Proven Process Medical Devices02.11.16
Proven Process Medical Devices Inc. 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, Ill.), 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 U.S. Food and Drug Administration 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.”
Innoblative Designs Inc. develops products to innovate and improve the way surgeons treat surgical margins post excision. Its first product is a radiofrequency ablation (RFA) applicator that allows surgeons to effectively coagulate and ablate soft tissue beds intra-operatively.
Proven Process Medical Devices designs and manufactures Class II and Class III medical devices. The Mansfield, Mass.-based company was founded in 1994.
Incubated at Northwestern University’s Center for Device Development (Evanston, Ill.), 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 U.S. Food and Drug Administration 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.”
Innoblative Designs Inc. develops products to innovate and improve the way surgeons treat surgical margins post excision. Its first product is a radiofrequency ablation (RFA) applicator that allows surgeons to effectively coagulate and ablate soft tissue beds intra-operatively.
Proven Process Medical Devices designs and manufactures Class II and Class III medical devices. The Mansfield, Mass.-based company was founded in 1994.