CORPORATE TRANSLATION CASE STUDIES
Real stories of how expert human translation prevents million-dollar mistakes
AI Translation Fails, the Cost Is Real
Over the past two years, companies rushed to adopt AI translation for cost savings and speed. What they discovered: the hidden costs far exceeded any savings.
These are real stories from our clients who learned the hard way—and came back to human expertise.
Medical Device Manufacturing
The $2.3M FDA Rejection
The Problem
A medical device manufacturer used AI translation to prepare Instructions for Use (IFU) for a Class II device launch in three European markets—German, French, and Spanish.
The AI translation seemed accurate. Fast. Cost-effective. The team submitted to the FDA for approval.
Two weeks later: Rejection.
The issues discovered:
German version: Critical safety warning about sterilization procedures had steps 3 and 4 reversed
French version: Temperature units inconsistent (Celsius vs. Fahrenheit confusion in different sections)
Spanish version: Medical terminology used consumer language instead of regulatory-compliant terms
FDA’s response: “Resubmit with certified translations from qualified medical translators.”
6 months
Lost first-mover advantage
$2.3m
Lost first-mover advantage
$63K
Re-translation + resubmission fees
Lingua Solution
When they came to us, we approached it differently:
Assigned translators with medical device backgrounds (one former surgical nurse, one biomedical engineer)
Cross-referenced all terminology against FDA and EMA regulatory databases
Had a third medical expert review each safety-critical section
Delivered formatting-ready files that met all regulatory layout requirements
Provided certification documentation for FDA submission
The Result
FDA approval: 3 weeks after resubmission
Total cost of expert translation: $28,000
Cost of doing it wrong the first time: $2.3M+ in delays and lost opportunity
“We thought we were being smart by using AI. We ended up costing the company millions. The $28K for expert translation wasn’t an expense—it was the cheapest insurance we could have bought.”
Next Steps
We believe there's an easier way to manage your language projects.
Stay in touch with us. We’ll send you tips and tricks, news and updates, discounts and deals, plus we promise not to spam your inbox.