Medical devices are the backbone of the pharmaceutical industry, and almost anyone who has ever come into contact with a medical professional has come into contact with them. The term categorises anything from dressings to defibrillators as a medical device. And with manufacturers creating medical devices which are used worldwide, making them accessible and easy to use for everyone who needs them is essential.
Why are medical devices so important?
The continuing development and innovation process which goes into developing medical devices has made them indispensable instruments for ensuring quality of life for patients in the UK and around the world. The globe’s best minds in the field of scientific research are constantly collaborating on new equipment, and the medical device industry has itself been valued at $140 billion in the United States alone.
The importance of medical devices also comes from the sheer diversity of what the term can represent. The World Health Organization (WHO) defines a medical device as any piece of medical equipment which is used for the “diagnosis, prevention, monitoring, treatment or alleviation of” any disease, injury, or investigative procedure. This definition extends beyond the machinery which goes into any medical processes, but smaller instruments like syringes and tongue compressors, as well as implants (including pacemakers). And any pharmaceutical software required by medical professionals or end users.
Why are translations so important in the medical device industry?
As a global industry, with companies sending their medical devices to users around the world, the ability to identify and understand how they are used is of the utmost importance. Particularly with the rise of new technologies such as wearable devices—the market for which is set to see a growth of over 26% by 2026—medical device translation services are going to be increasingly necessary. However, if the accompanying materials, from packaging and instruction manuals to any text on the devices themselves, are not translated correctly, it could lead to the device being broken, misused or even cause further medical damage.
They require accuracy
When it comes to medical device labelling, all text needs to be translated with the utmost accuracy. Thanks to the 1993 introduction of the WHO’s Global Harmonization Task Force, there has been a drive towards increased standardisation around the presentation of all printed materials accompanying medical devices. This includes an expanded usage of symbols and graphics, rather than text, to teach people the best way to use any given piece of equipment.
However, no matter how clear these images are, they cannot always be relied on in isolation, and accompanying text should be included, presented as plainly as possible. The EU’s Medical Device Regulation states that any instructions or packaging must be written in the native language of the end user, and be “clearly comprehensible to the intended user or patient.” This must also apply to any updates which need to be made to instructions as the device itself is upgraded, and carry through to any labelling pertaining to aftercare.
They must be appropriate for the audience
It isn’t just translations that are important when it comes to making it easier for people to use medical devices. Overly technical language should be avoided altogether, but the text itself should cater to whoever a product’s end user will be. Although the labels for any consumer medical devices will have been tested for comprehensibility, taking steps to further localise this text can further reduce any possibility of mistakes being made.
Going global with medical devices can be challenging
Of course, one of the most difficult elements of the industry is expanding into international territories, and ensuring that all translated medical device materials comply with the regulations within each country your products will reach. It is important that all medical devices are compliant with restrictions laid out by each country, as well as the WHO’s wider guidelines.