For medical device manufacturing in Costa Rica to continue as a pillar of the economy, issues such as regulations must be improved.

Medical device manufacturing in Costa Rica will continue to grow at a double-digit rate over the next five years. This assessment is according to an estimate by Pedro Beirute Prada, General Manager of the Costa Rican Foreign Trade Promotion Agency (Procomer).

In this regard, it should be noted that Precision and Medical Equipment is the leading export sector in the country. In 2021 it comprised 36% of the country’s exports, equivalent to 5.2 billion dollars. According to the Costa Rican Coalition of Development Initiatives (CINDE) data, this figure is correct. This represented a growth rate of approximately 30% compared to the previous year.

The future of exports of medical devices manufactured in Costa Rica is optimistic. This is because each year, the cluster of this class of manufactured products develops a little more. The sector for medical device manufacturing in Costa Rica presently consists of more than 90 companies. As a result, its ecosystem comprises global leaders and small and medium-sized local companies that act as industry suppliers.

“We continue to see growth in exports this year. And perhaps what is most relevant to this optimistic vision that I have of the sector is that it is an expanding industry. Global demand will continue to grow as the population increases, as longevity and health services increase,” says Beirute Prada.

Innovation is vital for medical device manufacturing in Costa Rica

During the last few years, the country has transitioned from predominantly agricultural exports with little added value to manufacturing-based exports with a high level of sophistication.

This is the specific case of medical device manufacturing in Costa Rica. Currently, its portfolio is made up of multiple products. Among them are kits for medical use, parts, accessories, needles, catheters, prostheses, and serum infusion and transfusion equipment. In addition, to the list must be added diagnostic devices, contact lenses, implants, and heart valves, among others.

In terms of value, of the total exports of Precision and Medical Equipment, 70% of the exports are very sophisticated, points out the Procomer executive.

“Costa Rica is a more boutique country, characterized by generating a lot of sophisticated medical products. It is a country that has responded well to the demands for complexity, let’s say, of medical devices. Companies have found that Costa Rica is a country where they can make the most complex products. This is because of the human resource talent, the inputs, the experience, and the educational level of the engineers, the assembly workers, the managers, etc.,” he points out.

Reference companies and products

From his point of view, among the most complex products that companies manufacturing medical devices in the Central American nation are:

• Medtronic manufactures spinal devices. These implants treat traumatic fractures of the spine and cervical diseases.
• Boston Scientific makes a spinal cord stimulator. They also function for deep brain stimulation. Additionally, the product reduces symptoms of diseases such as Parkinson’s or hereditary tremors.
• The domestic company Establishment Labs produces the latest breast implants in the world. It is recognized for its drop-shaped implants. These have unique silicone and a texture well-recognized by surgeons around the world. They are also known for their safety.
• CooperVision’s contact lenses are distributed worldwide due to its innovation.

What improvements does medical device manufacturing in Costa Rica require?

The director of Procomer attests to the fact that the medical device sector in Costa Rica aims to develop the most complex and sophisticated products in the world. He emphasizes that the country is an excellent place for prototyping and manufacturing but also a suitable environment for research and development.

For this to happen, he believes that it is necessary to improve in the following areas:

• Maintain legal certainty, develop human resource talent, and offer incentives and a business climate conducive to investment.
• Reduce bureaucracy. This will allow companies to operate more agile, safer, and transparently.
• Make regulatory improvements. Therefore, it is necessary to update the legislation around clinical trials for this to occur.

Regarding this last bullet point,  Beirute Prada explains that it is necessary to make clear what can and cannot be done when testing medicines, products, or devices, with the risk that they may or may not work.

In this sense, the products must be approved by the Food and Drug Administration (FDA) of the United States Government. However, they must undergo validation processes for functionality and side effects, among others, for this to happen.