WARSAW, Indiana, April 17, 2012 /PRNewswire/ --
Organizers of the third annual OrthoTec conference have announced two keynote presentations that will be held at the Orthopaedic Capital Center at Grace College in Warsaw, Indiana. The keynote is part of a conference that attracts over 400 orthopaedic technology professionals each year with the co-located expo attracting hundreds more.
Emerging initiatives within the Office of Device Evaluation have resulted in new guidance documents being issued to assist in the preparation and review of premarket submissions. In addition, MDUFA III negotiations are ongoing, potentially altering the timeline under which premarket submissions are being reviewed. On June 6, Stephanie Bechtold, Scientific Reviewer in the Orthopedic Spine Devices Branch, ODE, CDRH, FDA will discuss how these changes may affect the orthopedic technology and regulatory communities and outline some "best practices" to consider when preparing a premarket submission for FDA review.
Headlining the second day, Christopher Loose, PhD, Chief Technology Officer, Semprus BioSciences will provide a case study outlining the process of rational design of orthopaedic devices with a focus on biointerfaces. Founded out of the labs of MIT Professor Robert Langer, Semprus BioSciences has rationally engineered the medical device/human biology interface to enhance performance and safety. First applied to vascular products, the non-leaching Semprus™ Technology is redefining expectations for duration of performance, with sustained reduction in bacterial biofilm formation, even after 90 days of blood product exposure. Under the guidance of the US Army Institute of Surgical Research, Semprus has developed a novel orthopedic device prototype that combines eight weeks of controlled release of an antiseptic agent with the Semprus™ Technology.
OrthoTec is produced by UBM Canon, the leading producer of conferences, trade events and media brands that support the flow of information, commerce, and innovation in the world's $3 trillion advanced, technology-based manufacturing sector, including the medical device, packaging, design engineering, process technology, automated assembly, electronics, quality control, and plastics processing segments."
To learn more, visit OrthotecConference.com or call +1-310-996-9435.
SOURCE UBM Canon