Feb 19, 2016

Anyone who has worked in the medical device industry for more than 10 minutes knows there are certain states in the US buzzing with device activity. California, Massachusetts, Minnesota, Florida, Texas - all have an abundance of medical device companies. But have you ever wondered which metropolitan areas are submitting the most new device applications to the US FDA? Wonder no more.

Emergo analyzed 12,000 FDA 510(k) submissions cleared by the US Food and Drug Administration between 2011 and 2015 and sorted them by US state, eliminating cleared device applications from outside the US. We then grouped all US companies on the list by metropolitan area. Here's what we found.

Medical device innovation in USA

Here are the top 20 cities listed by the percentage of 510(k) submissions cleared by FDA: Los Angeles/Irvine/Anaheim (8.8%); San Francisco/San Jose (7.7%); Boston/Cambridge (6.8%); Minneapolis/St. Paul (5.8%); New York/Newark (5.8%); Philadelphia/Wilmington/Trenton (5.5%); San Diego (4.6%); Baltimore/ Washington DC (4.0%); Chicago (3.1%); Denver (2.5%); Memphis (2.4%); Salt Lake City (2.1%); South Bend (1.8%); Atlanta (1.8%); Cleveland/Akron (1.7%); Milwaukee (1.7%); Miami/Fort Lauderdale/West Palm Beach (1.7%); Indianapolis (1.7%); Fort Myers/Cape Coral/Naples (1.6%); Austin (1.5%)

The California juggernaut

The states below accounted for 70% of all traditional 510(k) applications submitted by US companies and cleared by the FDA between 2011-2015. California remains the undisputed heavyweight champion of med tech innovation, accounting for nearly a quarter of all 510(k) submissions. Interestingly, despite all the news of businesses leaving California, the percentage of device applications cleared for Californian companies has been steady since 2011. It is also noteable that although Florida and Texas do not have any single metro area in our top 10, these states have device hotspots in several metro areas. 

1. California (22.5%)
2. Massachusetts (8.0%)
3. Florida (6.1%) - tie
3. Pennsylvania (6.1%) - tie
5. Minnesota (5.5%)
6. Texas (4.9%)
7. New Jersey (4.8%)
8. Indiana (3.8%)
9. Ohio (3.4%)
10. Illinois (3.3%) - tie
10. New York (3.3%) - tie

* Based on 12,000+ FDA 510(k) cleared device submissions from US companies between 2011-2015. It is important to note that many larger foreign companies often submit their 510(k) through their US subsidiaries.  

FDA 510(k) applications by ex-US companies during 2015

Between 2011 and 2015, nearly three quarters of the medical devices cleared by the FDA were submitted by US companies, or the US subsidiaries of multinational companies. In each of the last five years, China has dominated as the country submitting the most 510(k) applications outside the US. In fact, there has been tremendous growth in 510(k) submissions from China, Japan, Korea and Taiwan. Together these four Asian countries accounted for 14.7% of cleared 510(k) submissions in 2015, up from 8.8% in 2011. Switzerland (population 8.2 million) and Israel (population 8.5 million) win kudos as innovation leaders, having the highest number of cleared 510(k) devices per capita. Overall, the FDA cleared more than 1,015 medical devices from non-US companies in 2015, up from 672 in 2014. That’s an increase of more than 50%! This is partially due to the strength of the US currency which gives imported devices a price advantage over US made products. 

1.    China (7.1%)
2.    Germany (3.5%)
3.    South Korea (2.9%)
4.    France (2.4%)
5.    Taiwan (2.4%)
6.    Japan (2.2%)
7.    United Kingdom (2.0%)
8.    Switzerland (1.6%)
9.    Israel (1.5%)
10.  Italy (1.5%)

NOTE: In some cases, devices are designed outside the US, but submitted to the FDA by the US subsidiary of a company with headquarters outside the US. 

If you enjoyed this analysis of 510(k) data, you might also enjoy our in-depth analysis of FDA 510(k) review times and our 510(k) review times calculator.


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