Interview with Katalin Bucsy, CEO, Norma Industries

04 Jun Interview with Katalin Bucsy, CEO, Norma Industries

With strong research and growth in in-vitro diagnostics (IVD) — where Norma Instruments is a global player — what is your experience and perspective on the sector in Hungary?

Hungary’s strong tradition in life sciences and engineering gives us a solid foundation for the IVD regulation(IVDR) sector. At Norma Instruments, this means access to skilled talent in R&D, software development and manufacturing — key areas for our hematology analyzer development. We are proud to have grown and competed internationally from our Hungarian base. However, the sector faces challenges, especially with the increased regulatory complexity of the EU IVDR. While necessary for patient safety and credibility, the new rules demand significant investment in documentation, performance evaluation and compliance, which can be tough for smaller companies and startups.

Hungary supports innovation with EU grants and R&D tax benefits, but administrative processes can be slow and local venture capital for medtech remains limited. These are areas that need improvement. Despite this, we see great opportunities. Hungarian and mid-sized IVD devices are gaining respect for their reliability and performance. At Norma, over 90% of our products are exported and our global distributor network is growing. With the right support and focus on quality and innovation, Hungary can become a regional leader in diagnostic technology.

Can you share how Norma Instruments grew from a small Hungarian company to establish an international presence?

Norma Instruments was founded in 2012 and has been active for over a decade, focusing on human and veterinary segments. We started with the human portfolio and added veterinary products in 2018. Over the past five years, we have achieved a steady annual growth rate of over 5% and upgraded from three-part to more advanced five-part analyzers. Sourcing is crucial to ensure stable production. As an R&D-driven company, we consistently reinvest a double-digit percentage  of our revenue into research.

To optimize costs, Norma collaborates with universities and seeks R&D funding. Currently, we have an ongoing project with the globally recognized Eötvös Loránd University in Budapest. As an international company, we must carefully manage varying inflation levels worldwide. Since most of our revenue comes in foreign currency while costs are both local (Hungary) and international, balancing this is a key to our sustainable operation. We are also closely monitoring global economic trends, including tariffs, to understand their impact on our company and location.

How is Norma Instruments structured and open to international investors? Do you focus more on exporting products or also on developing R&D facilities abroad?

Norma Instruments is a truly Hungarian company, with all core activities — R&D, production, product development, customer service, logistics, marketing and finance — based in Budapest. The only exception is sales, which is international. We have sales managers and consultants in LATAM, the U.S., Europe and the Middle-East, Asia Pacific and Africa, making us diverse and globally connected.  Since my arrival, we have strengthened ties with the Hungarian market, such as partnering with the Sovereign Order of Malta on mobile laboratories providing complete blood count testing for remote locations — a model that fits well with similar projects we have in Colombia and Malaysia.

Originally focused on laboratory segments, we now target niches in the human market with our unique product, especially in near-patient applications. Our products’ human applications are broad, for example, in Spain, we won a project for oncology point-of-care and in Italy, we work with a leading distributor serving outpatient clinics and emergency care. We are also bidding in Lithuania for military use.  I am also confident that our analyzer ranks among the top five veterinary analyzers worldwide. Further expanding in Europe, Asia, LATAM and North America with our veterinary portfolio is a key goal for this year and the coming year.

Norma is an international company, present in over 80 countries, mainly through local distributor partnerships. We focus on delivering high-quality, reliable and affordable diagnostic solutions. A key strength is our fast, flexible technical and clinical support, which sets us apart from competitors. While our core portfolio is human diagnostics, we are developing a veterinary portfolio targeting both companion and livestock animals, with a new product launch planned for Q4 this year. We see strong growth potential in Asia and LATAM and we are currently exploring partnerships to enter the more mature US veterinary market later.

How important is R&D to Norma? What portion of revenue is invested in it and what are the key benefits of using modern technology?

R&D is at the core of Norma’s DNA. We focus on developing small, modern and compact hematology systems designed for space-limited labs, clinics and veterinary practices where fast, on-site results are needed. Our compact analyzers and reagent packs offer a key advantage. Norma invests a double-digitpercentage of its revenue in R&D, funding modern technologies, research and partnerships that deliver the best value for cost — a crucial factor in our industry. As Peter Drucker said, “Culture eats strategy for breakfast,” so we also prioritize nurturing corporate values and investing in our people.

R&D at Norma is future-focused. The hematology and diagnostics market is being transformed by digitalization, automation and AI. AI, especially in hematology, improves accuracy by analyzing individual cells through advanced algorithms. Automation also enhances production quality and reduces risks. Our user-friendly touch screens allow easy access to diagnostic data, which can be shared with service providers via customized middleware or laboratory information system solutions.

What are Norma’s top products now? Besides veterinary development, what are your current project priorities?

In recent years, we have seen steady 5% annual growth. In April, we set an ambitious three-year strategic plan, aiming to grow revenue by 50% this year. Last year, we signed a major corporate contract with a veterinary business partner covering the UK, Australia and Ireland, fueling this growth. We are focusing heavily on the veterinary market because it has fewer regulatory barriers and faster market entry compared to the human segment. For human products, new distributors outside Europe must register the product, which slows expansion. For 2025, most growth will come from veterinary sales and seeking new market entry opportunities to expand into the US market.

For 2026, we plan new product development in veterinary, including the upcoming launch of the iVet-5R hematology analyzer with reticulocyte measurement capability by year-end. This will help us further penetrate and gain market share in the segment. Additionally, we are entering the livestock industry, a new market for us, by developing species profiles and parameters, expected to be ready soon. This represents a strong growth opportunity in veterinary medicine.

Norma’s core expertise has been in the human segment, mainly with three-part analyzers. Now, we are shifting focus to five-part analyzers, which are more advanced and boost revenue. We are also developing near-patient testing, conducting pilot studies and building a key opinion network for areas like general practice, emergency care, military, oncology and remote locations. Our R&D projects, including manufacturing improvements, support our plan for strong double-digit growth this year and into 2026–2027. Currently, 90% of our revenue comes from the human segment. With our renewed focus on veterinary, we aim to achieve a 50/50 revenue split by 2027. This balance will strengthen our stability and open new growth opportunities across a broader portfolio and market segments.

What is your 5- to 10-year vision for Norma Instruments and where do you see the company headed?

Looking ahead, we aim to be a key global player in hematology diagnostics, balancing human and veterinary markets. We want to lead in near-patient and point-of-care testing, a segment growing around 13-15% annually through 2030. Our focus is on delivering high-performance, adaptable solutions that support decentralization. We also plan to expand our portfolio through strategic alliances with companies in complementary fields like clinical chemistry, offering customers a broader range of diagnostic tools. We are already collaborating with Asian and European partners to build a strong global presence as a unified alliance.

Why would you say now is a good time for investors to come visit or invest in Hungary?

Hungary has a strong history of smart, innovative science and has produced many renowned scientists. Despite its small size, Hungary is open-minded and offers great opportunities for investors. The government provides strong support and benefits for foreign investors, including efforts to promote investments beyond Budapest into the countryside with good infrastructure. Hungary also has quality education in science and engineering, with improved foreign language skills, reducing barriers for international business. Becoming more global benefits Hungary by exposing it to worldwide trends, creating exciting opportunities for young talent and supporting the country’s sustainable development through continued investment. The food, music and landscapes are incredible. For culture lovers, there are concerts, art and rich traditions to explore. We are a very safe country with plenty to enjoy.