understanding emerging drivers, barriers, and opportunities
DESCRIPTION
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 exploredTRANSCRIPT
Erin M. Lyons, LLC © 2011
Understanding Emerging Drivers, Barriers, and Opportunities in Medical Translation
Presentation snapshot
• Introduction and background
• Challenges and barriers
• Trends and new technology
• Drivers and opportunities
Introduction and background
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
Medical translation overview
• Medical translation prioritizes quality and expertise over deadlines and costs = more profitable market for proficient specialists
Drivers and opportunities
• Sector growth and increased regulation = medical translation is one of the most aggressive verticals in the GILT industry
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
Sector world market trends
Introduction and background
Tier 1 Tier 2 Tier 3 Mature
China
#3 pharma market with
sales driven by locally
manufacturedbranded
generics + imported
products from multinationals in urban centers
Brazil, Russia, India
Consistent double-digit growth with
rising middle-class populations,
improved infrastructure and IP rights
Fast Followers
Complex, rapidly changing
markets contributing $1-
5 bn(Venezuela,
Poland, Argentina,
Turkey, Mexico, Vietnam, etc.)
“Pharmerging” markets
Traditional Markets
High-volume markets with lower growth
due to penetration of
generics, tighter government restrictions,
increased safety spending, etc.
ActuallydriveGILT
growth
1Globalization
Aggressive overseas
marketing for sustained growth
2Communications
and IT technology
Increase in text-based information
3Development
Pipeline
More products in the pipeline to ensure ROI/”blockbuster”
products
Introduction and background
Increase in Medical Translation Volumes
What it means to specialize
Vertical specialization means industry expertise and advanced knowledge
HOWEVER!there are still many points of entry
and growth opportunities
Introduction and background
Extremely specialized
Minimally specialized
ICFs
Drug monographs
Protocols
PH BrochuresIn-country validation
RA + QC
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
Introduction and background
Lifecycle and opportunities
Regulatory
Clinical stage
R & D
Manufacturing Sales & Marketing
Trends and new technology
Stakeholders
Challenges and Barriers
“Skillful pilots gain their reputation from storms
and tempests.”- Epicurus
Challenges and barriers
Regulatory constraints
Acquiring linguists
Strategic placement
Pharmaceutical companies
must dive into the new
“pharmerging” markets, but
they also must build
confidence in their brand
and products
An expanding geographic market
Challenges and barriers
Changing regulatory environment
Challenges and barriers
• 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
In-country localization
Challenges and barriers
In-country localization and adaptation is essential in the developing world
Exhibit A: Rural health in China56% 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.”
Community translation
Challenges and barriers
• 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
Risk management
Challenges and barriers
• Risk management affects all manufacturers’ operations – including labeling and translation
• Remember: people do not do what you expect, only what you inspect
Risk treatment
Risk avoidance Risk retentionRisk transfer
Risk management in action
Risk management in action
Challenges and barriers
Barriers to entry
Challenges and barriers
• 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”
Trends and new technology
“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
• 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
Multilingual harmonization
Trends and new technology
Global-ready product lines
• 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
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
Applied controlled language
Upstream internationalization
and localization
Trends and new technology
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 translation and
retooling for international markets
Trends and new technology
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
Localizing embedded systems• Issues faced are similar to those in
telecom/software sectorsDynamic resizing Visuals vs. textKeyboard supportSorting in non A-Z alphabetsCountry/health system-specific tagsNaming conventions and identifiers
• 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
eCRFs and electronic records
• 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
Virtual collaborative environment
• 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
e-medical records
Drivers and opportunities
“Act after having made assessments.”
- Sun Tzu, The Art of War
Drivers and opportunities
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
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 termTerminology is a quality-driver
Drivers and opportunities
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
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
Drivers and opportunities
A quality-driven workflow
Remember: enhanced
quality and increased
productivity rarely go hand in hand
Video content
Media syndication
Website publishing
TitleYour
medical translation
Content repurposing
Drivers and opportunities
TitleYour
medical translation
Content repurposing translation
Drivers and opportunities
Content has a completely different
look and feel through “chunking” and push-button
publishing
Comment consolidation and contextual review
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
Drivers in medical translation• Success breeds success: quality experience
leads to deeper insightMore credible value proposition
• Knowledge of regulatory changes and new technology and terminology
Differentiate yourself from your competitors
• Consider translation-related add-on servicesConsulting, terminology, review, process design, etc.
Drivers and opportunities