Medtech Engineers Deserve Better Than Microsoft Excel

It’s time to boycott Excel as a means for maintaining a design controls traceability matrix.

Amanda Pedersen

February 13, 2023

2 Min Read
Pedersen POV 2-13-23_0.png

It's time for medtech engineers to boycott Microsoft Excel as a means of design controls traceability.

I've always had a personal aversion to using Microsoft Excel (or any spreadsheet program) for anything other than analysis purposes. And even then, I'm much happier with a big sheet of unlined paper and a variety of colored pens or markers.

As it turns out, medtech engineers hate Excel as much as I do. One of my favorite medtech influencers on LinkedIn, Greenlight Guru's Etienne Nichols, recently posted a humorous hypothetical story about why Excel is not an ideal tool for design controls traceability.

For those of you unfamiliar with the exciting world of medical device regulation (like my mother-in-law – hi, Loretta!), design controls are how companies show FDA that a product meets user needs, intended uses, and specified requirements. A traceability matrix is an industry best practice for linking all related design control elements throughout the verification and validation journey.

And as the hypothetical story below shows, completing such a critical record-keeping task in Excel can quickly lead to frustration.

My favorite part of this hypothetical story is the lost magnifying glass and the product development manager stealing a pair of company calipers and walking out, presumably to go back to being a CNC machinist.

The very idea of using Excel for a task like that makes me shudder. I'm not an engineer myself, but it's my understanding that keeping design controls traceability up to date for a medical device project is quite a time-consuming endeavor.

As Nichols wrote, "I don't know any engineer who went to school because they wanted to become an Excel junkie – we became Excel junkies by necessity, through a rigorous amount of PC brain washing ... and a will to survive."

Fortunately, there are better solutions out there for design controls traceability than a general-purpose tool like Microsoft Excel. Greenlight Guru, for example, has a software solution built specifically to meet the regulatory needs of a medical device company. But there are also dozens of other quality management systems solutions for the industry to choose from.

The moral of the story is that medtech engineers deserve better than Microsoft Excel for such a critical and time-consuming task.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like