The changing regulatory and political actions imposed upon medical device OEMs are pressuring them to further scrutinize their businesses to remain competitive. Industry reports estimate that more than 75 percent of the average $31m cost to bring a low-to-moderate 510(k) medical device to market, and 75 percent of the average $94m cost to bring a high-risk device that requires pre-market approval to market, are related to clearing regulatory requirements. Added to that is the impact of the Affordable Care Act's 2.3 percent excise tax on all U.S. sales of medical devices-a projected $30bn industry hit over the next decade and a 33 percent increase in the medtech industry's overall tax burden.' While medical device OEMs cannot control regulatory costs and increased taxes, they can control both the production costs and selling of their products. Passing along increased costs and charging customers more is only a partial solution for OEMs. For sustained competitiveness, manufacturers should re-examine how they streamline the manufacturing of their devices and lower production costs.
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机译：对医疗设备原始设备制造商施加的不断变化的法规和政治行动迫使他们进一步审查其业务，以保持竞争力。行业报告估计，将中低端的510（k）医疗设备推向市场的平均成本为3,100万美元，其中超过75％的成本是将需要预先准备的高风险设备的平均成本（9,400万美元）的75％。 -市场批准进入市场，与清理监管要求有关。此外，《平价医疗法案》（Affordable Care Act）的2.3％消费税对所有美国医疗器械的销售产生了影响-预计在未来十年内将冲击300亿美元的行业，而医疗技术行业的整体税负将增加33％。''尽管医疗设备OEM无法控制监管成本和增加税收，但他们可以控制生产成本和产品销售。传递增加的成本并向客户收取更多费用只是OEM的部分解决方案。为了保持持续的竞争力，制造商应重新考虑如何简化其设备的制造并降低生产成本。
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