understanding emerging drivers, barriers, and opportunities

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?


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


Sector world market trends


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


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


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



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


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

In-country localization


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


• 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


• 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


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”

“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


• 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


Multilingual harmonization


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


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)


Applied controlled language

Upstream internationalization

and localization


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


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


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


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


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


e-medical records

“Act after having made assessments.”

- Sun Tzu, The Art of War


Terminology management• Terminology

investments have an early break-even point

• Terminology changes during updates is 200 times more expensive than during authoring


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


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


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”



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


TitleYour

medical translation

Content repurposing translation


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 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.


understanding emerging drivers, barriers, and opportunities

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