Maintaining a well-oiled data trail and supply chain is critical in any industry, but it’s especially important in the life sciences sector. Not only does this industry make up a large portion of the global economy, but there are other reasons that traceability and transparency are important for the health field, too; namely that people’s lives are potentially on the line if something goes wrong.
The regulations surrounding this sector are particularly strict, especially given the FDA’s final ruling on unique device identifies from 2013. With growing complexities in the global marketplace and higher demand than ever for more control over and transparency within the product development process, it’s becoming critical for companies to step back and assess their data. Design data, therefore, is a crucial aspect of this industry.
Regulations regarding medical devices and UDIs will continue to evolve as other jurisdictions develop and finalize their unique device identifier legislation.
The news on UDIs
Industry standards involving UDIs have been evolving over the past few years, and will continue to do so for several more. As of Sept. 24, 2015, medical device manufacturers were required to label all medical implantable, life-saving or life-supporting devices with UDIs, as well as register the products in the GUDID (Global Unique Device Identifier Database) in order to facilitate increased transparency in the supply chain. By 2018, compliance will be required of all Class I, II and III devices.
The idea behind requiring all medical businesses to comply with UDI requirements stems from the need for traceability of medical devices. The important thing to note is that with this kind of transparency, companies will be able to better and more swiftly manage product quality issues and potential recalls that could have an impact on patients’ lives. In addition, consumers can access the data about their own medical devices through the GUDID.
Technology in the supply chain
“Supply chain managers need to have complete oversight over their operations at all times.”
With the stringent regulations surrounding UDIs and the need to have effective practices for implementation, manufacturers should ensure they have the right tools for managing UDI data and processes, as well as maintain clear documentation trails. In this endeavor, technology solutions and data-gathering functionality play an important role.
The more critical the performance of these devices, the more imperative the need for medical device companies to have complete oversight over product development. Innovation management solutions from Inspirage, such as the UDI solution that leverages Oracle Agile Product Lifecycle Management technologies, offer companies within the medical device supply chain the oversight necessary to maintain transparent operations in the wake of changing regulations. Inspirage is the leader in helping medical device companies become UDI compliant because of our deep expertise in the medical device industry and history of rapid and effective UDI implementations across the globe. For more information, contact Inspirage today.