Prevention Over Rework: A Coloplast Quality Manager's Perspective on Medical Content

By Elena Varga

My Starting Position

Let me say this plainly: most medical content errors are preventable, and the ones that cost the most are usually the ones that were checked too late.

I work as a quality and brand compliance manager in the medical device space. At Coloplast, that means I review patient education materials, clinician guides, product pages, support-portal text, and videos before they go out. The volume changes by quarter, but it is roughly 200+ pieces a year. When a piece comes back because of an error, the expensive part is rarely the minutes it takes to fix the text. It is every conversation that follows: why the error happened, which other materials could have the same issue, and whether customers still trust the next update.

That is why I keep using an old idea: prevention over cure. Five minutes of verification at the start of a job costs almost nothing. Five days of correction after publication costs a lot.

The Cost Curve Gets Steep, Fast

Why do I put it that strongly? Because the cost curve gets steep fast.

A typo caught in a draft costs five minutes. The same typo caught in a final PDF costs an hour. If it reaches customers, it costs an afternoon. If it reaches a regulator, the cost is no longer about time. This pattern is not a theory. I remember a print project where a team skipped a final file check to hit the mail date. The PDF went to the printer with an outdated product name. The reprint cost somewhere around $1,800, and nobody said afterwards that the decision had been worth it.

From the outside, quality control looks like a net that catches problems. The reality is less glamorous. By the time I see a problem in a final layout, the piece has already passed through design, technical review, and approval. Each step created another chance for a hidden assumption to become a published error.

The regulatory world uses the same logic. Per FTC guidance (ftc.gov), marketing claims have to be truthful, not misleading, and substantiated with evidence. I read the word 'substantiated' as 'verified before publication'. A claim that gets support only after it is challenged is no longer substantiation; it is a defense.

The Same Principle Applies to Login Pages and Product Videos

In my work, the verification target is not always the wording. It can be the path a user follows or the video they watch.

Take a Coloplast login help page. When a portal changes, the updated page can look fine in isolation. The problem appears when a user reaches it through an old bookmark, an old email, or a support link from a PDF. The login may still work, but the user lands on a generic page and has to start over. That moment of friction is a content defect, even though no sentence contains a typo. The prevention step is to test the user flow before publishing the new page.

Video content follows the same rule. Reviewing a video is not just watching it. I verify the file, the title, the disclaimer, and the claims in the script. If a Coloplast Titan video lives under an old name or contains a claim that has changed, the video stops being an educational asset and becomes a consistency problem. One verification pass before publishing fixes that; an apology after publishing does not.

It Sounds Abstract Until You See a Device Manual

I am not a clinician. But the principle I am describing is exactly how trained clinicians think about equipment.

A mechanical ventilator is a good example. It has alarms, sensors, and backup systems. None of that matters if the circuit is not checked before the ventilator is connected to a patient. The pre-use check exists because the cost of discovering a setup error during ventilation is unacceptable.

A centrifuge machine uses the same logic in a less dramatic way. An unbalanced rotor can create vibration, noise, and mechanical damage. The balance check takes seconds, and it has to happen before the machine starts, not after it begins shaking.

For the same reason, I respect clinical educators who teach simple procedures clearly. When a checklist covers how to use an oxygen flowmeter, it usually includes setting the prescribed rate, confirming the indicator, and watching the patient afterward. None of those steps is complicated. The point is to build a check into the routine before something goes wrong.

What Goes Wrong When 'Please Verify' Is Too Vague

I have also seen the phrase 'verify before publishing' become its own problem.

I once told a team that a video needed to be checked against the approved script before it was scheduled. The person heard that as 'watch it if you have time.' It got watched, but the narration and the on-screen disclaimer did not match. The video went live and stayed up for a few hours before anyone spotted it.

Pulling it down was easy. The hard part was explaining to the customer team how it had happened. We were using the same words but different standards: to me, 'check the video' meant compare the visuals and dialogue to the final script; to them, it meant give it a careful view. I had stored the instruction in the message instead of in the workflow.

Now I name the exact review step in the checklist: compare the recorded narration to the approved script, time-coded by section. It is not a more creative process. It is a less ambiguous one.

The Part That Surprises People: Careful Teams Need Checklists Most

The most counterintuitive pattern I found is that careful people are the ones who benefit most from checklists.

Careful people tend to hold a lot in their heads. That is fine on first pass. After the third review, though, they cannot tell the difference between a detail that has been verified and a detail that just looks familiar. A checklist is not an accusation. It is a way to move the important items from memory into the open.

I built a twelve-point checklist after one early launch review failed. It includes the link destination, the product name, the claim's supporting evidence, the video disclaimer, and the approval comments. I want to say it has saved us around $8,000 in potential rework, but I cannot add it up exactly. What I know for certain is that it has prevented more than one late-night emergency.

Ask Not Whether It Adds Time, Ask What It Removes

When I recommend this approach, the first response is usually: 'We don't have time for more checks.'

Look, I understand that. Launch dates move and budgets shrink.

But the same team that says it has no time for a ten-minute check also finds time for a rework meeting, an email to apologize, a new version, and a quieter check of every other page that might contain the same mistake. That is not faster. It is just slower in a different place.

The question isn't whether a checklist adds time. It's where that time gets spent. Not every content piece needs five levels of approval. It does need one deliberate verification point before it is handed to a customer. That should not be optional.

The Bottom Line

Quality review is not about being heroic. It is about designing a process where the important checks are hard to skip.

I would rather spend ten minutes running through a checklist than spend ten hours explaining why a bad version went live. That is not a personality preference. In medical content, it is the cheapest policy I know.

Five minutes of prevention can save five days of correction. At least, that has been my experience in the work I do.

Elena Varga

Elena Varga is a medical imaging systems analyst covering CT scanners, MRI systems, ultrasound platforms, digital radiography, mammography, and ophthalmic imaging equipment. She references IEC 60601-2-44 for CT safety and essential performance while examining CTDIvol, dose-length product, spatial resolution, slice thickness, field uniformity, throughput, uptime, and DICOM interoperability. Her work helps radiology leaders, medical physicists, biomedical engineers, and procurement teams compare image quality, radiation management, workflow integration, serviceability, and lifecycle cost.