Our author says to expect UDI costs to be as much as 1%+ of annual sales. Ongoing costs and post-market surveillance factors are also discussed. This new regulation is not without its costs. Some are significant, especially to small medical device labelers. There are the obvious implementation costs and ongoing maintenance. There are also “Post-market Surveillance Factors,” which may be a cost or benefit, but Post-Market Surveillance Factors certainly have long-term implications for your company.
UDI Costs to Industry
“The [UDI] final rule may have a significant economic impact on a substantial number of small entities that label medical devices.” (Federal Register – Cost and Benefits) Eastern Research Group, Inc. (ERG), under contract to FDA, “…estimated present value of the costs to domestic labelers is $620.4 million using a 7 percent discount rate and $713.2 million using a 3 percent rate…” over 10 years. Over the same time period, the annualized costs for domestic labelers are estimated to be $82.6 million at a 7 percent discount rate and $81.2 million at 3 percent. Medical device labelers will incur most of these costs. Labelers include manufacturers, reprocessors, specification developers, repackagers, and re-labelers that induce a label to be affixed to a medical device. ERG estimated costs would not eclipse 1% of revenues annually, except for a small percentage of companies required to mark specific devices directly. Some multi-use device manufacturers required to direct mark their Class I devices could benefit from reduced total costs if all of their device labels only need static barcodes, rather than more costly variable barcodes (DI +PI). ERG also estimated 32 firms out of 5,234 domestic medical device labelers (5,010 are small businesses) will bear costs greater than 1% of revenues, due to needing costly laser direct marking equipment. Interestingly, all 32 firms are all considered small businesses.
Most of the costs associated with UDI are related to implementation. The following is a list of examples:
- planning and integration of UDI throughout information systems
- creation, review, and approval of labeling changes
- digital printers to print the new barcodes and date formats
- increased printing due to variable barcodes
- joining issuing agency and obtaining labeler ID
- requesting Global Medical Device Nomenclature (GMDN) Preferred Term (PT) codes
- registering new barcodes
- laser-etching of UDI barcodes on devices for direct marketing
- compliance with the FDA’s UDI data uploading requirements
- review and approval of procedure changes
The first item on the above list, planning, and integration, will be the highest cost of UDI implementation. The price of planning and integration includes installation, testing, and validation of barcode printing software. You will also need to retrain almost every department to understand how UDI is being integrated with existing processes. You may also need to temporarily increase your workforce to help ensure timely implementation to ensure compliance with the data attributes required for each device entered into the Global UDI Database (GUDID).
The highest annual ongoing cost includes labor, operating, and maintenance associated with equipment for printing labels, and labor related to software maintenance and training needed to maintain the GUDID system. Other ongoing costs include paying initial and annual fees to the Issuing Agencies and/or the GMDN agency (http://bit.ly/GMDN-Agency) for ongoing maintenance of the system. You will need to have additional personnel in most cases to manage these other requirements.
Post-market Surveillance Factors
Post-market Surveillance Factors are either a cost or benefit to the labeler, and are directly related to the Patient Safety and transparency aspects of the UDI Regulation. The goals of the FDA in enacting the UDI Regulation are:
- reduce medical errors
- simplify assimilation of device use information into database systems (such as Electronic Health Records and Personal Health Records)
- provide for quicker identification of medical device adverse events; improve the speed of the development of solutions to reported problems
- hasten and improve the efficient closure of device recalls
- more focused and effective FDA Safety Communications
- allow professionals and end-users access to additional product information via GUDID
In my opinion, there are other factors just as important which companies should pay attention to as they complete UDI requirements, including the ability to:
- develop complete safety and effectiveness profiles for devices
- reduce waste by helping to eliminate duplicate inventory at healthcare facilities
- identify new uses for devices, which will help increase value for shareholders, customers, and end-users
Today, the identity of labelers is hidden from users and patients. Tomorrow, when the FDA’s goals are realized, labelers will be faced with increased transparency. You will need to address increased transparency by acting quickly to product performance trends. In today’s world of instant communication, you cannot afford to ignore safety issues brought to light by post-market surveillance factors. Anyone who does does so at their peril.