Alejandro Covalin [00:00:01]:

Have you ever wanted to know the full story of a medical device company, from the initial spark of an idea to launching FDA approved product? I'm Doctor Alejandro Covalin, chief technology officer at Spark Biomedical. With me are my co founders, Daniel Powell, CEO, and Doctor Navid Khodaparest, chief science officer. Welcome to Spark a conversation.

Daniel Powell [00:00:24]:

Yeah. So, Alejandro, before you were chief technology officer and a neuroscientist, neuroengineer, what did you do? Completely tears.

Alejandro Covalin [00:00:35]:

Yeah, that was my past life. I was designing machinery for heavy industry, for lumber. So I used to work. I used to fly out to the jungle and making big, big machines. It was fun. I liked it.

Daniel Powell [00:00:54]:

So fast forward, you say, enough with lumber mills, I'm going to become a neuroengineer.

Alejandro Covalin [00:01:00]:

I got bored. I wanted to. I wanted to do. I wanted to get into. So, Alejandro, I wanted to get into more. You know, like, I like the information, I like the computational stuff and making things, and I was looking for to do something different, and I like the medical field to help people. And then I found this degree called neural engineering. And, like, oh, that has everything.

Alejandro Covalin [00:01:32]:

You have the engineering, you have to make devices, and you get to do something for people, and you have all the computation and all the information processing. So I went and went into that.

Daniel Powell [00:01:45]:

Went to UCLA and not got a PhD in neuroengineering. So, yeah. How many years you've been doing this now? And not lumber yards, but stimulation, I.

Alejandro Covalin [00:01:55]:

Guess, since I started the PhD, I started doing stuff. So I guess. Well, the PhD was started in 2000, but I think I started really working on doing, like, a year later, 2001.

Daniel Powell [00:02:08]:

I was just making more than two decades.

Alejandro Covalin [00:02:10]:

I was making devices. I was making electrodes.

Daniel Powell [00:02:12]:

So what led. So, we all know the sparrow device for Spark really is derived from an original invention that you made before we even met. So how did that all come about?

Alejandro Covalin [00:02:26]:

I was all in, of course, implanting stuff. And then it was one paper that I remember I was reading. Maybe I mentioned this to you guys before. It was about treating migraines and with implantable devices in the occipital. And when I saw that paper, I was reading it through it. It was very interesting. Like, why are they implanting? You know, the occipital nerve is pretty much on the surface. I mean, close to the surface.

Alejandro Covalin [00:02:57]:

Like, you don't implant anything.

Navid Khodaparast [00:02:59]:

Right?

Alejandro Covalin [00:02:59]:

And that got me going and thinking, and I started working on the migraine project even before, actually, as I was living, I can't finish my PhD, and I was looking for a job and while I was looking for a job, I was working on the migraine thing, the migraine project, non invasive. And then I got sidetracked because I went to Minnesota to work again on implantable stuff. But I kept that thing going in my head.

Navid Khodaparast [00:03:32]:

Oh, how to keep it out of.

Alejandro Covalin [00:03:33]:

The brain, how to keep stimulating, how.

Navid Khodaparast [00:03:36]:

To do things non invasively. Wearable stimulation.

Daniel Powell [00:03:39]:

You were thinking about that in the early two thousands. Nobody was thinking about that. And you were the only one. I mean, I remember the first time I heard about non implantable was 2014 or 15.

Navid Khodaparast [00:03:54]:

That was when the german company, those one.

Daniel Powell [00:03:56]:

Yeah, cerbomed was stimulating the vagus nerve for. And I said, that's crazy, it'll never work.

Navid Khodaparast [00:04:03]:

Well, they were doing it for epilepsy.

Daniel Powell [00:04:06]:

For epilepsy, yeah, they're going after epilepsy. I was working for an implanted epilepsy product at the time, and I said, that'll never work. You can't stimulate the vagus nerve through the ear. That's stupid.

Alejandro Covalin [00:04:19]:

So that got me going, actually, and I came back to California and with another startup, and then, but I was still working on the migraine. And then I started, I tried to start a company with the migraine. So I made the vices and everything. And then I told me where was it? At some point the migraine, basically the migraine device morphed into the first generation of our device.

Navid Khodaparast [00:04:55]:

Yeah.

Alejandro Covalin [00:04:55]:

So because I already had the circuitry, I knew what, you know, the waveforms that you needed, specific waveforms that are better than others to stimulate the nerves. And you needed to have a current source instead of a voltage eventually. So that migraine device, the migraine aspect is the electrode, but the stimulation source, you can use it for whatever you want, right?

Navid Khodaparast [00:05:22]:

So you can change, you can essentially, instead of stimulating the back of the head, you can change the electrode, make it for the ear, the forehead, the face, the arm, the leg.

Alejandro Covalin [00:05:31]:

What exactly. Once you have the correct depends. I mean, for example, if you wanted to go to the leg, you probably need more, more current. Yeah, but if you still going to go for cranial nerves that are superficial, close to the surface, same thing.

Daniel Powell [00:05:45]:

So then we all met and got together and we're like, all right, and we looked at the device and we're like, this thing needs to be worn all day long.

Navid Khodaparast [00:05:53]:

It was there because how big it.

Alejandro Covalin [00:05:54]:

Was, it was big because you needed to hold it. And you have this.

Navid Khodaparast [00:05:58]:

Well, you had a, I remember the first device you had, the old ipod.

Alejandro Covalin [00:06:03]:

It was a trucker, the tracker, remember.

Navid Khodaparast [00:06:05]:

The thing for ipods.

Daniel Powell [00:06:06]:

Oh, yeah, yeah.

Alejandro Covalin [00:06:06]:

You had a tracker, you can push the center button, the buttons. Yeah.

Daniel Powell [00:06:10]:

So we determined to move forward with spark. We really needed an ambulatory device. We need something belt worn.

Alejandro Covalin [00:06:16]:

Right.

Daniel Powell [00:06:17]:

We had no money pocket.

Alejandro Covalin [00:06:19]:

Yeah, that was the thing we needed to make. So we needed, we needed, I needed to shrink the entire thing to something. You can just walk around with it, not, not be large. Of course, it's cheaper to make stuff bigger. Yeah. To miniaturize. It cost money. And so that's the main reason why it was so big, because I was.

Alejandro Covalin [00:06:43]:

No, no, the money, spend that money.

Navid Khodaparast [00:06:47]:

The Achilles heel of all startups. You need more money. Money, money, money, money.

Alejandro Covalin [00:06:52]:

So at least we have something to go with. And then we shrunk it. And also the electors, we needed to make electors for the year. That also we went with the without, you know, integrated circuit type of electrode.

Navid Khodaparast [00:07:12]:

Because that's what inspired you. Like, what did you see that was already out there that you said this was not appropriate, or I could do better, or that's good enough.

Alejandro Covalin [00:07:22]:

Well, for the device, it was, you know, make it smaller. It had to be affordable, and you couldn't find something that had, because we needed to have a very small resolution, we needed steps that are where like 0.1 milliamps and devices out there are not set for that. So that we needed to do that, we needed to change. That was a must that brought that.

Daniel Powell [00:07:52]:

In, that and multiple current sources.

Alejandro Covalin [00:07:56]:

You needed a multiple current source. But to make it inexpensive, we needed to play a little bit with probably multiplexing the current into different channels. And so that's how we got that device.

Daniel Powell [00:08:08]:

So we had the first device. Black, little black box, molded plastic.

Alejandro Covalin [00:08:14]:

No, it was 3D printed, or 3D printed. 3D printed nylon.

Navid Khodaparast [00:08:17]:

3D printed, yeah.

Daniel Powell [00:08:18]:

And kind of look at where we are now. The second generation just got approved, but.

Alejandro Covalin [00:08:24]:

I think it was crucial that we didn't overspend in that first device. We knew that it was good enough to test the hypothesis to people to use it. It was safe, but it was probably not for mass adoption. I mean, it was not friendly.

Navid Khodaparast [00:08:44]:

Well, you had to stay within regulation, you had to stay, had to be safe for human use, had to be safe for long term use. Biocompatibility, biocompatibility, electromagnetism, all of these things had to be looked at, right?

Alejandro Covalin [00:08:57]:

I mean, but usability was also looked at, but, but it was not, it was just good enough for what it was needed.

Navid Khodaparast [00:09:05]:

It's one thing to make a device, but it has to be something that can be used clinically for having developed.

Daniel Powell [00:09:10]:

Product as long as we have. There's, you always know, there's iterations, there's learning, and you need to get your first one in the field.

Navid Khodaparast [00:09:16]:

Right.

Alejandro Covalin [00:09:17]:

Well, I think the most important thing to know when you're making a device is that perfection is the enemy of.

Navid Khodaparast [00:09:24]:

Right.

Alejandro Covalin [00:09:25]:

Perfection is the enemy of delivering, basically.

Daniel Powell [00:09:27]:

Yeah.

Alejandro Covalin [00:09:27]:

Right.

Daniel Powell [00:09:28]:

Well, and so we're not done yet. We have. So that we got. Sparrow was the first device. Sparrow ascent, because we're going up. We're going up is our second device has a screen now and then I believe tomorrow you two are testing Sparrow Hawk.

Navid Khodaparast [00:09:45]:

Yeah, Sparrow Hawk.

Alejandro Covalin [00:09:46]:

All in one.

Daniel Powell [00:09:47]:

So an all in one, self contained, no wires, no cables.

Alejandro Covalin [00:09:52]:

They're awesome.

Daniel Powell [00:09:52]:

It's gonna be nice.

Navid Khodaparast [00:09:53]:

Came from military questions, right?

Alejandro Covalin [00:09:56]:

Yeah.

Navid Khodaparast [00:09:57]:

How do you help soldiers on the battlefield that are suffering from ASR, acute stress reaction, but then you can't have a cable, you can't have a controller. They need things that are compact, rugged, fit under a helmet, doesn't interfere with their communications. So we went from just thinking about someone in an impatient to a soldier on a battlefield running around and saving lives. Pretty cool.

Daniel Powell [00:10:21]:

Exciting.

Alejandro Covalin [00:10:22]:

Yeah. But that's, you know, making it smaller and smaller and smaller. It just requires.

Daniel Powell [00:10:27]:

So the evolution continues. We have the compact all in one coming up, and then I'm excited to.

Alejandro Covalin [00:10:34]:

Add sensors to it.

Daniel Powell [00:10:36]:

That's the ultimate goal.

Navid Khodaparast [00:10:37]:

I mean, close loop nerve.

Alejandro Covalin [00:10:39]:

Yeah. You can have a closed loop. Yeah.

Daniel Powell [00:10:41]:

So that project is funded, is moving forward, where we're going to start to be able to measure withdrawal with the system in a closed loop environment.

Navid Khodaparast [00:10:49]:

Yeah. We've always looked at treating, not necessarily looking at diagnosing. Right. Understanding the physiology and then changing the physiology that makes people feel better.

Alejandro Covalin [00:11:02]:

Right.

Navid Khodaparast [00:11:02]:

Right.

Alejandro Covalin [00:11:03]:

Now with this new project, adding the sensors, we don't know yet which is going to be which sensor is going to be the best for us, but that's how. What are we going to study? What signals are we going to be able to use from the body to help us trigger the treatment and keep the treatment to a minimum, because you don't need to overdo it. So the signals from the body will tell us how to stimulate.

Navid Khodaparast [00:11:29]:

Not only that, if you think about it from the standpoint of, for opioid withdrawal, what if you can prevent it?

Alejandro Covalin [00:11:36]:

Right.

Navid Khodaparast [00:11:36]:

Right. What if you can actually, you know, because sometimes people don't really know that they're feeling bad until I'm sweating and I'm not feeling well. A parent or someone tells me hey, you look pale. You okay? But in this case, you may be picking up those physiological signals before you even know that you're having a symptom. And so then you can intervene before. Yeah. So. But I think closed loop is a really.

Alejandro Covalin [00:12:02]:

Oh, it will be really nice.

Navid Khodaparast [00:12:04]:

I can't wait for that.

Alejandro Covalin [00:12:05]:

It would be really nice to have the closed loop system, and it will basically help people not to reach that threshold where they actually feel bad.

Navid Khodaparast [00:12:13]:

Right. Then you remove some of the subjectivity away from just general practice. Doctors look at you and say, tell me how you feel. Instead of just having a report, you can look at a monitor and say, oh, wow, look at. Your heart rate is elevated. This is elevated. That's elevated. Your cortisol is elevated.

Navid Khodaparast [00:12:32]:

You know, and someone's gonna be like, oh, I feel fine.

Alejandro Covalin [00:12:36]:

Yeah, but you might not in the five minutes.

Navid Khodaparast [00:12:38]:

You may not in five minutes.

Alejandro Covalin [00:12:39]:

Right.

Navid Khodaparast [00:12:39]:

You know?

Alejandro Covalin [00:12:40]:

Yeah.

Navid Khodaparast [00:12:41]:

Cardiologists do this now. You know, we should do it ourselves.

Daniel Powell [00:12:44]:

Exciting times ahead.

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