The United States of America is a world leader in the fields of medical research, medtech and the development of pharmaceuticals. With $ 4.5 trillion in annual healthcare expenditure and diverse patient needs, accurate, culturally aware translations are vital to ensure regulatory compliance, improve health outcomes and build trust among patients, healthcare professionals and industry stakeholders alike. Ready to navigate this complex landscape? Let an expert translation service provider be your guide.


The US comprises a federation of 50 states, the federal capital district of Washington, D.C., and 326 Indian reservations. The country boasts the world’s third-largest land area, second-largest exclusive economic zone and third-largest population, with over 342 million people, trailing only India and China.

Life expectancy in the US stands at 79.3 years, which is 2.4 years lower than the UK’s 81.9 years. Among the G7 countries, the US even ranks last in terms of life expectancy and has the highest infant mortality rate, despite its high healthcare spending. Rates of preventable and treatable mortality are also generally higher compared to other industrialized nations.

Chronic diseases are the primary cause of illness, disability and death. The majority are caused by a handful of risk factors, including smoking, poor nutrition, a sedentary lifestyle and excessive alcohol use. Some demographic groups are more affected than others due to social determinants, such as where they are born, live, work and age.

For instance, certain communities lack safe areas such as parks for physical activity or access to grocery stores offering fresh produce. In rural regions, doctor shortages, hospital closures and long travel distances make it challenging to get timely access to preventive screenings and specialist follow-up care. Diabetes prevalence also exceeds the OECD average, largely due to the soaring rates of obesity. Leading causes of death and disability in the US include heart disease, cancer and diabetes, followed by stroke, chronic lower respiratory diseases, Alzheimer’s and nephritis.

In 2023, one in six people in the US was over 65 years old, a relatively low proportion compared to other OECD nations. This demographic trend is largely due to the influx of younger immigrants into the country.

Health market

The healthcare sector in the US differs greatly from the systems in other countries, such as the UK, particularly in the structure and organization of health insurance. In the US, there is no compulsory insurance, which emphasizes personal responsibility, but it also leads to major differences in insurance benefits. As a result, around 9% of US citizens are uninsured, and around 33% are underinsured. To address this issue, the state programs Medicare and Medicaid were founded in the 1960s to provide coverage for residents over the age of 65 or those with health impairments. The Affordable Care Act (ACA), commonly known as Obamacare, introduced state and federal insurance marketplaces, expanding access to health coverage with income-based subsidies.

Regulatory oversight is managed by multiple federal agencies, including the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), ensuring compliance with healthcare laws and standards.

Providers range from doctors and nurses to pharmacists and allied health professionals, working across various settings, from large hospitals to small outpatient clinics. With a growing emphasis on electronic health records (EHRs) and telemedicine, the system aims to enhance efficiency and patient care, although challenges such as fragmentation and disparities in access persist. Overall healthcare spending amounts to 16.6% of the country’s GDP, compared to 10.9% in the UK.


The US is not only the largest consumer market in the world but is also the largest and most important sales market for medical technology, providing enormous opportunities for manufacturing companies. The country itself is the largest manufacturer of medical technologies, accounting for around 40% of the national market volume, with six of the world’s ten leading medical device manufacturers based in the US. Experts predict that the market volume of the medical device industry will grow to almost $ 800 billion by 2030. The demand for imaging technology, such as computerized tomography scanners and X-ray machines, as well as blood sugar monitoring devices and pacemakers is particularly high, driven in part by large hospital modernization projects.

Like in many other industrialized nations, the increase in diseases and the aging population are key issues. The “Silver Tsunami,” a term used to describe the aging baby boomer generation, is fueling demand for new and innovative medical solutions. Home care technology, such as mobile dialysis machines and remote monitoring solutions that allow patients to stay at home as long as possible, shifts the focus away from hospitalized care.

Digital solutions have seen significant expansion in recent years. The latest trends show the widespread use of artificial intelligence (AI) and networked IT solutions that allow for completely new ways of diagnosing and treating patients. In the future, strong growth is expected for medical products in the areas of mHealth, telehealth, automation technologies and AI to realize efficiency gains in patient care. Here, global tech companies based in Silicon Valley are setting the standards in this new digital era.

In the pharmaceutical sector, the US accounts for around half of global sales, with the driving factor again being the aging population. Top-selling medicines include anti-cancer treatments, biologics such as antibodies and vaccines, as well as diabetes medication and drugs for hypertension, respiratory disorders and depression. The country currently imports about 26% of its medicines, with Ireland and Germany being the largest suppliers.

Legal and regulatory conditions

The FDA plays a central role in the oversight of pharmaceuticals and medical devices to ensure their safety and effectiveness. For medicines, the process involves several stages: preclinical research, clinical studies and New Drug Application (NDA) submission. Clinical trials are conducted in phases to assess safety, dosage and effectiveness, with successful trials leading to an NDA, which the FDA reviews rigorously before approval.

For medical devices, the FDA classifies products into three categories based on risk: Class I (low risk), Class II (moderate risk), and Class III (high risk). Class I devices require general controls, Class II devices need special controls and sometimes premarket notification (510(k)), and Class III devices undergo the most stringent review through the Premarket Approval (PMA) process, demonstrating safety and efficacy through extensive clinical data.

Sensor apps for Continuous Glucose Monitoring Systems (CGMs), which are used in diabetes management, are generally classified as Class II medical devices due to the moderate risk associated with their use. Many health and wellness apps, on the other hand, do not qualify as medical devices and are therefore not regulated by the FDA. These include general fitness apps, lifestyle trackers, and wellness monitoring tools that do not provide specific medical advice or connect to medical devices.

Both medicines and medical devices must comply with Good Manufacturing Practices (GMP) to ensure consistent quality. Additionally, post-market surveillance monitors products for adverse effects, ensuring ongoing safety.

International health market

While FDA approval is highly respected, it does not automatically grant access to international markets. Some countries, like Canada and Japan, may expedite their review processes for FDA-approved products. Global regulatory frameworks, such as the International Council for Harmonization (ICH) and the Medical Device Single Audit Program (MDSAP), help align standards, making compliance easier. Mutual Recognition Agreements (MRAs), like the US-EU MRA, can also streamline approvals for medical devices. Yet many countries still require additional data or bridging studies to address local factors. European companies holding an EMA marketing authorization can also use their research to file for FDA approval in the US.


Internationalization plays a crucial role in enhancing the US healthcare landscape. It fosters medical innovation through global research collaborations and accelerates drug development via diverse clinical trials. International medical professionals contribute to addressing workforce shortages and enrich patient care with multi-faceted perspectives.

Translations and localizations are crucial elements that support the entire life cycle of medical devices, medications, dietary supplements, as well as health and lifestyle products. Skilled translators know the ins and outs of different communication channels and match the language to the needs and expectations of the target audience, be it laypeople, specialists or regulatory authorities. This task demands not only subject-matter expertise but also extensive training and a keen understanding of linguistic and cultural nuances.

The most relevant languages for the US market are by far English and Spanish, with 239 million and 41 million speakers, respectively, followed by Chinese, Tagalog, Vietnamese, Arabic, French, Korean and Russian (all with more than 1 million speakers). Relevant Indigenous languages include Navajo, Cherokee and Lakota, among numerous others. Nearly 22% of US residents report that they speak a language other than English at home.

Interestingly, the US has no official language at federal level, and there are varying provisions in individual states, e.g. Hawaiian as the official language in Hawaii, Spanish in Puerto Rico and New Mexico, Indigenous languages in Alaska and even French (de-facto) for official communications in Maine and Louisiana. Especially in states with large immigrant communities, such as California, official documents (and promotional materials) are translated into various languages.


As the world’s largest economy, the US represents a lucrative sales market for medical devices and pharmaceuticals, and the strong trading partnership between the US and the UK opens up significant opportunities for UK companies. Particularly promising are innovative products that enhance efficiency and digital medical technology, such as advanced imaging machines and apps. These sectors offer UK businesses a chance to thrive in the competitive US market by delivering cutting-edge solutions to meet the growing healthcare demands.

Skilled professional translators are essential for navigating this highly sensitive market. They bring extensive expertise in medical terminology and a deep understanding of local cultural nuances. After all, accurate communication is crucial for demonstrating a company’s commitment to quality, while also ensuring user safety and building trust in its brand.



autor_eurotext_100Author: Eurotext Editorial Team

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