Understanding the life cycle stages of a medical product is an essential requirement for assuring the product’s continuous performance and protection of patient safety. Today’s products include combinations of one or more of the following components: hardware, software, application and at times middleware that together provide the platform for intelligent features, flexibility in application and connectivity to other systems. Each one of these components may change its performance and its risk exposure level. These changes can take place with or without user appreciation of the hazardous change taking place. Hardware and software may demonstrate failures at different stages during the product life. Therefore, successful technology life-cycle management requires systems expertise and resource optimization.
The progression of new product through a sequence of stages from innovation, to early adoption, to obsolescence and replacement is known as the product life -cycle and is associated with the application of an effective life-cycle healthcare technology management program. Such a program consists of specific processes from design and product testing to product introduction, service support, assets management, qualified upgrades and improvements, and planned obsolescence. Both the vendor and later the user must comply with specific requirements. The safety continuum in the medical product life-cycle is a critical state that must be managed from pre-clinical testing to post-clearance/approval and throughout its deployment.
BEC and its medical device consulting associates have extensive experience in the assessment, improvement and implementation of programs to maximize benefits of technology over its life-cycles. BEC and its associates are also intimately knowledgeable with repair and maintenance services that such products’ performance is dependent upon. Life-cycle risk management demands organized programs managed by qualified professionals having systems understanding. BEC and its associates have hands-on experience with the design and implementation of process assessment and program improvements that lead to best practices and seamless collaboration between service providers within, as well as externally to, the hospital.
BEC offers its medical equipment planning services to customers from Houston, Pasadena, Pearland, League City and Cypress, Texas.