Technology Life Cycle
Understanding the life cycle stages of a medical product is an essential requirement for assuring the continuous product’s performance and the protection of the patient safety. Today’s products include combination of one or more of the following components: hardware, software and at times middle ware that 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 the user appreciation that hazardous change took place. Hardware and software usually demonstrate failures at different stages in the product life. While hardware failure or defect can be experienced immediately upon out-of-the-box use while software failure maybe experienced later in the product life during upgrade or the application of service patch.
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 life cycle technology management program. Life cycle technology management program consists of specific processes of product testing, product approval, product introduction, product service support, application monitoring, qualified upgrades and improvements, and obsolescence or end-of-life planning. Both the vendor and later the user must comply with specific requirements. The safety continuum in the medical product life cycle was the topic of a 3-days conference with FDA executives in September 2010 that dealt with assessing and managing risk from pre-clinical testing to post approval and use.
BEC and its associates have extensive experience in the stages of technology life cycle and how care providers use medical products during the management of their patient’s conditions. BEC and its associates are also intimately knowledgeable with the repair and maintenance services that such products’ performance is dependent upon. Life cycle risk management demands organized program managed by qualified professionals having the understanding for their responsibility. 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.