Reshoring medical devices: Compliance challenges

In recent years, the idea of bringing medical device manufacturing back to the United States has gained momentum, driven by tariffs, supply chain disruptions during the COVID-19 pandemic, growing geopolitical tensions, and an increased focus on national security. Supporters argue that reshoring can strengthen domestic supply chains, create jobs, and ensure faster, more reliable access to critical medical technologies.

But the path to reshoring is far from straightforward. The U.S. medical device sector faces significant hurdles, starting with cost. Manufacturing overseas—especially in Asia—has long benefited from lower labor expenses and production costs. Replicating that cost structure domestically is challenging, particularly for high-volume, price-sensitive products.

Skilled labor shortages add another layer of complexity. Many specialized manufacturing roles have shifted abroad over the past two decades, leaving gaps in the domestic workforce. Recruiting, training, and retaining workers with expertise in precision manufacturing, cleanroom operations, and quality control is a major undertaking.

Infrastructure and supply chain dependencies also play a role. Even if assembly is brought back to the U.S., many raw materials, electronic components, and subassemblies are still sourced internationally. Creating a fully domestic supply chain requires significant investment and coordination across multiple industries.

Regulatory and quality requirements further complicate the transition. Medical device manufacturing is tightly regulated, and any shift in production location can trigger new validation processes, inspections, and compliance hurdles that slow timelines and increase costs.

Despite these challenges, momentum for reshoring continues, fueled by tariffs, federal incentives, state-level economic development programs, and rising interest from both public and private sectors. As companies weigh the trade-offs, the key question becomes not just whether to reshore, but how to do it in a way that balances cost, quality, and resilience—while keeping innovation at the forefront.

Medical Economics spoke with Rodney Schutt, president and CEO of Orion Innovations, about reshoring manufacturing to the United States. In this episode, Schutt discusses the compliance challenges of reshoring.