OMTEC 2015 Speaker Presentations

UDI: Uncover and Overcome Challenges Facing Orthopaedics (OMTEC 2015)

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How is UDI is being adopted globally? There's more to learn, here.

The complex manner in which orthopaedic devices are managed presents unique challenges for manufacturers required to comply with FDA's Unique Device Identification (UDI) rule. FDA has tasked manufacturers to work with surgeons, nurses and hospital supply chain personnel to develop effective mechanisms to label orthopaedic and spine products in a manner that will enable UDIs to be captured at the point of use for products that are often removed from their original packaging and placed in procedural trays. Learn about efforts underway at the Duke Simulation Lab and how those efforts can help your company meet fast-approaching compliance deadlines.

Karen Conway recaps UDI challenges unqiue to orthopaedics and shares why OEMs will benefit from OMTEC.

Session Takeaways
  • How UDI data can be used for internal improvement
Who Should Attend
  • Product Management
  • Supply Chain Management
  • Regulatory and Clinical Affairs

Speaker Bios


As executive director for industry relations at GHX, Karen Conway works internationally with standards bodies, government agencies, analysts and academic researchers, industry associations, and both suppliers and their customers to identify opportunities to optimize supply chain operations and improve business and clinical performance.

Prior to joining GHX, Ms. Conway served as principal of Conway Associates, a strategic communications firm built on the principles of continuous quality improvement. She has also worked as a journalist and in government and regulatory affairs.

Conway is co-author of Leading from the Edge and a contributing author for the book, e-Business in Healthcare.

Conway serves on the boards of directors of AHRMM, the supply chain organization for the American Hospital Association, and the Arizona State University Health Sector Supply Chain Research Consortium. She also co-chairs the HIMSS Supply Chain Special Interest Group and is active in the Medical Device Supply Chain Council and the Strategic Marketplace Initiative (SMI).


Dennis P. Orthman, CMRP, is Senior Director for SMI (Strategic Marketplace Initiative), a nonprofit industry organization dedicated to advancing the future of the healthcare supply chain.

Mr. Orthman has more than 30 years of healthcare supply chain management experience, having worked in purchasing, central sterile processing, distribution, OR supply, value analysis and logistics at integrated provider organizations, including Boston City Hospital and Boston-based Partners Healthcare and Caritas Christi Health System. As a consultant, he has successfully worked for BD Healthcare Consulting and VHA Improvement Services.

Mr. Orthman is active in AHRMM and a supporter of the data standards movement, serving as a member of the GS1 Healthcare U.S. Leadership Team for the last eight years.

Prepare for this Session

UDI is a Strategy, Not a Project

UDI has a wide range of applications and impacts on the healthcare industry. As such, manufacturers should treat UDI as a strategy, not simply an exercise in regulatory compliance, by looking at the benefits as well as requirements. For example, can the use of standard identifiers improve your internal processes, or could adoption of standard identifiers before the required date increase customer satisfaction? Healthcare systems participating in the Healthcare Transformation Group and many group purchasing organizations have called on suppliers to use standard identifiers in business transactions. Increasingly, U.S. hospitals and healthcare providers will be looking for data on which products deliver the best value, in terms of quality and cost, over time and across patient populations.

Access to post-market data can help manufacturers more effectively market their high-performing products. By recognizing the value of UDI to your organization, to your customers and to the patients, you can help realize a much greater return on what is a required investment.

Ms. Conway has shared this theory for years. Read the entire article, Unique Device Identification: From Compliance to Value, and find comprehensive coverage of UDI in BONEZONE.