CoapTech News

CoapTech News for Summer 2018

Sep 6, 2018 12:30:00 PM / by Jack Kent, MBA, MPH

With Labor Day bringing the unofficial end to summer, here's a quick recap of our Summer Milestones:
  • The spring conference season dovetailed into increased clinical interest over the summer. Several interested doctors followed up with us directly to pursue clinical research opportunities. Stay tuned for more updates on this - and of course, if you're interested in research at your institution, see our early adopter page.
  • Summer also yielded CoapTech's first commercial-level manufacturing effort. We are excited to share some pictures below. Subsequent lots are in the works. 

  • Final product testing is underway for FDA (and CE Mark) technical files. Preliminary test results have been promising - including our GLP canine study in June.

  • The company just won an award for "Medical Device Incubator Company of the Year" for Maryland Incubators! A big Thank You to everyone who helped us along the way. 

Summer Update 2018

 

 

Topics: Updates from CoapTech

Jack Kent, MBA, MPH

Written by Jack Kent, MBA, MPH

Mr. Kent is an experienced medical device executive with significant prior work leading companies in efforts to deliver novel technology and positively impact patient care. In his most recent endeavor, Mr. Kent directed 6 product development projects from concept to delivery. These products are now available in the United States, the European Union, and Canada. His team successfully navigated FDA reviews, CE Mark reviews, FDA inspections, and ISO 13485 Notified Body audits – among other activities. Mr. Kent has worked with diverse product types, ranging in specialty (e.g., IR, GI, ORTH), use (therapeutic/diagnostic), and other characteristics (e.g., electrical, single-use vs. reusable, sterile/nonsterile, software).