How to Succeed Without Venture Capital

Seek Clinical-Engineering Synergy for Optimal Acceleration

Making decisions with limited information is a reality in medtech. Asha stresses, “Early on, clinical feedback is so important,” and she credits their internal clinical expert, Adam, for the company’s ability to move fast without losing business focus.

"You can’t wait for 100% certainty,” explains Asha. It slows you down. But at the same time, you need enough data to make an informed decision. The point is, if you get caught up in every detail, you’ll never move forward. “If you have somewhere between 40 to 70% confidence, make a move,” Asha says. This mindset draws heavily from surgeons, who frequently make critical decisions in uncertain, high-stakes scenarios. Asha says she’s more of a 70% decision-maker, while Adam leans toward 40%. This balance works for them because they’re aligned on where they want to take the company.

To scale a company successfully, you need this trust and alignment between co-founders. Asha emphasizes, “What is more important than your founding relationship? To be aligned even from those early conversations about that is so, so important.” If you sense disagreement during the early days, it’s a red flag. It’s better to address those issues—or even walk away—than to struggle later. That’s why it’s vital to have those conversations upfront and ensure everyone’s on the same page.

Front Line’s clinician-engineer co-founding team has been a major factor in their success. The duo was able to iterate rapidly, and what made that possible was their ability to get feedback on the spot. For example, if a manufacturing partner couldn’t meet a specific technical specification, Adam would ask, “What can you achieve?” Often, the adjusted spec was clinically sufficient. Thanks to their complementary expertise, they didn’t have to wait weeks for feedback from external clinicians.

For founders without this setup, where in-house expertise isn’t an option, Asha suggests finding ways to get clinicians involved early. “If you don’t have a clinician co-founder, bring them in as close as possible—whether through partnerships, advisory roles, or even as investors.” 

That said, it’s also important to keep operations simple and lean. Fewer partners mean fewer delays. The Front Line team was able to manage as many functions in-house as they could, saving time and cutting costs. To achieve this, you need to be involved across all aspects of the business, just as they were—from quality and regulatory to clinical studies. “We didn’t pretend to be experts in everything, but we made sure we understood enough to make informed decisions and move quickly,” Adam explains. Their motto is, “Don’t trust anyone; do your own homework.”

Your homework also includes listening to feedback. It should be a part of your identity as a CEO, even after the development phase is over. The market itself can reveal unexpected applications for a technology once it’s in use. Front Line’s aortic occlusion device was initially developed for trauma cases, particularly non-compressible bleeding in civilian hospitals. As its use expanded, it proved effective in military settings and, more recently, in managing postpartum hemorrhage. The device's features made it a natural fit for this application, and its adoption spread organically. While Front Line was expanding into Europe, another application came into view: pre-hospital care. Unlike in North America, Europe has a robust system of pre-hospital physicians who started using the device for situations like cardiac arrest, not just for bleeding. This opened up a whole new avenue for its use.

While they didn’t need to pivot, Asha underlines that exploring new applications strengthened Front Line’s position and could provide an essential fallback strategy if market conditions shift for any reason. Reminiscing on how listening to feedback enabled them to find new applications, Asha notes, “When you innovate, especially way back before it hits the market, you only have an idea of what your technology might be able to treat. You often don't realize the different avenues that your technology might be able to take. The eyes do not see what the mind does not know.”

Global Expansion Without Compromise

Front Line first started to commercialize in Canada, with the ambition of going global. “This is where we started, and we want to be global, period,” Asha says. 

“We chose to start in Canada, not just because we’re proud Canadians, but also because of the resources available. As an academic vascular surgeon working at the hospital, I was able to conduct our first clinical study very inexpensively—essentially, I worked for free,” Adam explains. 

Regulatory pathways differ significantly between regions, and understanding these differences is crucial for prioritizing markets. Starting with a CE mark was more popular in the past. But these days, it’s becoming more favorable to begin in the U.S. For example, COBRA-OS is a Class II medical device through the FDA while it’s recognized as a Class III medical device in Europe.

Regulatory approvals in different regions can get you into other markets, too. “FDA approval opens many doors, but CE Mark is still preferred in certain countries,” says Adam. Asha adds, “Health Canada, FDA, and CE Mark are the big three. If you have one of these, it can help you catapult into other markets, though there’s always additional work to do.”

Yet, meeting regulatory requirements isn’t always enough to gain market traction, which is why Front Line has proactively gathered clinical data. “We didn’t need human data for the North American market,” explains Asha, “but we collected it anyway to demonstrate efficacy and support adoption.” This dataset paid off when MDR requirements shifted, and clinical data became necessary for European approval. Asha reflects, “It’s always worth considering what evidence the market wants to see, not just what regulators require. That foresight can make all the difference.”

Canada has become an increasingly popular option for early-stage clinical studies due to its smoother Investigational Testing Authorization (ITA) process. “ITA is much simpler than an IDE in the U.S.,” says Adam, “If you get Research Ethics Board approval at your institution and meet the criteria, the process is very straightforward. It’s faster, cheaper, and helps you get data to move forward.” Canada’s clinical infrastructure also offers cost-effective options, with busy academic institutions often able to recruit patients quickly. “Finding quicker, less expensive pathways to collect data can make a big difference,” Asha says.

Lastly, Adam and Asha touch on their pricing strategy in the global market, an aspect that many medtech startups wrestle with, especially for cutting-edge technologies. Adam notes, “The market will often tell you what it needs. Stay open to feedback, and don’t lock yourself into a rigid plan.” Asha and Adam knew they could price higher, thanks to their superior technology. But making a profit out of fewer uses doesn’t help patients. “At the end of all this, we won’t be proud of our bank balance. We’ll be proud of the patients it helps,” says Adam. That’s why they decided to keep COBRA-OS’s price lower and aim for deeper reach in the global market.