Why common translation tools won’t cut it in medtech

With regulators like the FDA, EMA, and NMPA setting the bar high, MedTech companies can’t afford ambiguity.

Every clinical trial document, product manual, and regulatory submission must be translated with absolute accuracy. Yet, most translation tools fall short, and even high-quality professional services struggle with regulatory complexity.

So, what’s the solution?

Why MedTech Translations Go Wrong

Medical and technical terms require more than just direct translation; they demand contextual accuracy.

Automated translation tools and general language service providers often lack the specialised knowledge needed to maintain precise medical meanings, leading to errors that can alter medical meanings and jeopardise regulatory compliance.

As companies expand into new markets, they face significant challenges in translating medical and regulatory content with precision.

Even small terminology errors can lead to delays in product registration, costly resubmissions, and regulatory setbacks.

For instance, a mistranslation in an Instructions for Use (IFU) document could result in improper device usage, increasing the risk of adverse events for both healthcare providers and patients.

Medical terminology is highly specialised, and many terms carry different meanings depending on the medical field.

The term “shunt”, for example, carries different meanings in cardiology and neurology.

Without subject-matter expertise, these differences lead to critical inconsistencies across product manuals, clinical reports, and regulatory filings.

Beyond terminology, regulatory adherence requires absolute consistency across all multilingual documentation.

Even minor differences in translated terminology can trigger additional review cycles, delaying approvals and increasing costs.

After all, regulatory bodies demand standardised terminology, particularly in patient-facing materials and technical documentation.

The European Medical Device Regulation (MDR) exemplifies this, as it mandates that medical device labels follow strict terminology guidelines to prevent ambiguity.

If a single term is translated inconsistently across product packaging, technical files, and regulatory submissions, authorities may demand corrections, prolonging approval processes, delaying market entry, and adding significant costs.

Although free or automated translation tools may appear to offer a quick fix, they fail to account for the complexity and regulatory demands of MedTech translations.

These tools lack contextual understanding, making errors that can compromise both compliance and patient safety.

Additionally, many generic translation platforms struggle with less widely spoken languages, creating barriers for MedTech companies looking to expand into emerging markets where precise terminology is equally critical.

Relying on multiple translation providers without a unified approach further increases the risk of inconsistencies, leading to discrepancies across clinical documents, product labels, and regulatory filings—ultimately resulting in delays, higher rejection rates, and expensive revisions.

The True Cost of Translation Errors in MedTech

Translation errors in medical device documentation go beyond minor inconveniences—they can have significant financial, legal, and operational repercussions.

When mistakes occur, companies often face costly resubmissions, prolonged compliance reviews, and additional regulatory interventions, which can add up to hundreds of thousands of dollars per market.

Beyond direct costs, these delays disrupt go-to-market strategies, preventing companies from capitalising on commercial opportunities and slowing revenue generation.

Regulatory penalties can further escalate expenses.

The FDA and other agencies impose heavy fines for non-compliant documentation, with penalties reaching up to $10 million in severe cases.

The financial impact extends beyond regulatory fines—reputational damage and loss of market trust can erode a company’s standing, making it harder to compete in the long run.

A clear example of how translation mistakes can lead to severe financial and operational consequences is the Berlin hospital incident, where 47 patients received incorrect knee implants after a U.S. prosthesis manufacturer failed to translate the outer packaging of its product.

The implant was available in two versions—one requiring cement and one not—but the English label “non-modular cemented” was mistakenly translated as “without cement” by hospital staff.

As a result, the implants were used incorrectly, causing severe pain and requiring corrective surgeries.

Both the manufacturer and the hospital faced lawsuits and significant financial losses, demonstrating how even small translation errors can have costly, far-reaching consequences.

Naturally, these consequences are also felt internally, as translation errors disrupt workflows, create bottlenecks in product development and commercialisation, and divert resources away from innovation toward correcting documentation mistakes.

The most serious consequence, however, is the risk to patient safety.

Inaccurate translations in clinical studies, IFUs, or safety warnings can lead to misdiagnoses, incorrect treatments, or improper device usage, directly impacting patient outcomes.

Accurate Translations in MedTech: A necessity; not an option

In a field where precision, compliance, and patient safety are non-negotiable, MedTech companies cannot afford the risks associated with inaccurate translations.

The complexities of medical and regulatory language, coupled with the high stakes of global market expansion, demand a specialised approach to translation—one that prioritises accuracy, consistency, and regulatory adherence.