How to Talk About a Technology No One’s Seen Before

How To Get Stakeholder Buy-In When You’re Developing First-of-Its-Kind Technology

For companies developing novel technology or creating an entirely new category, credibility can’t rely on comparisons — because there often aren’t any. 

That was the case for Asensus in 2017–2018, when the company began pivoting from robotic surgery to what it would later define as “performance-guided surgery.” At the time, there were no clear market comps or regulatory frameworks for a digital-first, AI-enabled surgical platform.

“When you have some good technology, you assume it’s going to shine on its own,” Anthony says. “But futuristic technology that’s too early — it doesn’t always work. People don’t know how to receive it.”

Rather than leading with what made the technology radically different, Asensus anchored its platform in what stakeholders already understood. For investors, that meant positioning the digital layer as an extension of robotic surgery — a category with proven commercial models and success stories. “We had to position it differently depending on who the audience was,” Anthony explains. “You might believe digital is the lead actor in the future, but you have to introduce it in a way that makes sense now.”

Internally, the team worked to earn early validation through targeted clinical activity. Even without massive resources, they knew that data would speak louder than vision. “Some companies I’ve seen do this well,” Anthony says. “They run a certain number of patients through, get a couple publications, and show a head-to-head comparison. That exponentially increases your credibility. You’re no longer trying to prove viability — now you’re just proving scalability.”

It was a lesson in sequencing: start with the familiar, introduce the new through context, and build a track record that reduces perceived risk. “You need to connect the dots between what you see in the technology and how others can relate to it,” Anthony says. “That’s how you move to the next phase.”

Navigating FDA — Without Clear Precedent

Securing FDA approval for a first-of-its-kind device often means entering uncharted territory. For Asensus, the regulatory process wasn’t just about submitting data — it was about helping define how their AI-powered digital surgery platform would even be evaluated. “There was no regulatory precedent for what we were building,” Anthony says. “The reviewers were smart and open, but they were figuring it out as we went.”

That lack of precedent meant the company couldn’t rely on standard templates or direct comparisons. Instead, the team initiated a series of in-depth conversations with the FDA to understand their evaluative frameworks and anticipate their questions. “We had multiple dialog sessions,” Anthony recalls. “They asked, ‘Where else is this being used? Can we look to other regulated industries like aviation?’” Those questions signaled an important opportunity: the agency wasn’t rejecting the novel technology — they simply needed a way to assess it.

To close that gap, Asensus reframed its approach. The team leaned on parallels to safety-critical systems in other industries, such as aviation, and anchored their AI models in academically supported frameworks with demonstrated reliability. “We weren’t just saying, ‘Trust us, this works,’” Anthony says. “We showed them that the methods we used had been validated elsewhere — and explained why they were applicable in the surgical setting.”

Just as important was the tone of engagement. Asensus didn’t treat the FDA as a gatekeeper, but as a collaborative partner. “They were transparent about what they needed from us,” Anthony says. “And we made sure to be equally transparent in how we built our models, how we validated them, and why we believed they were safe.”

This two-way exchange paid off. The FDA gained clarity on how to review a new class of digital surgical tools, and Asensus built credibility that would carry into future interactions. “It’s not just about getting to ‘yes,’” Anthony says. “It’s about building a relationship that helps you keep moving forward — especially when you're the first one through the door.”