Medical Device Translation: Top 5 Considerations
February 11, 2015
Almost half of the top 30 medical device companies worldwide are headquartered abroad and all of the major U.S. medical device companies have branches in other regions. This means that translation plays a large role in this booming international industry.
In addition to the legal documentation necessary to cut through the red tape associated with the sale and distribution of medical devices in most countries, there are a host of other materials that will need to be translated. Below, we’ve provided a list of the top 5 considerations for medical device translation.
#1 Instructions for Use:
Abbreviated to IFU, Instructions for Use are the direction sheets or user manuals that accompany a medical device. This information tells the user, who may be the doctor, nurse, or patient, how to safely utilize the medical device. Information on risks and precautions is also included in the Instructions for Use which must be translated into all major languages that a potential user of the device may speak. Multiple languages are usually included in the same document, which is something to keep in mind when designing the layout for the IFUs in a medical device translation. Additionally, many countries require a Certificate of Accuracy for translation of IFUs and similar documentation.
#2 Training Materials:
When a given medical device is adopted in a new market, all the healthcare professionals that will be working with the device must be trained in its proper usage. Most medical devices will need to be accompanied by training materials in all languages that may be spoken by the doctors, nurses, and hospital workers that will be implementing the device. Training materials usually take the form of multimedia presentations or e-learning modules which makes for many points to consider when translating, including: layout, graphics, and colors, as well as the cultural appropriateness of the way the information is conveyed.
#3 Marketing Materials:
The importance of marketing materials for a device that will enter a new market cannot be overestimated, especially since competition is fierce among companies which often offer very similar devices. Marketing materials for medical devices range from posters, pamphlets, and statistical information, to even billboards and commercials. As with all translation of marketing materials, many aspects of the device will need to be analyzed, including the brand name, to ensure success of the product in a given market.
#4 Software Localization:
Today, even medical devices that are used on a daily basis for routine procedures utilize software and thus require a user-interface. One of the legal requirements for medical devices is that they must be designed to be used easily and reliably; the consequences for a miscommunication during a complex medical procedure can be severe. This means that not only an accurate and effective translation is required, but many formatting considerations come into play as well such as the text’s size, color, placement, and font. Be sure to use expert software localization professionals for a medical device that employs a user interface.
#5 Translation Memory:
Translation memories are best utilized for large amounts of repetitive text such as the legal documentation needed for official approval of a medical device. In addition, there is often quite a bit of overlap between the Instructions for Use and the training material of a given device which must be updated after any small change is made to the product. Talk to your language service provider about the possibility of using a translation memory for your medical device translation in order to streamline the process, ensure success and reduce costs.