Move Fast Early, Slow Down When It Counts

Lay the Groundwork for Success

Running a medtech startup is a huge undertaking. Timelines often stretch over a decade, and the resources required are intense. One of the foundational steps, Steffen explains, is ensuring the market opportunity is large enough to justify the commitment. “If the problem you’re trying to solve isn’t really big enough to be attractive, it will be really hard to raise capital,” he notes. In any startup—and especially in medtech—it’s essential to make sure that solving this problem truly matters. Steffen suggests asking yourself, “What happens if you don’t solve it? Will the world really be in a worse place?”

Once you validate the market need, getting the right people involved early on can help pave a smoother path forward. “Having that nice balance between somebody with the external customer perspective and somebody who thinks about the technology, being able to marry that up early on, I think will minimize the number of stumbling blocks that you will come across,” he shares. Bringing in industry experts—particularly physicians—on board from the start provides invaluable, real-world insights and adds credibility as the product eventually reaches other stakeholders. 

“The world is big, but it’s very small at the same time,” Steffen notes. A handful of key stakeholders often form the core opinion pool in a field. When you have relationships with these insiders, he adds, “Whoever checks into your idea, they will go to those people.” And having these people on your side makes gaining traction easier when it’s needed most.

Of course, none of this matters without a solid technical foundation. From his experience at Neuspera, Steffen knows that proving the technology works is essential. Having a founder or lead engineer who can take charge of technical validation is invaluable. “The work that our founder did with the fundamentals was just amazing,” Steffen shares. And that solid foundation is exactly what he’s building on today.

Get the Pacing Right 

One of Steffen’s main takeaways is understanding and committing to the time medical device innovation takes, especially the clinical and regulatory pathways. Medical device companies, particularly those with Class III products like Neuspera, have to contend with long timelines and extensive regulatory scrutiny. “Accept the time it takes,” Steffen emphasizes.

In the early technology development phase, moving quickly is paramount. During this stage, you can experiment, iterate, and even fail fast to arrive at a working product. However, once the clinical and regulatory processes come into play, the pace needs to change. “Be thoughtful, be cautious when you get into the clinical work and when you get into the regulatory work,” he explains. This stage isn’t one where you can “move fast and break things.” For Steffen, rushing to hit milestones is a mistake; instead, he focuses on maximizing value during the maturity process as the milestones approach.

Steffen also suggests thinking about market access as early as possible because decisions made during the development and clinical phases can impact commercialization down the line. “You might actually be able to capture information during the clinical trial that can either help you or make your market access more complicated,” he advises. Bring in the right specialists early on for coding, coverage, and payment mapping.

Once regulatory milestones are achieved, in Steffen’s words, “Prepare to accelerate on the back end.”

One of the most effective ways to approach regulatory work thoughtfully is by engaging with  FDA from a relationship-building perspective rather than treating the process as a checklist to complete. Understanding their concerns and engaging them proactively—rather than skipping steps in hopes of moving faster—is the best strategy. This way, you lay a strong foundation, which can smooth out future interactions with the agency. 

While specialized consultants can play a valuable role, Steffen advocates for developing internal teams in regulatory and clinical areas rather than relying solely on external help. With a core team that understands both the product and the clinical challenges it addresses, a company can present itself more confidently and navigate regulatory and clinical hurdles with consistency and depth.