Establishing Stakeholder Needs for Medical Devices

Regulatory bodies require manufacturers of medical devices to use formally planned design processes that provide improved understanding of user and other stakeholder needs, and so enable traceability of designs (e.g. functional requirements and design parameters) to facilitate the control and reduction of risk. Current processes involve significant consultation with users, but are generally unstructured and hence the value of their input is not maximised. User needs and design requirements are not demonstrably aligned. This paper discusses the problem of establishing stakeholder needs from information that typically results from marketing activities and introduces the NASo technique as a means to address these problems. An application of the technique to establish stakeholder needs is demonstrated through a case study of hip joint surgical instruments. The case study showed that the rigour of the NASo technique enabled both the identification of needs, which would otherwise be overlooked, and their documentation in a traceable manner. This is necessary to support not only the derivation of design requirements that are aligned with stakeholder needs but also the prioritisation and quantification, where applicable, of such requirements. The business benefit stemming from this is the confidence gained in evaluating new product and/or service opportunities and in an improved capacity to respond to design changes.