Maryland Technology Development Corp.
The Maryland Technology Development Corp. (TEDCO) has designed mdPACE, a program helping entrepreneurs in the medical device industry in Central Maryland prepare for faster approval of their devices by the Food and Drug Administration (FDA).
TEDCO said more FDA-approved medical devices from Central Maryland companies could help attract more investors and new businesses and jobs to the region. mdPACE is designed to help entrepreneurs get FDA clearance in 18 to 20 months, instead of the 36 to 42 months needed now by inexperienced companies, according to Neil Davis, TEDCO’s director of entrepreneurial development and one of the program developers. Significant savings are projected.
“Efficiently navigating the FDA clearance process is a potential bottleneck for any young medical device company,” said Howard Carolan, co-founder and CEO of CoapTech. “TEDCO has created a high-value program that is really making a difference.”
The first two medical device start-up companies in Baltimore entered the program in January 2016. By March 2017, the program was serving 11 companies and considering others for admission, Davis said. The first FDA applications are expected to be submitted this year.