EW 005 – How To Bring An Innovative Medical Device To Market In The United States – How COO Kelly Mottet And Her Team Got A Win For Mach32

Gordon Sheppard (00:01.838)
Okay, here we go. Kelly, welcome to the show.

Kelly Mottet (00:06.788)
Thanks, Gordon.

Gordon Sheppard (00:08.458)
It's really great to have you here because what strikes me about spending a bit of time with you is there's sort of brains oozing out of your ears in terms of what you folks are tackling here. Although there's gonna be some people here that aren't even aware of that high level of acumen that you and your team have. So for the people that don't know you, can you please introduce yourself and say who you are, your title, and then also your venture and what you're doing. It's so exciting.

Kelly Mottet (00:32.698)
Yeah, thank you. So I'm Kelly Mottet. I'm the Chief Operating Officer at Mach32. At Mach32 we stop people from bleeding to death. It's really as simple as that. We are taking a generic medication and giving it a new route of administration. So an easy and simple way to think of this is as an EpiPen, but for traumatic bleeding. I have spent...

most of my career in the medical device product development space, in working on startups, working on new products. And this is actually the second product that I've done in hemorrhage control or bleeding control, specifically designed for outside the hospital. So think military medics, EMS, police officers, firefighters, and hopefully one day these products will be available for.

people like me without a clinical background, without medical training so that we can use them if we need to to save lives.

Gordon Sheppard (01:29.783)
Wow, that is ambitious and remarkable all at once. And I mean, it takes a tremendous amount of expertise to kind of get into this area to tackle something that is such a significant issue along and you're getting that along the way. How long has your startup been in business and what sort of stage are you at now?

Kelly Mottet (01:50.256)
Yeah, so Mach 32 was founded in 2019. We took a little bit of a COVID pivot, if you will. So let's say we haven't been fully working on our...

auto injector or EpiPen for traumatic bleeding the whole time. But what we have done is we have built functional working prototypes and we have tested them in live tissue to ensure that they work. We have developed a unique proprietary formulation of the generic drug that we're working at. So we have a bona fide pharmaceutical asset. And we just recently announced a U.S. government contract to support our R &D work. So we're very excited about that.

that.

Gordon Sheppard (02:31.649)
Well, congratulations. I mean, it just takes so much work along the way. And I remember chatting with you in the pre-interview and just talking about, you know, it's a big deal to lead a team to actually kind of get this thing done. And there's the ups and downs of the reality of what you've been dealing with since 2019. You've gotten it this far. If you had to describe your sort of biggest win in this venture so far, and I'm sure there's been many, what would it be and how would you describe it?

Kelly Mottet (02:54.692)
Yeah, I think from a business perspective, what I'm going to list as our biggest win because it's most recent is the execution of the BARDA contract as BARDA being part of the U.S. government. It's tremendous validation for what we're doing, that there's a really strong market pull. It took a year to get it to happen. And it's just super exciting, game changing for us as a small little Edmonton, Alberta company being on the radar of

an organization as big as BARDA in the United States.

Gordon Sheppard (03:29.707)
It sounds like the big leagues, right? You're the minor leagues for a little while there, you're chipping away, you're doing your thing, you know it's got potential. And I'm gonna really slow down for the audience here to make sure that we understand Barda and the significance of this. So if I'm trying to take a product like yours into the United States, what are a couple of the steps that get me to Barda and then tell me about Barda?

Kelly Mottet (03:49.476)
Yeah, so I'll start with telling you about BARDA. So BARDA is part of Health and Human Services in the United States. They have a two billion dollar budget every year to prepare for natural and manmade disasters. They do everything from flu vaccine every year to developing antidotes for chemical agents or radiological agents. So they are very interested in bleeding because whenever you have trauma or injury,

You often have a lot of bleeding and uncontrolled bleeding or any sort of mass casualty situation where you got limited resources. Our tool is perfect for those situations. so BARDA funds projects. They fund them all the way through to FDA approval. So that kind of speaks to like, what is the pathway going into the United States or kind of what is the pathway anywhere? Anywhere we as a medical device or a medical

product, we need to get regulatory approval in the United States. That's with the FDA. That might involve conducting clinical studies. Those can be quite expensive. And as well as preclinical testing to make sure that we're safe even before we go into the clinic and test it clinically. So this BARDA agreement at $750,000. So that's a significant chunk of change for

a small company like ours, and it finds interactions with the FDA to confirm the regulatory approval. It confirms development of a proprietary drug, and it also involves preclinical testing. So it really moves us forward. And it's also the gateway to the future. They have expressed interest in funding the entire development pathway all the way through to FDA approval. And BARDA has done this for many other groups that they're interested in.

developing and commercializing those technologies.

Gordon Sheppard (05:48.622)
That's remarkable. And talk about getting skin in the game. I mean, this is not a couple hundred bucks here. This is a significant investment on the part of your company. You're playing the full game, which is the long game, right? Because you're in in this sort of medical space and that's what it takes to kind of get there. Just for fun, how did you get on Barda's radar? Did you, do you just sort of like, you call them up and go, we're in kind of thing or what happens?

Kelly Mottet (06:07.6)
you

Kelly Mottet (06:11.94)
you hustle. And I have no other way to describe it than you hustle it and you hustle a lot. for us, it was a combination of asking who could introduce us, going to networking events. Barda has specific industry days where they invite companies to come. They also go to some of the conferences that we also attend. It's just hustling to try and meet the right people. It probably took us six months to meet the right person and then

a year to get the contract together. But once we met the right person, we knew we were going to get a contract fairly quickly because we were talking to the right people. We just needed to jump through the government hoops then.

Gordon Sheppard (06:55.694)
Well, congratulations. mean, that's the trepidation there. Like we're gonna try, we think we need to meet somebody, we met the wrong person. I'm sure there's sort of, if we broke down your whole journey, that would be quite a story in and of itself. But in the meantime, you've got this win, which is getting this BARDA to stage, you know, moving forward for your business is significant in the way that you've set us up. So we're all in good shape for understanding where it's at. Now we get into what I call the anatomy of a win. And this is this idea of, you know, what is the strategy, the work plan?

operations and results behind this win. And when I say strategy, I mean, what was the vision? You what was the sort of the mission, the values in a sense, or the goals and objectives that went into going after this in the first place?

Kelly Mottet (07:36.666)
Yeah, so my background is in product development, other medical technologies. So we knew very early on that BARDA was an attractive target for us, similarly to the way you would imagine that the military is an attractive target for us. And so we had identified them really early and just knew that we needed to get to the right people and that it would take time. We knew that we would have to start early and have to be extremely persistent.

and also be very clear in our messaging. We had to be ready for the opportunity, know, whenever it came, right? You don't know at an event who you're going to meet. And I've definitely been at BARDA industry days where their staff has been like, hey, come meet this like high ranking individual and go tell them what you're doing and where you're at and be prepared to answer all of their specific questions. So.

Gordon Sheppard (08:31.469)
I love it. And so did you do some like, don't know, it's not like a mock interview, but it's almost like a mock networking moment where you've got to be like an actor kind of prepared with your script. Is that about right?

Kelly Mottet (08:41.604)
Well, it's not that much different than pitching, to be honest. I don't know that investors would like to hear that it's an actor with a script when we're pitching, but it's just about telling your story over and over to as many people as you can and getting feedback and finding the themes in the feedback and then tailoring your message, making sure that you get it as clear as possible. and you know,

It's rare that I get questions now that I haven't gotten before, but you know, it's taken a lot. I've told the story often and I've gotten lots of questions and then I'm prepared. that's, that's what I think it is, is just keep telling it when someone doesn't understand, figure out another way to tell it. Just, just keep pushing and telling that story.

Gordon Sheppard (09:28.395)
I love the tone in your voice because there's a patience, there's an entrepreneurial patience in what you're describing around not being discouraged in the first 10, 20, 30 tellings of this story. You can hear the enthusiasm because you took it as a learning opportunity to actually, if I get to tell it again, that's a great opportunity because I'm getting a feedback loop.

Kelly Mottet (09:48.33)
Mm-hmm, exactly, exactly.

Gordon Sheppard (09:50.594)
That's fantastic. So the strategy early on, you knew BARDA was in your sites early on and you were ready for it. So when the moments came, you went to these networking events, that was a persistent thing to do as well. And again, huge goal and you sort of met that objective and you've gotten through now to this next step. What was the, if we had to describe the what, who and the when, the work plan in a sense to execute the strategy. Take me back to some, it sounds like minutiae a little bit, but there's something like, okay, well, we have to pick the first event to go to, to go see if we can, you know, intersect with these people. Is it?

Take me through some of those moments along the timeline.

Kelly Mottet (10:22.692)
Yeah, so it's interesting because I've been in this space for a little while, but my co-founder is Dr. Mark Curiel, emergency room physician at the Misercordia and this is his first time doing a medical product. So I kind of knew where to go, but it was a matter of us getting our story straight and us functioning as a team so that we were looping each other in on the feedback that we were getting when we were telling that story.

you know, we often didn't have the resources or the bandwidth to send both of us to events. So we'd have to divide and conquer those events and then make sure we are closing the loop on, all of that communication. And I mean, travel is tough. mean, you think business travel, this will be fun, but it grows old so fast. And so it takes a lot of perseverance to get through some of the crazy travel schedules and

I mean, I know my schedule is not as bad as some, like there's been weeks when I've been on 10 different planes going here or there and everywhere. So, but it's, it's that level. I'll come back to it. That's that level of hustle that's, that's needed. it's, it's needed from your whole team, right? Like we have a very small team and we need everyone to be helping out on whether it's preparing for an investor pitch or preparing to pitch a group like BARDA.

which we view very similarly as an investor, more of a strategic investor and customer.

Gordon Sheppard (11:54.386)
is remarkable. So again in the work plan if we actually broke it down we would hear something like what dozens of meetings, dozens of flights, dozens of coordinating calls, dozens of learning on top of learning from who do we see and who do we intersect, how do we then bifurcate the contacts that we had and not talk to this person next but talk to that person next. So many things along the way that if we really got into the the nitty-gritty we would hear the fine-tooth comb of all those details. That's well congratulations again and it

Kelly Mottet (12:06.416)
Thank

Gordon Sheppard (12:22.701)
Again, you don't sound disappointed. You sound so enthusiastic. It's just a wonderful thing because you're getting payoff for your strategy and the work plan that you put in place to get this far. So that's remarkable as an entrepreneur. And I hope the folks that are entrepreneurs listening to this are inspired by the way you're tackling it in terms of your own approach. I think that's really great. The third step that I talk about in the Anatomy of a Win is who are the people involved? Who are the stakeholders involved? And I'm hearing there's you and your team. And then there's the

the gentleman that you mentioned as well is the physician and you know that's sort of your core group in a sense and then there's the people at BARDA that you're running into and maybe even other people. So who would you say the key stakeholders are in making this go forward?

Kelly Mottet (13:03.652)
Yeah, so I'd like to add a new group into that, which would be our contractors. And let's go with advisors being maybe a better term for them. But we're a small team, and we have knowledge gaps. And sometimes we're a little blind to those knowledge gaps too. So we did a really good job at the beginning of identifying where are knowledge gaps and where do we need subject matter expertise. I think of who's the expert on the regulatory side with the FDA with a combination product

or an auto injector specifically like what we're doing. Who are the experts in IP that can help us navigate this landscape? Even though I've been in the space for a while, those are things that I know a little bit about, but not enough. And when you're trying to get a government contract, especially with somebody like BARDA, they have experts on their side and they're going to be asking tons of tough questions. these SMEs, subject matter experts that we were able to bring in as advisors, whether as a

consultant or just a friendly individual who works in the space, is a first responder that can give us advice is extremely, extremely useful. And I don't think we would have developed a good strategy for go-to-market, a good strategy for product development, and even a good product without that user feedback and that network. So that's a key piece to it.

And then I think the other key piece is investors. Not everyone can bootstrap their own startup. We need external financing to make things happen.

You know, we've received a lot of non-dilutive funding being here in Alberta. We've been very successful with Alberta Innovates funding that helped us get off the ground as well as NRC IRAP. The very first money in came from NRC IRAP in 2019 in the form of a youth employment program. so like it's that type of thing that allows us to exist today to do some of that initial product development work before we can derisk.

Kelly Mottet (15:14.37)
get to the point where angel investors are interested. And so we need those angels and those angel investors that are interested in investing in products and know the risks that startups are risky.

Gordon Sheppard (15:31.566)
That's, again, so interesting to hear along the way. Again, if we got the timeline out, we would hear there's sort of you and a few other people. You've got your idea. You're getting it off the ground. You've now got the strategy that leads to this win at this moment in time. And this isn't obviously the last stop on your route as you kind of go forward. Then you're bringing in these subject matter experts kind of as needed. You've got this expertise coming in to fill in those knowledge gaps. You're aware of those knowledge gaps, in a sense, and getting those things along the way. You would have gotten so many great tips.

just anecdotal moments from some of those people along the way. There's the investors themselves, and then there's all these different levels of government funding that you're describing. Federal, you've got your provincial support along the way. So all those pieces take so much time, obviously. You know what it's like probably to burn the midnight candles to get those applications filled in and whatever, and then you would have gotten some help here and there. So again, tremendous persistence through that. What a great group that you've had going forward to this point, and who else?

is going to be in your future. you would have almost a roadmap for some of the other people along the way. And if we had lots of time, we would go for those future wins as well and find out who those experts are going to be. But you're going to meet more people along the way because you've got the muscle to build out that group. The fourth step is operationally what was needed to be in play here. I'm going to suggest things like regulatory understanding, any sort of government cross-border issues, those types of things. There might also be even some.

not IP, but original types of applications for actually building things or putting chemicals together. And I'm saying that in the roughest way, because I don't know your business, but it's this idea of like operationally, if you had to give us the highlights for this win, how would you describe them?

Kelly Mottet (17:00.912)
you

Kelly Mottet (17:06.916)
Yeah, so that's interesting.

I think I'm to take it in like a slightly different direction if you don't mind. And we're a virtual team and we've been a virtual team for most of the duration of this, of Mach 32 that we've been working on operationally virtually. And so some of the things that we did virtually was to really focus on team cohesiveness because it can get quite isolating when you work at home.

Gordon Sheppard (17:13.389)
Sure. Yeah.

Kelly Mottet (17:39.772)
in front of your desk, the work, there's tons of advantages to that, but there's also some downsides to that. so we put some things in play operationally to make sure that we had that team cohesiveness because everyone, we had to lift above their weight and we had to all punch above our weight class, right? And we had to be greater than the sum of our parts. So, you know, one of the things that we did, and this wasn't even work related per se, is we did a virtual

Starbucks Fridays, where we would just meet on Fridays, not always, and we wouldn't always have Starbucks, but it would be like, bring your coffee or bring your drink, and we're just gonna spend half an hour having water cooler talk. And we're just gonna chat, and it's gonna be non-work related, and we're just gonna make sure that we keep those connections and that human touch point there, in addition to our regular.

meetings and team meetings and everything like that. I think that kind of cohesiveness of our team in a in a virtual, very spread out environment, we're spread out throughout the province, helped a lot in making burning the midnight oil, making sure we're all pulling in the right direction, and making sure I mean, the grant writing lifts were big lifts. And so hours and hours and hours of lifts.

Gordon Sheppard (19:05.837)
would you describe, I mean, you you could be cold about it in a sense and not do Starbucks Fridays, right? If you just want to sort of bang things out, why was it important? How would you describe the attitude or the values of this team at this moment in time that made that important?

Kelly Mottet (19:12.25)
Mm-hmm.

Kelly Mottet (19:22.98)
Well, you know, one of my big values, and I think this translates to the team is that people matter, right? You know, it's often said that investors invest in the management team because a good management team will know how to pivot. And well, when you're a four person company, your whole team is essentially the management team. They're all in extension. They're all doing heavy lifts. They're all working outside their comfort zone potentially. And so I think that that's

that's important that people matter and you get to know your people. We also had a couple of younger people on our team. And when I say younger, I mean recent graduates. And when you're coming into the workforce for the first time and you're working remotely, I think that can be really challenging. So we want it to develop those relationships and those touch points and make sure that myself is approachable for this group. And we're talking.

I like to be very transparent about what's going on. Not everyone's like that, but that's who I am.

Gordon Sheppard (20:25.901)
you're building a people first approach. But aren't you supposed to just be excited about tech and cool chemistry things and all that kind of stuff?

Kelly Mottet (20:28.56)
you

Kelly Mottet (20:34.992)
well, I am excited about cool tech and stuff, but it's the people who drive it. you know, I heard an interesting saying, and that is like, we volunteer our creativity, right? I can pay one of our staff members to do a job and they can, they can do it, but they're volunteering their insights, their creativity, their, their work ethic into that. They don't have to give me that. And so I'm trying to create an environment where everybody can.

can thrive and they want to be a part of it and they want to bring their ideas. I mean, this is the third startup that I've been a part of that's been founded out of Edmonton. And I still have the relationships with the original people that I worked with and it just all cycles back around. I don't know, people matter. And that's kind of the end of that.

Gordon Sheppard (21:28.983)
We could end the interview there. If someone just heard the last 30 seconds of gold that you just brought to that, is just, doesn't that say a ton about your approach, your team's approach and why you've been successful through what is not easy as you're hacking through the jungle, right in those grant applications, you're developing, you're inventing, you're doing your things along the way. This is not a straight path. It's not like, we do this and then we're there. You would have had to travel, it's a winding road. Is that correct?

Kelly Mottet (21:55.182)
Yeah, it's a winding road, sometimes like upside down through the jungle and you're hacking your way through it. Like there are times, I don't know if I should share this story, but we were in the States and we were doing some product testing and it wasn't going so well and we didn't have any workspace in the States. So like you like took over the lobby of the hotel, trying to, build our prototypes in the lobby and we were going there. I mean, we probably started that day at

6, 6 30 a.m. and we were and you know going out to the testing site then we were back in the lobby of the hotel till 11 p.m. trying to trying to problem solve right that's that's the drive you have to have sometimes too and that's what you have to instill in your team like we're gonna make this happen no matter what so

Gordon Sheppard (22:47.246)
We're gonna make this happen no matter what. Hotel lobbies or fancy labs, whatever you're doing, you're making it happen. wow, that is just good. So I've heard the strategy, I've heard the work plan. We talked a lot about the people, the attitude of the people is really, really clear about why you're getting to this level of success. You get this win, how do you measure the results? What do you measure, qualitative, quantitative, to know that this was a success?

Kelly Mottet (23:13.732)
Yeah, I mean, so obviously there's very specific metrics and deliverables that we have to hit as part of this contract. But I mean, at the end of the day, the success is, are we farther along the commercialization pathway than we were when we started this? You know, I hope not, but it's possible that there's going to we're going to learn something and we're going to have to pivot, right? But it's are we closer to commercializing this? And when I think of commercializing, I think of

are we closer to getting this into the hands of the people that need it? Right? And it's not just, can I make a buck? It's can I get it into the hands? You know, before Christmas, I was out meeting with, how should I describe him? Let's go with Doc, who works for Department of Defense and who is actively deployed. So let's go with military physician.

you know, he had just come back from being down range. He had just come back from being deployed and he said, you know, we went through all our thing. It's hard work. We're slugging. And he goes, I really got to thank you for what you're doing. That we really need this. This is going to make a difference for me and the patients that I treat. Like, let's just keep going. And it's, it's words like that from end users. We're like, I can, what you're doing is going to help me save a life as soon as you have it available.

That's how we measure success is like how much closer to that moment are we?

Gordon Sheppard (24:44.152)
It sounds like you're in it to win it, like for those right reasons. There's something about your own values that's screaming through this. Again, because I'm sure you could be talking about the potential dollar aspect, which is significant, I would think, in this type of application that you're talking about. But here you are emphasizing the end user and how it's going to benefit them.

Kelly Mottet (25:05.328)
That's where it's on.

Gordon Sheppard (25:07.009)
Well, congratulations. has just been, it's been so insightful for me to learn about this win where you've gotten it to this level of commercialization or the next step towards what you're doing in the States. And then thanks for describing so articulately your journey and thanks for not renting out your creativity, but simply bringing it, right? Again, super insightful for myself. And I know the folks listening are gonna get a ton out of this. Thank you so much for being on the show. Really appreciate it.

Kelly Mottet (25:24.24)
you

Kelly Mottet (25:35.696)
Thank you.

Gordon Sheppard (25:39.649)
That's how we do it.

Kelly Mottet (25:41.53)
That was good. That wasn't so bad.

Gordon Sheppard (25:43.704)
That wasn't so bad. Yeah, that's what we do. So I'm just going to stop recording here for just a second.