The FDA's upcoming UDI rule will impact all medical device manufacturers. To what degree, however, will vary from company to company, based on what systems and technologies are already in place. For this month's Perspectives, industry leaders gave their opinions on how they thought the rule would affect the industry.
What impact will the FDA's UDI Rule have on the medical device industry next year and into the future?

CEO, SigmaQuest

UDI is poised to help manufacturers only remove/recall a select or a specific lot of products from market rather than an entire product line. One analogy to contemplate is mad cow disease. What if there was a simple way to identify only those cows that have eaten bad feed? This would eliminate needless slaughtering and recalls.

Fortunately for medical device manufacturers, pinpointing only those products with defects can be relatively simple. With product quality management systems, companies can get a 360 degree view of product information coming from component suppliers, engineering, manufacturing, and return and repair. Users can search device history records (DHRs) via serial numbers or lot numbers and find products that demonstrated like characteristics during manufacturing and test. Of course, the best course of action is preventative maintenance, as implementing product lifecycle/quality management software early in the process can help medical device manufacturers avoid issues before products get to market.

Product Manager, Sparta Systems

The medical device industry faces manufacturing and quality challenges in 2010 as corporations ramp up to meet the recently passed FDA UDI regulation. For many companies, adhering to the new regulation by ensuring that manufactured devices have unique identifiers means introducing new process steps, materials, and manufacturing technology into existing manufacturing lines. This will create new challenges for companies already scrambling to comply with other recent and impending regulatory requirements, including the electronic submission mandate (eMDR). While ultimately enabling stronger product traceability, these new regulations will initially increase the risk of quality to products and processes.

It remains imperative that companies maintain an automated system for handling and complying with regulatory mandates to ensure that processes continue uninterrupted with the introduction of new requirements like UDI. Automating quality and compliance processes across the enterprise via a quality management system will also enable companies to mitigate the risks of potential defects, quality incidents, and adverse events while ensuring a smooth transition to new manufacturing procedures. A quality management system will enable companies to leverage the benefits of unique identification compliance as well as streamline processes such as customer complaint handling, audits, and incoming inspections. With a smooth transition and a well-planned quality foundation, medical device companies will be in a strong position to greatly benefit from the FDA UDI regulation while providing increasingly safer and higher quality products to their consumer base.

President, InterTech Development Co.

While the FDA's goal in rolling out the UDI rule grows from a concern for patient safety, to any cost-conscious manufacturer of medical devices, this new regulation should not really require any new practices. This is especially true for any Class 2 or Class 3 devices, such as cardiac catheters or infusion pumps, that require extensive testing on each and every unit to ensure patient safety.

Tried and true best practice methods for test-intensive assembly would always ensure that every component is uniquely identified and tested in-process, such that any and all extra labor and costs for finishing otherwise defective parts are eliminated. For example, state-of-the-art leak testing software automatically provides detailed documentation on each uniquely identified part being tested. This is a cornerstone principle of test-centric assembly. If the UDI rule accelerates the adoption of routine automated identification of all parts and product components during assembly–such that they can be thoroughly tracked at all stages of production–it will help drive down assembly and test costs and help device manufacturers' bottom lines.