For medical device startups and OEMs in Europe and Asia, the United States has always been an important destination. But in 2026, the strategy for entering the U.S. market is shifting.
New geopolitical trade uncertainties and widening regulatory disparities have flipped the script. It is no longer always cost-effective to design in Europe, manufacture in Asia, and ship to America. Today, the smartest path to the ~$200 billion US healthcare market is to build a foundation directly on American soil.
At Kapstone Medical, we understand the real challenges of getting new devices to market—and we are seeing the economics fundamentally shift to favor domestic manufacturing in the United States.
For decades, the "low-cost labor" narrative drove manufacturing to regions like China, India, or Eastern Europe. However, that model ignores the total cost of ownership in a volatile trade environment.
As of 2026, we are witnessing a shift toward risk mitigation that accounts for scenarios like "Universal Baseline" tariffs and "Reciprocal Tariffs." When you layer logistics, shipping delays, and a tariff burden ranging from 10% to 54% (depending on origin) on top of your unit cost, the margin from foreign labor is significantly eroded.
References: Internal Scenario Model based on USTR Section 301 & Tax Foundation analysis of trade proposals
The Reality Check: Based on current projected impact models, domestic manufacturing with a partner like Kapstone may be the lowest total landed cost option.
By establishing production with an ISO 13485-certified manufacturing partner in the US, you protect your business case from trade uncertainties.
Time is the other variable to consider. In the medical device world, time waiting for regulatory review means that more cash is burned in the business before revenue can be made.
The transition to the European Union’s Medical Device Regulation (MDR) has created a certification bottleneck that is slowing innovation. Industry surveys and feedback indicate that obtaining MDR certification can now take 18 months or longer. For a startup burning cash, that delay can be life threatening to your business.
Contrast this with the FDA: While rigorous, the US FDA 510(k) pathway remains predictable. A typical review period for a 510(k) clearance is approximately 5 months (based on MDUFA performance goals and industry averages).
The Strategy: By prioritizing a US launch first in this scenario, you may be able to generate revenue 12+ months faster than your competitors waiting in the EU queue. You can then use that US revenue to fund your eventual European expansion.
The biggest mistake we see startups make is to settle for fragmented partners and supply chain. They may hire a boutique design firm for the concept, a separate regulatory consultant for the paperwork, and a large contract manufacturer (CM) for production.
Here is why that fails:
The Kapstone Difference: Kapstone Medical was built to solve the problem of fragmentation. We are not just engineers, and we are not just a factory. We are an integrated commercialization partner.
The barriers to entry such as tariffs and regulations are higher than ever, but so is the reward. The US market has continued to grow year over year.
Don't let your margins disappear in customs, and don’t let a lengthy regulatory approval delay profitability. Partner with Kapstone Medical. Together, we can find the most direct and cost-effective path to US market success.