How FDA Mandate on UDIs Will Impact Medical Device Manufacturing
All devices as defined by 21 USC 321 (h), i.e., a “medical device,” are subject to the requirements of the UDI rule unless an exception or alternative has been granted. (For more background, click here.)
Gone are the days when manufacturers could comply by placing a tracking code on the pouch. You’ll now be required to track and identify the product itself. Medical devices will be required to interface with a global federal database and use automatic identification and data capture technology (AIDC).
Traceability requirements include tracking the labeler, the date, the version or model, the serial number and the batch number on the product. While the rule only applies to implantable, lifesaving, and life-sustaining devices at the moment, the FDA foresees more expansive legislation as time goes on.
The challenge of integrating a code onto a product itself will be daunting enough. But for medical device manufacturers, a bigger threat looms.
Printing Hurdles Just the Beginning
We envision numerous engineering obstacles for manufacturers as a result of the mandate.
Now more than ever, a manufacturer will need to work closely with a medical device manufacturer during the R&D process, collaborating to find an innovative way to produce product and toe the FDA line.
In the past, contract converters could meet the needs of medical device manufacturers by creatively working within the confines of their equipment. For example, they’d run the sub-assembly through on a first pass for the die-cut and laminating, roll it up then make the second pass to make the final part. While it will still be possible to manufacture a part in multiple passes, the new mandate may necessitate a full evaluation of the effectiveness and efficiency of manufacturing your product in one versus two passes.
The end judgment call will be one of efficiency versus flexibility.
Data Dilemma: How Will You Handle More Back-Up Data?
Adding a serialized code and date to your product is one hurdle. Running the product in one pass so you can track it effectively is another. But yet another obstacle is creating the IT infrastructure to store the tracking data.
You’re currently responsible for tracking a part through the entire printing run, but now you’ll also be required to maintain a database of everything that’s run through the machine. Comprehensive information must be provided to the FDA’s Global Unique Device Identification Database (GUDID) during production for each unique device in plain-text and AIDC compatible forms, and the infrastructure will need to be developed and approved before manufacture within your organization. (See “Final Rule: Summary”.)
The specific data requirements are still a bit murky at this point, but it will definitely be a new endeavor for smaller contractor converters. Large pharma companies are equipped with an IT department with the bandwidth to handle these types of projects. But for a contract converter, this is unchartered terrain, and will require an expansion of your IT department.
Your Next Step: Profit or Perish?
How these FDA mandates impact your operation depends entirely on the size of scope of your company.
For larger medical device manufacturers, you’ll soon be faced with the task of serialized products. This will (or should) impact your R&D process; a silo mentality for product development won’t work. You’ll need to coordinate with your machine manufacturers to find innovative ways to produce your product.
For contract converters, there looks to be rough sledding ahead. Some of you may not find you have the capital needed to meet the new mandates, and you may decide to redirect your focus on other markets. Others will see this as a market opportunity, as your competitors decide not to make the internal structural changes required to compete.
Any type of federal mandate will trigger changes throughout an industry. We’ve seen it before, we’ll see it again. Creative manufacturing tools are available and we’re here to help alleviate your pain in these changes. It’s up to you to determine whether you’ll see this as a glass half-full or half-empty situation.
One thing that’s absolutely certain: You can expect mandates to continue into the future. Find the means to adapt to the new marketplace order, and you’ll not only survive, but thrive.
For more information on how to manufacture your product to meet this mandate, contact your Delta ModTech Manufacturing expert.