Litigation happens. It's a simple truth when doing business, that no matter how tight and orderly your company's processes are, mistakes happen, and litigation can happen as well.
- Design Defects – Cases where there is a likelihood that the product will cause an injury based on its design.
- Marketing Defects – Cases where the manufacturer or others give inadequate/poor instructions or warnings about a product’s risks.
- Manufacturing Defects – Cases where design and marketing are good, but a mistake occurs during the manufacturing process resulting in a defect.
But not all devices are destined to be used in the country that designs and manufactures them. There are a wealth of customers abroad, and so, of course, manufacturers pursue those customers across the globe.
To Translate or Not to Translate
Even the best Medical Devices manufactured in North America, though, cannot simply be packaged and shipped for use in Europe, the Middle East, or Asia as-is without carefully considering a strategy for handling things like user interface content, instructions and labeling for the target market(s). Any company trying to do so would be taking on a tremendous amount of risk and potential liability, which is why this doesn't happen very often today. Manufacturers do not want their product to be seized upon arrival because the package did not have the CE label present.
Liability is similar for Medical Device manufacturers that don't put an adequate investment of time and resources to properly address the myriad of rules and regulations inherent in producing medical devices for use in other markets. When the language work is poor, the manufacturer opens themselves up to lawsuits that could range well into the millions of dollars.
Liability Risks from Translation and Localization Issues
If someone using your product suffers an injury or death that can be attributed to a failure to understand an IFU that was only available in English, or they didn't understand a poorly translated IFU, you will have a very difficult time avoiding a heavy financial penalty. That is why most companies that manufacture medical devices are so careful when it comes to product documentation, including instructions, labels, packaging, and even the sales and marketing pieces that promote the features of the device.
Yes, that's right, your in-country sales team and/or product distributor is another potential point of liability. If they are making assertions or promises about your product - in writing or in person - that your products cannot definitely deliver, then you could be in just as much hot water as you would with a manufacturing defect that has led to an injury or worse.
Bottom line, the safest way to mitigate risk and avoid liability when it comes to documentation and labeling is to make sure that everything is professionally translated for each target market, or in the case where you have in-country distribution handling the translation, at least have that reviewed by an objective professional translation resource.
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