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It may only be three letters, but for some manufacturers, UDI is a four-letter word. There are others who see the regulation as an opportunity to better understand product performance, speed up regulatory approval and coverage decisions, and improve the cost of doing business with customers.
For those not familiar with the acronym, an increasing number of regulatory bodies around the world, including the U.S. FDA and the European Commission, are requiring manufacturers to fulfill three primary requirements: 1) assign unique device identifiers (UDIs) to their products; 2) label those products with the UDIs in both human and machine (think bar code, RFID) readable formats; and 3) publish additional attributes about those products to regulatory databases.
Compliance with those requirements is an ongoing effort (not a one-time project) that requires coordination across a wide variety of functions within a manufacturer organization, from regulatory affairs and printing to marketing and information technology.
Data governance is also critical, especially as more countries and regions of the world begin to publish their own UDI regulations. China recently published its draft regulations, and UDI activity is underway in Saudi Arabia, Taiwan, South Korea, and Brazil, to name just a few. Despite efforts by regulators to harmonize their UDI regulations according to guidelines published by the International Medical Device Regulatory Forum, even minor differences in regulatory language and implementation can create compliance challenges for manufacturers and for their customers. Further complicating things are regulations, such as those issued by the Department of Health in the United Kingdom, requiring use of GS1 standards as part of its eProcurement policy. The GS1 identifier for products—the Global Trade Item Number (GTIN) —is one of three UDI compliant codes in the United States and Europe and likely in other regions.
Regulatory compliance is not cheap. Prior to the publication of the U.S. UDI rule in 2013, the federal government published research that predicted complying with the three steps would not exceed one percent of revenues for most companies. Anecdotally, some manufacturers estimate the costs could be higher; some also recognize the potential for a return on what is essentially a required investment, but only if they go beyond checking the regulatory box. The following are opportunities that can help expand how manufacturers view and value the UDI regulation.
Stronger Customer Relationships
UDI can form the basis for more-productive customer conversations. Hospitals in the United States, and soon in Europe, are required to capture UDIs for patients’ implantable devices in electronic health records and share them as part of the Common Clinical Data Set. Beyond this regulatory requirement, providers increasingly need to understand what it costs to deliver care and how those costs relate to quality and financial metrics. Understanding how and why providers will use UDIs to solve the cost-quality equation can help manufacturers forge stronger relationships with their customers.
Evidence to Tailor Marketing and Improve R&D
As providers around the world begin capturing data on product performance in routine clinical practice, suppliers will be able to leverage a robust source of real-world evidence to demonstrate when specific products work better on specific patient populations. In some cases, this data can be used to demonstrate when a more expensive product is warranted based on specific patient needs. Further, because UDIs can also be tied to specific product attributes, manufacturer R&D organizations can use this data to improve future product designs.
Faster Regulatory Market Approval
FDA has made it clear that it wants to reduce regulatory burden for manufacturers and bring innovative products to market faster. At the same time, FDA Commissioner Scott Gottlieb says innovation and safety must go hand in hand. By unambiguously identifying products in post-market surveillance research, manufacturers can gather data to support supplement pathways for approval of new product iterations (many of which do not require new clinical data based on human testing), while also providing market assurance that product safety is being monitored. The European UDI regulations go further by requiring manufacturers to use UDIs “to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including the clinical benefits, of the device when used as intended by the manufacturer.”
Earlier and More Robust Insight into Adverse Events
Despite the best efforts of manufacturers and regulators, Commissioner Gottlieb told those attending the Medical Device Innovation Consortium Public Meeting in September that you can never have absolute uncertainty as to a device’s safety and effectiveness. As UDI regulations proliferate around the world, there will be more data sources globally where UDIs are used to identify which products are used on which patients. Then, if something does go wrong, there will be more opportunities to spot the problems sooner and take corrective action, minimizing patient harm and reducing manufacturer liability.
Business Case for Master Data Management Investments
When the UDI regulation was published in the United States, some manufacturers used the regulation as the business case to invest in master data management. Not unlike many providers, and even FDA, manufacturers historically have often identified products differently for different purposes and in different systems, e.g., for billing, rebates, e-commerce, inventory management, etc. Manufacturers that have taken this approach have eliminated redundant work and potential version control issues that come with managing multiple databases. Their customers have also reported that manufacturers that have gone beyond regulatory compliance are easier to do business with because they can provide accurate, comprehensive, up-to-date, and standardized information about their products.
In the end, UDI compliance is a fact of life for manufacturers. They must either comply with the rule or risk no longer being able to sell their products in a given market. How a manufacturer approaches UDI compliance is less certain and can make the difference between more regulatory burden and higher costs of doing business or the opportunity to build better relationships with customers and building better products for patient care.
Which is better for your organization?