• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution

    Zeus Introduces Absorv XSE Oriented Tubing

    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access

    Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz

    Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Medbio LLC

    Cirtec Medical

    JBC Technologies

    Providence Enterprise USA Inc.

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Cirtec Medical

    JBC Technologies

    Providence Enterprise USA Inc.

    Arthur G. Russell Co. Inc., The
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Localizing Medical Devices

    Why translating medical devices is not enough.

    Localizing Medical Devices
    Localization is the process of adapting content for the target audience/market.
    Ofer Tirosh, CEO of Tomedes12.11.19
    The medical device industry depends on medical translation services to make their products accessible to global markets. Translation, in general, is needed by all global businesses to penetrate foreign markets. Global businesses may also request professional localization services to significantly enhance their products and content’s local relevance. Businesses are not required to localize, but opt to anyway, to be one step ahead of their competition.
     
    This is not exactly the case in the medical device industry, which works somewhat differently from other global businesses. In this article, you’ll get to know how different the context of localization is under the medical device industry and why medical device companies cannot export to other markets without localizing their products.
     
    What Is Medical Translation?
    Medical translation involves translating medical documents. Although translation and interpretation are often used interchangeably, they’re both very different. Medical interpreters deal with live language translation, while medical translators deal with paperwork.
     
    Medical translation services are often requested by medical tourists and domestic patients that do not speak the local language very well. They are required to have all of their health records and relevant documents translated.
     
    This is for the benefit of both the patient and healthcare professional, ensuring that any diagnosis and treatment is based off of accurate information. Any mistranslation could result in the wrong diagnosis, wrong treatment, and in extreme circumstances, the patient’s death.
     
    Medical device companies are also clients of medical translation services. They have documents that need translation namely: marketing materials, labeling, product descriptions, manuals, software, etc.
     
    Medical devices in this article’s context include everything from complex life support machines, pacemakers, and dialysis machines, to simple medical equipment such as syringes, tongue depressors, and latex gloves. As with any other exports, medical devices need to be translated to the target market’s native language, but translation is only one of the numerous criteria that medical device companies need to comply with.
     
    Professional Translation Agencies
    Since medical translation is an extremely delicate form of translation, medical device companies can only rely on trusted vendors. This is where professional translation agencies come into the picture. Professional translation agencies work with translators with native language skills, some with their own specializations; medical translation included. Medical device companies regularly tap into professional translation agencies and other relevant language service providers.
     
    Because of their vast global network of translators, they can easily form a team for high-volume projects that medical device companies regularly commission. In short, medical device companies need to routinely rely on proven vendors that can not only guarantee quality but also have the capacity to handle high-volume projects.
     
    On top of translation services, professional translation services also offer localization services. Localization is the process of adapting content for the target audience/market. A good general localization strategy involves incorporating factors relevant to your target audience/market. Depending on the product and business, these factors include their native language, consumer preferences, aesthetic choices (ex. color), etc.
     
    Every global business needs a good localization strategy to successfully market their products, content, and services to other countries. But medical devices aren’t your average consumer goods. Medical device localization is done in a different manner.
     
    Can Any Professional Translator Do Medical Translation Work?
    Medical device translation can only be done by certified medical translators. Having stellar language and translation skills is just one requirement to be a medical translator. Even with years of experience, no professional translator is legally allowed to do medical translation work until they have gone extra training and earned the right certification in their language specialization of choice.
     
    Potential medical translators need to complete a specific set of hours in approved training programs. There, trainees will be bombarded with vast medical terminology, medical code of ethics, healthcare regulations, and more. This is why many professional translators rarely specialize in medical translation.
     
    Having medical experience beforehand is usually not required, but it is very useful indeed compared to someone with no medical experience or at the very least, exposure to medical terminology. With enough study and training, a professional translator can certainly become a fully certified medical translator.
     
    To sum it up, medical device companies simply can’t pull out a freelance translator online and have her/him translate the manuals of a dialysis machine. Although it falls under the scope of technical document translation, the inclusion of medical terminology means that only medical translators are both suited and legally allowed for the job.
     
    Why Medical Devices Are Required to Undergo Localization
    Even though medical translation is as complex and comprehensive as it gets, it’s still only part of process as mentioned earlier. Indeed, medical devices don’t exactly fit into the category of common consumer goods, but that doesn’t mean that medical device companies can do away with localization. 
     
    Localization can be done in many forms, but in this context, localizing medical devices is done by strictly complying with the target market’s regulations and quality assurance standards on medical devices.
     
    Unlike other industries that utilize localization to improve their product success and content relevance, the medical device industry can’t regard localization as something supplementary. Standards on medical device translation and localization involve nearly endless proofreading, quality assurance testing, linguistic validation, etc.
     
    For example, if the medical device comes with integrated software, then its language and user interface (UI) have to be translated to the native language. It then has to be subsequently localized through highly stringent linguistic validation and quality assurance testing to ensure that every translation and UI configuration complies with both the industry and target market’s approved standards.
     
    These strict standards exist since any mistranslation down to the punctuations and decimal points might entail dire and even fatal consequences.
     
    International Standards and National Regulations
    The medical device industry is a tightly regulated industry. Medical device manufacturers simply can’t market and export to whichever markets they wish compared to common electronics and consumer goods companies. After all, a heart monitor sensor is totally different from smartphones and televisions. When human lives are at stake, it’s only natural that such products are heavily regulated.
     
    Each country has their own regulations for imported medical devices. This what makes medical device localization uniquely challenging. These regulations cover everything from manufacturing standards, safety standards, sanitation standards, UI quality assurance testing, linguistic validation, clinical testing, and more. 
     
    A. ISO Certifications
    To establish themselves as not only experienced but also qualified vendors of medical device translation and localization services, professional translators agencies commonly display their acquired ISO certifications loud and proud. Common ISO certifications include ISO 9001, ISO 17100, ISO 10993, ISO 13485, etc.
     
    B. U.S.A.
    The U.S.’s Food and Drug Administration is responsible for laying out the regulations on medical devices. The FDA categorizes devices according to class (Class I, Class II, Class III, Class IV). As the class ascends, the regulations become stricter. Class I comprises of low-risk devices such as tongue depressors while Class IV are high-risk devices featuring critical life-support functions. 
     
    C. European Union
    The E.U.’s regulations mimics the U.S.’ in terms of categorizing devices to corresponding classes. After years of stagnation, the EU’s recently rolled out new regulations on medical devices. It updated its Medical Device Regulation (MDR) in 2017. The updated In-Vitro Device Regulation  (IVDR) will be effective in 2022. 
     
    These new regulations also require all medical device companies to translate their products to all languages of the European Member states. This means a medical device company based in the U.K. or Ireland will have to translate their products from English to Spanish, English to German, English to France, etc. and even English to Maltese and English to Croatian.
     
    The reason why the U.S. and E.U. were singled out of all the countries is that they’re home to largest medical device companies. The U.S. claims world titleholder as the largest medical device manufacturer and medical device market. However, more countries are coming into the fore.
     
    Why Medical Device Companies Need Translation and Localization Services
    As stated earlier, countries and economic regions (E.U. specifically) regularly update their regulations on medical device manufacturing and importation. This however makes it exponentially harder for medical device companies. Let’s take a look at the E.U.’s updated regulations for us to get a clearer perspective from their end.
     
    The E.U.’s announcement of the MDR and IVDR means that medical companies based in the E.U. and those that are currently exporting to the E.U. are all scrambling to comply with the new regulations as fast as possible before they become fully in-effect. You have to remember that their inventory number is a few dozen to hundreds of medical devices.
     
    Depending on the device, some come with manuals and relevant documents that are hundreds to thousands of pages long, including software. Multiply that by dozens to hundreds of products and you can see the immense hurdle that medical device companies have to face. While big-name brands such as Siemens and Phillips have the resources to comply with the EU's new regulations, smaller medical device companies aren’t so lucky.
     
    Be that as it may, this presents a major opportunity to professional translation agencies and language vendors offering medical translation services. Medical device companies, both large and small, will be needing translation agencies and localization companies more than ever if they want to continue operating in the E.U.
     
    Additionally, more medical device companies coming from competitive countries such as China and India are now entering the market. Naturally, they have their own regulations but will inevitably have to conform to international standards. China in particular is a relatively new but emerging exporter of medical devices. 
     
    If a Chinese medical device company wants to export to the EU and English speaking markets (U.S.A., Ireland, U.K., Australia), then they inevitably will have to comply with the target market’s regulations. This includes providing Chinese to English translations.
     
    Protecting the Welfare of Developing Countries: Final Takeaway
    Although complying with regulations is a hassle, it is done to ensure that medical devices are manufactured with the utmost quality with patient safety and well-being in-mind. That being said, these regulations set the ground for the future of the medical device industry. Late comers in the market are given little to no room to develop sub-standard products and export it to developing countries.
     
    Developing countries in Africa, Latin America, South Asia, and Southeast Asia are also emerging markets for medical devices. Many of the world’s public health concerns originate from those regions so it makes sense that medical devices are really needed there. Medical device companies might take advantage of these countries’ lax and out-of-date healthcare and medical device standards.
     
    The medical device industry is an increasingly competitive industry, but ever-changing regulations mean that they can’t innovate as fast as they want. However, healthcare regulations exist for a reason—to ensure standardized practices and to protect the patient’s health and well-being.
     
    Ofer Tirosh is CEO of Tomedes, a professional language services provider, specializing in SEO translations and localizations in more than 100 languages, serving tens of thousands of business clients worldwide.
     
    Related Searches
    • consumer
    • electronics
    • fda
    • devices
    Related Knowledge Center
    • R&D & Design
    Suggested For You
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    Babson Diagnostics Raises $31 Million in Series B Funding Babson Diagnostics Raises $31 Million in Series B Funding
    Picarro Unveils EtO Gas Concentration Analyzer Picarro Unveils EtO Gas Concentration Analyzer
    PTI Engineered Plastics Wins a 2021 Macomb Business Award PTI Engineered Plastics Wins a 2021 Macomb Business Award
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    The Benefits of Computer Vision Technology for Healthcare Applications The Benefits of Computer Vision Technology for Healthcare Applications
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Midwest Products & Engineering Acquires MindFlow Design Midwest Products & Engineering Acquires MindFlow Design
    908 Devices Develops New Data Integrations With Key Industry Partners 908 Devices Develops New Data Integrations With Key Industry Partners
    CE Mark Granted to Expandable, Biodegradable Biliary Stent CE Mark Granted to Expandable, Biodegradable Biliary Stent

    Related Videos

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

      MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

      Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.
      MedTech Innovator 09.21.21


    • CE Mark Granted to Predictive Software for Kidney Allograft Survival

      CE Mark Granted to Predictive Software for Kidney Allograft Survival

      Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
      Cibiltech 09.21.21

    • Surgical
      Precision Coating Merges with N2 Biomedical

      Precision Coating Merges with N2 Biomedical

      Expands its medical coatings platform.
      Ampersand Capital Partners 09.20.21

    Loading, Please Wait..

    Trending
    • Cardiosense Begins SEISMIC-HF I Heart Failure Trial
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Exo Introduces The Exo Iris To Market
    • A New Approach To Post-Market Surveillance
    • Varian Buys Aspekt Solutions To Bolster Advanced Oncology Biz
    Breaking News
    • 3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    • Zeus Introduces Absorv XSE Oriented Tubing
    • Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    • Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz
    • Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    View Breaking News >
    CURRENT ISSUE

    October 2023

    • MPO's 2023 Medtech Supply Chain Survey
    • Exceeding Medical Device Extrusion Expectations
    • Medical Device Micromolders Discuss the 'Minor Details'
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    PLT Health Solutions Granted Claims for Botanical Ingredient in Canada
    CRN Files Petition with FTC For Clarity on Health Products Compliance Guidance
    Vitafoods Europe Relocates to Barcelona Starting 2025
    Coatings World

    Latest Breaking News From Coatings World

    Arkema Will Decarbonize Acrylics Production at its Carling, France Site
    PPG to Announce Third-Quarter 2023 Results October 18
    IGL Coatings Partners with DHL Express
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    Zeus Introduces Absorv XSE Oriented Tubing
    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ono, Admid Partner on Novel Antibody Drugs in Oncology
    Theradaptive Awarded DOD Clinical Trial Award of up to $7.4M
    Ginkgo Bioworks, Pfizer Enter Multi-Target RNA Discovery Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    NYX Professional Makeup Partners with the New York Liberty
    BASF and StitchCrew Introduce Educational Bootcamp for Indigenous Beauty Brands
    Top 10 Most Popular Fashion Designer Makeup Brands—According to Landys Chemist
    Happi

    Latest Breaking News From Happi

    Evoke the Beauty of Spring with Epopack
    Micro Powders Appoints IMCD US New Regional Distributor for Personal Care Products
    American Cleaning Institute Praises Draft Proposal on Cleaning Product Ingredient Transparency
    Ink World

    Latest Breaking News From Ink World

    Arkema Will Decarbonize Acrylics Production at Carling, France Site
    Micro Powders Showcases New Natural, PTFE Alternative Additives at 2023 WCS
    Roland DG Direct-To-Film Printer Ink, Powder Receive ECO PASSPORT Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    INX brings inkjet and sustainable packaging to PRINTING United Expo
    Schreiner MediPharm introduces Freeze-Light-Protect syringe label
    Kodak launches PRINERGY 10.0
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    ExxonMobil Works with JL Goor to Help Drive Growth in Ireland and U.K. Healthcare Sector
    Lee C. Stewart Resigns from Glatfelter Board
    Ana Fraisse Joins The American Cleaning Institute
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    CTL Amedica Granted ECAT Approval from Defense Logistics Agency
    Intech Acquires Lenkbar LLC
    ONWARD Completes First-in-Human for ARC-IM to Restore Upper Extremity Function
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Wiliot to Show Enhanced Version of Wiliot Cloud, IoT Pixels, at MWC Las Vegas 2023
    Fraunhofer FEP Integrable Solution for 2D Inline Process Monitoring
    Jabil Announces Definitive Agreement to Divest Mobility Business for $2.2B

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login