The trends, events, and developments that shaped the IVD industry during the past 10 years. By 1995, the major trends that would shape the IVD industry during the next decade had already begun to materialize. Reimbursement policies were driving belt-tightening measures in all areas of healthcare around the globe. Clinical laboratories were passing on cost pressures to their suppliers. Bayer’s acquisition of Technicon in 1989 foreshadowed the ensuing industry consolidation that is still under way. Researchers were dreaming about IVD tests tailored to individuals. And even though IVD manufacturers and clinical labs recognized the potential of nucleic acid amplification technologies, few understood what molecular diagnostics would ultimately deliver. On the regulatory front, FDA was accused of being too conservative for holding back beneficial technologies. Clinical laboratories in the United States were coming to grips with the complexities of the Clinical Laboratory Improvement Amendments of 1998 (CLIA). The quality system regulation (QSR) was imminent, and with a high percentage of recalls attributed to design flaws, manufacturers were losing the debate over extending regulatory controls to new product design and development. New European regulations were on the horizon due to economic forces driving the creation of a single market. And with country-specific regulatory hurdles varying from highly prescriptive to none, global harmonization initiatives began emerging. The consolidation that occurred among IVD manufacturers and laboratories was the inevitable result of healthcare reforms and new reimbursement policies. Once Medicare and private insurance companies began to view IVD tests as commodities, labs had to reduce their costs to compete. Group purchasing organizations like (Charlotte, NC) helped hospitals put pressure on their suppliers to lower prices. In addition, as hospitals organized into networks to gain efficiency, many of their laboratories became redundant. The acquisition of independent clinical labs led to the establishment of commercial chains such as
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Electrical and EMC Testing Services
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Regulatory communications and safety communications services firms aid companies in authoring, writing and editing environmental, health and safety (EH&S), good pharmaceutical proactive (GxP) documents, and signs and labeling required by federal, state or local regulations.
Topics of Interest
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