ENNOVI Expands in Tijuana, Tapping MedTech Nearshoring Boom

SINGAPORE – January 27, 2026 – In a strategic move to bolster North American medical device supply chains, ENNOVI has announced a major expansion of its OCP Tijuana facility in Mexico. The initiative significantly enhances the company's capabilities, positioning it as a crucial partner for medical device original equipment manufacturers (OEMs) seeking to navigate complex regulatory landscapes and optimize logistics through nearshoring.

The expansion focuses on providing comprehensive, end-to-end services, including EU MDR and FDA-compliant labeling, packaging, traceability, and fulfillment for critical medical components. This development comes as the industry grapples with persistent pressures to streamline supply chains, ensure stringent regulatory adherence, and manage costs effectively.

"We're seeing strong demand from medical device OEMs for reliable, cost-effective fulfillment and packaging solutions," said Theron Mackey, Sr. Director of Business Development at ENNOVI. "By leveraging our expertise in cable assembly and wire harness manufacturing, and expanding into finished accessory components and sub-assemblies, we're able to deliver significant value to our customers, whether they're outsourcing for the first time or looking to optimize existing operations."

A Strategic Hub for North American MedTech

The choice to expand in Tijuana is a calculated decision rooted in the region's emergence as a powerhouse for medical device manufacturing. Baja California, and Tijuana in particular, has become the largest hub of medical device manufacturing employment in North America, hosting over 70 companies and more than 55,000 skilled workers in the sector. This dense ecosystem provides a robust foundation of talent and infrastructure that ENNOVI's expansion will tap into.

A critical component of this strategy is the facility's compliance with the United States-Mexico-Canada Agreement (USMCA). This offers a powerful economic advantage, allowing products that meet the agreement's rules of origin to enter the United States with a 0% tariff. For medical device manufacturers, this translates into substantial cost savings and simplified cross-border logistics, creating a compelling alternative to more distant manufacturing centers. The USMCA framework also promotes regulatory alignment and strengthens intellectual property protections, further de-risking the supply chain for high-value medical technology.

By deepening its investment in Mexico, ENNOVI is directly addressing the growing trend of nearshoring among North American OEMs. This strategy aims to build more resilient and responsive supply chains, reducing lead times and mitigating the geopolitical and logistical risks associated with trans-oceanic shipping. The Tijuana location provides unparalleled proximity to major U.S. markets, particularly the medical technology innovation centers in Southern California, facilitating closer collaboration and faster turnaround times.

Navigating the Labyrinth of Global Regulations

Beyond logistics and cost, the expansion is squarely aimed at solving one of the most significant challenges for medical device manufacturers: regulatory compliance. Navigating the intricate requirements of bodies like the U.S. Food and Drug Administration (FDA) and Europe's Medical Device Regulation (EU MDR) is a resource-intensive and high-stakes endeavor.

These regulations impose stringent rules on everything from labeling and packaging to end-to-end device traceability. The EU MDR, for instance, mandates a Unique Device Identification (UDI) system to track every device through its lifecycle, a complex requirement that demands sophisticated data management and fulfillment processes. Failure to comply can result in market access denial, recalls, and significant financial penalties.

ENNOVI’s expanded Tijuana facility is engineered to function as a compliance solution center. As an FDA-registered site, it is certified to critical quality management standards, including ISO 9001:2015 and ISO 13485:2016, the latter being the international standard for medical device quality systems. Adherence to workmanship standards like IPC/WHMA-A-620 further underscores a commitment to medical-grade production. By offering services that are pre-validated to meet these demanding global standards, the company enables OEMs to outsource these critical functions with confidence, reducing their internal regulatory burden and accelerating their time-to-market.

Expanding Value in a Competitive, Growing Market

The strategic investment is backed by powerful market dynamics. The North American medical device market is not only massive, valued at over $200 billion in 2024, but is also projected to grow at a compound annual growth rate (CAGR) of 6.7% through 2032. The specialized logistics and packaging segments are expanding in lockstep, driven by the increasing complexity of medical technology and the paramount importance of patient safety and infection control.

In this thriving but competitive environment—where global giants like Medtronic, Becton Dickinson, and Stryker also have a significant manufacturing presence in Mexico—ENNOVI is differentiating itself by moving up the value chain. The expansion goes beyond the company's established expertise in custom-molded cables and wire harnesses. It now encompasses dock-to-stock fulfillment for a wide range of components, including industry-standard cables, as well as plastic and metal accessories sourced from a global network. This integrated offering transforms the company from a component supplier into a comprehensive solutions partner.

This holistic approach allows OEMs to consolidate vendors and streamline procurement, achieving greater operational efficiency. By handling the critical final steps of labeling, packaging, and fulfillment in a compliant and cost-effective manner, ENNOVI helps its partners focus on their core competencies of research, development, and innovation.

"Our customers trust us to handle the critical components that keep their medical devices running safely and efficiently," Mackey added. "This expansion is about giving them even more reasons to connect with confidence and with ENNOVI."

As the medical device industry continues to evolve, the demand for partners who can deliver on quality, compliance, and cost-efficiency will only intensify. ENNOVI's expanded presence in Tijuana positions it to meet this demand, offering a timely solution that strengthens regional supply chains and supports the next generation of medical innovation.