Defining Medical Device Manufacturing

The U.S. medical device sector includes surgical and medical instruments; orthopedic, prosthetic and surgical appliances and supplies; dental equipment and supplies; x-ray apparatus, tubes and related irradiation apparatus; electromedical and electrotherapy apparatus; and ophthalmic equipment. Industry coverage also includes in-vitro (i.e. not taken internally) diagnostic (IVD) substances.
 
The U.S. medical device industry is known for producing high quality devices using advanced technology resulting from heavy investment in research and development (R&D). There are approximately 8,000 medical device firms in the United States, mostly small and medium-sized enterprises (SMEs). More than 80 percent of medical device companies have fewer than 50 employees, and many (most notably innovative start-ups) have little or no sales revenue.

U.S. Dept. of Commerce, International Trade Administration, Invest in America Initiative, Medical Device Sector, 2007