On September 24, 2013, the U.S. Food & Drug Administration published its final rule for unique device identification (UDI), which requires medical device manufacturers to assign and label their products with unique device identifiers or UDIs (in both human and machine readable formats) and to provide additional data on those products to a Global UDI database (GUDID).
While most manufacturers have focused their attention on UDI assignment and labeling changes, few have considered how they will comply with the more challenging aspect of the FDA UDI rule, which is sharing product data attributes with the FDA for the GUDID.
In this article, we’ll examine the FDA’s product data sharing requirements under the UDI rule, the challenges most medical device manufacturers face in complying with this legislation, and factors medical device manufacturers should take into consideration when developing a product master data strategy.
Product Data Requirements Under the UDI Rule
The FDA UDI rule requires manufacturers of Class I, II and III medical devices to publish unique device identifiers (UDIs) and product data attributes to the FDA Global UDI database (GUDID). Manufacturers with high volumes of items can publish to the GUDID electronically via HL7 Structured Product Labeling (SPL) messages through the FDA Submissions Gateway. The graphic below outlines the compliance dates for manufacturer submission to the GUDID.
A recent survey of medical device manufacturers on UDI adoption and use trends by management and technology consulting firm Booz Allen Hamilton Inc. found preparing product data for submission to the GUDID to be “one of the larger challenges for manufacturers as data attributes may be spread throughout various production and legacy IT systems within organizations.”1
Our work at GHX to help medical-surgical manufacturers meet UDI requirements corroborates this finding. Most manufacturers, even global leaders selling tens of thousands of products in numerous countries and regions, face an uphill battle as they attempt to gather the required product attributes from various sources, assimilate the data in a central repository, share the data with the FDA (as well as other regulatory bodies and business partners), and communicate to the FDA and other data consumers product changes that impact these attributes.
Key findings from our implementation experience include:
- To meet UDI requirements, our customers have identified between 70 and 120 individual attributes that have to be collected, depending on the specific product; significant effort is required
- At one customer, over 60 individuals from 10+ functional areas of five sister companies have been involved in the effort to become UDI compliant; truly cross functional
- After 6 months of effort, one manufacturer discovered that both an owned U.S. based original equipment manufacturer (OEM), and a foreign division, had been duplicating UDI / standards efforts; internal awareness is key
- Initial test load by customers into the GHX Health ConneXion (GS1 GDSN-certified data pool) routinely result in rejection of 50+% of the lines due to format, accuracy and incomplete records; identifying and harvesting the data is only a part of the process
Moving Beyond Spaghetti Product Master Data Processes
A major roadblock to compliance with the UDI rule is that medical device manufacturers simply don’t have all of the product information they need in one place in a format that meets the FDA’s requirements for the GUDID. Various product attributes are often stored in separate IT systems with manufacturers unable to reconcile the data and easily merge it into an electronic file. In the worse case scenarios, the product data necessary for UDI resides in manufacturing and labeling specifications scattered throughout an organization.
Furthermore, most device manufacturers currently rely on, what I call “spaghetti product master data processes,” to share/update product data attributes with regulatory bodies and business partners (e.g. customers, GPOs, distributors). Examples of this include:
- Providing product updates to distributors, providers and GPOs via Excel spreadsheets and emails
- Sharing regulatory data with global authorities via Excel spreadsheets and emails
- The inability to share real-time product master data updates with trading partners using current processes
And this isn’t a new problem isolated to the FDA UDI legislation. Manufacturers have struggled for years to accurately and efficiently share product data externally. Organizations today have armies of people trying to keep product data in sync – though the level of effort to TRY to stay in sync is still mind-blowing and overwhelming. And since updates are not being done in real time, the industry continues to have significant discrepancies with orders because of mismatched product attribute data.
The reality is that the FDA, and most of the other global regulatory bodies, GPOs, distributors and healthcare providers, are asking, and will soon be demanding, regular updates to product master data. Add up the hundreds to potentially thousands of trading partners and regulatory bodies that need to receive timely product updates and it becomes clear that existing messy spaghetti processes will not work.
With Crisis Comes Opportunity
While at first glance compliance with the FDA UDI rule poses many costly, labor-and technology-intensive challenges to medical device manufacturers with little business reward, at second glance it becomes clear that UDI presents an opportunity for them to transform their product master data management strategy for greater process efficiency and business transaction accuracy.
Medical device manufacturers surveyed by Booz Allen Hamilton Inc. on UDI implementation rated “information sharing” as the highest significant benefit of the legislation.
In our experience at GHX, those manufacturers that are garnering the greatest business benefits from their UDI investments are those that are taking a step back and implementing a product master data management strategy that not only enables them to comply with the FDA legislation but also tackle the product data challenges they are currently facing with other regulatory bodies and business partners.
Considerations When Developing a Product Master Data Strategy for UDI
To comply with the FDA UDI rule and gain incremental business value from their product data management investments, medical device manufacturers must take a systematic, holistic, sustainable approach to product master data management. Below are factors a manufacturer should take into consideration when developing its strategy:
Sourcing Product Attribute Data
When asked how they will source attribute data for the GUDID, many manufacturers tell us that they plan to take a piece meal approach. Because the UDI regulation rollout is risk-based, requiring manufacturers of Class III products to comply first, manufacturers often plan to initially source product attribute data for this category of products and then tackle UDI data for their other product classes as they are required to do so.
The problem with approaching the UDI regulation in phases is that a manufacturer will end up allocating three-times the cost and effort compared with if they sourced attribute data for ALL of their products at the same time. The work to segregate Class III products from other classes of products alone is an enormous undertaking. In our experience working with medical device manufacturers on UDI preparedness, investing the time and effort up front to source product attribute data for all products saves considerable costs in the long-term.
Storing Attribute Data Internally
Medical device manufacturers have no choice but to move beyond Excel spreadsheets and paper files to comply with the FDA’s UDI initiative. These methods simply do not provide the change control and management required for regulated data. Product data in the device world is fluid and constantly changing and even minor changes to a product require a manufacturer to assign a new SKU number. With product portfolios comprised of 25,000, 50,000, even 100,000 SKUs, there is no way a manufacturer can effectively and efficiently manage this level of change manually in a spreadsheet or paper file.
Because this product data is now regulated, it must be accurate and accuracy must be maintained. Manufacturers are turning to solutions that enable them to establish a single source of truth for their data. By moving from manual to electronic, automated processes that enable them to store product data in an electronic repository, manufacturers can manage the multitude of changes and maintain data integrity to both comply with regulations and meet the requirements of their business partners.
Sharing Data Externally
The reality today is that regulatory bodies and business partners require manufacturers to share product data in an accurate and efficient manner. If a manufacturer takes the traditional approach to external data sharing, using individual, disjointed methods to connect with various stakeholders (e.g. regulatory bodies, partners, customers), it must manage protocols, specifications, support and maintenance for each pipeline separately. This increases both cost and complexity.
The best way to streamline the data sharing process and reduce associated costs is to share data with various parties through a single, common connection – taking the one to many route. By using a single pipeline for product data sharing, a manufacturer need only invest in one development process and maintain a single support mechanism. This approach enables a manufacturer to manage all of its product data attributes in one place and draw from a single repository to transmit data updates to regulatory bodies, distributors, group purchasing organizations (GPOs) and providers.
Benefits of leveraging a single connection for product data sharing:
- Source product data electronically from internal systems
- Establish a single, electronic source of truth for product data and manage all data in once place via a single process
- Share product data electronically with the FDA, other regulatory bodies, and business partners
- Leverage automation to update product data and synchronize this data with regulatory bodies and business partners in real time
Now that the long-awaited FDA UDI rule has been published, the clock is ticking for medical device manufacturers to comply with the regulation and sharing product data attributes with the FDA for the GUDID is one of the greatest challenges. Most device manufacturers are currently at a cross-roads: they can try to comply using their long-established disjointed, manual processes for managing product data, which might seem like the easier route in the short-term but will only lead to greater effort down the road as manufacturers face the challenge of keeping their data accurate and up to date.
The other option is for manufacturers to move beyond antiquated “spaghetti product master data processes” and embrace a holistic approach to their product master data strategies that leverages an electronic source of truth and automation to source, store and share product data attributes. This approach not only enables a manufacturer to comply with the FDA and other regulatory bodies, but also greatly improve its efficiency with customers and business partners.
1 Unique Device Identifier Study: Adoption and Use Trends for Medical Devices. Booz Allen Hamilton Inc. May 2013.