In the New World of UDI, Spreadsheets Only Go So Far

What’s wrong with spreadsheets for UDI management and submissions? After all, we’ve used them for years.

Friends and colleagues at healthcare manufacturers continually assure me they’re fine using spreadsheets to manage their UDI data and submissions. And it may feel true today – after all, by now they’ve developed processes and workarounds that mostly get the job done. But if that’s true, why is everyone feeling so anxious? And what exactly is wrong with spreadsheets?

Let’s look just around the corner at the impending level of complexity being introduced by EUDAMED, including:

• B-UDIs (Basic Unique Device Identification)
• UDI-DI triggers that can require creation of a new DI
• 3x the number of data attributes, growing from 50 to 150

And coming on the heels of EUDAMED (or before, in some cases) are 12-15 more countries rolling out their own versions of UDI databases over the next 5 years.?

So there’s our challenge. Can spreadsheets really keep up with surging requirements?? If you’re using spreadsheets to manage data today, are you capturing any benefits from UDI? Is your data really ready for EUDAMED?

What’s top of mind for manufacturers?

Risk and change management are at the forefront as medtech leaders search for cost and efficiency gains in an increasingly uncertain economic environment.? Most often, I’m hearing 4 themes from medical device manufacturers:

Efficiency

While it may have been (somewhat) possible to manage 50 data attributes for the GUDID with spreadsheets, trying to manually track 150 data points for EUDAMED will be the straw that crushes this camel.?

There’s an inefficiency cost that multiplies – and this manual tracking will rob manufacturers of valuable resources needed to execute more strategic regulatory activities, which in turn deliver vital competitive advantages. Sure you can use lower cost resources (a summer intern, perhaps?) but then you introduce greater risk, especially in the unstructured format of spreadsheets. Let’s consider this further.

Risk Management

We’ve lived with the risk of submitting and deploying incomplete or incorrect data, but so far, the stakes have been relatively low. As we advance toward global standards and requirements, medtech leaders must lean into managing risk and averting errors as the cost of mistakes grows.

Here’s the dilemma. Spreadsheets are fraught with risk and ripe for human error. Product information users need more guided experiences, with built-in guardrails to mitigate the risk of toxic data that can spread through the company’s global systems. (Risk which just gets magnified with the deployment of EUDAMED and additional country databases!)

Fundamentally, spreadsheets aren’t the answer to risk management. They lack the accountability mechanisms necessary to identify and correct errors. With the UDI data lifecycle becoming even more dynamic – especially with the introduction of broader and more complex?UDI triggers – version control and auditability are vital to maintaining UDI data integrity.

Which brings us to the greatest risk of all: The cost of non-compliance.

EUDAMED compliance has a quickly approaching deadline, and if your data is considered incomplete or your submission is missing at that time, your products could be removed from the EU market altogether.? Unlike registering in the GUDID after your product has been approved, submitting your data to? EUDAMED is central? to the approval process, so the penalties for non-compliance are severe.

And there will be a long backlog of companies needing a remedy, with resources of the EU organizations managing the submission and error processes becoming increasingly strained as the deadline approaches.? Delayed submissions will translate into costly delays and lost revenue.??

Forward-thinking companies won’t take this chance.?

Change Management

It’s not cliché to say the only constant in the new world of UDI is change. When we add EUDAMED triggers on top of GUDID triggers, the ground on which companies manage their data can quickly become unstable. We’ll see unprecedented acceleration as:

• Multiple countries individually establish their unique requirements, driving inconsistency in the activities that constitute a trigger.?
• Because triggers are not the same across countries, manufacturers of global product lines may need to change a product DI for all countries in which their product is sold, when a trigger occurs in just one country. This may involve changes to things like production identifiers, direct marking, catalog numbers, etc., making the impact on the broader supply chain enormous.
• The other issue is BUDI, its associated data attributes, and the fact that almost all of BUDI’s data attributes require a new BUDI be assigned – which means all of the associated DIs would need to change because a DI cannot be used in more than one BUDI.
• Issues have also not yet been fully identified around how changes to a Single Registration Number (SRN) will be managed in EUDAMED.? GUDID allows for movement of records; EUDAMED does not.

So the question of whether spreadsheets can support global data management becomes vitally important as complexity increases exponentially. If we follow the path of even a simple change – now spanning multiple countries and hundreds of products – the change management impact is severe. It’s not likely we can manage this degree of complexity across multiple tabs and worksheets; trying to do so will be time-consuming, costly and error-prone.?

Progressive companies see the need for proactive management systems that perform four key functions:

1. Organize their UDI data in a central platform
2. Support flexible updating and editing
3. Automate validation and database submission
4. Maintain version history and a comprehensive record of data activity, critical for audit control

Global Strategy, Global Execution

Which brings us to the final theme, centered around the importance of having a global strategy for UDI management. While EUDAMED is capturing the headlines, manufacturers of all sizes are recognizing the importance of a holistic approach to the global end game.

New updates on country-specific databases seem to be announced every day. And while it’s important to understand this information, it’s even more important to apply it in an actionable context. You see the requirements coming. But what will you do to manage and meet them??

How do we solve what’s coming – especially given what we know today?

In addition to emerging country and market requirements, the pace of new product development, mergers & acquisitions, cross-company collaboration, and global distribution is relentless. These activities alone put UDI data into a constant state of flux. The need for greater diligence and a more effective model of data management is here now. Not in 2024.

We must look for new efficiencies, gained by applying workflow, templates, and a front-end experience that mirrors the familiarity and ease of consumer apps. We can quickly accelerate the adoption curve by giving users control of their data and activities. Relying on 3rd party resources to perform tasks like editing, validation and submission won’t win the quick sprint toward EUDAMED and beyond.?

Instead, let’s look at ways to:?

• Automate these activities
• Combine with best practices workflows
• Trigger actions with built-in rule sets
• And ultimately, enhance productivity and efficiencies

We have to be smarter.? Nimble solutions built with flexibility and intelligence will propel the winners of the global regulatory game onto UDI management platforms with expansive capabilities that grow to meet evolving needs.?

Spreadsheets can’t do that.