That's what I didn't appreciate, was like, when you're in a lab and you design the thing, it seems real obvious, right? But when you are not the person that designed it, and maybe you're in a suboptimal situation and maybe you're scared cuz maybe the surgery isn't going very well, or maybe it's a car wreck, or a bus with a bunch of kids, something that you're not used to dealing with.

Your mental capacity is lower then. So you've gotta get yourself in that mindset in order to design something that's easy enough to use when you've just had one quick training and now things are scary.

[00:35:39] Ty: That is such a great example and you lived that too, so you understand the limitations that you're in and the stressful emergency situation.

[00:35:47] Galen: I don't know how to recreate that with engineers. Like the design team, like how do you have them use the device when they're scared? It seems like a bad hazing process for Yeah. HR, my wife's in HR and I've run a bunch of ideas past her and she's those are terrible ideas. But yeah, so emergency medicine is one, but most medicine, a lot of medicine can get scary quickly, right? Designing something that works in those situations is important.

[00:36:10] Ty: We've had a couple questions come in. One is from Rumneet. He asked what need identification slash validation work would you suggest founders do before investing more?

And how, so to clarify, we're at the before investing more. So that's, pre-seed at that point or seed stage to series A. I dunno if you wanna break those down.

[00:36:30] Galen: Yeah. So I think and I may be biased here, but I think knowing if something's gonna work technically or not is something that you can do internally. Can we design this? Do I know a way that we can make this work? And that's something I am usually more comfortable with. But is the market there? Do people value the problem that I'm trying to solve usually is the hard part.

And being ruthless with the market research. So you tend to talk to friends, you tend to talk to people that know you. And that's a bad way to do it cuz no one wants to say Hey Ty, your idea is really dumb and I don't like it. Because I know you and I don't wanna be rude to you.

You've never held back on my dumb ideas. So I think market research is a huge deal to note, are you solving a problem that people care about and people will pay to have that problem solved? So doing the time and talking to people and will they believe it?

Like sometimes you may have a great idea, but they're like, yeah, there's been 50 companies that have all promised this and I just don't believe any of 'em anymore. And that can be hard to overcome. Like you need to be like, you know what, we're gonna need some amazing clinical trials to get people interested in this.

And it's gonna have to be different than everything else. And do I have the money and funds to get there or do I not? I've had good ideas that I think would be good ideas that, I'm just like the market's not there. It's not gonna be there. Like it is a good idea. If it was implemented, it would help people, but what it will take to get the market there is too much.

[00:37:50] Jared: I think we're getting, close to the end over here. Hoping that maybe you could tell us, more about your newer venture. You're the principle of Vital Simplicity. How are things going so far?

[00:37:59] Galen: Yeah, it's been an exciting time for me. I'm looking at starting a new venture. So I started Vital Simplicity, and what I'm doing is, I've mentored a bunch of people along the way and being able to help people and consult with people is something that I enjoy doing. And it's also nice to get some revenue in the meantime.

It takes a while to get a new idea up and running. And then I'm working on a number of exciting ideas that, trying to get to that point where, I can raise the money and lead that project or company. And yeah. And it may be that the entire stable of ideas I have right now is not gonna be the ones I take forward.

But, I missed the early days of 410 where it's I wanna do this from the beginning again, and there might be something wrong with me. But yeah, so I'm excited to be back at that point and be in the early days. I'm doing a mix of helping other folks and consulting and stirring up new ideas that I can help found and help lead.

[00:38:51] Jared: I know we're getting to the end. I kinda wanna ask this to you, which is just what kind of risk appetite do you have to have, done something like 410, taken that through and you're like, you know what, I'm doing my next thing and you start right back over risk on once again. I know a lot of people don't have the stomach for that.

[00:39:06] Galen: There might be something wrong with me, as I said before but I am fully aware none of these ideas that I have now, like you have to be comfortable that none of these ideas will work out, and you also have to have the runway, right? You have to give yourself enough time to make things work, and you have to have the funding to do that, right?

So you want to avoid at all cost a situation where I have three months to make this work, or I'm in trouble, right? Don't be in that situation. That makes me feel better. Like I am taking risks, but I also know, I've done this a number of times, I kind of know how long, it should take, and being able to if I have that long plus a little buffer, I I'll either be close enough or I won't.

And and I'm comfortable with any of those outcomes. So I think, yeah, it is about taking risks and it is about. None of this may work. It may all fold, but I also don't wanna have to worry about the roof over my head or feed my family. Like I don't take that risk, right?

So you wanna have a situation where you're not in a panic, desperate mode. But you want to be able to take some risks as well. And it may be that I do all this and I may have been better doing something else.

And you just have to be comfortable with that too. Be like I had fun though. I had fun, I made a difference, and I'm happy with what I did. So I took a risk. It didn't pay out, but I don't regret it.

[00:40:17] Ty: It sounds like you're thinking about like just the idea of startups and the same way you're thinking about prototypes.

That you've got a smart way to fail and a dumb way to fail, and you're controlling for the dumb way to fail and setting yourself up. So it's okay with the unknowns that like, will inevitably emerge with any, new venture, new startup and whatnot.

[00:40:34] Galen: Yeah. That's a good way of saying it. Don't fail the dumb ways, but failure's still gonna happen. Yeah, I like that.

[00:40:42] Jared: And so as we're closing up, we have our final question for you. For people that are earlier in their career and they want to follow in the path that you have as an innovator, as an entrepreneur, as an executive what advice do you have for them moving forward?

[00:40:56] Galen: Yeah I would say, go through the cycle. Go through the process as many times as you can. So whatever you like doing, whether it's medical devices, do as many, medical device cycles as you can. That's one. And then the other thing I would do is keep learning. Always keep learning, right?

So when you are partnered with an awesome regulatory person. Learn from them right when you're partnered with an awesome business person. Learn from them. Help them figure out a way to contribute and help them so that you are involved. And that you see how different parts of the business work.

Now, I didn't do that all at once. I didn't like, let me learn from everybody all at once. I started and then J & J had the chance to do a little bit of marketing stuff. So it's awesome. I did a little bit of marketing stuff and I wouldn't lead a marketing project now, but I have seen it and I know what works and what doesn't. That helps me when I'm working with a marketing consultant and, or, marketing lead on the team, right? And that's what I would say is keep picking up, learn how things work and, I'm an engineer, so I always like the design side of it. Knowing the business side of it, knowing the clinical side of it, knowing the marketing side of it, pick up that as you go and be patient, right?

Like there'll be failures. You don't have to learn it all at once. Build as you go.

[00:42:02] Jared: And on that note, thank you so much Galen Robertson for joining us. Thank you for your insights and thank you for your time. Really appreciate it.

[00:42:08] Galen: Yeah, it was great to be here and thanks for inviting me.