Back in 2019, no one believed we could create even a viable product. Fast forward to 2025, our Esper Hand bionic prosthetic is available across all major US prosthetic clinic chains. We now have 250 users in the US and Ukraine and are preparing to expand further into European markets. Scaling a healthtech product, especially one as complex as a robotic prosthetic, was anything but straightforward. During the last two years, we have managed to scale up in the US market, deal with the medical sphere's bureaucracy, and secure partnerships with clinics.
Why the US market?
The answer is simple: size, consistency, and opportunity.
Over 5.6 million people in the US live with limb loss or limb differences, making it the largest market for prosthetic devices. Unlike the European Union’s fragmented regulations across 27 countries, the US has a standardized regulatory framework, which simplifies scaling.
In the US, prosthetic coverage varies by insurance provider and individual policy. Some plans fully cover advanced prostheses, while others offer partial coverage. Overall, the market offers accessibility for end-users and presents viable growth opportunities for our business.
What was crucial for us was the collaborative mindset of American clinicians and prosthetic centers. They are open to testing new technologies, and actively engage in refining and improving them. This culture of innovation allowed us to fine-tune our product alongside industry experts, ensuring it met real-world needs.
How we entered the market
We knew no one in the US prosthetics field when we started. So, we hit the phones, emails, and LinkedIn hard. Cold outreach isn’t glamorous, but it works. Over time, we built relationships with clinics, prosthetists, and engineers who gave us valuable feedback on our product.
We also leveraged existing networks, such as Ukrainian clinics that had relationships with U.S. specialists, especially those working with veterans. These introductions often led to warm referrals, which were critical in building trust in a tight-knit industry where “everyone knows everyone.”
We realized personal connections were key to scaling. In 2021, we took our first tour in the US, meeting with clinics and prosthetic centers. Over six weeks, we demonstrated our product, gathered feedback, and formed personal relationships. This hands-on approach made a significant impact, as US clinicians value seeing and testing products in person.
Clinics became our strongest allies. They aren’t just distribution points, they’re hubs of expertise and innovation. American specialists are willing to engage at various development stages — providing feedback, testing prototypes, and offering insights. Partnering with clinics like Handspring Prosthetic Clinic gave us access to end users and invaluable insights into the US market.
Key lessons learned
1. Plan for delays
Our biggest challenge? Underestimating the time needed to navigate regulatory and bureaucratic hurdles.
We initially expected trials and certifications to take a couple of months. In reality, they stretched to more than six months due to unforeseen hurdles. From obtaining FDA approval to securing insurance billing codes, each step required months of paperwork, test samples, and follow-ups. Bureaucratic processes are often out of your control, so always build extra time into your roadmap.
2. Collaboration is crucial
The willingness of US clinicians to collaborate was a game-changer. Unlike some markets where only fully polished products are accepted, U.S. partners were eager to provide feedback on early prototypes. This iterative approach allowed us to refine our device to meet their needs better.
3. Relationships drive success
Scaling in the USs is as much about who you know as what you build, so networking is crucial. Personal connections with clinicians, prosthetists, and industry leaders opened doors we couldn’t have accessed otherwise.
4. Be persistent
From cold outreach to multiple rounds of feedback and product demonstrations, breaking into the US market required perseverance. The process is demanding, but the payoff — better product-market fit and a thriving user base — is worth it.
5. Plan meetings ahead
US business culture requires scheduling weeks or months in advance for effective engagement. Planning ahead was key. In the US, meetings are typically scheduled weeks or even months in advance. Without careful coordination, your work can be unsuccessful.
6. Leverage awards and recognition
Americans place high value on industry recognition, awards, and “best of” lists. Being named one of TIME magazine's Best Inventions of 2022 and featured on its cover significantly boosted credibility and opened doors to new connections. Winning the Red Dot Award and CES Innovation Award further established us as leaders in design and innovation. Personal founders’ recognitions like Forbes’ 30 Under 30 in North America and TIME 100 Health strengthened our positioning. Such achievements help gain trust among industry professionals, investors, and potential partners.
With a solid foundation in the US, we’re now preparing for Europe, starting with Germany. As one of the most regulated markets, Germany will test our ability to scale in a fragmented landscape. But with a roadmap in place — including ISO certification and regulatory approvals — we’re confident in our next steps.
