Panel one: commercialising in the US and looking beyond FDA approval

The US medtech market is projected to reach US$666.25 billion by the end of 2026, making the United States one of the largest opportunities for medtech innovators worldwide. Accounting for almost half of the global medtech market, the US offers access to world-leading healthcare providers, significant investment capital, advanced reimbursement pathways and some of the largest commercial opportunities available to growing healthcare companies.

At our recent Medtech Founders Summit, investors, founders and industry leaders came together for a lively discussion on commercialising a medtech business in the US. Moderated by Synthace Chair and Board Director Willem Baralt, we heard from founders on the front line scaling in the US and investors supporting the next generation of healthcare innovation.

Panellists included:

• Carolina Bell, Co-founder and COO, NeuroVirt
• Andrew Cameron, Founder and CEO, FeelTect
• David Van Zuydam, CEO, Head Diagnostics
• Yara Alenaz, Investor, Crane Venture Partners

The conversation covered everything from market readiness and fundraising to FDA approval, reimbursement strategies and the realities of selling into complex US health systems. Here are some of the key takeaways from the discussion.

1. The US offers access to much more than a larger customer base

For many medtech companies, the attraction of the US is not simply its size. While the country accounts for a significant share of the global medtech market, its real value lies in the concentration of world-leading healthcare providers, influential clinicians, investors, strategic acquirers and commercial partners. Expanding into the US gives companies the opportunity to validate their technology within one of the world’s most influential healthcare ecosystems. It can also accelerate both growth and credibility on a global scale.

2. Readiness is defined by market opportunity, not a single milestone

One of the most interesting themes from the panel was that there is no universal definition of being “US-ready”. While regulatory progress, reimbursement planning, funding and pilot customers are all important, market demand is often the deciding factor. As Carolina Bell explained, NeuroVirt was effectively pulled into the US by customers actively seeking innovation. Rather than waiting for the perfect moment, founders should focus on understanding the market early and positioning themselves to capitalise on opportunities as they emerge.

3. FDA approval is essential, but reimbursement drives scale

The panel drew a clear distinction between regulatory approval and commercial success. FDA clearance enables a company to enter the market, but reimbursement often determines whether a product can achieve widespread adoption. Healthcare providers need a clear route to payment, and without one, even approved technologies can struggle to gain traction. The discussion reinforced the importance of considering reimbursement strategy from the earliest stages of product development, rather than treating it as a challenge to address after launch.

4. Success in the US remains a relationship business

Despite the rise of virtual meetings and global connectivity, the consensus was that meaningful relationships are still built in person. Whether engaging with investors, clinicians, hospital systems or commercial partners, a physical presence in the US can significantly improve both the speed and quality of those interactions. Trust remains a critical factor in healthcare purchasing decisions, and founders who spend time on the ground often find it easier to build credibility, shorten sales cycles and create commercial momentum.

5. Hospital adoption takes time, but the rewards can be significant

Selling into US healthcare systems requires patience and persistence. Large hospital networks often involve lengthy procurement processes with input from clinical, technical, legal and compliance teams, making sales cycles of a year or more entirely normal. However, the rewards can be substantial. A successful deployment within one part of a healthcare network can create opportunities across multiple hospitals, making the initial investment of time and effort worthwhile for businesses pursuing long-term growth.

6. Capital is one of the biggest determinants of success

A recurring message throughout the discussion was that US expansion almost always takes longer and costs more than expected. Regulatory requirements, clinical programmes, commercial hiring and market development all place significant demands on resources. Founders were encouraged to think carefully about their funding strategy and ensure they have enough capital not only to enter the market, but also to withstand inevitable delays and maintain momentum. As several panellists noted, being underfunded can be a greater risk than entering the market too early.

7. Ultimately, adoption is the metric that matters most

While regulatory approvals, funding rounds and commercial partnerships are important milestones, the panel repeatedly returned to one central point: adoption is the clearest indicator of success. Investors and customers alike want to see evidence that healthcare providers are willing to use, implement and pay for a product. The companies best positioned for growth are those that can align clinical value, reimbursement, customer demand and commercial execution into a compelling and sustainable business proposition.

Overall, entering the US market is rarely a simple or linear process. The companies most likely to succeed are those that understand the market early, build strong relationships, plan for reimbursement from the outset, and equip themselves with the capital and patience needed to navigate a complex healthcare landscape.

Watch the panel discussion

Missed the session or want to revisit the conversation? Watch the full panel below.

Continue the conversation

This discussion was just one of several sessions at the Medtech Founders Summit exploring the opportunities and challenges facing healthcare innovators today.

Want to see what was covered in Panel Two? Read our key takeaways and highlights from the second discussion here.