mdPACE is a Program jointly funded by TEDCO and a Federal Department of Commerce EDA i6 Grant. The output of the program will be an increased flow of FDA cleared devices from the Central Maryland region.
The core value proposition of this program is quite simple - by applying the continual expertise of individuals who have successfully navigated the medical device commercialization process, the Program will assist entrepreneurs generate 510(k) cleared technology in 12-18 months less than the 36-42 months needed by an inexperienced, unguided team.
It is estimated that the cost of a team going through the Program's efficient process will be $300- $500K (including modest team salaries) versus $600- $800K for the unguided team. Program experts will focus the team on an early design freeze and on the specific, proven, design control oriented requirements of the 510(k) submittal process. The nuances of these requirements are often apparent only after taking several medical devices through the process; they are not readily apparent to an inexperienced team.
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