requirements in the life sciences industry: a different ball-game?
DESCRIPTION
Richard Korn, Senior Manager of Localization and Packaging Development at St. Jude Medical, and Clio Schils, Account Director of Life Sciences for Lionbridge, explain the requirements of the life sciences industry in the different Latin American countries and prove that the region has a great potential for both medical device manufacturers and, consequently, translation and localization providers. The video of this presentation can be seen here: http://www.youtube.com/watch?v=2YYSz_0Y81ATRANSCRIPT
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.
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