As a medical device manufacturer, you are required to submit product data to the GUDID in order meet UDI compliance requirements.  If your company markets relatively few products in America, you may simply choose to do so by uploading spreadsheets directly to the GUDID portal.  But if your product range is larger, say more than a few hundred items, you’ll probably benefit from a more robust product data management and submission approach.

 

Many medical device manufacturers and suppliers choose to outsource this process to a Bureau Service (or Third-Party Submitter).  What do they do exactly?  Well, quite simply a Bureau Service takes a company’s product data files, then re-formats, validates and manually submits product data to the GUDID on their behalf.  For companies accustomed to outsourcing, the process sounds simple and cost‑effective.  After all, it may indeed lower the overall complexity of your company’s IT landscape.  However, it most certainly comes at a cost along with some risks.

 

Therefore, if you’re considering working with a Bureau Service, here are the top 3 potential pitfalls:

 

Reduced Transparency

Working with a Bureau Service will require that you transfer control of data maintenance and data validation processes. And this may be problematic.  For example, once the data is passed to the Third‑Party Submitter (TPS) you will lose visibility on how they convert and ‘massage’ your source data before submission to the FDA’s GUDID.  Further, you are assuming that your TPS has correctly converted and fully validated your data before submission.  It can also reduce the ability for your company to easily access and work with that data.

 

Limited Scalability

Transferring the data manually to a Bureau Service also limits ‘process scalability’.  While it may be manageable at a regional level, this process is not well-suited for those manufacturers with a broader, more global, market presence.  It will ultimately become far more costly to outsource UDI submissions for multiple market compared to using a solution that leverages your investment in the US market for re-use in other markets with similar UDI compliance needs.  It’s important to note the effort in data cleansing, data conversion and maintenance cannot be re-used from one market to the next.  These internal ‘master data management’ tasks must be done repeatedly across each market.

 

Increased Errors

Product data that is sourced from internal systems needs to be validated before it can be safely and successfully submitted to a Medical Device Regulator.  With outsourcing, additional time is required for the external third-party review.  For manufacturers with thousands of product records that are sourced from multiple internal systems and data repositories, this approach can become extremely inefficient, ineffective and with a high possibility of errors.  Done manually via spreadsheets and emails, the process becomes a time-consuming administrative headache with greater risks of omissions and inaccurate data capture.  This multi-step manual process also makes it challenging to provide an audit-able history and could put your company at risk of failing to meet “21 CFR Part 11” regulations.