Requirements in the  Life Sciences Industry  A Different Ball Game?  Richard Korn – St. Jude Medical Clio Schils – Lionbri...
Introduction <ul><li>Different regions - different markets </li></ul><ul><li>Different way of doing business </li></ul>
Introduction <ul><li>Different languages </li></ul>
Introduction <ul><li>… but a  few common denominators </li></ul><ul><ul><li>->  product line or services </li></ul></ul><u...
  Focus <ul><li>Focus:  Explore the wealth of talent and opportunities that Latin America offers in the fields of life sci...
How do we define  Life Sciences  and  Localization ? <ul><li>Life Sciences </li></ul><ul><li>All fields of science that in...
Key topics <ul><li>Life sciences and localization: Key trends </li></ul><ul><li>Survey of regulatory and business environm...
  What makes Latin America different from other markets in the Life Sciences? <ul><li>Spirit of growth and opportunity </l...
  Life Sciences: Key trends <ul><li>Worldwide </li></ul><ul><li>Emphasis on regulatory compliance and standards (GMPs and ...
  Life Sciences: Key trends <ul><li>Latin America </li></ul><ul><li>Internal consumption has mitigated the impact of the r...
Localization: Key trends <ul><li>Worldwide </li></ul><ul><li>Increasing use of tools and processes </li></ul><ul><li>Centr...
Localization: Key trends <ul><li>Latin America </li></ul><ul><li>Translation agencies target the gaps in the market place,...
Localization: Key trends <ul><li>Increasing competition in all markets </li></ul><ul><li>Decreasing reliance on one model ...
Regulatory environment in  Latin America <ul><li>Argentina </li></ul><ul><li>Bolivia </li></ul><ul><li>Brazil </li></ul><u...
  Regulatory environment in  Latin America <ul><li>“ Country of origin” requirements </li></ul><ul><li>Biocompatibility te...
Regulatory environment in  Latin America <ul><li>Harmonization in regulations:  As internal consumption increases, the nee...
Economic and political dynamics in Latin America <ul><li>Both local consumption and export manufacturing are fueling growt...
  Economic and political dynamics in Latin America <ul><li>Regulatory environment not fully developed in many markets </li...
How does Latin America stand to gain through the current economic climate? <ul><li>Steady growth while other markets are s...
How does Latin America stand to gain through the current economic climate? (cont.) <ul><li>. </li></ul><ul><li>BRIC </li><...
Manufacturer and end-user case study: A shift in focus for Latin American medical device industry <ul><li>St. Jude manufac...
Medical devices manufactured / used in Latin America Biocor™/Epic ™ Biocor™/Epic™Supra Manufactured in Belo Horizonte, Bra...
Medical devices manufactured / used in Latin America Sample medical devices manufactured and distributed in Latin American...
Analysis of market penetration for pacemakers and implantable defibrillators * GDP CAGR (2003-2008) (IMF) **US Dept of Cen...
Convergence of life sciences and localization in Latin America <ul><li>Greater attention paid by multinationals to markets...
Conclusion <ul><li>Latin America has seen considerable growth in manufacturing and internal consumption of goods in the li...
OBRIGADO! ¡GRACIAS! THANK YOU! Clio Schils  Richard Korn [email_address]   [email_address]
Additional notes on  life sciences differentiators <ul><li>Life sciences industries are currently regulated differently ba...
Additional notes on economic and political dynamics in Latin America <ul><li>Regional alliances – a push for harmonization...
Upcoming SlideShare
Loading in …5
×

Requirements in the Life Sciences Industry: A Different Ball-Game?, by Richard Korn and Clio Schils

2,225 views

Published on

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.

Published in: Health & Medicine
0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
2,225
On SlideShare
0
From Embeds
0
Number of Embeds
2
Actions
Shares
0
Downloads
0
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide
  •  
  •  
  •  
  •   The life sciences comprise all fields of science that involve the scientific study of living organisms , like plants , animals , and human beings . However, the study of behaviour of organisms, such as practised in ethology and psychology , is only included inasmuch as it involves a clearly biological aspect. While biology and medicine remain centerpieces of the life sciences, technological advances in molecular biology and biotechnology have led to a burgeoning of specializations and new, often interdisciplinary , fields. The following is an incomplete lists of life science fields, as well as topics of study in the life sciences, in which several entries coincide with, are included in, or overlap with other entries: Agrotechnology Bio-engineering Biochemistry Biocomputing Biocontrol Biodynamics Bioinformatics Biology Biomaterials Biomechanics Biomedical sciences Biomolecular engineering Biomonitoring Biophysics Biopolymers Biotechnology Botany Cell biology Cognitive neuroscience Computational neuroscience Developmental biology Ecology Environmental science Evolutionary genetics Food science Genetics Genomics Health sciences Immunogenetics Immunology Immunotherapy Medical devices Medical imaging Medicine Microbiology Molecular biology Nanotechnology Neuroinformatics Neuroscience Oncology Optometry Personalized medicine Pharmacogenomics Pharmacology Physiology Plant sciences Proteomics Structural biology Systems biology Tissue engineering Zoology
  •  
  •  
  •   The life sciences comprise all fields of science that involve the scientific study of living organisms , like plants , animals , and human beings . However, the study of behaviour of organisms, such as practised in ethology and psychology , is only included inasmuch as it involves a clearly biological aspect. While biology and medicine remain centerpieces of the life sciences, technological advances in molecular biology and biotechnology have led to a burgeoning of specializations and new, often interdisciplinary , fields. The following is an incomplete lists of life science fields, as well as topics of study in the life sciences, in which several entries coincide with, are included in, or overlap with other entries: Agrotechnology Bio-engineering Biochemistry Biocomputing Biocontrol Biodynamics Bioinformatics Biology Biomaterials Biomechanics Biomedical sciences Biomolecular engineering Biomonitoring Biophysics Biopolymers Biotechnology Botany Cell biology Cognitive neuroscience Computational neuroscience Developmental biology Ecology Environmental science Evolutionary genetics Food science Genetics Genomics Health sciences Immunogenetics Immunology Immunotherapy Medical devices Medical imaging Medicine Microbiology Molecular biology Nanotechnology Neuroinformatics Neuroscience Oncology Optometry Personalized medicine Pharmacogenomics Pharmacology Physiology Plant sciences Proteomics Structural biology Systems biology Tissue engineering Zoology
  •  
  •  
  •  
  •   What makes life sciences localization different from other types of localization? ·       Regulations ·       Premium placed on quality above all else ·       Specialized knowledge required by translators and editors ·       Cutting edge for life sciences is often years behind that of other industries
  •  
  •  
  • Latin America has cultivated a manufacturing focus in the past 30 years. Development of manufacturing hubs in Mexico, Costa Rica, Puerto Rico, Brazil, Argentina, Chile Goods produced and shipped to other areas of the world Growing phenomenon – development of internal markets for consumption Recognition by multinational corporations of the importance of the needs of internal markets within Latin America. Translation for each market is important. Understanding that localized user interfaces and supporting documentation increase comprehension and adoption of new technologies Governments are increasingly requiring stricter regulation of products Ecuadoran government revamped its department of health in recent years ANWAT in Argentina is implementing stricter regulations of medical devices Brazilian ANVISA requiring inspection of manufacturing sites to comply with GMPs Mexico and Costa Rica enforcing legislation to regulate industry
  • In medical device industry, Latin America has low market penetration for medical devices. In this case, pacemakers (low voltage) and ICDs (high voltage) represent a potential growth sector using Brazil as an indicator for the rest of the region.
  •   ·       In-country review required, in most instances, for regulatory compliance ·       Subject matter expertise in the field of medicine, nursing or a related clinical field are often required of translators and reviewers ·       Sale of products in many markets is based on government tenders. Complying with language requirements is a key ingredient to procuring a tender to sell products in the country. ·       Clinical studies are required to begin distributing medicine or medical devices. Understanding of the role each study plays in the development of patient populations to whom administer drugs. ·       Knowledge of regulations for all markets is necessary to run a global life sciences company. Includes CE mark, RF regulations, FDA, Health Canada, TGE (Australia), SFDA (China). ·       Symbols help reduce need for translation. Enable product labeling to include multiple regulations in a small space. ·       Understanding of symbols (EN 980 / ISO) is important. ·       Country of origin requirements – products approved by FDA or TUV or another notified body – countries use the product approval in one market to substantiate a case to approve the product in their market ·       Biocompatibility studies to ensure the product is safe to use on target population in specific market. Each country has its own regulations for biocompatibility, including sterilization, reuse, etc.
  •  
  •  
  •  
  • Requirements in the Life Sciences Industry: A Different Ball-Game?, by Richard Korn and Clio Schils

    1. 1. Requirements in the Life Sciences Industry A Different Ball Game? Richard Korn – St. Jude Medical Clio Schils – Lionbridge
    2. 2. Introduction <ul><li>Different regions - different markets </li></ul><ul><li>Different way of doing business </li></ul>
    3. 3. Introduction <ul><li>Different languages </li></ul>
    4. 4. Introduction <ul><li>… but a few common denominators </li></ul><ul><ul><li>-> product line or services </li></ul></ul><ul><ul><li>-> share, sell, go global </li></ul></ul><ul><ul><li>-> quality of life </li></ul></ul><ul><ul><li>-> collaboration </li></ul></ul><ul><ul><li>-> competition </li></ul></ul>
    5. 5.   Focus <ul><li>Focus: Explore the wealth of talent and opportunities that Latin America offers in the fields of life sciences and localization </li></ul><ul><li>Objective: </li></ul><ul><ul><li>Review… </li></ul></ul><ul><ul><li>Major developments in both life sciences and localization </li></ul></ul><ul><ul><li>Areas where these industries converge </li></ul></ul><ul><ul><li>How Latin America plays a role in the growth of these sectors. </li></ul></ul>
    6. 6. How do we define Life Sciences and Localization ? <ul><li>Life Sciences </li></ul><ul><li>All fields of science that involve the scientific study of living organisms such as plants, animals and human beings ( Wikipedia) </li></ul><ul><li>Include fields of medicine, biology, molecular biology and biotechnology </li></ul><ul><li>Today’s focus: the medical device industry </li></ul><ul><li>Localization </li></ul><ul><li>Translation of documentation or software to meet the specific linguistic requirements of a local market. </li></ul>
    7. 7. Key topics <ul><li>Life sciences and localization: Key trends </li></ul><ul><li>Survey of regulatory and business environment for medical device industry </li></ul><ul><li>Manufacturer and end-user case study: A shift in focus for medical device industry </li></ul><ul><li>Convergence of life sciences and localization in Latin America </li></ul>
    8. 8.   What makes Latin America different from other markets in the Life Sciences? <ul><li>Spirit of growth and opportunity </li></ul><ul><li>Markets are growing steadily year to year </li></ul><ul><li>Regulations are less uniform and tend to vary from country to country </li></ul><ul><li>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 </li></ul>
    9. 9.   Life Sciences: Key trends <ul><li>Worldwide </li></ul><ul><li>Emphasis on regulatory compliance and standards (GMPs and audits by national agencies) </li></ul><ul><li>Heightened quality standards </li></ul><ul><li>Reorganization of submission strategies to receive quicker approvals </li></ul><ul><li>Focus on research of new technologies for the medium- to long-term </li></ul><ul><li>Unnecessary projects cut from budgets </li></ul><ul><li>Clinical studies that prove the efficacy of a product and increase the company’s potential earnings </li></ul><ul><li>Creative outsourcing of tasks traditionally performed in-house – project management, vendor management, quality assurance </li></ul>
    10. 10.   Life Sciences: Key trends <ul><li>Latin America </li></ul><ul><li>Internal consumption has mitigated the impact of the recession on Latin American economies </li></ul><ul><li>Increased production in Latin American countries for use in-country and abroad </li></ul>
    11. 11. Localization: Key trends <ul><li>Worldwide </li></ul><ul><li>Increasing use of tools and processes </li></ul><ul><li>Centralization of translation memory within a single content management system </li></ul><ul><li>Machine translation </li></ul><ul><li>Crowdsourcing and social media as a mechanism for reducing translation time and cost </li></ul><ul><li>Focus on localization project management as a field of knowledge and study </li></ul>
    12. 12. Localization: Key trends <ul><li>Latin America </li></ul><ul><li>Translation agencies target the gaps in the market place, including creative forms of outsourcing </li></ul><ul><li>Latin American translation agencies become local advocates for consulting and business trends </li></ul><ul><ul><li>Assist customers to reach new markets through localization techniques </li></ul></ul><ul><ul><li>We know our own backyard </li></ul></ul>
    13. 13. Localization: Key trends <ul><li>Increasing competition in all markets </li></ul><ul><li>Decreasing reliance on one model </li></ul><ul><li>Specialization in life sciences (bio-tech and pharma) as a differentiator </li></ul><ul><li>Technology and web-services as a differentiator </li></ul>
    14. 14. Regulatory environment in Latin America <ul><li>Argentina </li></ul><ul><li>Bolivia </li></ul><ul><li>Brazil </li></ul><ul><li>Colombia </li></ul><ul><li>Costa Rica </li></ul><ul><li>Ecuador </li></ul><ul><li>Guatemala </li></ul><ul><li>Mexico </li></ul><ul><li>Panama (public sector only) </li></ul><ul><li>Peru </li></ul><ul><li>Uruguay </li></ul><ul><li>Venezuela </li></ul>
    15. 15.   Regulatory environment in Latin America <ul><li>“ Country of origin” requirements </li></ul><ul><li>Biocompatibility testing (ISO 10933-X) </li></ul><ul><li>GMP certificates required by markets such as Brazil </li></ul><ul><li>More authority given to ministries of health / notified bodies </li></ul><ul><ul><li>ANMAT – Argentina </li></ul></ul><ul><ul><li>ANVISA – Brazil </li></ul></ul><ul><ul><li>SSA – Mexico </li></ul></ul><ul><ul><li>Costa Rica – new medical device regulation in 2008 </li></ul></ul><ul><ul><li>Ecuador – restructured ministry of health </li></ul></ul><ul><ul><li>Colombia fully applied regulations for external electrical medical equipment </li></ul></ul>
    16. 16. Regulatory environment in Latin America <ul><li>Harmonization in regulations: As internal consumption increases, the need for harmonized regulatory practices also increases </li></ul><ul><li>Testing and certification: Currently required for electrical medical devices to achieve market access in Brazil. Other markets to follow this trend. </li></ul><ul><li>TüV and US FDA act as notified bodies: </li></ul><ul><ul><li>Recognized by Brazilian testing institutes </li></ul></ul><ul><ul><li>Argentina, Mexico, Puerto Rico and US Virgin Islands use FDA actions </li></ul></ul><ul><ul><li>FDA / European Commission offices in Latin America check manufacturing </li></ul></ul>
    17. 17. Economic and political dynamics in Latin America <ul><li>Both local consumption and export manufacturing are fueling growth of medical device industry in Latin America </li></ul><ul><li>Largest consumer markets for medical devices: Brazil and Mexico </li></ul><ul><li>Brazil has strong local domestic policy (e.g., biotech firms) </li></ul><ul><li>More imports of high specification medical technology products: Brazil, Argentina and Chile </li></ul><ul><li>More consumables imported: Peru, Mexico and Venezuela </li></ul><ul><li>Regional exports low except for Mexico </li></ul><ul><li>Dental devices and implantable exports: Growth in Brazil </li></ul>
    18. 18.   Economic and political dynamics in Latin America <ul><li>Regulatory environment not fully developed in many markets </li></ul><ul><li>Brazil and Mexico: more mature systems in place </li></ul><ul><li>MERCOSUR: Brazil, Argentina, Paraguay, Uruguay, Venezuela promote free trade and the fluid movement of goods, people and currency </li></ul><ul><li>Requirements for medical device registration: MERCOSUR members to follow the medical regulation established by Brazil </li></ul>
    19. 19. How does Latin America stand to gain through the current economic climate? <ul><li>Steady growth while other markets are stagnant (U.S. and Europe) </li></ul><ul><li>Talented and well educated teams that work at competitive rates compared with their counterparts in other parts of the world </li></ul><ul><li>New alliances with other emerging regions such as India, China, South Africa and Russia (BRIC) </li></ul>
    20. 20. How does Latin America stand to gain through the current economic climate? (cont.) <ul><li>. </li></ul><ul><li>BRIC </li></ul><ul><li>25% of the world's land coverage </li></ul><ul><li>40% of the world's population </li></ul><ul><li>Combined GDP of 15.435 trillion dollars </li></ul><ul><li>among the biggest and fastest growing emerging markets </li></ul>
    21. 21. Manufacturer and end-user case study: A shift in focus for Latin American medical device industry <ul><li>St. Jude manufactures tissue valves for the heart in Belo Horizonte, Brazil. Costa Rica in next two years. </li></ul><ul><li>The company also manufactures pacemakers and defibrillators in Puerto Rico. </li></ul><ul><li>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 </li></ul>
    22. 22. 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. 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
    24. 24. Analysis of market penetration for pacemakers and implantable defibrillators * GDP CAGR (2003-2008) (IMF) **US Dept of Census (2008 Data) 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
    25. 25. Convergence of life sciences and localization in Latin America <ul><li>Greater attention paid by multinationals to markets with new requirements. Translation agencies with this knowledge offer an advantage to life sciences companies. </li></ul><ul><li>Localization of submission forms, Instructions for Use (IFUs) and software for Latin America is becoming a requirement for product approval as well as reimbursement. </li></ul><ul><li>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) </li></ul><ul><li>Quality is always the top priority </li></ul>
    26. 26. Conclusion <ul><li>Latin America has seen considerable growth in manufacturing and internal consumption of goods in the life sciences and localization arenas. </li></ul><ul><li>Regional alliances play a large role in Latin America’s ability to standardize regulations and ensure high quality of products. </li></ul><ul><li>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. </li></ul>
    27. 27. OBRIGADO! ¡GRACIAS! THANK YOU! Clio Schils Richard Korn [email_address] [email_address]
    28. 28. Additional notes on life sciences differentiators <ul><li>Life sciences industries are currently regulated differently based on each market‘s laws. Efforts are in place to harmonize the registration of medical devices. </li></ul><ul><ul><li>Global Harmonization Task Force (Latin American Harmonization Working Party and the Pan American Health Organization) </li></ul></ul><ul><li>Hospitals tend to purchase most critical products – Budget limitations </li></ul><ul><li>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) </li></ul><ul><li>Increased emphasis on product registrations and regulatory requirements </li></ul>
    29. 29. Additional notes on economic and political dynamics in Latin America <ul><li>Regional alliances – a push for harmonization of standards </li></ul><ul><li>Regulatory strategies focus attention on greater accountability by manufacturers </li></ul><ul><li>Increased attention to safety and efficacy in all products used to treat patients </li></ul>

    ×