Medical Device Development



The medical device industry in the United States and worldwide is immense in its economic impact (sales in 2009 were $260 billion worldwide, $120 billion in the United States alone, $64 billion in the European Community, and $45 billion in Japan; in 1998 the US medical equipment trade surplus was $18.2 billion). Between 87,000 and 140,000 different devices are produced in the United States annually by approximately 8,200 different manufacturers employing some 311,000 people. Furthermore, it is believed that more than 1,000 of these manufacturers are development-stage only companies without products yet on the market.


Medical Device Combination Product Device Manufacturer Biocompatibility Testing Investigational Device Exemption 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Gad Consulting ServicesCaryUSA
  2. 2.Spainhour Consulting ServicesClarks SummitUSA

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