Faster PMAs Mean Quicker and More Efficient Market Access
Companies at all experience levels in Minnesota’s Medical Alley gain 510(k) clearances faster than anywhere else in the country. But how do these companies compare to the rest of the U.S. in navigating the most rigorous approval pathway: FDA’s Premarket Approvals (PMA)?
While 510(k) clearances are more distributed geographically, first PMA approvals are the most concentrated in Minnesota, California, and Indiana. In fact, these three states make up 59% of all first PMAs and 83% of similar approvals in Cardiology. From 2010-2014, Cardiology and In Vitro Diagnostics (IVD) products accounted for the lion’s share (62%) of first PMA approvals nationwide.
How long does it take?
The national average for gaining first PMAs is 575 days. Minnesota companies average these approvals in just 376 days, 199 days or six and a half months faster than the rest of the country. In Cardiology - the largest category for first PMAs and Minnesota’s dominant device category - our companies gain approval 73 days (nearly two and a half months) faster than the national average.
Take a moment to consider the implications. After talking to a number of company executives and successful serial entrepreneurs, we came up with an approximate monthly burn rate of $1 - $3 million for medtech companies at or near the stage of FDA approval. That means that on average across all product categories, Medical Alley companies can save anywhere from $6.5 - $19.5 million in reaching first PMA approval 199 days faster. For Cardiology companies, that number is anywhere from $2.4 - $7.2 million.
Gaining first PMA approvals requires highly-specialized expertise in navigating a rigorous process, something that Minnesota medtech companies do very well. It also requires a proven commitment to finding impactful and efficient solutions to both clinical and system-wide needs. Medical Alley’s device companies can not only save money on faster FDA approvals, but can also save precious time in getting products to market, allowing for earlier patient access to life-saving therapies.