Why Your Startup Should Ditch Excel for Regulatory Submissions: A Unified Tool for Cross-Functional Team Success

In the world of small startup medical device companies, managing projects and tasks efficiently is crucial, especially when it comes to regulatory submissions like a 510(k), CE Mark, or any other similar submission. Yet, too many organizations still rely on Excel spreadsheets for this critical task. While Excel is a powerful tool, it’s not designed to handle the complexities of cross-functional team collaboration. And it’s at this intersection—where R&D, Manufacturing, Operations, Regulatory, Clinical, Marketing, and Quality must work together—that friction often arises.

The Problem with Excel for Cross-Functional Teams

Let’s take a real-world example: A company was preparing for a minor version change in their hardware, which also required reflective changes in the software. What seemed like a straightforward update quickly turned into a massive project. The Excel spreadsheet used to manage this effort grew to over 400 rows, each representing a different task or document needed for the 510(k) submission.

The organization was caught off guard by the delays that occurred. Why? Because managing such a complex, cross-functional project in Excel became a monumental challenge. The tool simply wasn’t equipped to handle the nuances of professional project management. The lack of real-time collaboration and ownership led to miscommunication, duplicated efforts, and bottlenecks—issues that could have been avoided with the right tool.

Why a Unified Tool is Essential

The key to overcoming these challenges lies in adopting a tool that brings all your departments—R&D, Manufacturing, Operations, Regulatory, Clinical, Marketing, and Quality—onto the same page. A unified project management tool can serve as a single source of truth, where tasks can be assigned, tracked, and discussed in real-time, ensuring that everyone is aligned and accountable.

For instance, consider how using Monday.com or Asana for document managment could transform your process. Instead of manually tracking document versions and updates in a sprawling Excel sheet, Monday offers a clear dashboard where documents are managed across the organization with minimal effort. All relevant versions are maintained through task tickets, significantly reducing version control issues. Every previous comment, change, and approval is documented within the ticket itself. This feature is particularly beneficial for new team members who can quickly get up to speed by reviewing the documented history within the platform.

Moreover, the use of tags and dates in such tools allows for more streamlined project status meetings. Instead of spending valuable time manually updating spreadsheets or chasing down status reports, teams can view real-time task allocation and status updates automatically. This automation not only saves time but also ensures that everyone has access to the most current information, reducing the risk of miscommunication or missed deadlines.

Which Tool is Right for Your Organization? It Doesn’t Really Matter.

There are plenty of project management tools out there, and truthfully, the specific tool you choose isn’t as important as the fact that you choose one. Executives might gravitate towards tools like Monday, engineers may prefer Asana, marketing teams might find Trello more intuitive, and software teams could argue that Jira is the only way to go. The tool itself is secondary to the fact that it’s being used consistently across the organization.

What truly matters is that your entire team adopts a single platform—whatever it may be—and commits to using it effectively. When everyone is working within the same system, it minimizes friction, enhances collaboration, and ensures that your regulatory submissions (and other critical projects like customer complaints and CAPAs) are handled with the precision and efficiency they require.

The Bottom Line: It’s Time to Move Beyond Excel

For small startup medical device companies, the regulatory submission process is too important to be managed with a tool that’s not up to the task. By moving away from Excel and adopting a unified project management platform, you can reduce cross-functional friction, improve communication, and increase your chances of a successful submission. In the end, the specific tool doesn’t matter nearly as much as the fact that it’s not Excel.

So, what’s stopping you from making the switch?