Medical supply chain executives find regulatory compliance, and the associated complexity, increased administration, and bureaucracy a major hurdle. However, there is hope on the horizon for medical device manufacturers (MDMs) struggling to comply with UDI guidelines and other regulatory requirements governing the medical device industry.
A Much-Needed Transformation in the Wings
In order to keep up with the demands placed on it by regulatory entities, the medical device industry needs to transform itself. The transformation in question is a digital one. It involves taking all of the technological developments that have transformed other industries and applying them to every aspect of the medical device manufacturing process.
We’ve seen a similar transformation in the pharma industry, where it has resulted in the total revamping of the pharmaceutical product supply infrastructure, from manufacturing to packaging and dispensing to patient delivery. If MDMs take a similar approach, the results will be nothing short of a revolution in the way they do business, including simplifying the road to regulatory compliance.
This is a look at how a digital transformation impacts the medical device label production process and the related regulatory requirements.
Offline catalogs are prevalent in the medical device industry. Paper-driven processes make compliance with regulations like the Unique Device Identification (UDI) system, 21 CFR Part 11 and the EU’s medical device regulations (MDR) a costly, time-consuming nightmare.
Post-transformation, paper-based catalogs and manual checks are things of the past. All of the information needed to produce and maintain labels has gone digital. Data can be accessed and updated in real time. Manufacturers can easily track products in the event of an issue and correct errant information more quickly and efficiently.
With all the production data at your fingertips, you will be able to search for anything in the system: print jobs, label content, specific users. It will be like having Google for your label data, but you can control the level of access each system user has. By taking full control of your label production process, you will be in the driver’s seat when it comes to regulatory compliance.
Going digital will also give you a complete version control history. You will be able to track who made what changes to a template, preview those changes before they are printed, and reproduce labels years later in order to respond to customer queries or audits.
The Key to Clean Data
Transitioning your database from paper binders to a document management system will also give you an opportunity to clean up your database. If you’re juggling multiple offline label catalogs, the idea of reviewing all of your data to check for accuracy can be a daunting one. Some companies haven’t cleaned up their data since Y2K. With the digital transformation opening the door to a centralized label database, suddenly you can get a handle on your label data and address any data quality issues before they create problems.
A New Approach to Quality Assurance
Despite all of the modern advancements we’ve seen in quality control, the number of recalls is actually going up. In fact, a recent Medical Device and Diagnostic Industry (MDDI) article noted that in 2016, the industry had the highest number of medical device recalls since 2000. What’s more, the number of units recalled in the third quarter of 2016 reached the highest level in four years.
After digital transformation, best practice quality assurance will be about having the right technologies at each stage of the production process so you can validate that each step has been completed according to the specifications and requirements defined for that process. The right technologies may include a modern label management system that can facilitate the transition from paper-based processes to full digitalization and provide the necessary transparency and traceability to monitor label production.
From Fragmented Systems to One Solution
Today, device manufacturers print labels for numerous markets and several languages in various locations. It’s not a simple process to make changes to these labels, since legacy printing systems use label templates that cannot be easily modified. Looking toward future requirements, as barcodes and unique identifiers need to be added and recorded for every saleable unit, digitalization provides a big benefit.
In a digital world, everything is connected. There are no longer disparate systems and home-grown solutions. The IT department, instead of spending time implementing label change requests and updating templates, is focused on helping the organization develop a deeper understanding of its production processes and how to optimize these steps. Label design is placed in the hands of the business users, the ones who are closer to the customers. This also paves the way for centralizing label creation and setting up centers of excellence with super-users who can ensure you’re getting the most business value out of your label management system.
Every Printer Is Your Friend
Post-transformation, label templates will be intelligent, able to adapt dynamically to the printers being used, even adjusting the resolution of the label and barcode information so that labels print correctly, regardless of the printer. No more hard-coded templates and manual checks for template variations. Everything is handled by the system. Complete integration with all printers will also mean less unscheduled downtime, as users can be notified when printers are offline and view the real-time status of all label print jobs.
Ensuring Consistency across the Supply Chain
Of course, this newfound template flexibility doesn’t have to be limited to your own production sites. After undergoing a labeling digital transformation, you can then extend your processes to third-party vendors and contract manufacturers via web printing. You can choose which aspects of a label template are open to editing by an external party, pre-defining certain fields before sending the template. The type of printer becomes irrelevant, and you can ensure consistent labels across the board.
Going Digital Improves the Process
As this example of how a digital transformation changes the labeling process reveals, digitalization can give medical device manufacturers a better handle on much-needed data. The potential of improvements through digitalization may extend beyond the label production process to other areas of medical device manufacturing. It offers insight into the production process, helps identify flaws in the process, and improves productivity. These benefits could combine to allow manufacturers to make smarter choices for the business.