CIDM Journal – October 2011
Over the past 20 years, the explosive growth in medical device translation has been driven by aging worldwide populations and heavily influence by standards, evolving content types, and technology. Combined, these factors have produced a fundamental shift in requirements, methods, and scope of medical device translation/localization.
Based on the changing nature of device translation, along with the need to control translation-related expenses, manufacturers are in the process of re-evaluating how they select providers. In many cases, a pure focus on direct cost (often defined in terms “per word” expense) has led to a growing awareness of the unavoidable risks that result when price is the sole basis of supplier selection. In response, manufacturers are now broadening their criteria to include a number of emerging considerations – all with the aim to achieve quality, compliance, and scalability at an affordable price. Below are the “Top 10 Considerations” that are driving translation supplier selection at device manufacturers around the world:
1. Industry Specialization & Experience–In years past, “all languages, all subject matters” was the standard marketing tagline for translation suppliers…this is no longer true. Today, manufacturers prefer specialized providers–either in the form of verticalized production departments within large translation providers or boutique firms with a life sciences focus. In fact, it is now possible to find suppliers who only provide services to the medical device industry. Specialization is a key determinant for competence and is especially valuable when combined with long-term experience. Translation suppliers, like other professional service firms, benefit from focus and repeated practice in a single subject area. This, in turn, benefits manufacturers in the form of expert resources and specialized processes.2. Quality System Parity/ISO 13485–Since inception, ISO 13485 has had an enormous impact on the medical device industry–largely through its requirements for risk management and software validation. One area that has been strongly affected by 13485’s risk management emphasis is supplier control (the subject of several industry presentations by FDA). Notified Bodies have addressed this issue through the concept of “Quality System Parity”–encouraging manufacturers to source from translation suppliers who are also registered to 13485 (hence, “parity”). While important, Quality System Parity is not an absolute qualifier–another important consideration is who issued the supplier certification. Manufacturers should look for suppliers who are certified by well-known registrars such as TUV, DEKRA (formerly KEMA), and BSI.
3. Risk Management/ISO 14971–Risk management has been a topic of growing importance for manufacturers since an informative reference to ISO 14971 (risk management standard for medical device manufacturers and suppliers) first appeared in ISO 13485:2003. Risk management now touches all aspects of product realization for manufacturers and serves as an important “lingua qualitatis” between manufacturers and suppliers. Most recently, the 3rd edition of IEC 60601 (governs electrical medical devices) contains a normative reference to ISO 14971–firmly enshrining it in the cannon of required device standards. Manufacturers seeking “parity” are now looking for translation suppliers who subscribe to the same risk management principles, including formal certification to the standard.
4. Quality/Risk Management System Documentation–According to Kim Trautman, FDA’s Quality Systems expert, a significant percentage of compliance issues originate with suppliers who are registered to ISO 9001 or ISO 13485. Therefore, it is critical for manufacturers to obtain, in addition to registration certificates, evidence that a translation supplier’s quality system is adequate to appropriately control service risk. With labeling the #1 cause of product recall, the risk for manufacturers is clear. However, controls and audit items can be less obvious. A good place to start is the supplier’s Management Report. This crucial document can provide an important window into the quality system. Does it track error rates in a standardized, objective manner? Are the quality systems objectives sufficiently evolved? How is Corrective Action/Preventive Action (CAPA) feedback reported? And, it is also important to examine per project documentation. Are project hazards documented and mitigated? Are risk management activities sufficiently documented in the project management files? If your translation supplier has a robust, well-defined process, this can save you time and effort and serve as the basis for your own translation process documentation–a requirement of ISO 13485.
5. Validated Translation Memory (TM) Technology–20 years ago, translation memory technology was in its infancy. Now a ubiquitous part of every supplier’s process, translation memory (or TM) is a powerful tool for reducing cost and ensuring consistent quality. However, when not used properly, TM technology can also be the source of significant error risk. According to ISO 13485:
The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affect the ability of the product to conform to specified requirements. Such software applications shall be validated prior to initial use.
If your supplier uses TM (and they do), they should be able to provide you with appropriate validation records or a plausible plan for accomplishing the effort.
6. Enterprise Solutions for Translation/Localization Project Management–As manufacturers have grown larger, either organically or through acquisition, a growing need has emerged for enterprise-level solutions for translation/localization project management. Sometimes termed “Globalization Management Systems” (GMS) or “Translation Management Systems” (TMS), these software applications serve the same essential function: customizable workflows for file intake and tracking, online access to translation memory (TM) assets, and customizable reporting for cost estimation and monitoring/improving process performance. Properly implemented, these systems can form the backbone of a robust translation/localization process and lay the groundwork for further process automation, improvement, and cost savings.7. Enterprise Solutions for Content Management–Independent estimates put the total “Cost of Content” for the medical device industry at $1 billion (approximately 1% of total industry revenue). This figure includes the cost to create, check for compliance, approve, translate/localize, and manage the regulatory, training, and marketing content that is required to make and sell your product. But is it all necessary? As much as $400 million (40%) of this total amount may, in fact, be avoidable by employing the latest content management strategies, including XML (“single-source”) publishing processes and technologies. A content management strategy that includes upstream re-use and authoring automation, along with downstream integration with GMS and printing systems has the potential to both save significant cost and reduce risk: pure bottom-line alchemy.
8. Software and Process Solutions for Specialized Requirements – Although part of the same industry classification, medical device manufacturers actually represent a broad variety of technologies and internal process requirements. For this reason, an ability to develop customized processes and solutions is an important function for today’s translation/localization supplier. Examples include
- Risk-based translation/localization strategies–Differentiated approaches to high vs. lower-risk labeling content can provide manufacturers with appropriate risk management at a lower cost. Distinct processes for labeling vs. marketing content help to minimize review time and cost…or eliminate them altogether.
- Solutions for review management and control–In cases where translation review is an important requirement (e.g., marketing content), a combination of software tools and well-designed process can help manage costs and complexity.
- Solutions and process for audit–As many manufacturers grow through acquisition, audit of legacy content has become an important risk assessment exercise. In situations where the manufacturer uses multiple suppliers and a common TM, audit of incoming content is critical to ensure overall TM quality. Standardized, Notified Body-approved methods (such as the SAE J2450 standard) help to ensure consistency and reliability.
- Outsourced labeling–In cases where re-branding is necessary to address changes to corporate or regulatory requirements, thousands of individual artworks may be affected. Outsourcing this work can significantly lower costs and risks while protecting critical deadlines.
- Cost reduction and quality improvement initiatives–GMS integration with label printing systems, reduction in document page counts (through formatting/font changes), standardized document templates, and source content optimization are all examples of common initiatives that your translation/localization provider can support.
10. Consultative Partnership–Unfortunately, this last item is not yet on the evolving requirements list for every medical device manufacturer…but it should be. The value of partnership in a professional services relationship cannot be underestimated and has implications for both suppliers and manufacturers. For suppliers, it requires a commitment to continual improvement and the client’s best interest–a willingness to “tell the truth” about service challenges and maintain diligence in service execution. For manufacturers, it requires a willingness to engage the supplier in an open conversation regarding costs, risks, and efficiencies. A crucial question in the supplier selection process is simple trust: can you trust the supplier to act in your best interest? Strictly speaking, this determination lies outside of RFPs, supplier surveys, and audits, but is essential to a successful, long-term, and valuable relationship.
Conclusion
Industry growth and globalization, the importance of quality and risk management standards, and the steady march of technological innovation are having a significant impact on manufacturers’ selection criteria for translation/localization suppliers. Based on these factors, the “Top 10 Considerations” discussed above are driving internal discussions at medical device manufacturers around the world.
About Crimson Life Sciences
Crimson is a division of TransPerfect Translations International, Inc. and is the only translation practice devoted exclusively to high-risk medical devices and IVDs. Crimson is the world’s first translation firm registered to ISO 13485 and ISO 9001 and the only translation firm registered to ISO 14971.
TransPerfect, registered to ISO 9001 and EN 15038, is the world’s largest privately held language services provider with more than 60 offices worldwide.
Contact:
Marc H. Miller, President
+1 617.597.1984
mmiller@crimsonlanguage.com
www.crimsonlanguage.com