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Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

Experience, Experience, Experience: The Secret to Faster 510(k)s

Recently we released data on the states with the fastest 510(k) clearance times across the U.S., which put Minnesota on top, followed by California and Massachusetts. We dug into the data a bit further, looking at different types of medical devices and different experience levels for the period 2010-2014. As expected, geography and experience matter, putting Minnesota at the top in several categories. Given the relatively lower barrier to entry represented by 510(k)s versus Premarket Approvals (PMA), 510(k) filings for medical devices were much more geographically distributed. In fact, the top three states - Minnesota, California, and Massachusetts - make up only 36% of all national filings for the period 2010-2014, with at least one filing coming from 47 of 50 states. Amidst this competition, Minnesota companies achieve 510(k) clearances 26% faster than the national average. In fact, our companies gain clearance 30% faster on average in the area of Cardiology, 39% faster in Endoscopy, and 26% faster in Diagnostic Imaging and In Vitro Diagnostics (IVD). In order to evaluate experience levels, we categorized companies filing 510(k)s into three groups: high experience (those that filed 10 or more 510(k)s from 2010-2014), medium experience (those that filed 2-9), and low experience (those that filed only one 510(k) during that period). For the more highly experienced companies, Minnesota companies gained clearance 26% faster than the national average (103 vs. 130 days). However, for low-experience companies, Minnesota’s average clearance time is 34% faster than the U.S. average (149 vs. 199 days). These results speak clearly to the value of accumulated knowledge and expertise in preparing and submitting medical devices for FDA clearance. What Minnesota’s Medical Alley has in the highest concentration anywhere in the world is a fully-developed OEM and supply chain community, allowing for faster and more capital-efficient access to all areas of expertise in developing and launching medical devices. Stay tuned for an upcoming look at approval times and trends for first Premarket Approvals (PMA) across the U.S.

 

510K Clearance Report: 2010-2014