Requirements in the Life Sciences Industry: A Different Ball-Game?
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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_0Y81A
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Requirements in the Life Sciences Industry: A Different Ball-Game?
- 1. Requirements in the Life Sciences Industry A Different Ball Game? Richard Korn – St. Jude Medical Clio Schils – Lionbridge
- 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. 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. 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
- 27. OBRIGADO! ¡GRACIAS! THANK YOU! Clio Schils Richard Korn [email_address] [email_address]
Editor's Notes
- 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.