The recent SARS–CoV–2 pandemic has shown the importance of a dynamic, precise, and responsive healthcare system. It has also taught the general public how a coordinated international medical community can control a public health crisis.
For instance, numerous countries from the Global North provided developing regions with the medical equipment they needed to face this pandemic. Those medical devices allowed quick diagnostics, data sharing, and coordinated work between specialists.
Regardless of whether a medical device was developed by a local company, or thousands of miles away from where it’s going to be used, it should be as easy to operate as possible. Language is one of the dimensions that can hinder or facilitate the usage of a medical device.
In this post, we’ll explore medical device localization.
What Is Medical Device Localization?
What we refer to as medical device localization is the process of adapting and translating the written content and components of a product made specifically for the healthcare industry, so it can be used by foreign medical professionals. Medical device localization involves revising all aspects of the product to ensure it meets cultural, regulatory, and usage standards.
Aside from the product itself, its support material and packaging should also be translated. For instance, when dealing with a tool that comes with supporting software, a localization team may have to work with:
The exporting and importing of medical devices tend to involve heavy documentation. Therefore, aside from these “user-facing” elements that should be subjected to medical device localization, a team of linguists may also have to work with patents and critical regulatory documentation, which will require translation and potentially some reformatting.
Translating for the medical sector tends to require precision since the patient’s health is at stake. Therefore, medical device localization should always be in the hands of professionals. These professionals must handle medical terminology precisely while understanding the true purpose of this type of localization.
While marketing localization, for instance, has the goal of making a brand engaging and attractive to a new target audience, the goal of medical device localization is ensuring that a precision tool is easy to understand and easy to operate.
Hiring a proficient translator is not enough for a reliable medical device translation. Knowledge of medical terminology, procedures, and medical device regulation is fundamental. And, if you’re striving towards complete localization, a linguist alone may not suffice. Gravitate towards companies that provide integral, cross-disciplinary solutions.
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The Tangible Benefits of Medical Device Localization
Unlike medical documentation, medical devices are manufactured goods, though they don’t fit into the category of “consumer goods”. As such, they’re still part of a brand that has its identity and needs to appeal to customers and users.
But, as we previously explained, this is a minor function when talking about localizing medical devices. The delicate nature of the healthcare context is reflected by the fact that it is a highly regulated sector, so medical device companies need to comply with the target market’s laws and quality assurance laws to sell their products in a target market. Laws like the European Union’s European Medical Device Directive (2007/47/EC), as well as the ISO 13485 standard, set clear quality standards for medical device localization.
As a stakeholder, you may be wondering whether medical device localization is essential. At the end of the day, it’s a costly and time-consuming process. So, is it really worth it?
It is. Some markets may be impossible to enter if your product is not localized. This may be due to regulatory barriers, or merely a consequence of a very low degree of English penetration in your target country. And with the industry steadily moving towards an app-based approach to healthcare, the demand for healthcare software localization is on the rise.
For companies with products that are not in a regional *lingua franca*, expansion may not be just complicated, but absolutely impossible. If your product’s user interface and manual are in Ukrainian and you want to sell it to a hospital in Germany or Spain, the chances of winning the customer against a local (or localization-prone) competitor are quite skim.
People like tools they can understand. Usability is a huge competitive advantage, and a language barrier is undoubtedly a usability concern.
Planning a Medical Device Localization Project
Before you embark on the medical device localization process, it’s essential that you take the following steps:
1. Select the content to be localized
Companies that have a well-established international presence usually manufacture their products with international markets in mind.
Smaller manufacturers that create their products for a specific market and then plan for expansion, may be unable to localize all aspects of their products. Since doing so may involve having to change product components that are crafted by third-parties or that can’t be replaced without reducing profitability.
For example, if the Turn on button is printed in English on the product’s casing, there may be no way to translate it after production, so the user manual needs to clarify in the target language which function it serves.
2. Prepare the source text
If you’re working with an editable text file, preparing the source text may be as simple as feeding it to your translation management software.
But, in some cases, the material is made available in other formats, which the translator can’t work with directly. In these cases, transcribing the source text is an essential first step. By doing so, you ensure a concise foundation for the translation of equipment functions. The use of short and clear sentences is extremely advisable. Avoid cultural references and idiomatic expressions at all costs, since they are difficult to adapt to other cultures. This will make it easier for further translators if the content is going to be set up for international markets.
3. Build a glossary
One of the most common medical translation challenges comes with the frequent use of complex terminology and words. Translation consistency is key when working with a team of linguists. And it may even be challenging when a single person is working on a lengthy text. A glossary of commonly used terms will allow them to easily understand complex medical terminology, streamlining the process and ensuring an accurate translation.
4. Use Back Translation
Due to the high level of precision that medical subjects require, the most commonly used method to check the quality of a medical translation is back translation. It consists of translating an already translated document back to its source language and comparing the original with the re-translated text to verify that they match. Back translation is performed by an independent translator who hasn’t seen the original document before. Therefore, the process results in an unbiased evaluation of the translation quality.
Can You Handle Medical Localization In-House?
The sooner you include medical device localization in your list of business priorities, the better. Some manufacturers working at a global scale consider localization from so early on in their process, that they produce different varieties of their product for different regions. Even if you’re not a global business leader yet, properly translated documentation and user resources can go a long way.
If this is your case, you may be wondering if you can handle document localization in-house. Truth is this is rarely convenient. In order to conduct a successful medical device localization process, you need:
You’ll also need to establish and manage the implementation of localization-related best practices at several company levels.
Some of the world’s biggest companies in the medical devices industry, such as Siemens or General Electric, have entire departments dedicated to translating and localizing their devices. Handling localization in-house is within the means of companies of such scale, with hundreds or thousands of products released every year, to a wide and international customer base.
In order to handle localization and translation in-house, a company has to transfer considerable resources to the creation of a whole new department. Even if this is within a company’s means, it unnecessarily maximizes the risk associated with expansion. Hiring medical device translation services appears as a cost-efficient and low-risk alternative.
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Work with a Medical Device Localization Expert
Working with an experienced translation company will allow your business to expand your brand to new markets. Life sciences translation grants healthcare providers the context and guidelines they need to operate their medical equipment properly, thus minimizing potential mistakes. An accurate medical devices translation represents a competitive advantage when you’re looking to reach a global customer base.
But how can you ensure you’re hiring medical translation services that fit your needs? You should seek a company that has a proven record as an industry leader, solid quality assurance processes, the trust of renowned customers, and extensive experience dealing with international laws and regulations.
At bayantech, we deliver top-quality medical translation services at an extremely competitive rate. We grant our customers global support, the use of cutting-edge technology, along with ISO 17100 and ISO 9001 compliance.
Our team of specialists has vast experience in clinical subjects.
We deliver flawless results across formats, including: