The United States led the world trade in medical instruments and devices in 2021, with imports and exports of 62,348 million dollars.
Both in its sales and in its foreign purchases, the United States broke a record last year.
On the one hand, its exports totaled 30,907 million dollars, an increase of 11.5% compared to 2020. Its main destinations: the Netherlands (4,318 million dollars), China (3,742 million) and Mexico (3,055 million), according to Department of Commerce data.
International trade plays an important role in the US medical device industry.
Ultimately, 35-40% of US domestic production is exported and a similar proportion of US domestic consumption is imported.
Overall, the medical device industry manufactures a huge number of products, ranging from surgical gloves to artificial joints to imaging equipment, and plays a crucial role in developing new medical technologies that can improve the ability to diagnose and treat disease.
The industry has a relatively small number of large, diversified companies and a large number of smaller companies that are primarily engaged in research and development of new devices for specific therapeutic areas.
The industry is also distinguished by both its tendencies to make frequent incremental changes to its products and its extensive ties to physicians.
On the other hand, US imports were 31,441 million dollars in 2021, a year-on-year increase of 17.9 percent.
Of these purchases, Mexico (8,530 million dollars), Germany (3,653 million) and Costa Rica (2,688 million) were the largest suppliers.
Like prescription drugs, medical devices are regulated by the Food and Drug Administration (FDA).
However, the regulatory framework that the US Congress has established for medical devices is less stringent in many respects, due in part to the underlying differences between medical devices and prescription drugs.
Most low-risk devices can be brought to market without prior FDA review, and most medium-risk devices only need to demonstrate that they are substantially equivalent to an existing device before they are brought to market.
Very few devices need to be shown to be safe and effective before being marketed.
Among the main companies operating in the United States in this business are: Medtronic, Johnson & Johnson, GE, Baxter International, Siemens and Becton Dickinson.