As a leading manufacturer of biomaterial products, Kensey Nash has invested heavily in equipment and personnel as well as built the infrastructure necessary to allow us to develop unique fabrication and processing methods for numerous biomaterial platforms and products.Annually, KNC manufactures over 4 million resorbable product units representing approximately 150 commercialized products for a wide variety of customers.

Our facility is equipped with multiple ISO class 8 clean room facilities and our Quality System is certified to the international quality standard ISO 13485. From art-to-part, KNC has extensive in-house facilities for tool and die as well as mold and model making to support our developmental and commercial programs. Our manufacturing capabilities include injection molding, extrusion, compounding, cleanroom machining, collagen production and cleanroom lyophilization, all of which are performed to cGMP standards. These resources provide KNC with the unique ability to develop products and transfer the completed design to manufacturing for rapid commercial production. KNC’s integrated infrastructure also includes analytical test labs with both chemical and mechanical testing abilities. We have a separate in-house quality assurance department that sets standards, monitors production, writes and reviews operating procedures/protocols and performs final testing of products.

KNC’s expertise in biomaterials encompasses multiple material platforms to address specific needs of our customers. We have significant experience working with a variety of biomaterials such as synthetic polymers, collagen, and ceramics.

Our design and development team includes experienced engineers, scientists, technicians, and toolmakers. Together, they generate unique solutions through the integration of laboratory research, in vitro, ex vivo, and in vivo feasibility testing, prototype development and manufacturing. Research and development projects are performed under design controls in accordance with U.S. and international standards. KNC works with our customers to develop project schedules that included well-defined tasks and milestones to reduce risk and minimize time-to-market.