From simple disposable items such as syringes to cutting-edge medical equipment such as shockwave therapy machines, the medical device industry encompasses a vast range of products that diagnose, treat, and manage various medical conditions.
More and more companies are striving to develop innovative devices to address health and wellness issues, making the industry more global than most. But how do you tap into this global market and become part of its success?
In this article, weâ€™ll not only give you an overview of the industry’s global landscape but also provide you with the best practices to thrive in this exciting field. They include the obligatory use of high-quality medical device translation services in various stages.
Medical Device Industry: Market Overview & Future Insight
The global medical device industry was valued at $447.63 billion in 2019 and is expected to reach $671.49 billion by 2027.
The North American market took the lead in generating revenue in 2019 and is expected to maintain its position due to its well-established healthcare infrastructure. Nonetheless, the Asia Pacific region is quickly gaining momentum and expanding at a rapid pace, due to the aging population, an increase in per capita income, and heightened health concerns.
Within the industry, the medical device market is divided into two major segments: in vitro diagnostics (IVD) and medical devices. IVD products are used in medical laboratory testing of human body specimens.
In 2019, the market segment for in vitro diagnostic (IVD) devices constituted approximately 13% of the overall market share, primarily due to the rising prevalence of chronic illnesses and the demand for highly precise and efficient testing kits.
On the other hand, the Medical Devices segment encompasses a vast array of products, categorized based on their specific applications, including:
- General & Plastic Surgery Devices
- Diagnostic Imaging Devices
- Cardiology Devices
- Orthopedic Devices
- Ophthalmic Devices
Finally, hospitals and ambulatory surgical centers were the primary end-users in the global medical device industry in 2019 - they are the ones that are interested in buying and using these devices more and more with the passing of time.Factsheet: Overview of the Medical Device Industry
- The medical device market was valued at $447.63 billion in 2019 and is projected to reach $671.49 billion by 2027.
- North America dominated the market in 2019 and is expected to maintain its lead due to the highly developed healthcare infrastructure.
- Asia Pacific is the fastest-growing region, driven by a rising aging population, increasing per capita income, and growing health concerns.
- In vitro diagnostic (IVD) devices accounted for nearly 13% of the market in 2019.
- Hospitals and ambulatory surgical centers were the top end-users in the global medical device market in 2019.
- Main fields based on growth:
- Diagnostic Imaging
- General & Plastic Surgery
The Need for Translation in the Medical Device Industry
Medical device companies typically differ in size, budget, and objectives, with many life science organizations and start-ups competing for a share of the market. However, introducing medical devices to a new market is a challenging task that involves several stages, with certified translation being a necessary requirement in almost all of them.
From product development to regulatory approval, marketing, and distribution, medical device translation services help you communicate with experts, hospital staff, patients, international institutions, and other relevant entities.
In the initial stages of product development, the precise translation of technical documents and labeling is of utmost importance to ensure compliance with regulations in various countries and ensure the successful completion of clinical trials. Any inaccuracies in translations can have serious consequences, including misdiagnosis, injuries, lawsuits, and even fatalities. From the start to the finish line, two priorities that life sciences cannot compromise are regulatory compliances and scientific grounds.
Furthermore, during the manufacturing stage, medical device translation is vital for complying with local regulations, technical specifications, and quality standards. The proper translation of technical manuals, user guides, and labeling instructions ensures the safe and correct use of the device. Anything less than high-quality translation services can result in damage to the manufacturer’s reputation, lawsuits, and failure to proceed with the process.
Many medical device manufacturers employ a multilingual workforce that has the right to read the technical documents necessary for their procedures in a language they understand.
The demand for medical device translation services grows exponentially during the marketing stage, especially when multiple countries are involved. At this point, we have a variety of medical device documents that need to be translated in order to market the device to target audiences, institutions, hospital staff, and other groups.
Regulatory Requirements for Medical Device Translation
The regulatory requirements for medical device companies begin with the translation of the company’s certification and other related technical documents for the markets into which they want to expand.
Each country and region has its own regulations and institutions that regulate the medical device industry. Medical device companies in the USA are required to abide by the Food and Drug Administration (FDA). In Europe, the respective regulation is the Medical Device Regulation (EU MDR), which was recently updated.
If before only English would do the job, the updated Regulation in the EU, for example, now requires companies to translate into the 24 official languages, depending on the national market into which they wish to enter.
Also, before the medical device translation process could be done by the supervising Committees, it is now in the hands of the manufacturing company.
Of course, safety is the end goal, but you canâ€™t enter any market without following the regulations of these institutions. They can stall, disprove and really damage your brand image, or even sue you if you donâ€™t comply.
Itâ€™s normal for medical device companies to feel lost and confused, thatâ€™s why we always recommend hiring a certified translation service provider that specializes in life sciences and helps you understand each step, and pushes your project further seamlessly.
These projects require employing native project managers, subject matter experts, and medical translators familiar with the local medical and business culture, and can professionally render your academic, bureaucratic, and technical documents with precision and coherence.
4 Things to Take into Account in Medical Device Translation for Global Success
Bringing a medical device to a new market can be a complex and time-consuming process; working with local experts and professional medical translators can make it way easier. We list all the necessary steps to bring your devices to new markets around the world.
1. Language and Culture
To cater to the needs of a diverse population, it is essential to consider the language and cultural background of the target audience when developing and translating medical device materials. Neglecting cultural differences can lead to misinterpretation of instructions and warnings, which may cause harm or misuse.Moreover, having a deep understanding of the target language and culture is crucial to ensure that medical devices are well-received in local markets, whether the audience is consumers or hospitals and clinics. The success of the devices depends on the audience, and it is vital to choose the appropriate language and cultural understanding.Therefore, it is recommended to work with professional translators especially various medical translation typesdirected to end users such as user manuals, informed consent forms, and marketing materials to ensure accuracy and effectiveness. By doing so, medical devices can be made accessible to a wider range of patients, regardless of their language or cultural background.
2. Native Subject Matter Experts (SMEs) and Technical Terminology
Using a native SME team, such as certified medical device translation companies, is considered superior to employing freelancers. The reason for this is that many projects are extremely complex and entail more than just word rendering.SMEs are knowledgeable about both the language and technical terminology used in the medical device industries as well as the local market and legal regulations. Partnering with a language service provider guarantees that all translations are accurate and coherent for the target audience.Medical device translation presents unique challenges due to the serious consequences of poor translation. An LSP is better equipped to handle the complexity because, basically, they have more resources. They have their own terminology management and glossary database, as well as computer-aided translation (CAT) tools that allow for the identification and consistent translation of technical terminology across all medical device documents.Lastly, ISO 17100:2015 and 9001:2015 are two certifications that serve as guiding standards in building a process-based quality management system, promoting process control, organizational performance, and continuous improvement. Make sure youâ€™re LSP of choice has both of them.
3. Main Tools and Technology Used in Medical Device Translation Services
Translation technology assists translators and project managers in managing the translation process while also ensuring consistency and quality across all languages. Below we mention three tools that are most commonly used in medical translation services.
- Translation memory (TM) is a database that stores translated content and allows translators to reuse translations for previously translated content, resulting in consistent translations and lower costs. Since medical devices oftentimes will deal with the transferring of the same data from one document to another, TM can be of great help.
- Terminology management tools ensure that terms are used consistently across all languages, reducing the risk of errors or misunderstandings.
- Machine Translation MT + Machine Translation Post-Editing MTPE: MT is a technology that uses computer algorithms to automatically translate content from one language to another. Despite the fact that MT has high error rates to be acceptable in medical and healthcare settings, several companies are tempted by the speed and scale of machine translation (MT).
To that end, it must be followed by Machine Translation Post-Editing, where the machine-generated translation is reviewed by a professional human translator, as mandated by the US Department of Health and Human Services
4. Quality Assurance
Quality assurance in medical device translation involves a comprehensive process that ensures the accuracy, consistency, and clarity of translated content. The process includes several stages, such as translation, editing, proofreading, and review, to ensure that the final output meets the highest standards of quality and accuracy.One of the key practices is to work with professional translators who have expertise in the medical device industry and the target language. During the quality control process, the translated text is reviewed by a second linguist and an editor to ensure accuracy, clarity, and consistency.
Accurate and compliant medical device translation is crucial for reducing risks and meeting regulatory requirements. By following best practices, such as working with professional translators and utilizing standardized quality assurance processes and translation technology, medical device manufacturers can ensure high-quality translation.Laoret provides translations for medical device companies and manufacturers in over 120 languages, all complying with the latest regulations. Get in touch with us to request a quote and discuss your needs.
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