Requirements in the Life Sciences Industry

A Different Ball Game?

Richard Korn – St. Jude MedicalClio Schils – Lionbridge

Introduction

Different regions - different markets

Different way of doing business

Introduction

• Different languages

Introduction

…but a few common denominators

→ product line or services

→ share, sell, go global

→ quality of life

→ collaboration

→ competition

 

Focus

Focus: Explore the wealth of talent and opportunities that Latin

America offers in the fields of life sciences and localization

Objective:

Review…

Major developments in both life sciences and localization

Areas where these industries converge

How Latin America plays a role in the growth of these sectors.

How do we define Life Sciences and Localization?

Life Sciences

All fields of science that involve the scientific study of living organisms

such as plants, animals and human beings (Wikipedia)

Include fields of medicine, biology, molecular biology and

biotechnology

Today’s focus: the medical device industry

Localization

Translation of documentation or software to meet the specific linguistic

requirements of a local market.

Key topics

Life sciences and localization: Key trends

Survey of regulatory and business environment for medical device

industry

Manufacturer and end-user case study: A shift in focus for medical

device industry

Convergence of life sciences and localization in Latin America

 What makes Latin America different from other markets in the Life Sciences?

Spirit of growth and opportunity

Markets are growing steadily year to year

Regulations are less uniform and tend to

vary from country to country

Latin America is a geographic zone.

However, the diversity of markets within

the zone underestimates the diversity

of the region and the countries that make up the region

 Life Sciences: Key trendsWorldwide

Emphasis on regulatory compliance and standards (GMPs and audits by national

agencies)

Heightened quality standards

Reorganization of submission strategies to receive quicker approvals

Focus on research of new technologies for the medium- to long-term

Unnecessary projects cut from budgets

Clinical studies that prove the efficacy of a product and increase the company’s

potential earnings

Creative outsourcing of tasks traditionally performed in-house – project

management, vendor management, quality assurance

 Life Sciences: Key trends

Latin America

Internal consumption has mitigated the impact of the recession on Latin American economies

Increased production in Latin American countries for use in-country and abroad

Localization: Key trendsWorldwide

Increasing use of tools and processes

Centralization of translation memory within a single content

management system

Machine translation

Crowdsourcing and social media as a mechanism for

reducing translation time and cost

Focus on localization project management as a field of

knowledge and study

Localization: Key trendsLatin America

Translation agencies target the gaps in the market place,

including creative forms of outsourcing

Latin American translation agencies become local advocates

for consulting and business trends

Assist customers to reach new markets through localization

techniques

We know our own backyard

Localization: Key trends

Increasing competition in all markets

Decreasing reliance on one model

Specialization in life sciences

(bio-tech and pharma) as

a differentiator

Technology and web-services

as a differentiator

Regulatory environment in Latin America

Argentina

Bolivia

Brazil

Colombia

Costa Rica

Ecuador

Guatemala

Mexico

Panama (public sector only)

Peru

Uruguay

Venezuela

 Regulatory environment in Latin America

“Country of origin” requirements

Biocompatibility testing (ISO 10933-X)

GMP certificates required by markets such as Brazil

More authority given to ministries of health / notified bodies

ANMAT – Argentina

ANVISA – Brazil

SSA – Mexico

Costa Rica – new medical device regulation in 2008

Ecuador – restructured ministry of health

Colombia fully applied regulations for external electrical medical equipment

Regulatory environment in Latin America

Harmonization in regulations: As internal consumption increases, the need

for harmonized regulatory practices also increases

Testing and certification: Currently required for electrical medical devices to

achieve market access in Brazil. Other markets to follow this trend.

TüV and US FDA act as notified bodies:

Recognized by Brazilian testing institutes

Argentina, Mexico, Puerto Rico and US Virgin Islands use FDA actions

FDA / European Commission offices in Latin America check

manufacturing

Economic and political dynamics in Latin America

Both local consumption and export manufacturing are fueling growth of medical

device industry in Latin America

Largest consumer markets for medical devices: Brazil and Mexico

Brazil has strong local domestic policy (e.g., biotech firms)

More imports of high specification medical technology

products: Brazil, Argentina and Chile

More consumables imported:

Peru, Mexico and Venezuela

Regional exports low except for Mexico

Dental devices and implantable exports:

Growth in Brazil

 Economic and political dynamics in Latin America

Regulatory environment not fully developed in many markets

Brazil and Mexico: more mature systems in place

MERCOSUR: Brazil, Argentina, Paraguay, Uruguay, Venezuela

promote free trade and the fluid movement of goods, people and

currency

Requirements for medical device registration:

MERCOSUR members to follow the medical

regulation established by Brazil

How does Latin America stand to gain through the current economic climate?

Steady growth while other markets are stagnant (U.S.

and Europe)

Talented and well educated teams that work at

competitive rates compared with their counterparts in

other parts of the world

New alliances with other emerging regions such as India,

China, South Africa and Russia (BRIC)

How does Latin America stand to gain through the current economic climate? (cont.)

. BRIC

• 25% of the world's land coverage

• 40% of the world's population• Combined GDP of 15.435

trillion dollars• among the biggest and fastest

growing emerging markets

Manufacturer and end-user case study: A shift in focus for Latin American medical device industry

St. Jude manufactures tissue valves for

the heart in Belo Horizonte, Brazil.

Costa Rica in next two years.

The company also manufactures pacemakers and defibrillators

in Puerto Rico.

Latin American markets are a chief focus. Marketing and

regulatory teams based throughout Latin America -- São Paulo,

Buenos Aires, Santiago, Mexico City, San Jose, Costa Rica,

Bogota and Caracas

Medical devices manufactured / used in Latin America

Biocor™/Epic™

Biocor™/Epic™Supra

Manufactured in Belo Horizonte, Brazil / Implanted in patients in all major markets in the Americas, Europe, Middle East and Asia

23

Medical devices manufactured / used in Latin America

Sample medical devices manufactured and distributed in Latin American markets

Platforms localized for use in Latin America – Spanish / Portuguese

St. Jude Medical’s focus on devices and systems that treat heart disease – For use by clinicians and

physicians in Latin America

Analysis of market penetration for pacemakers and implantable defibrillators

Country Real GDP Growth*

Total Population**

Implants per million ≥ 60

Low Voltage High Voltage

China 13.8% 1330M 295 9

India 11.9% 1148M 220 10

Russia 10.0% 141M 450 25

Brazil 7.6% 192M 1700 140

EU 5.3% 491M 4000 900

US 5.3% 304M 6000 3500

* GDP CAGR (2003-2008) (IMF) **US Dept of Census (2008 Data)

Convergence of life sciences and localization in Latin America

Greater attention paid by multinationals to markets with new requirements.

Translation agencies with this knowledge offer an advantage to life sciences

companies.

Localization of submission forms, Instructions for Use (IFUs) and software

for Latin America is becoming a requirement for product approval as well as

reimbursement.

Creative forms of outsourcing are proving to be a necessary and potentially

lucrative new model for translation agencies to follow (e.g.,

functional/linguistic testing and project management of localization projects)

Quality is always the top priority

Conclusion

Latin America has seen considerable growth in manufacturing and

internal consumption of goods in the life sciences and localization

arenas.

Regional alliances play a large role in Latin America’s ability to

standardize regulations and ensure high quality of products.

Latin America is poised to increase its role on the global

marketplace for life sciences and localization, as the region’s

economies continue the trend toward expanded manufacturing and

growth of GDP.

OBRIGADO!¡GRACIAS!

THANK YOU!

Clio Schils Richard Kornclio.schils@lionbridge.com rkorn@sjm.com

Additional notes on life sciences differentiators

Life sciences industries are currently regulated differently based on each

market‘s laws. Efforts are in place to harmonize the registration of medical

devices.

Global Harmonization Task Force (Latin American Harmonization

Working Party and the Pan American Health Organization)

Hospitals tend to purchase most critical products – Budget limitations

Lack of reimbursement for certain technologies by government entities limits

potential growth of market (Examples: Delivery tools for tissue valves in

Brazil or implantable defibrillators in Mexico)

Increased emphasis on product registrations and regulatory requirements

Additional notes on economic and political dynamics in Latin America

Regional alliances – a push for harmonization of

standards

Regulatory strategies focus attention on greater

accountability by manufacturers

Increased attention to safety and efficacy in all products

used to treat patients