Think Commercially from Day One

Mission: Simplify Healthcare Workflow

One of the most important decisions you’ll make as an entrepreneur is selecting the right market. For James, it not only has to be large but also fast-growing and under-served. The LAAO market checks all those boxes. Currently valued at $1.5 billion, it’s projected to double within 2–3 years and quadruple by 2030, with annual procedures growing from 100,000 to 400,000. It’s one of the fastest-growing medical device markets in the world today, growing at more than a 20% CAGR. Boston Scientific’s Watchman dominates this space with a 90% market share, but James sees room for meaningful disruption.

Reflecting on his early days at Conformal, James recalls, “My first week, I had inbound interest from multiple funds and strategics. I kept thinking, ‘What dream scenario did I just fall into?’ This had never happened in my life.”

To accommodate the anticipated growth, procedural efficiency must improve. “We believe that this growth—from 100,000 implants to 400,000—really cannot happen unless the labs become more efficient,” James explains.

Currently, devices like the Watchman require extensive imaging to select one of six device sizes. Procedural imaging is typically performed using transesophageal echocardiography (TEE), an invasive procedure that involves inserting a large probe through the esophagus under general anesthesia. Additionally, the procedure requires a team of three specialists: the implanter, an echocardiographer, and an anesthesiologist.

The Conformal CLAAS AcuFORM system dramatically simplifies this process. With just two device sizes, it eliminates much of the complexity around sizing. Instead of relying on TEE, it uses intracardiac echocardiography (ICE), a less invasive imaging technique performed through the groin with local anesthesia. This approach removes the need for general anesthesia and allows the implanter to handle the procedure alone. “You’ve gone from three physicians to one,” James says.

This streamlined workflow reduces procedural complexity, making LAAO cases more accessible for labs and scalable for the growing market. Today, the CLAAS AcuFORM System is positioned as a practical and innovative alternative to existing solutions, and it was only possible by simplifying every stage of the procedure.

Commercial Thinking From the Beginning

“All my previous CEO roles were at companies either on the verge of commercialization or already commercial. At Conformal, even I had to ask myself—along with the board—why hire a commercial CEO when we’re still three or four years away from being commercial?” James shares.

Here’s the reasoning: Startups often stay too focused on clinical work and don’t prepare for the transition to commercialization. Laying that groundwork early, let’s avoid scrambling later when it’s time to scale. In James’s words, “You can’t afford to be purely clinical, even during trials. Preparing for commercialization early helps avoid a massive shift later.”

A commercial mindset can set your venture up for success in more ways than you may think. For example, James shares that the biggest hurdle to getting a product to market is clinical trial enrollment. Contracting with sites, approving budgets, and setting everything up takes time, but enrollment is the real bottleneck. Convincing physicians to use your device and, just as importantly, helping them educate patients about the process is critical. Patients need to consent to a randomized trial, where they might get your device or a competitor’s, without knowing which in advance. That’s not an easy conversation, and this is where a commercial CEO driving enrollment makes a difference.

Interestingly, James has leveraged the design of the CLAAS AcuFORM system in these types of clinical conversations. Physicians report that its marshmallow-like form makes it more approachable for patients. When patients see it alongside other devices, they often say, "I want the squishy one!"

But having the right people in place is just as important. For example, at Aptus, James learned the hard way that hiring the right sales reps depends on the market strategy. Their product required heavy market development—educating physicians, justifying costs in capped reimbursement categories, and supporting procedures. Initially, he hired reps that were more suited for maintaining existing markets. But soon, James realized the better fit was reps who had experience building markets from scratch. Teaching them technical procedure aspects was far easier than teaching market development skills.

Soft skills, like framing challenges from one’s perspective and communicating them effectively, can be just as critical as the technical expertise a CEO might bring to the table. For example, during the CONFORM IDE trial in early 2024, one of the patients was lost due to the length of the device’s anchoring barbs. In this particular case, the anchors nicked the pulmonary artery, which was unusually close to the appendage. 

The team quickly paused the trial to address the issue. They shortened the anchors and made additional design improvements. However, James says, “The reality is that stopping the trial was an easy decision. The fallout of the decision is what's hard to manage.” 

To ensure transparency, James personally reached out to all 50 trial sites to explain the situation. Not a single site withdrew from the study, and investigators and board members were impressed with the company’s openness and commitment to patient safety. Within eight months, the CONFORM Trial was back on track.

The company restarted enrollments in the CONFORM Trial just prior to the end of 2024 and initiated enrollment in the European GLACE trial in September. The uptake in both trials is robust and the company expects to meet enrollment goals for both trials. All current and future patients randomized to the Conformal in the trials will receive the newly enhanced device, CLAAS AcuFORM.