Global Diagnostics
Regulation of IVDs in Australia
Australia's Therapeutic Goods Administration (TGA) is planning to implement a new risk-based regulatory framework for in vitro diagnostic medical devices during 2010. The regulatory framework is based on the recommendations of the Global Harmonisation Task Force (GHTF). Australia will be the first GHTF founding member to implement a GHTF-based system for IVDs. The proposed framework will regulate IVDs as a subset of medical devices and will amend the current Therapeutic Goods (Medical Devices...
IVD business opportunities in China
              Kathy Turner is divisional vice president, global commercial strategic operations, at Abbott Diagnostics (Abbott Park, IL). Prior to holding this position, she served as the director of area business development for Europe, the Middle East, Africa, and India, and then the regional director for Central Eastern Europe. She has been with Abbott since 1986. Turner can be reached at kathy.turner @abbott.com. China's more than 1...
Developing IVD instruments for emerging markets
            PHOTO BY CORBIS. Most IVD companies have recognized developing countries such as India and China as growth markets. The challenge for manufacturers is to ensure that their product portfolios are adequately equipped to serve such countries, with each presenting their own particular market challenges.   In trying to serve emerging markets, IVD manufacturers face unique challenges in defining their product pipelines, considering that...
Don't overlook the developing world
          At this year's annual meeting of the American Association for Clinical Chemistry (AACC; Washington, DC) in Chicago, the 12th International Market Briefing on global issues in the IVD industry was held. At this briefing, which is cosponsored by IVD Technology, speakers discussed the current status of the IVD markets in various parts of the world, the opportunities for IVD manufacturers in these markets, and the potential hurdles that manufacturers will...
Adapting with the growing European IVD market
          Maurizio Suppo, PhD, is vice president of regulatory affairs, quality systems, and environment, health, and safety at Siemens Healthcare Diagnostics (Eschborn, Germany). Siemens Healthcare Diagnostics is a diagnostic solutions company specializing in automation and performance-driven products and services that assist in personalized healthcare and disease management. He can be reached at maurizio.suppo @siemens....
China, Brazil, and India: Crashing the gates of the top ten IVD markets
            PHOTO BY JUPITER IMAGES. This year, the mature IVD markets, North America, Western Europe, and Japan, will represent seven of the top ten slots on the list of the world's most important IVD markets. These markets will spend about $22 billion on their suppliers of IVD products in 2008. But growth in these mature markets will remain modest, while margins will continue to be squeezed. Breaking into these markets is particularly difficult...
Trying to make sense of the world
          The notion that the world is getting smaller could easily be applied to how the IVD industry has been evolving. At this year's annual meeting of the American Association for Clinical Chemistry (AACC; Washington, DC) in Washington, DC, the 11th annual International Market Briefing on global issues in the IVD industry was held. At this briefing, which is cosponsored by IVD Technology, speakers discussed the current status of the IVD markets in various...
Chinese counterfeit devices elevate health concerns
        This past summer, a Shanghai court fined a Chinese businessman 400,000 yuan ($53,000) and sentenced him to 3½ years in prison for producing fake versions of the OneTouch brand of diabetes testing supplies, a product of LifeScan Inc. (Milpitas, CA), a Johnson and Johnson company. LifeScan announced in October 2006 that it discovered counterfeiters were distributing the imitation test strips. Complaints about faulty results last year in September led to the...
Braving the Japanese IVD market
          Mark A. Colby is the president of CGIKK (Tokyo). He was responsible for the importation and implementation of the College of American Pathologists' standard in Japanese laboratories. His books include Negotiating the Gray Maze: the Business of Medicine in Japan, The Japan Healthcare Debate: Diverse Perspectives, and The Boxer Gate. He can be reached at mcolby@cgikk.com. Western companies that have entered the Japanese IVD marketplace have often...
The diagnostics renaissance of Brazil and Mexico
          Photo by Jupiter Images These are the best of times in the two largest IVD markets in Latin America. This year, Brazil's IVD market will pass that of the United Kingdom, becoming the world's eighth-largest IVD market. Mexico's IVD market, currently about the same size as Belgium's, is now the twelfth-largest worldwide and will break into the top 10 within three years. In 2007, these two countries will spend nearly $1 billion a year on IVD products...