In the medical and healthcare industry, medical devices hold an important position. In this blog, we will discuss the medical device market, approval procedures, and risk management while comparing them with pharmaceuticals.
We will also examine the key points for translating IFUs (Instructions for Use) and drug application documents.
- Table of Contents
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- 1. Size and Characteristics of the Medical Device Market
- 1-1. Market Size of Medical Devices
- 1-2. Characteristics of the Medical Device Market
- 2. Approval Process and Risk Assessment for Medical Devices
- 2-1. Medical Device Approval Process
- 2-2. Risk Assessment of Medical Devices
- 3. What is the demand for medical device translation and the translation company that meets it?
- 3-1. High expertise required for medical device translation
- 3-2. There may also be a need to translate large and rapid amounts of pharmaceutical application documents.
- 4. Leave medical device translation to Human Science Co., Ltd.
- 5. Introduction to Medical Translation at Human Science Co., Ltd.
1. Size and Characteristics of the Medical Device Market
1-1. Market Size of Medical Devices
Japan's pharmaceutical market boasts one of the world's largest scales, and the size of the pharmaceutical market after 2020 is estimated to exceed 10 trillion yen, although it varies slightly depending on the source. It is estimated to have the second largest share after the United States, major European countries, and China.
On the other hand, the medical device market in Japan is also a large market, which includes diagnostic equipment, treatment equipment, surgical equipment, rehabilitation equipment, etc. The size of the medical device market after 2020 is estimated to be around 5 trillion yen, although this may vary depending on the source.
1-2. Characteristics of the Medical Device Market
The medical device market is characterized by its wide range of products.
In pharmaceuticals, there are variations such as usage and dosage form, but they can be summarized as substances that have some effect when taken into the body. However, medical devices range from "instruments" such as tweezers to "facilities" such as MRI, making them significantly different.
The future of the medical device industry is expected to see further market growth, with a high demand for advanced medical devices incorporating the latest technologies such as regenerative medicine for organs like the heart and brain, robotics technology for surgery and caregiving, biosensor technology for wearable devices, medical image analysis, AI technology for diagnosis support and patient management.
2. Approval Process and Risk Assessment for Medical Devices
2-1. Medical Device Approval Process
The approval process for pharmaceuticals includes the submission and evaluation of clinical trial data, safety and efficacy, and typically goes through a rigorous multi-stage process before approval is granted.
The approval process for medical devices also includes clinical trials and performance evaluations, but due to the wide range of products, different processes and standards may be applied compared to pharmaceuticals, and specific standards and safety evaluations may be required.
2-2. Risk Assessment of Medical Devices
In the approval process for pharmaceuticals, the safety of the drug (severity and relevance of adverse events that occur after drug administration) is carefully examined, and in fact, there are many cases where approval is not obtained due to serious side effects. However, the balance between safety risks and benefits to patients is also considered important, and there are cases where a certain level of risk is tolerated.
On the other hand, in the approval process for medical devices, the evaluation of safety and performance, as well as the balance of risks and benefits, are considered. However, each medical device has its own risks and is classified into Class 1 to Class 4 depending on the level of danger to the human body and others.
As an example of potential risks in medical equipment, artificial respirators directly affect a patient's breathing and heart pacemakers directly affect the movement of the heart. In the case of a CT scanner, radiation is emitted to the patient and a very heavy X-ray tube rotates rapidly above the patient.
Strict risk management is necessary for these.
3. What is the demand for medical device translation and the translation company that meets it?
3-1. High expertise required for medical device translation
In medical translation schools and distance learning programs for translators and aspiring translators, the curriculum often focuses on "pharmaceuticals" as the subject matter. Additionally, there is a field of study called "pharmacology" that provides a systematic understanding of background knowledge. Therefore, it can be considered that the environment for learning "pharmaceutical translation" is relatively well-established.
On the other hand, when it comes to medical equipment, it is not easy for translators to prepare for all types of medical equipment due to the wide range of products.
Therefore, it is important to entrust a translation company that has a strong cooperation system with motivated translators and translation checkers who have a high level of expertise in each medical device, and are eager to absorb investigative skills and new knowledge.
In addition, for the translation of IFUs (Instructions for Use), a translation company that handles the creation and translation of various manuals for general consumers and internal use by manufacturers may have expertise in using expressions and notation that are easy for readers to understand.
In addition, many medical devices today are designed to be connected to PCs and networks, so it is possible that translation companies with experience in IT translation can provide the quality of translation that customers are looking for.
3-2. There may also be a need to translate large and rapid amounts of pharmaceutical application documents.
Just like clinical trials for pharmaceuticals, a large number of documents such as the device summary, clinical trial implementation plan, and overall clinical trial report are generated for medical device regulatory submissions.
In order to achieve quick approval, it is necessary to translate those documents quickly and accurately.
By entrusting a translation company with expertise in machine translation (MT) and translation support tools (CAT tools) such as Trados that use translation memory, it is possible to achieve large-scale and rapid translation of pharmaceutical application documents.
4. Leave medical device translation to Human Science Co., Ltd.
Human Science's Medical Translation Department has been working with highly specialized translators and translators with strong research skills and motivation.
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In addition, we have been utilizing translation support tools such as Trados, machine translation, and AI to provide fast and accurate translations.
Our company has a track record of utilizing Trados for English to Japanese translation of clinical trial reports for ophthalmic medical device manufacturers, achieving shortened delivery times and unified translations. We have also utilized Trados for English to Japanese revisions of user manuals for medical device manufacturers, ensuring consistency with previous versions in terminology and expressions. In addition, we have a wealth of experience in using Trados for Japanese to English translation of specifications, user manuals, UI, and FDA application documents for clinical medical support system companies, allowing for simultaneous translation of multiple items and providing consulting services for manual creation.
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Achievements and Case Studies
Medical Device Translation Services
Leave your medical device translation to Human Science Co., Ltd. without hesitation.
5. Introduction to Medical Translation at Human Science Co., Ltd.
At Human Science, we offer human translation services and post-edit services. We utilize translation support (CAT) tools such as Trados and Phrase TMS (formerly known as Memsource), as well as automatic translation tools, to improve efficiency and quality of translation, and contribute to the further development of our clients.
If you have any concerns or interests, please feel free to contact us.
In addition, we also provide information on medical/medical translation as follows. Please use it.
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