The medical device industry increasing every day and getting fastened and this fact has made medical device translation services evident. It is one of the largest industries in healthcare. Ever since the advancement of technology this industry has been witnessing new inventions that have been contributing to its growth and development with high-quality, technical, and medical devices. The invention of surgical robots and advanced nano-technology applications has a vital role to play in the success of this industry.
As per the reports global medical device market was reported to be at US$ 447 billion in 2019 and it is meant to rise even more and around US$ 671 billion by 2027. With the development in the device industry global need for translation services has also reached new heights.
The medical device industry has a promising future. However, there are problems and issues which come with every rising industry. In order to handle the medical devices company well, you need to be familiar with certain practices and strategies that may work for good. The regulations keep on changing for medical devices and the medical field. The changes and variations in the medical field make it harder to respond to the required issues instantly as they have a lot to keep updated on before they can make an appropriate response. They also have to ensure to tap the market at right time with the medical devices and their translation required in relevant languages.
The significance of the regulatory scrutiny has made it mandatory for manufacturers and companies to take help from the technology. As it helps them with the methodologies that they should be using which are budget-friendly too. Assure safety and increase the efficiency of devices with fewer non-compliance risks and better progress to meet the market requirements.
The process of taping an overseas market with your products which are medical devices can be exhausting and tough. This is due to all those regulation laws of the new market with administrative and linguistic issues. This industry is quite complex in nature and sensitive too as it is involved with human lives. It gets even tougher to expand it to the foreign market where the owners have to face issues that is related to compliance and laws.
Three relevant examples may include
- Canada does not allow the products in the country until businesses come with translation guides in French.
- Similarly, the process of expansion in Mexico may require the labels and packaging information in Spanish as the basic step. Mexican norms ask for the instructions and device user manual in the Spanish language at first.
- Medical device regulations and requirements for professional medical device translation services could be the same in Malaysia as in European countries. As these are quite similar as mentioned in the medical device directive of Europe.
This is why you just can’t tap any market overseas without doing your research and knowing the target audience well with the medical practices in the relevant country. This could turn all your efforts futile. Countries process in a systemic manner and have different patterns and officials working for different businesses. And when it comes to medical practices and businesses, the foreign vendors are expected to follow certain regulations.
The business of importing and distributing medical devices in different countries has to go through tough and strict approval phases and also has to look for compliance measures. Regulatory authorities in different countries set the rules for the state which foreign businesses have to follow. Therefore they also ask for a copy of the user manual translated into one of the official languages of the country. This is why translating medical devices can be a serious deal and require a lot.
A few of the documents that regulatory bodies of different countries ask for are
- Marketing material
- Instructions for use
- Packaging and labels
- Software and user interface
So, ideally, business owners need to translate all the content including clinical trials, quality management certificates, and administrative documents. Regulators may require assessing the device and approving it to check if it is good enough to import and distribute in the target market.
This is why the team has to be vigilant about the translation of medical equipment and medical device translation companies need to ensure that they have the proper documents required for the device approval process.
There are two key factors that you would be required to understand and know before starting medical device translation
It is extremely important for companies to initially identify their audiences and understand their choices and preferences. Also, the target audiences vary from the medical staff and team to patients. They come from different backgrounds and educational levels. And may experience difficulty with written documents in terms of complexity and user of technical and scientific terms.
Targeting patients may require you to go simple in the selection of words. The text should be translated with the people in mind who can understand the medical language carefully. The text which is used for medical professionals cannot be used for patients. As patients will have great difficulty struggling with understanding text and manual and later using the medical device.
The second factor includes reusing the content
The content for user manuals, packaging, and labels should be planned in a way that can be reused with a few changes. This factor is extremely important to consider. By avoiding unnecessary changes in the source text and applying for approved glossaries and style guides it is quite easy to get benefitted from the long-term advantages which may include going through the process of quality assurance, consistency, and other monitoring phases.
The translation vendor who is providing the medical device language translation can use a translation management system. And translation memories in order to cater to the updates that come with glossaries and medical terminology along with style guides.
Translation of medical devices is beneficial for one and all. In order to facilitate mankind of every race and region, translation services are evident. The field of medical equipment is sensitive and mishandling may bring grieving consequences. So it is important that medical translation is performed by professionals and that companies understand the importance of hiring professional teams. And that they are sorted with the expectations before they lock any translation vendor.