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Orthopaedic Industry Must Respond to Payor Denial of Implant Coverage
Simplicity of design and delivery key to industry’s future

CHAGRIN FALLS, Ohio, June 17, 2014 / Orthopaedic device manufacturers have long battled the regulatory landscape to product approval. A seemingly never-ending onslaught of globally-changing requirements has created a robust breeding ground for regulatory consultants, navigators and direct hires. But, “FDA [regulatory] approval doesn’t equal insurance [payor] approval,” surgeon entrepreneur and inventor Robert S. Bray, Jr., M.D., reminded industry during his keynote address at OMTEC®, the 10th Annual Orthopaedic Manufacturing & Technology Exposition and Conference.

Payor denial of procedures and products lacking long-term data are expected to escalate as both industry and government-sponsored payor systems scrutinize spend to support and comply with the Affordable Care Act. Bray’s keynote remarks echo observations offered in 2011 by veteran OMTEC speaker Kelli Hallas, when she urged attendees to integrate reimbursement strategy at the development phase and offered a ten-step checklist to aid in the process. “Even some of the most promising technologies have failed because of lack of reimbursement,” cautioned Ms. Hallas.

“Contract manufacturers and other suppliers are expected to take a vested interest in the bottom lines of their OEM customers as they seek to mitigate their challenges and identify opportunities. So too are OEMs compelled to assume a similar role in support of all payor systems, private and government-sponsored,” commented Carolyn LaWell, Content Manager of ORTHOWORLD®. “Ensuring reimbursement for hospitals and alternative sites of care is absolute.”

Dr. Bray closed his keynote address to 500+ industry professionals by advocating for investment in biologics, robotics, team problem solving, reduced sterilization needs and overall simplicity of use.

“OMTEC is honored to be home to such an impressive array of experts,” commented Julie Vetalice, Content Coordinator with ORTHOWORLD. “The last five years have fueled investment and education on clinical outcomes data collection, shifting of care to alternative sites, UDI (Unique Device Identification) preparedness and other business critical dynamics. OMTEC is the annual checkpoint that facilitates continued forward movement for the betterment of industry and the lifeblood of our future.”


Founded in 2005, OMTEC is recognized as an international conference that provides orthopaedic industry professionals the tools and partnerships needed to improve performance. OMTEC 2014 speaker presentations and 2015 event updates are available at www.OMTECexpo.com. Industry is encouraged to save the dates of June 17-18 for the 2015 event in Chicago, Illinois.


Founded in 1992, ORTHOWORLD is a highly specialized publishing firm offering strategic intelligence, integrated advertising and educational conferences exclusively to the global orthopaedic market. Its singular mission is helping orthopaedic companies and individuals improve their performance.


Carolyn LaWell
Phone: 440.543.2101
Email: carolyn@orthoworld.com

Watch Dr. Bray's Keynote Address here.