The FDA and Surgical Innovation

The United States is the largest single medical device market in the world representing more than a third of the global market which might reach as much as $133 billion by 2016. Most of the 6500 medical device companies in the USA are small- or medium-sized businesses with less than 50 employees. A significant percentage of these small businesses are startups with a little or no revenue. These small businesses are the lifeblood of innovation that has been responsible for the preeminent position that the USA has enjoyed thus far. The characteristics of the innovation pathway are critical to the success of device development, improvements in health, and cost-effectiveness of care in this country. Although the FDA stands as the first significant gatekeeper in the innovation process, this innovation pathway has several components in addition, such as the impact of CPT coding, payers, group pricing, training, and the like.