SimulTrans Localization Blog: SimulTips

Applications For Medical Translation

[fa icon="calendar"] May 31, 2018 / by Margarita Núñez

Empowering Patients

The Medical Technology, Pharma and Life Sciences industries are significant contributors to any economy of the world. They generate billions of dollars and employ thousands of people. With healthcare becoming increasingly globalized, the need for quality medical translation services in these industries is more critical than ever. Demand for these services are especially essential, particularly in the areas of regulatory approvals, medical devices, and clinical trials.

Regulation Approval Submissions

It is a legal requirement to have approval to distribute any medical device, and this approval is granted by government bodies. For instance, in the USA, a distributor will require a go-ahead from the U.S. Food and Drug Administration (FDA) and the same device will have to comply with the European Union regulations in Europe. 

Regulatory approval submissions typically must be translated if they are not in the language of the body that will approve them. Therefore, all the correspondence and paperwork related to the submission must be translated.

Here is an example of the items that will need translation:

  • Cover Letter
  • Labeling
  • Case Reports
  • Chemistry, Manufacturing and Controls (CMC)
  • Forms
  • Summaries
  • Study information
  • Meeting briefing materials

Therefore, to prevent your device from being rejected by the regulatory authorities of the country where you are hoping to distribute your medical device, provide a professional medical translation to ensure all the literature and correspondence is in the language of the regulatory authority (i.e. English for FDA).

Use of Medical Devices

A medical device is any apparatus, appliance, software, material, or other article intended to be used on human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease.

Around the world, 78% of countries require instructions for use for medical products sold to be translated into the native languages of their residents. Any company would then necessarily need to have their product translated. This would apply to pretty much any device: from monitoring systems to implants; big or small.

Here is an example of the items that will need translation:

  • The device or appliance itself
  • The User Interface (UI) on the device
  • The stickers on the appliances
  • The labels for the products
  • The Instructions for Use (IFUs) for the patients or doctors
  • The website from the company selling the product
  • Any marketing materials to promote the device
  • FAQ on the website

Therefore, almost if not all patient facing information would need to be translated into the patient’s own language in the country where that device is sold. For instance, if you are going to sell your product in Argentina, all the items above should be translated into Spanish (for Argentina, not Spanish for Spain) using a native Argentinian professional medical translator.

Clinical Trials

Navigating clinical trials is fraught with legal and ethical considerations, but the ability to clearly communicate all phases to all parties involved from patients to doctors to regulators can help mitigate risk.

Any Contract Research Organization (CRO) company that provides support to the pharmaceutical, biotechnology, and medical device industries should reduce liability by providing top grade medical translations, hence optimizing success by adhering to international protocols, and more importantly protecting human lives.

Over half of registered clinical trials are conducted in countries where English is not the primary language. So a professional medical translation can play a critical role in clinical trials. It can help to illuminate the full scope of the trial process, including the risks involved, the potential benefits and the likelihood that these benefits will materialize.

These clinical trials can be a matter of life and death to those who participate in them, so clarity is arguably even more important in this domain than any other.

Here is an example of the items that will need translation:

  • Labels
  • Questionnaires
  • Email correspondence
  • Approvals
  • Surveys
  • Summaries
  • Patient and Doctor Documentation
  • Protocols

Summary 

Translations, from regulatory submissions to distributing the medical device or drug, are not only compulsory by the authorities of the targeted country, but can also help medical professionals do their work more effectively, and patients understand their conditions, their treatment and the medical devices or drugs used better.

Demand for medical devices is growing at a double-digit annual pace in developing countries, compared to 3–5% in Western Europe, North America, and Japan. Only 4% of trade occurs within the US, and exports of medical devices exceeded $45 billion in recent years. Failure to capture this niche can be a costly mistake, but by translating products manufacturers can capitalize on this $340 billion industry.

If you are interested in medical translations, you might like to read our free Life Sciences Case Study.

Download   Life Sciences  Case Study

Topics: Medical Translation

Margarita Núñez

Written by Margarita Núñez

Margarita serves as SimulTrans’ Director responsible for European sales, overseeing a team of account managers who build and maintain relationships with customers. She travels frequently throughout Europe, advising clients on best practices in the industry and helping them successfully localize their products for a global market. Margarita has spent over 20 years in the localization industry.