Medical Device manufacturers are facing unprecedented pressures. Under the European Union’s Medical Device Regulations (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR), having a strong life sciences localization strategy has become critical. Documentation and labeling must be translated into every member state’s official language, and noncompliance can seriously hinder product approval and go-to-market timelines. With the rapid advancement and adoption of AI into medical device development, manufacturers must find ways to stay competitive and enter markets even more rapidly. Of course, medical device translation services must comply with expanding local and national data privacy regulations and protect sensitive patient information.

With all these (sometimes opposing) pressures, optimizing medical device translation strategy is more paramount than ever. Lionbridge’s life sciences translation services experts share four ways to optimize your medical device localization strategy.

#1 Manage an Enterprise Medical Device Localization Program; Stop Purchasing Translations

For optimal medical device localization, it’s crucial to stop approaching language needs one project at a time. Instead, coordinate all content, suppliers, language assets, and approval processes across your divisions and markets. Consider supplier consolidation (we’ll discuss that more below) to:

• Streamline your processes significantly
• Reduce vendor management
• Reduce costs per project
• Better define performance standards

To begin approaching your medical device translation services from a more holistic level, rather than project by project, organize all your life sciences language services procurement around three questions:

• What’s working well?
• Where should we use AI?
• How will we know it’s performing optimally for us?

#2 Consider Consolidating Medical Device Localization with More than One Provider

Many medical device manufacturers hold off on consolidating their medical device localization vendors because they’re concerned it means using just one. Consolidation can actually be done with a few vendors to cover all buying groups and geographies. One successful approach is to use a preferred global provider and a provider or two with the capacity to offer backup services. For best results with a few language services providers, it’s vital to define what materials need to be standardized:

• Terminology
• Language Assets
• Services definitions
• Reporting
• Intake
• Escalation

Another essential step when working with a few providers is to address transition planning and asset portability. These actions will ensure multiple providers can pick up your work and that it isn’t overly dependent on one of them.

#3 Protect Your Existing Language Assets Before Exploring AI Implementation for Medical Device Localization

AI implementation for medical device localization can cut translation spend and turnaround times, but it’s even more impactful when manufacturers can provide a strong portfolio of preparatory materials. Manufacturers should consider these steps in preparation:

• Gathering relevant Translation Memories (TMs)
• Creating a glossary of approved terminology
• Assembling version-controlled source content
• Assess and ensure completeness of content to be translated
• Assess and address migration readiness of materials

Approach AI-powered translation for life sciences with the same preparatory rigor as traditional translation workflows, if not more, depending on whether it’s an early or first usage for the device manufacturer.

#4 Position AI Localization Strategically to Internal Stakeholders

AI gives organizations several options to manage translation activity effectively. These include usage of in-house LLMs as a viable option for internal/low-criticality communications. However, AI should be considered a new tool in your translation toolkit, not a replacement for existing providers and workflows.

To gain buy-in from internal stakeholders, position AI localization as a series of solutions to implement within the content management processes. Outline a decision framework for your organization based on:

• Content purpose
• Potential consequences of errors
• Languages
• Source quality
• Required review

Distinguish automation, human post-editing, independent review, and final approval. Apply these terms, SLAs, and billable activities consistently across your vendor base. Finally, approach technical documentation, labeling, training, and marketing as distinct use cases that will each require AI differently. This is more accurate than suggesting they all require identical controls.

Get in touch

Interested in learning more about optimizing your medical device localization strategy and workflows? Wondering how AI could help you reach approval or get to market faster? Let’s get in touch.