Multi-dimensional readiness assessment of medical devices

Abstract

Medical device (MD) developers currently use the Technology Readiness Levels (TRLs) to determine the status of technology. However, the broad definition of each level makes it difficult to ascertain readiness of MDs. The TRL is also indifferent to the strict regulatory requirements for MDs, requirements for human systems integration, and market competition. This paper proposes a technology readiness framework for communicating and planning the development of Class III MDs called the Medical Device Readiness Levels (MDRLs). Five exit criteria were staged in a meaningful sequence within the framework: safety, clinical effectiveness, usability, comfort, and affective response. It also incorporates the stakeholders’ perspectives, mindful of the users’ varying needs in manipulating the MD. The usefulness of the framework was affirmed by professionals involved in MD development.