Medical device manufacturers navigate a global landscape – the US is the top exporter of medical equipment, which totaled $30.2 billion in 2022. Likewise, the US is #1 in imports, taking up about 30% market share, all of which requires clear and accurate communication with diverse markets that have distinct language preferences and cultural nuances.
Add to that our worldwide, online connection and the international marketplace suddenly transcends geography, making effective communication a necessity. Be first-to-market by creating a thoughtful Translation Management Plan (TMP) at the start of your product development lifecycle, eliminating the roadblocks common to regulatory compliance, technical accuracy, cultural adaptation, and data security, while setting the stage for a memorable product launch.
Case (Study) in Point: Boston Centerless
Woburn, MA-based manufacturer Boston Centerless produces precision bar materials for the medical and dental device, automotive, and aerospace industries. Over a decade ago, the company instituted a Translation Management Plan (TMP) to combat the ever-present issue of finding skilled labor. The TMP laid out a plan for incorporating translation and interpreting services throughout the hiring process:
- Outreach and recruitment
- Candidate selection and interviews
- Language testing
- Pre-employment assessments
- Onboarding and training
The company keeps language supports in place to ensure employee safety, to provide continuing education, and to foster a thriving diverse, equitable, and inclusive (DE&I) workplace, and continues to recruit and retain a skilled workforce of local, non- and limited-English proficiency (LEP) speakers.
The positive, problem-solving effects of a TMP are not reserved to internal operations, and medical device manufacturers can also expect significant cost- and time-savings when a language strategy is incorporated into the product development lifecycle. It’s the perfect collaboration between stakeholders and the corporate vision, the opportunity to plan for your product’s seamless transition from conception to international commercialization.
Find A Trusted Language Services Partner
First and foremost, find a language services provider (LSP) that will work as your partner, as invested in your success as you are. Look for an agency with industry-specific translators, successful client-translator pairings maintained over time and across multiple projects, and one with global sales and marketing resources and contacts. Other must-haves include transparency around pricing, process, project management, and the use of technology.
A Model TMP
Consider the following example of a simple TMP – an effective LSP will instinctively navigate toward a similar plan, customized to meet your far-reaching goals.
1. Research and Development Phase.
Objective: Incorporate translation and localization into the product development cycle to unify departmental efforts and align those efforts with corporate strategy, to shorten time-to-market.
Strategy:
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Establish a cross-functional team comprised of representatives from R&D, legal and regulatory affairs, and global sales and marketing to identify potential translation needs and regulatory requirements.
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Conduct linguistic risk assessments to evaluate the complexity of product specifications, user manuals, and packaging and labeling, and to identify potential areas that may cause translation issues.
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Integrate translation-friendly design principles into product development, such as reusable blocks of content (modular design), clear and concise language, and localization-ready user interfaces.
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Engage with language service providers (LSPs) early in the process to solicit input on translation management, cost estimation, and timelines.
2. Regulatory Approval Phase.
Objective: Ensure timely and accurate translation of regulatory submissions, labeling, and documentation to support in-country approval processes in target markets.
Strategy:
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Facilitate collaboration between legal and regulatory affairs and translation management teams to identify requirements for translation and localization of submission documents, including technical files, labeling, and instructions for use (IFU).
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Develop a comprehensive translation plan outlining timelines, resource allocation, and quality assurance measures for regulatory submission documents.
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Engage specialized medical device translators with expertise in regulatory affairs and familiarity with relevant regulatory frameworks (e.g., FDA, EU MDR) and medical device technical terminology to ensure accuracy and compliance in translations.
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Implement a structured review process involving subject matter experts and regulatory affairs professionals to verify the accuracy and completeness of translated regulatory documents before submission.
3. Product Launch and Marketing Phase.
Objective: Create localized marketing materials and product documentation to support market entry and customer engagement in target regions.
Strategy:
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Develop a multilingual marketing strategy aligned with product launch timelines and regional market priorities, focused on the linguistic and cultural preferences of target audiences.
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Translate marketing collateral, including product brochures, website content, and promotional materials, into target languages to enhance brand visibility and customer outreach.
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Leverage localization techniques to adapt marketing messages and branding elements to resonate with local cultural norms and preferences while maintaining brand consistency.
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Collaborate with your LSP to ensure efficient coordination and timely delivery of translated marketing materials, leveraging technology-enabled solutions for content management, consistency, glossaries, and possible reuse over time.
4. Post-Market Surveillance and Support Phase.
Objective: Provide comprehensive multilingual customer support and technical documentation to ensure product safety and user satisfaction throughout the product lifecycle.
Strategy:
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Establish a dedicated, multilingual customer support solution to address user inquiries, troubleshoot technical issues, and mitigate liability.
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Translate technical support documentation, including user manuals, troubleshooting guides, and FAQs into target languages to facilitate self-service support and drive market penetration.
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Implement a centralized knowledge management system (KMS) to store and manage translated support materials, ensuring consistency and accessibility across departments and languages.
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Offer training and development programs to customer support personnel to enhance linguistic proficiency, product knowledge, and communication skills and strategies in diverse linguistic contexts.
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By aligning translation management strategies with each phase of the product development cycle, any medical device manufacturer can enter international markets with confidence, and in a reliable, repeatable fashion that safeguards in-country regulatory compliance. It’s a holistic approach to translation management, guaranteed to foster efficiency, quality, and agility, with the goal of making you first-to-market.
Rapport International specializes in multilingual communications, providing language translation and interpretation services that are accurate and culturally appropriate. We use the right voice and the correct terminology to avoid liability, customize services to your needs, and deliver on time and within your budget. With our 100% satisfaction guarantee, you can trust that it’s done right. Contact us today if you would like more information or to get a free quote.
