Why Great Data Isn’t Enough to Drive Adoption

Building for the Real World: A Pragmatic Approach to Commercialization

For Adagio Medical, great clinical data is just the beginning. True commercialization success, as Todd sees it, depends on a grounded understanding of where procedures are performed, who interacts with the device — and how reimbursement will actually work.

“You have to think about where the procedures are being done,” he says. “If you’re launching a product like ours for VT ablation, you need to know that it’s a highly complex procedure — not every hospital does it. That impacts how you build your limited launch.” Rather than scaling quickly, once approved, the company plans to take a focused approach: identifying specialized centers that perform higher volumes and tailoring support accordingly. “For a technology like ours, we need to look at both high- and lower-volume sites because patients get care where they live. You have to serve both ends of the market.”

But setting up a thoughtful limited launch is only part of the equation. Equally important is usability — and making sure the product fits into real-world workflows. “Just because you have strong data doesn’t mean people will use the device,” Todd says. “If setup takes too long or the techs and nurses find it frustrating, the physician may walk in and be told, ‘We can set that up if you wait 15 minutes.’ That’s a killer.”

Designing for ease of use isn't just about efficiency — it's also about user experience. “We have to help patients, absolutely,” he says. “But we also have to delight the customer. If your product feels like a rotary phone when the world is using smartphones, people won’t reach for it.” For Todd, that means building a system intuitive enough to be set up by rotating teams, not just specialized staff.

Reimbursement is another critical piece of the commercialization puzzle. “You have to ask: who’s paying for this? How does it get reimbursed? Does it tuck into existing codes or have a pathway for new ones?” Breakthrough designation from the FDA was a major milestone — and not just for regulatory reasons. “Breakthrough isn’t just a badge. It could eventually open the door for better reimbursement, and that’s something hospitals really care about.”

Ultimately, the strategy is about focus and fit. “Don’t try to be good at 100 things. Be great at one or two,” Todd says. “Understand your product-market fit. Know why a hospital will buy your product — not in theory, but in practice. If the rep isn’t there, will they still pull it off the shelf?” At Adagio, that question is at the heart of every go-to-market decision.

Use Breakthrough Designation Strategically — Not Just Symbolically

When it comes to clinical and regulatory strategy, Todd’s message is clear: reverse-engineer your pathway based on the problem you’re solving — not just what your technology can do. Too often, startups pursue broad indications or crowded markets like atrial fibrillation simply because they’re large, without fully considering how entrenched the competition is or whether their approach adds unique value. “You can’t just say, ‘we’re going after A-Fib’ if the market is already saturated and your tech doesn’t offer something meaningfully better,” Todd explains.

Although Adagio’s technology could also treat A-Fib, that mindset led the team to focus on VT — a condition with high unmet need, where ablation has historically been a second-line therapy due to limitations in existing tools. With data suggesting that VT ablation could become a first-line treatment, Todd and his team built their clinical strategy around where they could make the biggest impact. “We had the only purpose-built catheter for VT. That’s where we knew we could win — not by trying to retrofit a product for a larger but crowded space.”

This laser focus shaped everything: regulatory planning, clinical trial design, and even capital deployment. The U.S. pivotal study mirrors the earlier European trial, but with more patients, consistent inclusion criteria, and endpoints chosen to support the company’s claim. Adagio also secured breakthrough designation, which Todd views as both a validation of clinical novelty and a strategic lever. “It’s not just a badge — it’s a pathway that could give us reimbursement advantages down the line,” he notes. That kind of foresight — linking regulatory strategy to potential economic benefit — is essential in today’s resource-constrained environment.

Bottom line: don’t let ambition dilute your advantage. Know where your product performs best, anchor your clinical pathway to that opportunity, and resist the temptation to chase bigger but less winnable markets.