The Case for Unique Device Identifiers managed in PLM
Today the FDA requires medical device organizations to submit device information to the Global Unique Device Identification Database (GUDID) for all medical devices sold in the United States.
Challenges during the development, testing and submission processes include reacting to market drivers and regulatory and governmental constraints. Organizations are always assessing whether their products are compliant while keeping the overarching goal to design and produce the best possible device.
FDA UDI was initiated to enable better traceability of medical devices throughout the supply chain and to improve the information available to manage product quality issues, which could impact the patient.
UDI and Digital Twin
Organizations have several options to explore:
- Build a stand along system which has interfaces to PLM, ERP and MES and a gateway to the FDA database
- Host UDI solution in one of the key systems, PLM, ERP or MES and pull other required information from the other systems
- Use a third-party provider to manage UDI information including submissions
UDI is the link between the physical product and the virtual twin in PLM. With UDI managed in PLM, it becomes easier to correlate the virtual twin to a specific UDI or device and simulate the behavior of the physical product in context to quality incidents in the field.
Case for PLM
There are a multitude of benefits from UDI adoption, from supply chain efficiencies to understanding what products, and more importantly, which clinically relevant attributes work best on which patients. In other words, it’s not just about knowing when something goes wrong, but also about what is working at any given time in the real world, which can help providers source the right products and manufacturers to design and market those products.
The majority of the information needed for driving the value of UDI resides in PLM. Managing UDI in the same system helps better associate information for increasing the value of electronic UDI.