Company Building Starts with Discipline

Why Fast Isn’t Always Best in Medtech

Howard’s “go slow to go fast” philosophy runs counter to typical startup urgency, but it’s grounded in the realities of medtech. In a field where rushing can lead to regulatory missteps, product-market mismatches, or failed adoption, a thoughtful upfront strategy is often the quickest path to a successful launch.

At Evident, that mindset shaped three foundational decisions:

1. Validate the Market First, Then Build the Product

Evident began not by designing a device, but by deeply understanding the problem. “We really spent our time from the ground up assessing the market,” Howard says. “Just doing all the basic things you need to come up with a unique design that’s differentiated.”

That meant an entire year of voice-of-customer work — not just asking what physicians wanted but digging into why existing solutions fell short. Starting from a loose concept, the team validated every assumption before committing resources. The result: clear alignment around the one problem no company had solved — delivering both image quality and ease of use in IVUS.

2. More Than Advisors: KOLs as Cultural Architects

Howard also approached building an advisory board with unusual intentionality. Rather than stacking the deck with obvious names, he curated a cross-specialty group that reflected the realities of peripheral vascular care — interventional radiologists, interventional cardiologists, and vascular surgeons — from diverse practice settings.

But what really made the difference: how early and directly those KOLs engaged with the team. “Before we even moved in here — when there were just a couple of us — I had each physician come in and talk to the team,” Howard says. “About their cases, about IVUS, and why a better solution is so important.”

That early exposure created what Howard calls a “foundational aspect of our culture.” These advisors weren’t just opinion-givers — they were mission-shapers.

3. Discipline Over Features: Defending the First-Gen Product

The third pillar of Evident’s approach: ruthless focus. From the start, Howard and his co-founders Danielo Piazza and Patrick Phillips, enforced strict guardrails on the company’s first-generation product. “With software and other bells and whistles, it’s very easy to have scope creep,” he says. “I started saying no as a complete sentence.”

And it wasn’t just engineers pushing new ideas — even their scientific advisory board brought big visions. Rather than squash innovation, Howard redirected it: “Yes, we can do these things — but not in the first gen. Let’s build a real pipeline, and we’ll get there. But we must stay maniacally focused.”

That same discipline extends to commercial planning. Despite his background in sales and marketing, Howard is resisting the urge to scale quickly. “There’s nothing like being in the lab the first time. And with this kind of technology, we’re going to be very methodical about where we go before we scale.” Because, as Howard confirms, “how a product performs in a clinical study is very different than how it performs in a commercial environment.”

De-Risk Early: Submission Isn’t Where the Journey Begins

The same discipline that guided Evident’s product development carried through to its regulatory strategy. On paper, Evident’s pathway is well understood from contemporary FDA guidance: a predicate-based 510(k) clearance with no clinical trials required. But Howard knows from experience that “well understood” doesn’t mean risk-free.

“We’ve had numerous presubs, and we have more ahead of us before we submit,” he says. The goal isn’t just box-checking — it’s relationship-building. Howard learned from past companies that regular FDA engagement is essential, regardless of how familiar the regulatory path may seem. “Whether it’s a modular PMA or not, to me, you’re constantly talking to FDA along your journey. FDA wants you to talk to them.”

That mindset reflects Howard’s commercial background: relationships matter more than transactions. “You don’t want to submit something that’s not fully ready for them to receive,” he says. He likens it to cold calling — showing up with no context or trust.

 This goes against the usual thinking that a predicate-based 510(k) doesn’t require much interaction. Howard sees that as a missed chance to de-risk. For him, it’s simple: your first submission isn’t the time to take risks. “I don’t think there’s room for creativity there,” he adds. “It may sound conservative, but you want to de-risk as much as you can with the resources you have.”

The benefits are both strategic and practical. Early and frequent engagement with FDA has given Evident clarity on expectations, reducing the chances of costly delays or unexpected requirements. “It actually saves FDA time as well,” Howard notes.

More broadly, this regulatory strategy mirrors Howard’s company-building philosophy: build trust early, then leverage it for more ambitious goals. For a startup preparing its first submission while developing a pipeline of future applications, establishing that foundation with FDA could be a critical long-term advantage.

Multiple pre-submission meetings also serve as a form of market validation, ensuring Evident’s regulatory interpretation aligns with FDA expectations. In a space where larger incumbents often have longstanding agency relationships, that kind of proactive engagement helps level the playing field — and can become a strategic asset.