Understanding emerging drivers, barriers, and opportunities


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Demand is exploding in the field of medical translation with the pharmaceutical, biotechnology, and
medical device sectors representing the second-largest market share in the industry. Despite fastgrowing demand and higher volumes of translation services in both traditional and emerging
markets, the life sciences vertical is set to face new challenges in an expanding geographic
environment that has become increasingly regulated and quality-driven. We will take a closer look at
the trends currently driving the medical translation industry, including the recent push towards
multilingual harmonization through controlled language and the implementation of common
technological applications. Recent changes in the regulatory environment, transitions to edocumentation, and new approaches to terminology management as determinants of quality and
consistency will also be explored

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  • Risk avoidance (avoid or eliminate the risk); Risk transfer (outsourcing the risk); Risk retention (budgeting for the risk)
  • Understanding emerging drivers, barriers, and opportunities

    1. 1. Understanding Emerging Drivers,Barriers, and Opportunities inMedical Translation Erin M. Lyons, LLC © 2011
    2. 2. Presentation snapshot• Introduction and background• Challenges and barriers• Trends and new technology• Drivers and opportunities
    3. 3. Introduction and background
    4. 4. It’s not enough to know anatomy and biology to be a doctor, so why would simply being bilingual be enough to be a medical translator or interpreter?Introduction and background
    5. 5. Medical translation overview• Sector growth and increased regulation = medical translation is one of the most aggressive verticals in the GILT industry • Medical translation prioritizes quality and expertise over deadlines and costs = more profitable market for proficient specialistsDrivers and opportunities
    6. 6. Fast facts – medical translation • 2011 pharma sales estimated at $880 bn • 25-27% growth in top 17 “pharmerging” countries to offset sluggish growth in traditional markets (forecast of only 1-3% growth NA/Europe this year) • Product lifecycle translation commitments + fast-growing emerging markets High-growth industry with a low barrier to entry despite the technical natureIntroduction and background
    7. 7. Sector world market trendsIntroduction and background
    8. 8. “Pharmerging” markets Tier 1 Tier 2 Tier 3 Mature Actually China Brazil, drive Fast Traditional Russia, GILT Followers Markets #3 pharma India growth market with Complex, High-volumesales driven by rapidly changing markets with Consistent locally markets lower growth double-digit manufactured contributing $1- due to growth with branded 5 bn penetration of rising generics + (Venezuela, generics, tighter middle-class imported Poland, government populations, products from Argentina, restrictions, improvedmultinationals in Turkey, Mexico, increased safety infrastructure urban centers Vietnam, etc.) spending, etc. and IP rights
    9. 9. Increase in Medical Translation Volumes 3 1 2 Development Pipeline Globalization Communications and IT technology More products in the pipeline to Aggressive ensure ROI/ overseas Increase in text- ”blockbuster” marketing for based information products sustained growthIntroduction and background
    10. 10. What it means to specialize Vertical specialization means industry expertise and advanced knowledge HOWEVER! there are still many points of entry and growth opportunities RA + QC Drug monographs In-country PH Brochures validation Minimally Extremely specialized specializedIntroduction and background ICFs Protocols
    11. 11. What is medical translation? • Case report forms/SOAPs • Clinical and instrumental reports • Clinical development/trial data • Drug monographs • Multilingual consulting • Informed Consent Forms • Linguistic validation • Marketing materials • Medical/scientific journal articles • Packaging and labeling • Pharmacovigilance/safety reporting • PRO and QoL instruments • Regulatory documentation • Sales materials • Software and website localizationIntroduction and background
    12. 12. Lifecycle and opportunities Clinical stage R&D Regulatory Manufacturing Sales & MarketingIntroduction and background
    13. 13. StakeholdersTrends and new technology
    14. 14. Challenges and Barriers
    15. 15. “Skillful pilots gain their reputation from storms and tempests.” - EpicurusChallenges and barriers
    16. 16. An expanding geographic market Pharmaceutical companies Regulatory must dive into constraints the new “pharmerging” markets, but Acquiring linguists they also must build confidence in Strategic placement their brand and productsChallenges and barriers
    17. 17. Changing regulatory environment • With the emergence of drug-device and biologic-device combinations, interdisciplinary skills are essential • Products are more complicated and markets are more diverse and challenging • Most companies now have pre- and post- review processes in placeChallenges and barriers
    18. 18. In-country localization In-country localization and adaptation is essential in the developing world Exhibit A: Rural health in China 56% of China’s population is rural. Rural diagnostic (Level III hospitals) needs are different from those in urban centers (Level I/II). Localized technology “bridges the gap.”Challenges and barriers
    19. 19. Community translation • Spanish is the primary language of 35.5 m people + the secondary language of 45 m as in the US – the world’s largest Spanish- speaking community outside of Mexico • Most Spanish-speakers do not use “neutral” Spanish • Boundaries between common and specialized language is not clear-cut • Certification programs vary greatlyChallenges and barriers
    20. 20. Risk management • Risk management affects all manufacturers’ operations – including labeling and translation • Remember: people do not do what you expect, only what you inspectChallenges and barriers
    21. 21. Risk management in action Risk avoidance Risk transfer Risk retention Risk treatmentChallenges and barriers Risk management in action
    22. 22. Barriers to entry • Medical translation tends to be a high-end vs. subprime game: there are those who will pay for quality and those who will overlook this for the right price • Don’t end up in the “poverty cult” – insisting on fair pricing means you will be working with more legitimate vendors who privilege quality over “selling quality”Challenges and barriers
    23. 23. Trends and new technology
    24. 24. “Technology is a queer thing. It brings you great gifts with one hand, and stabs you in the back with the other.” - C.P. SnowTrends and new technology
    25. 25. Multilingual harmonization • EU Medical Device Directive 93/42/EEC requires companies to adopt a specific multilingual documentation process • Multilingual content management has been further complicated by content adaptation to foreign locales/markets • Integration of end-client CMS with vendor TMS for top-down consistency • Back-translation is now an essential benchmarking tool and quality strategyTrends and new technology
    26. 26. Global-ready product linesTrends and new technology
    27. 27. Controlled language • The technical and simple syntax of medical language makes it friendly to the architectural dimensions of controlled language BUT • The potential consequences of inaccuracies have led to reluctance to using it in essential areas of practiceTrends and new technology
    28. 28. Applied controlled language • Electronic medical terminology databases (i.e.: WHO standard terminology physician terms patient terms billing codes) • Standardized data input for electronic medical records • Mappings to classifications and standard glossaries (Systematized Nomenclature of Medicine – Clinical Terms, SNOMED CT)Trends and new technology
    29. 29. Embedded systems • Life sciences technology often uses embedded systems as part of diagnostic, monitoring, and reporting tools Most systems are locally developed, proprietary applications = not global-ready Downstream Upstream translation and internationalization retooling for and localization international marketsTrends and new technology
    30. 30. Medical software • According to the European Medical Device Directive Amendment of 2010, software is now included in the definition of a medical device both integrated and stand- alone applications • New attention to software by global regulators for validation and verification new linguistic validation opportunitiesTrends and new technology
    31. 31. Localizing embedded systems • Issues faced are similar to those in telecom/software sectors Dynamic resizing Visuals vs. text Keyboard support Sorting in non A-Z alphabets Country/health system-specific tags Naming conventions and identifiersTrends and new technology
    32. 32. eCRFs and electronic records • Intelligent input documents result in clean data and improved quality • Real-time access to clinical data/ subject tracking • Multilanguage capabilities support trials worldwideTrends and new technology
    33. 33. Virtual collaborative environment • Data managers and clinicians work together using a centrally-managed database regardless of language or location • IVRS integration • Easy roll-out of protocol changes • Out-of-box adverse events, concomitant medications, and cleaned data still require linguistic reviewTrends and new technology
    34. 34. e-medical records • No more handwritten doctor’s/nurse’s notes (for the most part!) • Flexible data CAT tools vs. working from PDFs • Accelerated timelines + more commodity-driven process • Greater consistency and fewer reporting ambiguities across clinical sitesTrends and new technology
    35. 35. Drivers and opportunities
    36. 36. “Act after having made assessments.” - Sun Tzu, The Art of WarDrivers and opportunities
    37. 37. Terminology management • Terminology investments have an early break- even point • Terminology changes during updates is 200 times more expensive than during authoringDrivers and opportunities
    38. 38. Terminology management, cont. • Remember that terminology management (unified determinants) is different from TMs (archived examples of translations) • TMs are not an “intelligent” tool • Linguists are essential terminology evaluators in regulated fields • Back-translation is important as a reverse verification term Terminology is a quality-driverDrivers and opportunities
    39. 39. Terminology and QRD • The EMA requires that regulatory dossiers be submitted for simultaneous EU market authorization • Quality Review of Documents (QRD) set terminology, stylistic, and formatting requirements for compliance • Many companies are developing automated tools for QRD control => more efficient top-down controlDrivers and opportunities
    40. 40. Value-added translations • Translators often come from a place of less business-driven concerns (love of languages/cultures vs. love of money) • Ultimately translations need to turn into revenue/new business for clients…otherwise there is no point to them buying translations • It is important for translators to strategize to find legitimate ways to add value to their “product”Drivers and opportunities
    41. 41. A quality-driven workflow Remember: enhanced quality and increased productivity rarely go hand in handDrivers and opportunities
    42. 42. Content repurposing Media syndication Website publishing YourVideo content Title medical translationDrivers and opportunities
    43. 43. Content repurposing translation Comment consolidation and Your Content has a contextual review completely different Title medical translation look and feel through “chunking” and push-button publishingDrivers and opportunities
    44. 44. Finding your value niche? • Possibilities for sub-specialization: - Literature - Marketing - Multimedia - Medical Devices - Name testing - Patents • Find solutions for your clients: - Can you source other linguistic/in-country assets? - Can you help your client implement quality drivers (QA checklists, glossaries, TM clean-up, etc.)? - Can you add continuity to an account? - Can you offer translation management insight as a consultant?Drivers and opportunities
    45. 45. Drivers in medical translation • Success breeds success: quality experience leads to deeper insight More credible value proposition • Knowledge of regulatory changes and new technology and terminology Differentiate yourself from your competitors • Consider translation-related add-on services Consulting, terminology, review, process design, etc.Drivers and opportunities