When Regulatory Perfection Becomes a Business Risk

In regulated industries, we take risk seriously—patient safety, product quality, and compliance are non-negotiable. But there’s a growing challenge inside many organizations that quietly threatens progress: over-mitigating issues that pose negligible risk.

Recently, we’ve seen a familiar scenario. Management is aligned on a low, well-characterized risk. Cross-functional teams agree. Yet a single regulatory stakeholder becomes fixated on eliminating a minor, non-impactful deviation. The effort spirals. Timelines slip. Projects stall. Tension grows. And the business absorbs the cost of a risk that was never meaningful to begin with.

This is where the principle de minimis non curat lex—“the law does not concern itself with trifles”—comes into play.

Modern regulatory frameworks are intentionally risk-based. ISO 14971, FDA guidance, and MDR/IVDR expectations all rely on proportionality: the response should match the actual risk. Not the theoretical risk. Not the emotional risk. The actual risk.

When a risk is truly de minimis—no patient safety impact and low probability × low-to-medium severity for the business—over-correcting becomes the bigger danger.

The Hidden Cost of Over-Mitigation

Excessive control on low-risk issues often creates higher-risk outcomes:

• Project delays that affect market access

• Misallocation of engineering time

• Increased complexity (which itself is a risk factor)

• Erosion of trust in RA/QA leadership

• Decision paralysis at critical stages of development
  

In short, the pursuit of perfection in trivial matters diverts energy from the issues that truly matter.

Regulators Expect Proportionate Responses

There’s a misconception that regulators favor the most conservative path. In reality, they favor rational, documented, risk-based decisions.

Disproportionate mitigation actually contradicts the intent of risk management. It shows an inability to distinguish between signal and noise.

Right-Sizing Response: A Better Framework

When evaluating whether to escalate a low-impact issue, teams should ask:

1. Does the risk affect patient safety?

2. Is compliance materially impacted?

3. What is the measured severity and probability?

4. Will mitigation create new, larger risks?

5. Is the mitigation proportional?

If the answer is “no” across these questions, the issue is de minimis—and the organization is safer moving forward than over-reacting.

A Balanced Approach Protects Patients and the Business

A company that burns precious resources on non-impactful issues risks under-investing in the areas where risks are real. Sustainable compliance is not about eliminating every imperfection—it’s about understanding which ones matter.

Leadership means choosing the right battles. In a risk-based world, not all risks are created equal. And sometimes, doing less is the safest decision of all.