Deadlines are fast approaching for medical device makers to unveil their Unique Device Identifier compliance programs and, if last year’s survey results are any indication, many companies are unprepared.
When PricewaterhouseCoopers surveyed more than 300 industry participants last year, less than 1 in 5 said they were prepared for UDI implementation and 19% said that they had not even started planning their UDI programs.
The FDA finalized its UDI rule in September 2013, to a mixed reaction from the medtech industry. The UDI rule requires most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety. The program will assign unique codes to most medical devices and gather data to be stored in a publicly accessible database.
Device makers have been cautiously optimistic about UDIs and some are planning to use the labels to improve their own tracking, customer service, internal productivity and comparative effectiveness programs. Others are expecting only to fulfill the bare minimum to keep regulators off their backs.
"Most manufacturers consider UDI simply a regulatory requirement," according to the PwC analysis. "They most likely will not realize the full potential of UDI until they have had the opportunity to use their new capabilities in a variety of internal processes and transactions with providers."
As the cut-off for filing compliance extensions is less than 3 weeks away, analysts at PwC offered 4 tips to help medtech companies to get on track.
1. Assess the portfolio
The UDI program has varied deadlines and requirements for different classes of products, based on the FDA’s risk-classification parameters. Organizing devices and kits into appropriate categories will make it easier to determine the impact that UDI labeling will have on the full portfolio.
According to PwC: "A critical first step is for manufacturers to identify all of their devices by class and review their product configurations and convenience kits to ensure that they characterize their entire device portfolio. As they go through this process, manufacturers will develop a clear understanding of their product shelf-life and inventory on hand in order to manage their existing inventory of products with non-UDI compliant labeling."
2. Start NOW
Updating product labels is likely to take some time, so it’s imperative that companies get started right away, if they haven’t already. In addition to labeling requirements, device makers also need to establish reporting systems to update the Global Unique Device Identification Database on each applicable device.
According to PwC: "When they first read the UDI Final Rule, some manufacturers may think that compliance timelines are far on the horizon. However, when they determine the time required to update labels, create attribute data collection and reporting capabilities, and update quality and regulatory procedures, they realize that three years is not much time to prepare for, say, Class II compliance."
3. Take a holistic approach
An objective risk assessment and validation exercises can help ensure that individual companies’ labeling programs are practical and ready to handle any issues that may arise.
According to PwC: "The key is to recognize potential program risks before they occur and be ready to take action should they materialize. Good, old-fashioned project management is necessary to identify issues before they have a significant impact on schedule, cost, quality, or compliance. Organizations should define up front their key criteria for success and identify how they will verify stakeholder satisfaction during the course of implementation."
4. Work in phases
Companies need realistic timelines, efficient communication and support from varied sources early and throughout the UDI implementation project. Having a solid plan is vital.
According to PwC: "The implementation plan must account for the time required for estimated net resources to do everything from revise labels to update standard operating procedures. These time and resource budgets inform a multi-phase, multi-year schedule of expense and capital costs for the program."