ImplantBase, LLC and Matrix IT Medical Tracking Systems, Inc.
ImplantBase offers an industry-leading, all-in-one cloud-based software and inventory management platform that integrates with ERP & financial systems and provides manufacturers with real-time control over their sales, inventory, and supply chain. Matrix’s TRACTUS system has been integrated with ImplantBase to streamline the medical device tracking process, offer enhanced functionality for customers, and provide efficient point-of-care solutions.
Together, the ImplantBase and Matrix collaboration will advance medical device manufacturers’ ability to become compliant with FDA UDI (Unique Device Identifier) Final Rule regulations set to go into effect between 2019 and 2021. New UDI regulations for Class II life-supporting or life-sustaining medical devices will bring new standards for visibility and traceability and reshape how manufacturers will organize their products to be compliant.
The TRACTUS Scanner System offers a UDI-compliant, simplified and reliable documentation process for the sterile field of an operating room while communicating with the hospital’s EHR. Additionally, the Scanner System checks medical device attributes (i.e., serial number, model/version number) against the FDA database in real time to check for recalls or product issues. This allows for immediate adherence to product recalls before damaged or defective products can wreak unnecessary damage to a patient’s health.
The benefits of this joint venture allow participating locations to track the entire life cycle of a medical device or implant, from the manufacturer through the custody of representative to surgical implantation and beyond. This technology provides cloud-based solutions, improved accuracy and continuous device analytics.
“UDI compliance presents huge challenges for manufacturers,” notes Ethan Lauer, CEO of ImplantBase. “But it also offers extraordinary possibility for efficiency as companies evolve their systems and capabilities. We’re excited to play a role in bringing that kind of efficiency to the industry.”
With a strong standard for medical device traceability as a key driving focus, this collaboration offers a solution to many of the problems currently plaguing the medical device chain of command. Both companies are eager for the prospects of this collaboration and the shift toward a system which complies with the needs of an evolving industry.