Unique Device Identification (UDI) implementation will impact nearly every area of your company. Successful implementation will take careful planning and coordination throughout the organization and in some cases, outside of your company.
The UDI regulation is a maze. It is said that it is often easier to start at the end when trying to solve a maze. This same philosophy should be used to implement UDI in your company. Start your implementation process with the outcome in mind. Implementation is more than simply meeting a timeline. It should be viewed as a way to improve your business and the processes you use every day. It should help you standardize these processes, especially as they relate to data gathering, label design and communication with your trading partners. Implementation will ultimately yield useful marketing information, which is one of the greatest values of a UDI system.
The First Step
The first step is to make the decision to begin. FDA regulation has now mandated UDI implementation for most medical device labelers. Compliance dates have been established, with class III devices the first required to comply starting September 24. Future dates include compliance of class II devices in 2016 and class I devices in 2018. (See Exhibit 1.) Miss the date or dates relevant to your devices, and you no longer can legally sell your medical devices.
Exhibit 1: UDI Timelines
Manufacturers adhering to later deadlines shouldn’t wait to implement UDI. UDI systems have been used in healthcare for many years. Early adopters understood the benefits of developing UDI capabilities in advance of any regulatory requirements. These companies’ customers also played a role in their early implementation of UDI. Customers were telling them to employ standardized methods, such as UDI; otherwise they would discontinue buying their products. This is a very powerful incentive. These companies also understood the many benefits of being early UDI adopters, which include:
- Ability to control pace of implementation without concern with mandated timelines
- Becoming “easy to do business with”
- Reduction in transaction errors
- Decreased order-to-cash process time
- Ability to help customers ensure that patients receive right products
- Reduction in product recall costs and other business processes
- Increased patient safety and satisfaction
- Improved inventory management throughout the supply chain—reduced waste
- Increased revenue through increased product line exposure to customer base
- Increased speed-to-market of new devices
Now what? The next step…
Since this is a significant undertaking for any company, a UDI champion and implementation team should be created with members from key impacted departments before the planning process begins. It is also important to involve top management; obtaining their support is critical to having a successful implementation. Department managers from key departments—IT, regulatory, manufacturing/packaging, purchasing/supply chain and sales/marketing—should be involved in the initial planning for UDI Implementation.