The 'Quality' Illusion: Why FDA Compliance Can Make Devices Less Safe
When Regulatory departments prioritize 'documentation stability' over 'engineering reality,' patient safety suffers. A systems view on the conflict between Compliance and Quality.
In the world of Medical Devices, “Quality” and “Compliance” are often used interchangeably. This is a dangerous category error.
Compliance means the documentation matches the device. Quality means the device works safely and effectively.
In a healthy system, these overlap. In a pathological system, they become enemies.
The “Freeze” Trap
I recently worked with a device manufacturer that had a known bug in their firmware. It wasn’t critical—it was an annoying UI glitch that confused nurses about 1% of the time.
The engineering team had a fix ready. It was three lines of code. It would take 10 minutes to commit.
But the Regulatory team said “No.”
Why? Because a code change—no matter how small—would trigger a regression analysis. It might require an update to the 510(k) file. It would definitely require a “Letter to File.”
The cost of documenting the fix was perceived as higher than the cost of leaving the bug.
So the bug stayed. For two years.
The Hidden Cost of “Compliance First”
When an organization prioritizes Audit Safety (Compliance) over Patient Safety (Quality), it enters a slow death spiral.
Engineers stop reporting minor issues because they know they won’t be fixed. The “Technical Debt” pile grows until it becomes a “Safety Hazard” pile. And eventually, one of those “minor” glitches combines with a rare use case to cause a recall.
The Solution: A Validated Pipeline
The way out isn’t to ignore the FDA. It is to apply Theory of Constraints to the Regulatory pipeline.
If “Regression Testing” is the constraint that prevents bug fixes, then you must elevate that constraint.
- Automate the testing.
- Invest in a “Continuous Validation” pipeline that generates the compliance documentation automatically from the code changes.
You cannot afford to have a system where it is “too expensive” to make the product safer.
True Quality means building a system where the “Safe Path” (fixing the bug) is also the “Easy Path” (compliance). Until you do that, you are just performing “Compliance Theater” while the product degrades.