Mansfield, MA – February 9, 2016 – Proven Process Medical Devices Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, has been selected as the U.S. product development partner to further develop and manufacture Innoblative’s novel medical device. Incubated at Northwestern University’s Center for Device Development (Evanston, IL), Innoblative’s mission is to develop products to allow surgeons and interventionalists ablate surgical margins post excision.
To prepare the product for commercialization, Innoblative chose Proven Process as its product development and manufacturing partner. In doing so, Innoblative gains a partner that incorporates a full suite of services for commercial development of medical devices, from engineering and testing to project management and assembly, as well as ensuring all necessary FDA requirements are met. In addition, Proven Process holds ISO-13485 certification, covering contract services for the design and development, production and servicing of active implantable and in-vitro diagnostic medical devices.
“Innoblative’s impressive early-stage success to date underscores their efforts in developing a game-changing device,” said Ken Fine, President and Co-Founder of Proven Process. “We are excited to partner with Innoblative on the development of this surgical device, which complements Proven Process’ existing portfolio of medical device solutions designed to enhance the patient experience and the quality of care they receive.”
About Innoblative... Innoblative Designs, Inc. (Innoblative) is a medical device company whose mission is to develop products to innovate and improve the way surgeons treat surgical margins post excision. Our first product is a radiofrequency ablation (RFA) applicator that allows surgeons to effectively coagulate and ablate soft tissue beds intra-operatively.