Meeting highlights:

• Entrepreneurial Evolution: Bernal transitioned from electronics to MedTech in 2009, becoming an entrepreneur a few years later.
• The start of ITEK: His vision brought SMEs into Costa Rica’s booming MedTech ecosystem.
• Customer-Driven Manufacturing: ITEK evolved to serve the needs of both start-ups and SMEs, offering flexible manufacturing solutions that scale with the market.
• Pioneering Nearshoring: Before it became a trend, ITEK implemented nearshoring strategies to better serve clients.
• Expanding Horizons: With a forward-looking mindset, ITEK is exploring new opportunities in markets like the Dominican Republic.
• Relationship-First Approach: ITEK values long-term partnerships over transactions, maintaining high standards and trust with every client.
• People & Culture: The company fosters a strong internal culture focused on talent availability, development, and retention.
• Leadership & Vision: Guided by resilient leadership, ITEK navigates market uncertainty with agility and a commitment to innovation in care.

EF: You have a strong career in the sector. How has the life sciences and medical technology sector demonstrated resilience, and why is it important to keep investing in health?

BR: Medical devices and life sciences technologies are essential. Globally, we have seen how investments in these areas contribute to increased life expectancy and improve humanity's overall well-being. From the earliest breakthroughs like vaccines to today’s advanced therapies, medical technology continues transforming how we prevent, manage, and treat disease.

Investing in this sector has consistently proven to be of great value. Life sciences and medical technologies are among the most resilient industries and are almost recession-proof.

Speaking from years of experience in manufacturing, we have seen that demand remains steady even in times of global crisis. For example, one of our strongest growth years in Costa Rica was 2020, right in the middle of the pandemic. The same was true for many medical tech companies. It was a record year. While much of the world stopped, we were operating at full capacity. Why? Because critical care cannot be paused. Patients still need treatment. Emergencies continue. Non-elective surgeries cannot be postponed.

This is an industry that not only endures but also drives innovation. Every few years, we see the emergence of a new device that reshapes care for a particular condition. That continuous innovation cycle is why this field has shown remarkable, sustained growth.

EF: Could you share about the opportunity you saw in the market and how that led to the beginning of your journey with ITEK?

BR: After several decades in manufacturing, I began my career in the electronics sector, which was booming in Costa Rica at that time. I joined Intel when they established their facility in the late 1990s and gained valuable experience. In 2009, I transitioned to the medical device industry, which was experiencing significant growth, especially after Boston Scientific set up operations in Costa Rica. I saw great potential in the sector.

After a few years, I started my MedTech journey at Boston Scientific. I moved on to lead a greenfield project as General Manager for MicroVention, now part of Terumo Neuro. I managed the operations and growth of that facility for its first three years. During this period, I repeated the experience with two other companies, launching two additional greenfield projects in Costa Rica within a similar timeframe.

This gave me a front-row seat to the dynamic growth of the MedTech industry in Costa Rica. Over time, I noticed the sector’s shift toward specialization in startups. As the medical device market expanded, new demands emerged.

In late 2015, I decided to act on one of my ideas. I left my position to reflect and ultimately pursued this new direction. At that point, Costa Rica attracted large OEMs, particularly those interested in medium to large operations. However, smaller companies, especially from the United States, were not leaping due to the investment and local barriers.

ITEK was founded to address this gap. We built a fully integrated operation with all core functions in place: engineering, quality, production, and supply chain. We designed and built our cleanrooms, allowing clients to transfer their processes without establishing any facility, legal entity, or support infrastructure in Costa Rica. They can remain at their headquarters in New England, California, or Minnesota and trust us to manage the operation. We operate similarly to a contract manufacturer but with a closer relationship, greater visibility, and more control for the customer. Most of them view our cleanroom as an extension of their manufacturing footprint. They have full access to data and operations but without the burden of managing a facility.

We offer a single, all-inclusive rate tailored to their process's size and complexity. This allows even small OEMs and startups to tell their customers, "We manufacture in Costa Rica," without building a physical presence here.

In recent years, we have even attracted early-stage companies that skip in-house manufacturing altogether. These startups maintain small teams in the United States and focus on design, regulatory, and commercial activities, while we take care of the manufacturing.

That is how ITEK came to life. Eight years in, the results have been strong. Our growth has closely mirrored the broader MedTech sector in Costa Rica. What began as a hypothesis has proven to address a real market need, and demand for our model continues to grow.

We were doing nearshoring in many ways before it became a common term. Now, of course, we embrace that language in our marketing. ITEK is a nearshoring, manufacturing-as-a-service platform, purpose-built for MedTech companies seeking speed, scalability, and operational simplicity in Costa Rica.

EF: Could you elaborate on your current priorities?

BR: Over the past year, everyone’s crystal balls have shattered. No one truly knows what is coming next. However, we must maintain a strategic vision.

In our case, one of the key priorities has been to grow the part of our business that supports small OEMs and startups, allowing us to manage their full product life cycle. We have been investing in the right technologies to support Product Lifecycle Management (PLM) and design controls, ensuring they are fully integrated into our quality management system.

From day one, ITEK was built on a strong technology foundation. We are fully cloud-based and use digital tools daily to stay agile, efficient, and cost-effective. This helps us keep overheads low and deliver value to our customers without adding unnecessary costs.

In parallel, we are also focused on physical growth. We are not afraid to make bold decisions to expand. We strongly believe that nearshoring is not just a trend but a long-term shift, and that momentum is unlikely to reverse. As a result, we are strengthening the organization both technologically and operationally to serve more sophisticated customers, especially those seeking design and life cycle management capabilities.

EF: How do you work with your partners to build trust and position yourself as their long-term collaborator?

BR: We believe in more than just the transactional, relationship-based model that CDMOs have. Instead, we aim to get closer to our customers. Many of our customers view our cleanroom as an extension of their own. For smaller OEMs, which I refer to as "virtual OEMs," we are their entire team.

They can come and go as needed, always having access to our data. This transparency is critical for building trust. We make it clear in our value proposition that we focus on relationships, not transactions. A typical customer of ours stays with us for many years. For example, our longest-standing customer is approaching eight years, while the second oldest has been with us for six years. Our relationships are built for the long term, and we approach every situation and negotiation with a win-win mindset.

Each customer’s testimonial serves as a foundation for the next, helping to establish a higher level of comfort for new clients. If they can speak with an existing customer or see our work firsthand, it builds confidence in what we do. When customers visit us for the first time, they often comment on the atmosphere in our facility—how our employees' demeanor, body language, and enthusiasm are evident. It is not something we plan or rehearse, but it is noticeable to visitors.

EF: Given that each customer has specific requirements, how do you handle their diverse needs? How do you balance catering to all of these unique needs?

BR: It is a balancing act. We have refined our processes over time, many of which have been shaped by previous customer requirements. As a learning organization, we adapt to each request. If a customer needs data presented in a specific way or prefers a certain manufacturing method, we incorporate that knowledge into our quality management system.

Our QMS is not only strong but also comprehensive enough to handle a variety of situations. Our quality system sometimes dictates a specific approach that we communicate to customers. Over time, we have developed standard operating procedures based on how we typically do things. If a customer requests something different, we assess it through a risk evaluation. Often, after seeing how we operate, customers are comfortable with our standard practices.

EF: With your company growing from 5 to 200 employees, how do you keep your team engaged and ensure their continuous development?

BR: It has truly been a journey. We selected this location in Cartago, specifically the La Lima Free Trade Zone, because of the nearby talent, particularly for direct production workers. We have never had trouble attracting people to work on our production lines. As of today, the talent pool is still strong and far from exhausted.

In production, we have made a concerted effort to create a culture that makes employees feel included, respected, and valued. While we offer competitive compensation, we emphasize fostering a positive work environment and culture. As a result, we rarely face challenges in this area. Recently, we have had a lot of traction when joining our team.

On the administrative and engineering sides, we work closely with technical education institutions. For our size, we have a strong internship program. We bring a small team, with the clear objective that this is about talent acquisition, not a social responsibility initiative.

This approach works because of our customers, agility, and digital platform. Not everyone with medical experience is a perfect fit for us. We have found that people accustomed to working in larger OEMs sometimes struggle to adjust to our environment, where everyone wears many hats throughout the day. We have had great success finding top talent this way for our young, talented training. Bringing someone with entrenched experience from a larger OEM often does not work because they may struggle with the pace and variety of work we handle.

EF: What would you like to celebrate in 2 years, at your 10th anniversary?

BR: Looking ahead, we will have expanded geographically, at the very least.

We have realized that what we have built is more than just a company—a platform. This building is not ITEK. ITEK is the culture, the environment, the technology, and the digital platform. These elements can be transferred instantly anywhere. Geographical expansion is international expansion, without a doubt.

Looking forward, we want a more robust organization that can manage product development, design activities, and the entire product lifecycle for our customers. This has always been part of our vision, but we are actively working on it. We want to apply everything we have learned about manufacturing to help entrepreneurs in Costa Rica or the region with ideas for medical devices or technology that can improve lives. They should not have to sell their ideas to others. We want to be the platform where they can come and develop their products, managing the entire product lifecycle and design controls.

We also look at base technologies like injection molding, extrusion, and machine shop metalwork. We have never invested in these areas directly, typically relying on partnerships. However, we might start investing in these base technologies in the next few years. As the Costa Rican manufacturing cluster matures, we will be better positioned to meet the demands for plastics, metals, and other components.

Beyond Costa Rica, we have strategically decided to expand our business model into the Dominican Republic, which we see as an ideal location for the next chapter of our growth.

Posted May 2025

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