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Overcome procurement challenges in the US as a foreign medical device manufacturerOvercome procurement challenges in the US as a foreign medical device manufacturer
Strategically navigate through the US’ healthcare purchasing ecosystem with regulatory, supply chain, and market access essentials.
3 Min Read
The procurement of medical devices in the United States presents a uniquely complex challenge for foreign manufacturers, regulatory consultants, and physician-entrepreneurs aiming to introduce innovative technologies into the healthcare system. Characterized by its decentralized structure and stringent regulatory requirements, the US market demands a high level of operational preparedness and strategic alignment across regulatory, logistical, and financial dimensions.
Here we outline critical aspects of navigating US procurement systems and managing the supply chain effectively, from regulatory compliance to the importance of reimbursement and localized infrastructure.
Understanding the US procurement environment
Unlike countries with centralized health systems, the United States operates a fragmented procurement model. Hospitals, private clinics, integrated delivery networks (IDNs), and group purchasing organizations (GPOs) make independent or semi-coordinated purchasing decisions. For global manufacturers unfamiliar with this structure, it can be difficult to identify who the actual buyer is, how decisions are made, and what information is most influential in the selection process.
Regulatory clearance from the FDA, while necessary, does not guarantee market access. Procurement stakeholders typically evaluate a device based not only on its regulatory status but also on its clinical utility, reimbursement pathway, cost-effectiveness, and supply reliability. A product lacking an established billing code or reimbursement structure may face rejection, regardless of technical merit.
The role of regulatory readiness
One of the most underestimated components of procurement success is regulatory infrastructure. US procurement teams expect that devices are supported by a clearly defined compliance framework. This includes a registered US agent (for foreign firms), a designated initial importer, and documentation processes for traceability, post-market surveillance, and adverse event reporting.
While these requirements originate from the FDA, their importance is often felt at the purchasing level. Buyers need to know there is legal accountability in the US for any clinical or operational issues. Lack of clarity around responsibilities can delay a purchasing process, especially in hospital systems with strict internal compliance policies.
Supply chain management: more than just shipping
Effective supply chain management is fundamental to successful device procurement. US healthcare facilities demand high standards for delivery times, inventory accuracy, and transparency. Manufacturers must ensure warehousing, logistics, and tracking mechanisms are aligned with buyer expectations.
Key elements of supply chain readiness include:
Strategic warehousing that allows for timely fulfillment and reduces shipment delays.
Traceability systems for full visibility of inventory, including lot numbers and expiration dates.
Support for consignment models, which are popular in device-heavy specialties.
Responsive service and documentation, especially for customs, recalls, or clinical inquiries.
In addition, invoicing and billing must be optimized for the US context. Hospitals operate under specific payment terms, tax structures, and procurement systems that differ from international models. Misalignment can lead to delayed payments or strained relationships.
Strategic considerations for market entry
For foreign entities, success in the US often hinges on operational credibility as much as clinical performance. Hospitals and procurement teams must have confidence in both the product and the processes that support it, from importation and compliance to fulfillment and invoicing.
Some manufacturers attempt to manage these functions independently, only to find themselves overwhelmed by regulatory and operational requirements. Those who invest in understanding the full procurement lifecycle, including logistics coordination and financial systems integration, are more likely to succeed.
Time and effort are also required to build trust within the US healthcare system. Demonstrating regulatory diligence, supply reliability, and support capabilities is essential to establishing that trust.
Recommendations for stakeholders
- Regulatory consultants: Go beyond submissions. Help clients prepare for reimbursement, logistics, and buyer expectations.
- Physicians with innovative devices: Combine clinical development with early planning for regulatory and operational readiness.
- Manufacturers: Understand the broader procurement landscape. Prepare not only for FDA compliance, but also for how hospitals buy, store, and pay.
The procurement of medical devices in the United States is not just a purchasing function. It is a risk-managed, regulation-sensitive, and logistics-heavy operation. Foreign manufacturers can navigate it by aligning with trusted partners who bring regulatory knowledge, warehousing capacity, and business infrastructure.
Taking a systems-level view of market entry, one that integrates compliance, logistics, and financial operations, can help ensure not just access, but long-term success in the US medical device market.
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