What is the best path for UDI compliance? Examining Two Approaches for Medical Device Suppliers
As a global software solution vendor in Life Sciences & Healthcare, our customers include many of the top medical device suppliers managing high volumes of product data and tens of thousands of device records. Based upon our experience helping customers with FDA’s GUDID, we are often asked for recommendations related to UDI compliance:
What is the most cost-efficient and effective way to enable machine-to-machine UDI submission?
Depending on their IT landscape, master data management model and regulatory compliance practices, we’ve observed three common approaches adopted by medical device companies:
- Machine-to-machine (M2M) connections to the GUDID
- Manual data entry/upload to the GUDID portal (often preferred by suppliers with less than 5,000 products in the US market)
- Bureau Services where third-party organizations receive data files from medical device companies to reformat, validate and manually submit data to the GUDID
Many medical device suppliers with global product data syndication requirements have also implemented Innovit’s PIM or Product-MDM solution for machine-to-machine (M2M) data exchange. This has enabled our customers to meet compliance requirements for both regulatory submissions and GDSN publications by establishing a scalable solution for product and catalog syndication via:
- Direct M2M connection to the GUDID – using Innovit’s UDI Connector as their FDA-approved Third‑Party Submission system
- GDSN data pool to submit data to the GUDID – using Innovit’s GDSN Multi-Connector to publish device data in the GS1 XML format to data pool service providers such as 1WorldSync, Atrify, GHX and FSEnet (now part of Syndigo), which in turn re-purposes and submits data to the GUDID
Today, we’ll examine the two most common and scalable approaches noted above that are ideal for submitting a large number of medical device records to regulatory databases. Please note that Innovit does not exclusively endorse one approach over another – we provide solutions for both. Rather, it’s our intent to leverage our experience in UDI submissions and share our findings and help medical device companies objectively assess GDSN versus direct UDI connections.
The comparison of both approaches is summarized in the tables below.
Option 1: Using GDSN for UDI submissions (GUDID)
|Single channel for publishing commercial and regulatory product data||Higher cost of system validation due to high frequency of GDSN upgrades – many of which are not relevant to GUDID requirements|
|Re‑use of existing investment in GDSN services for regulatory submissions (higher ROI on GDSN investment)||
Questionable compliance with:
As GDSN data pools are usually not validated against such regulatory standards and in some cases do not have the required documentation
|Reduced cost of system training for company. All users, whether regulatory or commercial, are trained on the same application and data management processes||Inability to support use cases where GS1 standards do not apply (e.g. identifiers from other issuing agencies like HIBCC/ICCBBA resulting from Mergers & Acquisitions)|
|Reduced IT infrastructure costs (one system instead of two; one submission channel instead of two)||Inability to mask or encrypt confidential data on GDSN (e.g. Listing Number)|
|Loss of visibility to intermediate acknowledgement messages for troubleshooting with FDA’s GUDID support desk because GDSN only supports ACK3 acknowledgement messages (lose ACK1 messages from Electronic Submissions Gateway and ACK2 messages from Center for Devices and Radiological Health)|
|More complex end-user support as it’s harder to trace data lineage due to more multiple attribute mappings, i.e. from internal attribute names > GDSN attribute names > GUDID attribute names|
|Complexity in resolving errors due to product packaging hierarchy and dimensional data validations in GDSN that are not applicable to GUDID (e.g. at least one GTIN in a pack hierarchy needs to be Orderable)|
|Risk of GDSN standards not keeping up with regulatory requirements in a timely manner (more relevant for EU MDR)|
Option #2: Direct Submission to GUDID
|Better end-user support due to easier traceability of data flow (direct mapping to GUDID attributes and business rule validations – more user‑friendly and consistent attribute naming convention)||Two different systems and potentially different process to satisfy regulatory requirements versus satisfying commercial data requirements|
|Better agility to comply with UDI changes (i.e. not waiting for GDSN standards to keep up with regulatory requirements)||More investment in software and power-user training|
|Visibility to “all” acknowledgement messages including intermediary messages (ACK1, ACK2, ACK3)||Multiple connection points from source systems to external databases (i.e. separate connection from PLM/RIM to GUDID and PIM/MDM to GDSN)|
|Lower system validation (SQA) costs by avoiding the need to test and re-validate regulatory submission system because of frequent GDSN upgrades that have no relevance to regulatory master data (historically, 2-3 upgrades per year on GDSN)|
|Ability to protect sensitive data including device listing numbers through data masking and strong encryption|
|Ability to better support situations where GDSN requirements do not align with an issuing agency’s standards for device identification (i.e. supporting HIBCC/ICCBBA identifiers in case of M&A)|
In summary, the key benefits of each approach are:
- Using GDSN to submit UDI data lowers the overall complexity of the company’s IT landscape, but increases system upgrade and validation costs. It also increases the complexity & cost of regulatory compliance processes in terms of data lineage/traceability, process management, staff training and documentation.
- Using a direct GUDID connection increases the number of systems to maintain, but reduces the need for frequent upgrades and therefore, reduces system validation costs. A direct connection also simplifies regulatory compliance processes especially regarding end-user support, training and documentation.
Projections for 2020 (EUDAMED):
Looking ahead to EU MDR and the EUDAMED requirements, we are scheduled to release the Innovit EUDAMED Connector, an end‑to‑end solution for both:
- Structured master data submissions (BUDI and DI data) and
- Unstructured regulatory data submissions (FSCA, FSN, MIR, PMCF, PSUR, trend reports, Clinical Investigations)
Our solution will deliver a seamless user experience for the Regulatory Affairs, Quality Assurance and Master Data professionals. The EUDAMED Connector will capture the SRNs (Single Registration Numbers) from the Actor Registration process, Conformity Certificate identifiers from Notified Bodies, and the device data as inputs to the manufacturer’s device registration and UDI submission systems. It is planned to support the following three modules for EUDAMED data submissions:
- Device registration and UDI submission
- Vigilance reporting
- Clinical investigations and performance studies
Priority will be guided by EUDAMED’s roll-out plan with Device Registration being the first for Innovit’s EUDAMED Connector.