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FDA’s Unique Device Identification (UDI) System is expected to transform disparate medical identification methods in used by different Healthcare stakeholder into a single device identification system that is consistent, unambiguous, standardized, and globally harmonized.  To reach this goal will require the collaboration of all constituents in the medical device ecosystem.

The upcoming UDI Conference will provide an industry gathering to help medical device manufacturers, distributors, and hospitals prepare for implementing UDI.  Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food & Drug Administration (FDA) will be providing the keynote address at the UDI Conference.

Leading Healthcare Associations will help sponsor the event to help medical device manufacturers, distributors, and hospitals prepare for implementing UDI.  Association Sponsors include: AHRMM, AIDC 100, AIM, GS1 US, GS1 Global, HIBCC, and HIDA.

Axendia will be covering the UDI conference. Stay tuned for updates in Life Science Panorama. The UDI Conference is scheduled for December 1-2, 2010 at the Hyatt Regency Baltimore, MD.

To view the Conference Agenda at: http://udiconference.com/agenda.html

For additional information about this conference visit:  http://www.UDIconference.com

Outsourcing and Globalization have become increasingly prevalent in the Life Science Industries.  Yet Global Supply Chains have created unintended results.  Increased complexity and risk are driving Industry Executives to reevaluate globalization strategies, according to a major study conducted by Axendia. 

In the drive to lower costs, manufacturing and sourcing of ingredients and components in countries such as China and India are playing a more prominent role. Yet, according to the research, outsourcing to manufacturers in developing economies carries significant operational risks.  Industry Executives surveyed for the research said that Raw Materials sourced outside the US represented the greatest risk to the Value Chain, with 94% of those who responded seeing it as a significant or moderate risk.  When comparing the risk profile of US vs. foreign raw material Suppliers, United States Suppliers were classified as low risk nearly 10 times as often as foreign Suppliers.

The report provides a road map for Life Sciences Executive to achieve Real-Time Visibility and control of Global Supply Chains.  It also calls for the implementation of better collaboration among Brand Owners and their suppliers, distributors, shippers and regulators. Because of the size and complexity of global supply chains, the most cost-effective option to oversee the end to end supply chain will require cooperation and the sharing of information across all stakeholders in Life Science ecosystem to ensure the safety, efficacy and effectiveness of products.

The complete findings of this research study are available in a new report entitled, “Global Supply Chain Visibility, Control & Collaboration: Business Imperative, Regulatory Necessity”.

Read the Research Alert 

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