How to Get a Medical Device Startup Off the Ground: Interview with Asha Parekh, CEO of Front Line Medical Technologies

We recently caught up with Dr. Asha Parekh, a biomedical engineer and the co-founder & CEO of Front Line Medical Technologies, a Canadian medical device startup. Front Line has developed a novel REBOA device that helps trauma patients survive in emergency situations. If you're not familiar, REBOA stands for Resuscitative Endovascular Balloon Occlusion of the Aorta.

In this discussion with Asha, we learn about her medtech journey from early-stage device prototypes to raising venture capital to navigating the global regulatory landscape.

Guest

Dr. Asha Parekh

CEO of Front Line Medical Technologies

Asha has a PhD in biomedical engineering from Western University in Ontario. In 2015, she partnered with Dr. Adam Power, a practicing vascular surgeon, to co-found Front Line, which makes the COBRA-OS device for trauma patients.

Listen to the Interview with Dr. Asha Parekh

Read the Interview with Dr. Asha Parekh

The following interview has been lightly edited for readability.

Asha, welcome to Medsider. Please tell us about your background leading up to your time at Front Line.

I was born in Ottawa and did my PhD in biomedical engineering at Western University in London, Ontario. During a post-doc fellowship with the Medical Innovation Fellowship, I met Dr. Adam Power, who is a practicing vascular surgeon. He’s now my business partner, co-founder, and CMO of Front Line. We started developing the COBRA-OS together and it took off pretty quickly. We both felt very strongly about the impact this device could make, so I jumped into entrepreneurship to get it off the ground and we haven't looked back since.

When you were doing your post-doc work, did you envision getting into medtech or starting a company?

No, it was not planned at all. But the post-doc I completed through the Medical Innovation Fellowship was structured around medical device commercialization. To sum up the program in a sentence, you spend a year trying to engineer new medical devices for unmet clinical needs. That was my first exposure to entrepreneurship.

Can you give us a high-level overview of Front Line’s COBRA-OS device.

The COBRA-OS is a temporary medical device used mostly for trauma in situations where there’s internal bleeding. If somebody has an injury to their hand or their leg, you can apply pressure to it and try to stop the bleeding. But when it's in your torso region, you can't compress the injury to stop the bleeding. So, unfortunately, a lot of those patients bleed out if they’re not in a hospital setting.

The COBRA-OS blocks blood flow above the injury. In essence, you're turning off the tap to the lower limbs and to the injury site. By doing that, you're making sure that your brain and your heart continue to receive blood. Those are the two vital organs that need to maintain function if you are going to survive this type of injury. It’s a bridge therapy, so once the patient gets to a setting with definitive care, you remove the device.

What differentiates your technology from similar devices?

Our primary differentiator comes down to size. You’re putting a device into a relatively small artery and the bigger the device is, it’s more complicated and time-consuming. Similar devices were once called game-changers for getting down to 4 millimeters. We have actually engineered a 4-French device, which is 1.3 to 1.5 millimeters. It’s tiny, and that’s where a lot of the benefits come from. It reduces the steps and overall time to do the procedure, which improves patient outcomes.

Asha, you mentioned working with Dr. Adam Power. Tell us more about how this product idea came about.

As a surgeon, Dr. Power saw the problem firsthand. He saw patients that could have survived, but didn’t due to complications with these kinds of trauma. Adam identified the need, we started working together, and got funding pretty quickly. At that point, I decided to make the leap.

Before getting funding, did you struggle with finding the resources to start prototyping? Tell us a little bit more about those early days at Front Line.

That's the fun stuff. The way we went about it was to ask one fundamental question: if we want to achieve X, Y, and Z, what's the ideal combination to make the best device possible. We started prototyping with things as simple as party balloons and then transitioned to other balloon materials for proof of concept. There were definitely more than a few iterations to get things going, but it didn't take long before we knew we could make this into a working commercial device. Eventually, we needed to level up our prototypes, so we enlisted help from a bigger company.

Raising money for early-stage medtech concepts is extremely tough. You mentioned partnering with a bigger company, so did the initial capital infusion come from the accelerator or did it come from somewhere else?

The initial funding was from a program that was partially funded by a local medical network and then the Canadian government. That provided a runway for the first year before we had to start fundraising. We've received some small government grants, but have privately raised the rest of our funds.

More specifically, we used SAFE agreements for our first raise and then converted those in a follow-up round.

Asha, what are some of the best tips that you've learned raising early-stage medtech money?

We’ve always tried non-dilutive sources of funding. It may seem obvious, but it's surprising to me how many people don't look for non-dilutive funding. In terms of raising a round, when it comes to equity funding, don't settle too quickly. Some founders will try to convince you to settle and perhaps lower your expectations. Sometimes when someone is dangling money in front of you, and you need the money, it can be really tempting even if it's not the terms you want. My best piece of advice is to strive for your terms if you can. That's what we did. We set our terms and drew a line in the sand. It may not always be possible. You may not always get the terms you want, but the harder you try, I think the closer you'll get.

Finally, learn to trust your gut. You likely have some type of intuitive feeling about what you should do. One of the things that we have to do in this world of entrepreneurship is take risks. And learning how to trust your instincts is part of it as well.

The COBRA-OS device recently received Health Canada approval. Can you tell us a little more about your regulatory strategy.

Yes, we received the Health Canada approval and we're very excited. Navigating the regulatory waters was something that was intimidating to me at first because I just didn't know much about it. Initially, I tried to learn everything myself, but then eventually realized I needed to seek out regulatory expertise. It’s important to have a good regulatory expert. One of the critical things was making sure we were not headed down the wrong pathway. Our strategy was to pay more money for that right regulatory consultant to ensure we were taking the right route.

Was Health Canada your first regulatory approval?

Health Canada is our first. As a Canadian company, we were very happy about that. One piece of advice that somebody gave me once was this: where you sell isn't necessarily where you live. I think we oftentimes automatically default to commercialize where we live, but it's not always necessarily the best case. What we've learned is it makes a lot more sense to go to the market where your specific field of application is most relevant.

Most companies at your stage would consider pursuing a 510(k) clearance or some sort of reGogulatory pathway here in the US. Other than being a Canadian company, was there anything else that factored into your decision to pursue an approval in Canada before a CE Mark in Europe or a 510(k) clearance in the US?

The US and Canada regulatory pathways were done in parallel. When it comes to Canada, my business partner is still a practicing surgeon here. So, he can use the devices himself. But, beyond that, our approach was focused on North America first, and then to Europe and beyond.

Asha, let's talk a little bit more about clinical evidence. I know your first-in-human study was published in early 2021. Did you start with animal testing first?

We performed a lot of bench testing in addition to animal studies. We did our first-in-human study pre-market approval under an investigational testing authorization. It wasn't something that we needed for approval, but it was something we wanted because of two things. First, this is a new device and it has features that people haven't seen before. Two, REBOA is an emerging and growing market.

So, yes, we have regulatory approval. But, in terms of scientific and clinical evidence, we wanted to demonstrate how our device works and then broaden the scope to other potential applications.

We have some exciting things in our pipeline. And we have a product that people want and are excited about. By producing clinical evidence, surgeons and other potential end-users wanted to invest in the company, which tells a great story for investors.

A key message that's surfacing is identifying partners early on. If you don't have someone like Dr. Adam Power, who’s a practicing vascular surgeon, it’s important to find other clinicians that have an interest in what you’re building. Partners that can serve in some type of advisory position and potentially help with early data collection.

Definitely. You want to have at least one really good clinical champion. More if you can. I’ve seen medtech startups struggle because they don’t have a key clinical champion who supports them.

It sounds like your team at Front Line is up to some cool things. What are you most excited about over the next one to two years?

First, real-world use cases. For the trauma application, a lot of these patients don't make it to the hospital. It's staggering. Approximately 90% of patients don't make it. Making this device commercially available will be huge. I'm very excited about that because it has the potential for such a big impact.

We also want to get other applications off the ground in the developing world. For example, our device can be used for postpartum hemorrhage, and in some of these countries, maternal deaths are a major, major issue.

There is another application that's related to non-traumatic cardiac arrest. Picture somebody that has a heart attack. Some studies show that if you use a device like ours to block the aorta, followed by CPR, it's 180% more effective. Because you're not pumping blood to the entire body, you're isolating the brain and the heart. There have been human feasibility studies done that are very compelling. So, we’re very, very excited about that. When you think about the number of cardiac arrests worldwide, we believe we can make a big impact.

Asha, let’s transition to some rapid-fire questions. Is there one piece of advice that you'd like to provide to other medtech or healthtech entrepreneurs?

I would say be open-minded and willing to take risks. Adam and I challenge each other a lot, and it pushes us to get out of our comfort zones. I think it’s so important to have an open mind and consider doing something that you normally wouldn't.

Can you recommend any resources, books, or podcasts that you’ve found especially helpful during the early days at Front Line?

I definitely recommend the following books: The Hard Thing About Hard Things, The Lean Startup, Start with Why, Good to Great, and Crossing the Chasm.

I also recently read Seraf Investor. It’s geared towards the investors themselves. But I think that's why I found it so interesting because you get a glimpse into that side of the equation.

Last question, Asha. Starting over, would you do anything differently?

It's going to sound so cliché, but no, because I absolutely love where I am in life right now. I wouldn't change it. I truly wouldn't.

On a personal level, your own happiness and the people you work with are super important. From a business perspective, being passionate about what you're working on is critical. As we talked about already, the team of people behind any company is crucial to success. So, I think the project and people are super important. Choose both wisely.

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