Health Technology in the U.S. Remains a Massive Market Even in Unstable Times

Finnish companies, particularly those in the Tampere region, may have a competitive edge in the North American market thanks to their top-tier expertise. The health technology sector – which collaborates with foundations and research institutions – is less directly affected by global and trade policy turbulence, though tariffs remain a concern. According to companies, the choice often comes down to the U.S. or the EU. The U.S. is an attractive option due to its status as the world’s largest market and its relatively swift regulatory approval process.

The Tampere region is home to a thriving cluster of health technology companies, many of which have their sights set on international expansion. Typical market niches and research areas for companies in our region include pharmaceutical and biomedical technology, medical devices and hospital supplies, as well as health IT and digital health.

A round of interviews with companies in the Tampere region reveals a strong drive for international growth, though the turbulent global situation demands adaptability. Companies in the region have updated their strategies to align with the evolving operating environment, say health technology firms Lakka Health and Biomendex.

Medical device developer Lakka Health and Biomendex, a company specializing in synthetic bone substitutes, both see the United States as a key target market. The U.S. market is vast, with a strong private sector presence.

“Cardiovascular diseases are highly prevalent in Finland and the Western world. The United States has the world’s largest market for medical devices, with around 260 million adults—about half of whom have hypertension,” says Sami Lakka, CEO of Lakka Health.

Regulatory approval can be more straightforward compared to Europe – and a federal certification is recognized in many other countries beyond the U.S.

“Our strategic focus is on North America. Obtaining approval from the U.S. Food and Drug Administration (FDA) is easier than securing CE marking in Europe. One key difference is that clinical trials are not required in the U.S.—preclinical evidence is sufficient. The product must perform at least as effectively and safely as an existing market alternative,” explains Pasi Kankaanpää, CEO of Biomendex. Kankaanpää estimates that for many smaller companies, obtaining sales approval in Europe may prove to be an insurmountable challenge.

The CE marking indicates that a product has been inspected and meets the European Union’s safety, health, and environmental requirements.

According to Biomendex, the synthetic bone it produces is more malleable than those already on the market. Photo: Biomendex

Foundation and institutional cooperation as stabilizers

This spring, especially the cooperation between nations and international political and trade relations have been put to the test. The second term of U.S. President Donald Trump and Vice President JD Vance, which began in January, has shaken political relations and sparked unusual statements from mainstream politicians.

Trump has threatened the European Union with 25% tariffs. Finland’s second-largest export sector, the chemical industry, recently surveyed its members in March: 42% of companies exporting to the United States estimated that tariffs would significantly reduce exports, which, according to the Chemical Industry Association (Kemianteollisuus ry), would cost around 300 million euros.

The third year of the war in Ukraine began at the end of February, and European leaders are striving to form a coalition that can stand up to Russia. As a newly joined NATO member, Finland is seeking its place in the world.

Lakka Health and Biomendex have found a possible entry route to the North American market through foundation and research institute cooperation. Sami Lakka from Lakka Health mentions that their Siiring device, which measures blood pressure from a finger, caught the attention of GH Labs (Global Health), a nonprofit organization. The organization promised to support the development and attract interest from Gates Ventures, which is closely linked to the world’s largest charity, the Bill and Melinda Gates Foundation.

“We received help from GH Labs in the production of the prototype. We had a functioning device, but the overall package needed to be presentation-ready. Our device is of interest to organizations because, due to its small size, it can be placed in a doctor’s mobile bag outside of Western industrial countries, accelerating research in places like slums,” Lakka explains the initial spark for the collaboration.

A similar boost was received by Biomendex in its pursuit of FDA approval. The company approached the nonprofit Mayo Clinic and a medical research center, and in October, they reached a know-how licensing agreement.

“Mayo Clinic is an extremely important factor. They are naming specialists to assist us in getting FDA approval for sales,” says Kankaanpää.

Lakka Health’s Siiring blood pressure monitor operates based on smart metals, says Sami Lakka. It is user-friendly and quiet. Photo: Lakka Health.

What about in Finland?

Both interviewees emphasize the importance of maintaining operations in Finland while expanding globally.

“We strive to do things and manufacture in Finland. The cost structure of the domestic technology sector is such that cheap gadgets cannot be made, but it’s worth designing and exporting medical devices or related technologies, like Polar, Suunto, and Planmeca, which manufactures dental care technology,” says Lakka, continuing:

“Although the margins in medical devices are large, 25%, or a quarter, is still a significant amount in that equation. We are still in the proof-of-concept phase, and next year we will have a major release and go to market. The most promising thing has been that in test situations, no user has chosen the traditional blood pressure monitor over our device,” Lakka reflects.

Kankaanpää regrets what he sees as a fundamental flaw in Finnish companies: entering markets. Compared to neighboring Sweden, the funding and capital markets lag behind. He views the high level of Finnish technology as a positive trend, which attracts global interest. Cooperation with educational institutions and research works well, and companies receive support from business and development companies as well as Business Finland.

In Tampere’s Hervanta, Biomendex, according to Kankaanpää, employs around ten people, including engineers with doctoral degrees in materials science, cleanroom specialists, and product developers. There is room for growth in the Tampere region as well.

“Our intention is by no means to move all production to North America, even though we have planned subsidiaries and contract manufacturers. As sales grow, it also means new jobs here,” Kankaanpää sees.

LAKKA Health
• Founded in 2020.
• HQ in Lempäälä, Pirkanmaa region, Finland.
• Ten employees.
• Developing the Siiring blood pressure monitor and shape memory alloys (SMA).
• SMAs are metal alloys belonging to smart materials, whose shape and movement can be controlled.
• Company website.

Source: Sami Lakka / Lakka Health

Biomendex
• Founded in 2018.
• HQ in Hervanta, Tampere, Finland.
• Ten emplyees.
• Manufactures synthetic bone repair material.
• The material is used in veterinary medicine, with 1800 operations performed. Patient trials are underway, with applications in orthopedics and dentistry.
• Company website.

Source: Pasi Kankaanpää / Biomendex