General

Readers often contact us asking about the overall size of the medical device market and similar general statistics. Here’s what we found.

• $94.9 billion: Estimated value of U.S. medical device market in 2010¹
• 17.7%: Healthcare's percentage of GDP²
• The United States’ health expenditure is projected to reach $2.6 trillion for 2010, which is about 17.7% of the GDP.²
   

1. Espicom Business Intelligence; 2. CMS Office of the Actuary

Regulatory

It’s been a tough year (or two) for FDA, especially where the 510(k) process is concerned. And industry didn’t make it easier, submitting more 510(k)s than it has in at least five years.
 

• 1300: Approximate number of current part- and full-time CDRH employees
• 100: Approximate number of times FDA has ever rescinded a 510(k) clearance
• 1: Approximate number of 510(k) rescissions in which FDA admitted making an error

FY 2009 Submissions to FDA³

• 510(k)s: 4153
• PMAs*: 512

** includes original PMAs, panel-track PMA supplements, premarket reports, expedited original PMAs and panel-track PMA supplements, 180-day PMA supplements, and real-time PMA supplements

3. FY 2009 Performance Report to Congress

Imaging

Imaging was one of the dominant medtech headlines for 2010, whether for controversial mammography guidelines (click here for a bonus section on mammographies) or excess radiation doses. Here are some of the numbers behind the fuss.

Annual Spending on CT Imaging⁴

2000: $975 million
2007: $2.17 billion

Roughly 80% of the ionizing radiation most people get in their lives comes from radon gas, cosmic rays, and other natural sources—even bananas.⁵

4. Government Accountability Office; 5. Los Angeles Times