According to Gartner, master data management is “a discipline in which the business and the IT organization work together to ensure the uniformity, accuracy, semantic persistence, stewardship and accountability of the enterprise’s official, shared master data.” Specific to product data, Ventana Research defines product information management as “the practice of using information and technology to effectively support people- and product-related processes across the enterprise supply chain throughout the life of a company’s products.” Uniting these two concepts, we have an enterprise information management solution that enables centralization of product information from the various systems, creating a single view of that information which can be leveraged across all business units, lines of businesses and functional areas.
Master data management for product data, also referred to as a product data hub or a PIM solution, can be a valuable component of an overall solution in addressing unique device identifier compliance — especially when teamed with similarly focused data governance and data quality management programs. Having a centralized place to govern device information ensures that your organization can properly manage and rapidly respond to changes to that data. Much like the FDA’s Global Unique Device Identification Database, or GUDID, serves as a master data hub for information on approved medical devices, an individual device manufacturer’s product data hub enables the organization to unify and manage all of its medical device information.
Having a product data hub provides an opportunity to clean, rationalize and store an organization’s device data outside of the lines of business or manufacturing-centric systems. It also allows for the development of a standard way of creating and managing UDI codes and preparing data for FDA-mandated submission. Essentially, by “abstracting” the data needed to comply with UDI requirements into another system, it dissociates the creation, management and preparation of this data from the complexities of the underlying systems.
More than being just a repository for device attribute data and records, however, a PIM solution helps to automate the business processes necessary to create, track, manage and submit the information required for UDI compliance . By leveraging the workflow capabilities of a PIM solution, an organization can ensure proper approval processes are followed and an audit trail exists to demonstrate traceability and transparency to regulators. Employing a PIM solution also reduces the manual burden of data management and human intervention, which then increases efficiency and productivity associated with UDI compliance. For the purposes of this article, we will use the terms PIM solution and product data hub interchangeably, although technically, the PIM solution has more workflow capabilities than a typical product data hub.
The value of a product data hub to a device manufacturer becomes even more evident in light of the acquisition activity common in the medical devices industry. Companies that have grown through acquisition often end up with a plethora of different systems to create and manage their device data. Each acquired entity may also maintain its own labeling systems, processes and standards. Consequently, it becomes even more difficult to track and manage the uniformity, accuracy, semantic persistence, stewardship and accountability of label identifiers as well as other device data elements.
Managing Internal and External Data
In addition to enabling the consolidation of attributes and other device data necessary for ensuring that product information is complete and accurate, the product data hub also provides a landing place for the data enrichment and third-party data needed to build a complete UDI record.
Unlike the system in place for pharmaceuticals where the FDA distributes NDC (national drug code) numbers, medical device manufacturers will create, assign and maintain their own UDI codes according to ISO standards with the help of issuing agencies, such as GS1, HIBCC (Health Industry Business Communications Council) and ICCBBA (in the case of human blood, cell, tissue and organ products), that have been accredited by the FDA. Manufacturers will be assigned an enterprise-specific prefix by the issuer, which they will use in combination with their own device-specific code to build the device identifier portion of the UDI. The product data hub provides a convenient place to link such external data with device data generated and managed in-house.
Other third-party data required for submission to the GUDID include:
- The GMDN (Global Medical Device Nomenclature) code(s)
- The D&B D-U-N-S number for the manufacturer
- The FDA product code and listing number or the premarket approval submission number (as applicable)
With multiple feeds of data coming into an organization, a product data hub enables the aggregation of the data from all these feeds, facilitates the integration of this data with company-produced data and creates a unified data management environment.
A Platform for Unified Submissions
The device identifier component of the UDI code along with a standard set of identifying device and packaging attributes must be submitted to the FDA’s GUDID. This database is meant to serve as the authoritative “single source of truth” for all approved medical devices in the United States labeled with a UDI.
As with the UDI code itself, individual GUDID records will be maintained by device manufacturers. They will be able to submit UDI record data via the GUDID Web interface or as an XML file according to the HL7 SPL (Health Level Seven Structured Product Labeling) standard. In aggregating both internal and external data, a product data hub provides a single repository from which the manufacturer can draw the data required for submission to the FDA. Having all of the product data in one place eases data management efforts, from the data validation needed prior to submission to the handling of exceptions and errors that may bounce back from the GUDID as part of the submission process.
Medical device companies that are not able to acquire PIM solutions will, alternatively, be able to hire the services of a data pool company like GS1 or GHX to provide the HL7 SPL submission on their behalf.
Leveraging a Product Data Hub
Similar to the case for data governance, if your organization has an existing product data hub or PIM solution, it is possible to extend those capabilities to accommodate the needs of UDI compliance. However, if your organization does not yet have a standard approach to mastering device data, focusing on establishing a product data hub that will address UDI compliance presents the opportunity to subsequently extend those capabilities to mastering, optimizing and governing other organizational product data. This will, ultimately, enable your organization to be better prepared for future regulatory requirements.
The final article in this series will tie all three components of enterprise information management discussed — data governance, data quality management and master data management for product data — together and articulate a plan for getting started with UDI compliance.