Last updated on April 20, 2014 at 13:20 EDT

OrthoTec 2012 Keynote Speakers Announced

April 17, 2012

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(TM) 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(TM) 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: PR Newswire