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

1. Understanding Emerging Drivers,
Barriers, and Opportunities in
Medical Translation
Erin M. Lyons, LLC © 2011

2. Presentation snapshot
• Introduction and background
• Challenges and barriers
• Trends and new technology
• Drivers and opportunities

3. Introduction and
background

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. 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 specialists
Drivers and opportunities

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 nature
Introduction and background

7. Sector world market trends
Introduction and background

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-volume
sales 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,
improved
multinationals in Turkey, Mexico, increased safety
infrastructure
urban centers Vietnam, etc.) spending, etc.
and IP rights

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 growth
Introduction and background

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 specialized
Introduction and background ICFs
Protocols

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 localization
Introduction and background

12. Lifecycle and opportunities
Clinical stage
R&D
Regulatory
Manufacturing Sales &
Marketing
Introduction and background

13. Stakeholders
Trends and new technology

14. Challenges and Barriers

15. “Skillful pilots gain their
reputation from storms
and tempests.”
- Epicurus
Challenges and barriers

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 products
Challenges and barriers

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 place
Challenges and barriers

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. 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 greatly
Challenges and barriers

20. Risk management
• Risk management affects all
manufacturers’ operations – including
labeling and translation
• Remember: people do not do what you
expect, only what you inspect
Challenges and barriers

21. Risk management in action
Risk avoidance Risk transfer Risk retention
Risk treatment
Challenges and barriers Risk management
in action

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. Trends and new
technology

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. Snow
Trends and new technology

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 strategy
Trends and new technology

26. Global-ready product lines
Trends and new technology

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 practice
Trends and new technology

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. 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 markets
Trends and new technology

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 opportunities
Trends and new technology

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 identifiers
Trends and new technology

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 worldwide
Trends and new technology

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 review
Trends and new technology

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 sites
Trends and new technology

35. Drivers and opportunities

36. “Act after having
made assessments.”
- Sun Tzu, The Art of War
Drivers and opportunities

37. Terminology management
• Terminology
investments have
an early break-
even point
• Terminology
changes during
updates is 200
times more
expensive than
during authoring
Drivers and opportunities

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-driver
Drivers and opportunities

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 control
Drivers and opportunities

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. A quality-driven workflow
Remember:
enhanced
quality and
increased
productivity
rarely go
hand in
hand
Drivers and opportunities

42. Content repurposing
Media syndication
Website
publishing
Your
Video content Title
medical
translation
Drivers and opportunities

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
publishing
Drivers and opportunities

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. 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