Building Adoption Into the Design of Your Device
Interview with TRiCares CEO Ahmed Elmouelhi
Key Learnings From Ahmed's Experience
Adoption is the ultimate measure of innovation. The best device isn’t the one with the most features — it’s the one the whole care team can use with confidence. TRiCares iterated its Topaz system a dozen times, not to add complexity, but to make the procedure faster, smoother, and easier for everyone in the room. A focus on the core implant helped them prioritize what truly mattered for lasting adoption.
Managing trials means managing people, not just protocols. Multi-continent trials can overwhelm even well-capitalized startups. For Ahmed, progress came from two things: local teams close to the sites, and a small core of physician champions who carried the study forward. These “10X physicians” turned regulatory deadlines into momentum, showing that a critical mass of believers is more valuable than trying to win everyone at once.
Effective boards work in the sandbox, not the spotlight. The healthiest boards are about engagement, rather than ‘convincing’ members of a pre-determined route. Ahmed’s “sandbox approach” invites directors to build solutions alongside the company instead of judging finished plans. That requires transparency — with both successes and problems — and alignment across all investors.
In Formula One racing, the fastest drivers follow a counterintuitive principle: slow is smooth, and smooth is fast. The idea is simple — focus on fluid execution rather than raw speed, and velocity follows naturally.
Ahmed Elmouelhi has built his career on the same philosophy. The TRiCares CEO and 20-year medtech veteran uses this framework to guide everything from product development to clinical strategy. "Speed alone is never the goal," he says. "The goal is to be smooth."
That mindset shaped his approach when physician partners convinced him to leave AtriCure and take the helm at TRiCares, a company developing Topaz, the first purpose-built, minimally invasive transcatheter tricuspid valve replacement system. The tricuspid valve sits on the right side of the heart, controlling blood flow between the right atrium and ventricle — a fundamentally different environment from the more commonly treated mitral valve on the left side. While many companies have adapted existing mitral valve technologies for tricuspid use, TRiCares chose to build from the ground up.
Guest
CEO of TRiCares
Ahmed joined TRiCares in March 2024 after serving as SVP of Product Marketing, Strategy, and Business Development at AtriCure, where he established Left Atrial Appendage (LAA) therapies and built two business franchises. Earlier in his career, Ahmed held leadership roles at Medtronic’s Structural Heart division and AGA Medical (now Abbott Laboratories), helping launch multiple TAVR systems, congenital heart defect treatments, and percutaneous LAA devices. He also serves as Chairman of the American Heart Association in Minnesota.
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Build Standard-of-Care Devices by Designing for Adoption
Ahmed learned one of his most important product development lessons earlier in his career when pitching to potential strategic acquirers. The team had built an ambitious product roadmap — multiple device components and sizes bundled into a single system — assuming breadth would impress buyers.
Instead, the strategics bluntly redirected their focus: "It's the valve — stupid."
The takeaway was clear: rather than trying to build everything at once, concentrate resources on perfecting the one critical component that would stay with patients for life.
That philosophy guided the design and development of TRiCares’ Topaz valve system — a transcatheter tricuspid valve replacement designed specifically for the right side of the heart. Inserted through the femoral vein, Topaz replaces the native valve with a soft, conformable prosthesis that adapts to the highly variable tricuspid anatomy. Getting to that point required persistence: the team went through 12 to 15 design iterations before arriving at today’s configuration.
Equally important was ensuring the procedure didn’t add new complexity. “Typically, when we go to our cases, physicians are bracing themselves for a whole day procedure,” Ahmed recalls. “And 30 minutes later, we’re in the conference room saying, ‘That patient should get a lot of relief. What do we do with the rest of the day?’”
The impact extended beyond speed. Traditional tricuspid interventions rely heavily on echocardiographers, who can spend hours guiding valve placement. Ahmed worried simplifying the process might alienate them: “I thought I’m going to meet the echocardiographer, and they’re going to be upset at me because I’m taking their job away.”
Instead, the opposite happened. One echocardiographer told him after a case, “We’ve been overworked in these procedures, and now it’s reasonable. People aren’t looking at us to be the only decision makers in the room. We’re part of the team and we’re being utilized at the right level.”
For Ahmed, that experience reinforces a broader truth: innovation doesn’t have to mean more complexity. “If you want to build the standard of care, it’s got to be something where the physician can line up five cases in a day and treat them successfully and not have that totally overturn their schedule,” he says. “Everybody has to be able to participate in the case in a way that makes sense for them.”
Clinical Success Depends on Champions, Not Just Resources
Managing studies across continents is what Ahmed calls “punching above your weight class.” TRiCares is running an early feasibility study in the U.S., a 70-patient CE-mark trial in Europe, and preparing for a pivotal U.S. IDE — an aggressive strategy for a company of its size.
According to Ahmed, two things have made this possible. The first is local presence: having people on the ground who can visit centers, guide investigators, and keep studies moving day to day. The second — and even more important — is physician champions. “If you have two or three champions, true champions of the technology, that study will be successful,” he explains. “It doesn’t have to be everybody. A small critical mass can make all the difference.”
That dynamic was on display when the FDA requested an accelerated timeline for TRiCares’ U.S. study. “They said, ‘We need to get on the phone within 24 hours,’” Ahmed recalls. “Within 24 hours, we had physician champions on the line, had a wonderful conversation, and came out with exactly what’s going to work great for the physicians, the patients, and the study.”
Ahmed compares this impact to having a “10X engineer” on a startup team. Certain physicians act as accelerators and connectors, making it possible to align regulators, investigators, and company teams at remarkable speed. Without those champions, progress slows to a crawl no matter how much funding or staffing you throw at a study.
Equally important is recognizing the ecosystem around cardiovascular innovation. Experienced trial leaders, advisors, and local partners often step in with guidance that saves months of missteps. “You could try that,” Ahmed notes, “which is usually code for ‘maybe not the best idea,’ but they’ll also suggest better paths forward. Having those voices in the room makes a huge difference.”
Let Boards Play in the Sandbox With You
Ahmed’s philosophy on working with investors mirrors his product development strategy — focus on collaboration rather than persuasion. “You have to be on the same side of the table as your board,” he says. “You can’t be trying to sell them on something.”
Instead of arriving with finished solutions, Ahmed comes to the boardroom with problems to solve. “If I go in with an assumption of what I want on the other end, that’s never as successful as if I go in with a problem that I’m trying to solve, and we literally work through it together.” He calls this the “sandbox” approach — letting board members participate in shaping solutions rather than just reviewing them.
This method requires a different kind of preparation. Instead of crafting the perfect pitch, Ahmed focuses on transparent problem-solving. “Nobody wants to see the final product,” he explains. “What everybody really wants is to be in the sandbox. Let’s build it together.”
That openness demands maturity from both sides. Board members need the discipline to “delay judgment and see the sausage being made without having an instant reaction.” CEOs need the confidence to expose problems early and accept input that may alter their preferred path.
Ahmed extends this same philosophy to fundraising. “Investors love transparency. They want to be partners. They’re already well-informed (from past experiences) about everything that you’re going to tell them. Put the truth forward, they’re going to find it anyway.” In his view, transparency is what separates a transactional board from a durable partnership.
He also stresses the importance of alignment among investors themselves. “It’s not just the new investor, but how they relate and how their outlook is relative to the people you already have on the board,” he says. A misaligned group of smart, capable investors can create dysfunction that stalls even the strongest companies.
For Ahmed, the ultimate test of board health isn’t valuation or terms, but whether directors can sit on the same side of the table and work through challenges together. “It’s a two-way interview,” he says. “You’re choosing long-term partners, not just capital.”
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