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This article describes health technology assessment (HTA) as an evaluation tool that applies systematic methods of inquiry to the generation and use of health technologies and new products. The focus of this article is on the contributions of HTA to the management of the new product development effort in the biomedical organization. Critical success factors (CSFs) are listed, and their role in assessing success is defined and explained. One of the conclusions of this article is that HTA is a powerful tool for managers in the biomedical sector, allowing them to better manage their innovation effort in their continuing struggle for competitiveness and survival.