Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to achieve certain benefits.
To date, manufacturers haven’t addressed risk very well as part of product design quality. Handling design control as a document-centric process introduces a high risk of failure over the product lifecycle. That’s because documents are very limited representations of complex products. They typically represent only a subset of product design information at a specific point in time. Even worse, they lack resilience to change.
Medical device manufacturers must also account for the Internet of Things (IoT). IoT technology enables smart, connected products to send manufacturers information about their products and processes while in operation. In turn, manufacturers can offer innovative services for medical devices, including restarting devices remotely in order to significantly reduce service costs while boosting customer satisfaction.