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Pharmaceutical laboratory equipment

January 2026

Every Feature You Did Not Ask For
Is a Validation You Now Owe

In regulated industries, software bloat is not a UX problem. It is a compliance liability.

The Scene

Your compliance team has 47 open tickets. 12 of them exist because software vendors shipped features nobody asked for. Features that created new edge cases, new documentation requirements, new validation protocols.

$340Kaverage cost of a single re-validation
6-18 motimeline for 510(k) re-submission

In consumer software, an unnecessary feature is friction. A settings toggle nobody clicks. An onboarding step users skip. The cost is measured in churn and NPS points.

In aerospace, pharma, and biotech, an unnecessary feature is a regulatory event.

The Hidden Tax of Vendor Bloat

72%of features unused in enterprise software
3.2xvalidation cost increase per major release
23avg. FDA 483s citing software validation gaps
$2.1Mmean remediation cost per observation

Every feature your vendor ships becomes your team's responsibility. New UI means new training documentation. New workflows mean new SOPs. New integrations mean new risk assessments. New AI capabilities mean new regulatory questions nobody has answered yet.

Consumer software companies celebrate velocity. They ship weekly. They iterate in public. They break things and fix them later. That works when the cost of failure is a bad review. It does not work when the cost of failure is a warning letter.

Your vendor's roadmap is your compliance team's backlog.

What Vendor Bloat Actually Costs

When your LIMS vendor adds "AI-powered recommendations," that is not innovation. That is a regulatory question your quality team now has to answer. When your ERP ships a new workflow module, that is not a feature. That is a validation burden.

Extended Validation Cycles

Every major release triggers IQ/OQ/PQ protocols. A "simple" update becomes a 3-6 month project.

Training Documentation Churn

New UI elements require updated SOPs, new training records, and evidence of competency assessment.

Audit Surface Expansion

More features mean more potential findings. Every toggle is something an auditor can question.

Change Control Overhead

Vendor releases outside your control create unplanned change requests that consume QA bandwidth.

The software vendor ships features to hit quarterly targets. You pay for them in audit findings.

Clean laboratory environment

Two Different Worlds

Consumer software and regulated software operate on fundamentally different physics. The strategies that make consumer products successful—rapid iteration, feature experimentation, fail fast—are liabilities in environments where every change requires documentation and every feature requires validation.

Consumer Software
  • Ship fast, iterate later
  • Features are free to add
  • Users self-select what they use
  • Failure cost: bad reviews
Regulated Software
  • Ship validated, maintain forever
  • Every feature is a liability
  • Every feature requires documentation
  • Failure cost: warning letters

Most software vendors come from consumer backgrounds. They optimize for what they know: feature velocity, release frequency, market positioning. They are not building for environments where "we added a button" triggers a change control process.

Simplicity is not a UX preference.
It is a compliance strategy.

Signs Your Vendor Does Not Understand Regulated

Monthly Release Cycles

Consumer-grade velocity that creates constant change control overhead for your team.

Feature Announcements in Marketing

You learn about new capabilities from press releases instead of change notifications.

AI Everything Positioning

ML features shipped without clear validation guidance or regulatory position documentation.

Settings Sprawl

Hundreds of configuration options, each one a potential audit finding waiting to happen.

The vendor who ships less, documents more, and treats your validation requirements as their product requirements—that is the vendor who understands regulated.

Aerospace manufacturing precision

Every feature has a cost. In regulated industries, that cost is measured in validation hours, not story points.

What Regulated-Aware Software Looks Like

The best vendors in aerospace, pharma, and biotech do not compete on feature count. They compete on validation burden. They understand that what they do not ship is as important as what they do.

What to evaluate:

  • 1Release cadence with validation windows. Quarterly releases with 90-day advance notice and complete validation packages, not surprise updates.
  • 2Feature opt-in architecture. New capabilities disabled by default, documented clearly, and activated only when your team is ready to validate.
  • 3Regulatory position documentation. Clear guidance on how features interact with 21 CFR Part 11, EU Annex 11, GAMP 5, and industry-specific requirements.
  • 4Simplicity as a design principle. Intentionally minimal interfaces that do what you need without options you will never use but must document.

Does your software vendor ship features to hit their targets?

Or features you actually need?

Share this perspective

We build software for regulated industries. That means we ship less, validate more, and treat your compliance requirements as our product requirements.

Industries We Serve

Aerospace & DefenseBiotechnologyMedical & HealthcareManufacturingFinancial ServicesConsumer ProductsEnterprise Software

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