CRIL Tech’s Second Webinar Recap: Deep Dive into Nearshore Manufacturing
We are pleased to share a recap of our latest webinar, which explored nearshore medical device manufacturing strategies specifically for medical device companies. This session provided a focused look at Costa Rica’s unique advantages as a nearshore destination, featuring insights from both government bodies and industry leaders. It is a continuation of our first webinar, which delved into Costa Rica’s thriving medical device industry. Click here to watch the webinar So What We Covered: Understanding Nearshore Manufacturing: tamar Cohen, co-founder and CEO of CRIL Tech, opened the session by explaining the concept of nearshoring—manufacturing closer to your target market rather than in distant locations like Asia. He compared major nearshore destinations (Mexico, the Dominican Republic, and Costa Rica), highlighting why Costa Rica stands out as the optimal choice for companies targeting the U.S. market. Itamar concluded his segment by outlining CRIL Tech’s services: helping companies establish operations in Costa Rica through trusted local partners, handling everything from compliance to logistics. Costa Rica’s Advanced Manufacturing Ecosystem: Marcela Salazar Leitón, Specialist in Advanced Manufacturing at PROCOMER, gave a comprehensive presentation on Costa Rica’s manufacturing landscape. (PROCOMER is Costa Rica’s official government agency for export and investment promotion.) Marcela detailed the impressive growth of Costa Rica’s medical device sector, the presence of global leaders like Medtronic and Johnson & Johnson, and the robust support offered by the Costa Rican government. She also emphasized the country’s political and economic stability, the benefits of Free Trade Zones, and the full suite of services PROCOMER provides to companies investing in Costa Rica. A Manufacturer’s Perspective: Bernal Rodríguez Jiménez, CEO and founder of ITEK, provided a unique insider’s view. Bernal shared his perspective as a 100% Costa Rican manufacturer focused on nearshore production for U.S. clients. He discussed ITEK’s growth story, its full capabilities (from clean room production to stringent quality control), and Bernal also highlighted success stories of international clients who have benefited from ITEK’s end-to-end solutions. ITEK is a close partner of CRIL Tech and is represented exclusively by CRIL Tech in the Israeli market. Key Takeaways: Attendees gained actionable knowledge on: The tangible benefits of nearshoring for medical device companies. Why Costa Rica’s integrated ecosystem offers a competitive edge. Real-world case studies and regulatory insights that de-risk manufacturing investments. At the end of the session, Amir Rokman, Deputy Chief of Mission and Economic Attaché at the Embassy of Israel in Costa Rica, joined the webinar to express his strong support for CRIL Tech’s activities and to highlight the Embassy’s ongoing role in strengthening commercial ties between Israel and Costa Rica. Looking Ahead: This CRIL Tech webinar is part of our ongoing effort to provide expert insights and practical guidance for companies exploring nearshore manufacturing solutions. Our webinar series is designed to provide continuous value as global manufacturing evolves. Stay tuned for upcoming sessions by following CRIL Tech on LinkedIn and subscribing to our newsletter. Missed This Webinar? Click here to watch the recording
IQ, OQ, PQ: Three Critical Stages in Scaling Up to Full Production
When a medical device company transitions from development and prototyping to full scale manufacturing, one of the most critical challenges is ensuring that all processes, equipment, and systems are ready to deliver consistent, safe, and high quality products. At this stage, the three core validation stages IQ, OQ, and PQ, become essential tools. These stages act as structured checkpoints not only for confirming compliance with regulations from authorities like the FDA, but also for minimizing risk, improving efficiency, and ensuring the final product meets all specifications. What Are IQ, OQ, PQ and Why Are They Important in Scaling Production? While IQ, OQ, and PQ are essential whenever new equipment or processes are introduced, they become especially important during scale-up. This phase often involves transitioning from R&D or pilot batches into full production, where validation ensures that the infrastructure is ready to meet regulatory expectations and production goals. During the shift from pilot-scale production to commercial manufacturing, companies must ensure that every part of the production line functions properly, from the installation of equipment to its long term, consistent performance. The IQ/OQ/PQ process provides a structured framework to verify that equipment is installed correctly (IQ), operates as intended (OQ), and consistently performs under real manufacturing conditions (PQ). Each phase builds confidence in the manufacturing process and is crucial for regulatory compliance, internal quality assurance, and long-term operational success. IQ – Installation Qualification IQ is the foundation of the validation process. It confirms that all manufacturing equipment and systems are installed according to design specifications, manufacturer requirements, and regulatory standards. This phase typically includes: Verifying that equipment is located and anchored correctly per the approved layout Confirming all utility connections (e.g., electricity, compressed air, vacuum, water) are properly installed and operational Checking that installation follows cGMP standards and complies with safety and environmental requirements Ensuring all components and materials are correct, complete, and documented Reviewing calibration certificates for instruments, gauges, sensors, and control systems Example: Installing a new cleanroom filling machine and confirming that all connections – electrical, air, and water – are properly made, materials meet cleanroom standards, and documentation is complete. What does IQ verify? IQ verifies the Design Specification – ensuring the system was built and installed as planned. OQ – Operational Qualification OQ focuses on verifying that the equipment and systems operate as expected within predefined operating ranges. It evaluates functionality, safety features, and control capabilities. This phase typically includes: Running equipment at minimum, nominal, and maximum settings to verify reliable performance Validating critical alarms, interlocks, and emergency shutdown systems Simulating fault conditions to assess system responses Confirming automation and control logic (PLCs, HMIs) operate correctly Documenting all test results and deviations Example: Running a packaging machine at different speeds to confirm seal temperature stability, testing alarms and interlocks, and ensuring it stops properly during a fault condition. What does OQ verify? OQ verifies the Functional Specification – confirming the system functions safely and reliably. PQ – Performance Qualification PQ is the final validation stage. It verifies that the equipment consistently produces products that meet quality specifications under actual production conditions. This phase typically includes: Running multiple full-scale production batches (typically three) under routine conditions Sampling and testing finished products for critical quality attributes (CQA) Conducting statistical analysis (e.g., Cpk, PpK) Verifying documentation traceability and batch record completeness Example: Producing three full batches of medical tubing under standard production conditions and confirming that all dimensional, mechanical, and visual specifications are consistently met. What does PQ verify? PQ verifies the User Requirements Specification – proving that the system meets the real world needs of the user. The System Validation Journey CRIL Tech Support At CRIL, we specialize in helping companies scale from early-stage production to full scale manufacturing. Whether setting up new production lines or validating new processes, we work closely with our clients to ensure each step is completed accurately and efficiently – IQ, OQ, or PQ We closely monitor the entire validation journey, from installation to performance runs, ensuring that every requirement is met and documented. Our team works side by side with production, engineering, and quality personnel to address technical issues, streamline testing, and meet regulatory expectations without delays. Our goal is to give our clients peace of mind during the scale up phase – delivering robust validation processes that ensure readiness for commercial success. Planning to launch a new medical device production line? Let’s talk about how CRIL can help you get there.
Understanding Nearshore Manufacturing
In today’s global market, companies are constantly looking for ways to stabilize their operations, improve efficiency, and stay competitive. One strategy gaining momentum is nearshore manufacturing – producing goods closer to the target market instead of relying on distant offshore locations. But why are so many companies making the shift? What is Nearshore Manufacturing?Unlike offshore production (e.g., U.S. companies manufacturing in China or India), nearshoring is the concept of relocating production closer to the company’s interests. For companies targeting the U.S. market, this often means Central America or the Caribbean. The idea is simple: achieve lower costs without the risks of long supply chains, delays, and communication barriers. Why is Nearshoring on the Rise? Recent global disruptions have highlighted the weaknesses of long supply chains. Events like the COVID-19 pandemic and the Suez Canal blockage exposed the risks of relying on faraway production hubs. Nearshoring solves these challenges by offering: Faster delivery & fewer supply chain risks streamline operations and responsiveness to market demands Cost-efficient manufacturing with reduced logistical expenses Easier compliance with U.S. regulations and quality Real-time communication & faster decision-making Costa Rica: A Nearshoring Success Story Some countries have strategically developed nearshore industries to serve major markets more efficiently. Costa Rica is a great example, having built a strong and rapidly growing medical device manufacturing sector that meets U.S. quality standards. In 2023, Costa Rica exported over $8.3 billion worth of products to the U.S., with medical devices making up $5 billion of that total. The medical device sector alone has grown by more than 15% annually since 2014, reflecting the country’s increasing prominence in the global market. Its proximity to the U.S., stable political environment, and attractive tax incentives have made it a top destination for major U.S. manufacturers like Abbott, Medtronic, and Johnson & Johnson, all of which have established production facilities in it. Additionally, Costa Rica benefits from the CAFTA-DR free trade agreement, allowing duty-free exports to the U.S. Is Nearshoring Right for Your Business? For companies looking to expand, cut costs, or improve supply chain resilience, nearshoring is a game-changer. At CRIL Tech, we specialize in helping businesses transition to cost-effective, high-quality nearshore manufacturing. Let us guide you through the process and unlock the full potential of nearshoring. Learn more about our Costa Rica manufacturing solutions