Medical technology exports to the USA: Challenges for German medtech companies

Medical technology exports to the USA: Risks of market entry

While the American market offers enormous opportunities for medtech companies, they currently face numerous risks and challenges. One such issue is tariffs. Trump's trade policy is characterized by "America First" strategies, with his goal of rebuilding or strengthening domestic production.

On April 2, US President Donald Trump therefore announced comprehensive measures to impose new import duties. Initially, a flat tariff of 20 percent on goods from the EU was planned. Since the tariff rate does not differentiate between product groups, medical products would also be subject to this regulation. In addition, many medical technology companies rely on steel and aluminum components—materials that are now also to be taxed at a 25 percent surcharge. Although Trump suspended the tariffs again on April 9, the future of this issue remains completely open.

Another challenge facing German medtech companies regarding medical technology exports is the FDA's massive job cuts. This has resulted in certification processes coming to a standstill or being significantly slowed down, as well as emails with questions no longer being answered and consultations no longer taking place. Furthermore, the US has withdrawn from the ongoing international negotiations on the IEC 60601 standard. This could have serious consequences for the harmonization of standards and thus creates uncertainty in the industry.

One way to circumvent tariffs on medical technology exports is to establish locations in the US and produce locally – something some German companies are already doing successfully, including GHA members Cherry, Siemens Healthineers, B. Braun, Ottobock, Drägerwerk, WOM, KLS Martin, and Fresenius Medical Care. However, the current uncertain situation is causing companies to hold back their investment decisions.

German medical technology continues to be in demand in the US market due to its high quality and innovative strength. German companies have already established themselves well in areas such as imaging diagnostics, minimally invasive surgery (e.g., WOM), orthopedics, and implant technology (including KLS Martin, Ritter, and Bredent Medical). In these segments, they benefit from their reputation for precision, reliability, and technological excellence.

At the same time, there is still untapped potential in high-growth areas such as digital healthcare, robotics, wearable technology, and personalized therapeutic approaches. German companies could increasingly score points here with innovative solutions. Among the strongest competitors are large US corporations such as Medtronic, Johnson & Johnson, and Boston Scientific, as well as increasingly Asian providers entering the market with cost-effective alternatives.

How do companies succeed in entering the market despite the challenges? Maik Kränkel, Chairman of the North America Working Group of the GHA and Senior Vice President of Business Development at the Leipzig-based company ACL, emphasizes the importance of networks in the USA: "In the USA, universities are closely connected to politics and businesses. This creates strong networks and clusters that foster innovation and growth. They are very interested in collaborating with German companies and therefore represent good starting points for us."

In addition to universities and governments, the Economic Development Corporations (EDCs) of the individual states are among the potential points of contact for German companies. Their task is to promote targeted investments. "They also offer support," says Stefan Leitz, Chairman of the North America Working Group of the GHA and Director of Global Business Development and Sales at Cherry Digital Health GmbH, "to companies that don't want to invest immediately but want to first develop the market for themselves."

While German medtech products are valued in the US for their technical precision and quality, there is an urgent need to catch up in the areas of digitalization and artificial intelligence (AI). The US market is increasingly relying on data-driven solutions, from AI-supported diagnostic tools to digital platforms for patient management and care optimization. Companies that offer innovative digital applications secure decisive competitive advantages.

However, many German manufacturers are not yet competitive in this area. Leitz emphasizes: "Unfortunately, it is alarming how far ahead a large proportion of American companies are of the German ones in terms of the use of digital solutions and AI. German medtech companies urgently need to catch up in this area. We need to invest much more in these technologies and also enter into partnerships with technology companies to remain competitive and meet market demands. This is the only way we can assert ourselves in an increasingly digital healthcare world."

What options are there to secure sales in the US despite the expected price increases due to tariffs and other trade barriers? Leitz says: "We as German companies must join forces and offer solutions together. With entrepreneurial creativity and innovation, we can succeed in creating relevance and securing market share."

To support its members in medical technology exports and their activities in the USA and Canada, the GHA founded the AG North AmericaThe members meet regularly to discuss current developments and share experiences. AG traveled in December 2024 with twelve member companies traveled to Chicago, Minneapolis, and Minnesota. These three cities are considered the centers of the medical technology industry in the USA. They met with political representatives and market experts. They also visited numerous universities and hospitals, such as the renowned Mayo Clinic, which is considered one of the best hospitals in the world.