Counsel on a medical device’s barriers to entry for the U.S. Army Telemedicine and Advanced Technology Research Center
The U.S. Army Telemedicine and Advanced Technology Research Center (TATRC) asked FirstLink to examine a finger-mounted ultrasound probe that it had funded a small company to develop.
FirstLink identified regulatory, competitive, and IP barriers to entry and explored mitigation strategies. FirstLink identified one of the major barriers to entry as FDA approval, including FDA 510(k) pre-market notification. FirstLink also identified pursuing a Clinical Trial CRADA with the U.S. Naval Health Research Center (NHRC) as a potential method for moving through 510(k) more effectively.
Outcome
FirstLink facilitated the Clinical Trial CRADA with the Navy, and the analysis was used to garner private equity and other additional funding, totaling over $2 million, for the small company involved.
– John Dement, ORTA/Technology Transfer Manager, Naval Surface Warfare Center (NSWC), Crane Division
that a spin out was the best path for technology developed by Department of Homeland Security and partners...more
