Writer: Petter Sahlin
Business Development Executive Life Sciences
+46 8 599 204 56
April 04, 2017
The regulations for UDI (Unique Device Identification) are high on the agenda for most medical device companies. Many faced a race against time last summer to get the necessary submissions filed on time registered, and the process can be a challenge. But the key to UDI success is to view the regulation as an opportunity rather than a challenge. By embracing the change and connect it to an already available product definition in PLM medical device manufacturers can meet the new requirements while building up a core cross-functional device change process – from idea to regulatory or sales release.
Since the UDI regulation kicked in on the 24th of September 2016 for the large majority of manufacturers (the Class II devices in the US) every manufacturer that wants to sell medical devices on the US market must make sure they are complying with the new rules. This is a time-consuming process, and it’s one that cannot be avoided, but it doesn’t have to be a hassle. By viewing UDI as an opportunity to improve and standardize their own registration processes companies can turn this new legal requirement into something that can help their businesses going forward. And much of this can be done by using tools that are already available.
The processes necessary to register and approve the required information about a product during the engineering and product development stages can be found within PLM. TechniaTranscat offers a module within the 3DEXPERIENCE software called the Regulatory Affairs Manager that helps manufacturers to handle the entire process from start to finish making sure the correct data is created about a product and that the information goes through the required approval stages and is automatically submitted to Global Unique Device Identification Database (GUDID). In this way manufactures improve the quality of data from the start of their process – making every subsequent step easier and faster and provides them with regulatory guidance all through the submission assembly and registration processes. But the advantages are even more profound post-submission, both to handle the change, but also to benefit from reusing the information from the field and point-of-care, which the DI registration enables.
If done correctly the benefits of the new UDI system far outweigh the negatives. By following the new regulations each product will have one unique ID and serial number throughout its lifecycle. That means all information about the product will be available in one system, and companies will have an easier time tracking their products once they’ve been released to the market. If something goes wrong and a product must be recalled UDI ensures that the process of speaking to suppliers, compensating customers, and getting the product back out on the market will be much quicker.
Commercially there is a massive benefit in speeding up the turnaround on warranty claims and taking care of customers in a way that leaves them satisfied.
By using PLM tools the process of registering the necessary UDI information can also be partially automated. Once all the required data has been gathered and approved it must be registered with the FDA. Handling that process manually is not only slow, but increases the risk for errors. By using a PLM-driven approach companies can handle up to 10 - 200 times as many registrations or changes per day while improving the quality control and eliminating mistakes. With some companies having thousands of devices and parts to register the cost benefits of automating the process can be massive – in initial submissions, but foremost in post-submission maintenance.
And keep in mind companies may have to repeat this process in years to come. While the U.S. market was the first to implement these rules the EU and Asian markets are following soon – meaning the same information would have to be registered again with those regulatory agencies. By doing it right the first time you can save both time and money in the future as well.
At TechniaTranscat we understand this process and can help you get it right the first time. And even companies who don’t have 3DEXPERIENCE can use our hosted solution to manage UDI requirements. There is no way to avoid the work required to meet the UDI regulations – but with PLM there are ways of making the process work for you.comments powered by Disqus
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