Matt Otten
Partner, Regulatory & Quality
Matt is a medical device industry veteran with over 35 years of experience in the design, development, and manufacturing of numerous medical devices. He is the holder of several medical device patents and has designed, launched, and commercialized devices for endoscopic, laparoscopic, arthroscopic, cardiovascular, neurovascular, urology, gynecology, general surgery, and many other clinical applications. Matt has extensive experience in the development and implementation of FDA 21CRFR 820 and ISO 13485 compliant Quality Management Systems and championed the regulatory planning and clearance for multiple medical devices both domestically and internationally.
Matt started his career in medical devices with Ethicon (J&J) serving in both the product development and operations groups. Matt was a founding member and Vice President for Interplex Medical, a leading medical device contract manufacturer with facilities in the US, Asia, Mexico, and Europe. He was also the VP of Engineering and Manufacturing for SeCQure Surgical and Eccrine Systems.
Matt is a graduate of Miami University (Ohio) in Mechanical Engineering Technology and a Six Sigma Master Black Belt. As an established entrepreneur and leader, Matt has founded or co-founded and led successful medical device companies and service providers.
Fun Fact
He is an avid golfer.
