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The medical technology industry has firmly placed nearshoring, or the relocation of production activities to geographically close and culturally similar countries, on its strategic agenda. This has been the case since the coronavirus (SARS-CoV-2) pandemic. Previously, offshoring, or the relocation of production activities to distant regions such as Asia, was the focus. What began as a response to acute supply chain issues has evolved into a structural realignment. Increased quality requirements, stricter regulatory standards, and geopolitical uncertainties have put pressure on the traditional low-cost offshoring model.
This article examines the drivers behind this trend, the criteria for location decisions, and the resulting staffing needs. The implications are significant for both companies and qualified candidates.
The pandemic has ruthlessly exposed the reliance on individual, distant suppliers. Shortages of critical components pushed supply chains to their limits. Since then, many manufacturers have been building regional redundancy and relying on dual sourcing, that is, the strategy of procuring critical components from two independent suppliers to minimize the risk of supply disruptions.
At the same time, regulatory requirements are creating pressure to act. For example, the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Regulation) require consistent UDI (Unique Device Identification) tracking to ensure seamless traceability of medical devices, as well as clear chains of responsibility throughout the entire supply chain. Nearshoring facilitates compliance: Shorter distances, similar legal frameworks, and cultural proximity significantly simplify audits and supplier qualification.
Added to this is the concept of friend-shoring, i.e., the relocation of production activities to politically allied and regulatory-compatible countries. Customs disputes and export restrictions are accelerating this trend. In our consulting practice, we observe that companies increasingly view nearshoring as an investment with a clear ROI logic: lower logistics risks, lower transportation costs, and fewer regulatory compliance gaps.
For European companies, Poland, the Czech Republic, Hungary, and Romania have established themselves as nearshoring regions. These countries offer proximity to the EU market, an MDR-compliant environment, and a well-trained technical workforce that often already has experience in the automotive and electronics industries. High quality and process standards apply in these sectors.
For U.S. companies, Mexico is the leading nearshoring market. The advantages of the USMCA (free trade agreement between the U.S., Mexico, and Canada), established medtech clusters in Baja California and Monterrey, and a growing pool of skilled workers make the country attractive. Other locations, such as Costa Rica, the Dominican Republic, and Puerto Rico, are also becoming increasingly important.
Labor costs are just one factor. Equally important are: infrastructure, meaning the availability of cleanrooms, precision manufacturing, and logistics connectivity; the regulatory environment, specifically access to Notified Bodies, testing organizations accredited by EU authorities, as well as FDA experience and MDSAP compliance; and the local talent pool, all of which are of critical importance. Since process validations following the IQ/OQ/PQ scheme (Installation Qualification/Operational Qualification/Performance Qualification, a three-step process for validating production facilities) and regulatory adjustments cannot be arbitrarily accelerated, the payback periods span several years. The professional literature recommends conducting a regulatory gap analysis before making a location decision.
For job seekers, this means that quality engineers with MDR or FDA expertise, process engineers specializing in validation, and supply chain managers with experience in regulated industries are in particularly high demand in these regions.
Nearshoring creates specific staffing needs that are often underestimated. Five roles are particularly important in this context:
A hybrid model consisting of employees assigned abroad (expatriates) and local professionals is considered the most stable solution for the start-up phase until full operational readiness is achieved. Expatriates transfer the corporate culture and processes, while local professionals ensure long-term integration and market knowledge.
Employee turnover in new markets is an underestimated risk. Talent is highly sought after. To retain it, clear career paths and targeted investments in professional development are necessary. For applicants, these locations offer positions with a great deal of autonomy, though they also involve a steep learning curve and intercultural work in multilingual teams.
The most common mistake: treating nearshoring as purely a cost-saving initiative. Anyone who underestimates the challenges of change management, regulatory transition, and talent development risks project delays, quality issues, and higher non-compliance rates.
Knowledge transfer requires structure. Temporary expert rotations, documented best practices, and joint mock inspections (practice audits to prepare for actual regulatory inspections) are proven methods for transferring quality standards from the main plant to the new location.
Ramp-up times are systematically underestimated. Process validation, FDA registration updates, Notified Body audits, supplier qualification, and staffing all run in parallel. This is particularly critical for high-risk Class IIb and III devices. In addition, there are substantial infrastructure investments: cleanrooms, test equipment, and IT systems for UDI traceability and the QMS (Quality Management System) must be budgeted for in advance.
In our industries, we observe that the most successful companies treat talent strategy, regulatory planning, and site selection as an integrated project. For applicants, the maturity level of a nearshoring location should be assessed before making a commitment. A stable management structure, a clear commitment to investment, and defined processes are reliable indicators of a sustainably attractive location.
Nearshoring medical technology production is not a short-term cost-cutting measure, but rather a location decision with a multi-year horizon. Regionalization in Mexico and Eastern Europe will continue, and investment in these regions will increase. This creates opportunities for more resilient supply chains and specialized career paths.
Three specific recommendations for decision-makers:
First: Establish a realistic timeline from the outset, including validation and regulatory compliance. Second, the talent strategy should be launched in parallel with location planning, and key positions should be filled early on. Third, partnerships with local universities, industry associations, and government agencies should be leveraged to accelerate infrastructure and talent development.
If you are looking for qualified and motivated specialists and executives for your company, we can support you with our specialized network. Targeted access to experienced candidates is crucial, especially when filling key positions in the nearshoring sector of medical technology. For over 15 years, the recruitment consultants at BESTMINDS have been filling vacancies in the medical technology, healthcare, life sciences / pharma, energy / utility, and IT / media sectors with a wealth of expertise and dedication. We find the right candidates for you in a fair, loyal, and discreet manner. Contact us for a no-obligation initial consultation so that we can fill your vacancies promptly and effectively.
