Despite the availability of numerous ''Design for X (DfX)'' concepts/methods, their application is challenging for two reasons: because methods have been developed with different foci (e.g., manufacturing vs. quality), it is difficult to know how different methods complement each other; in what sequence and where at the design stage they should be applied. We address this challenge with a review of DfX methods with recommended design stages for their use from the published literature. We also provide a thematic clustering for their application along with a maturity index for each DfX concept.

This article describes the complex nature of the medical device development (MDD) process and presents a product design process model to aid designers engaged in MDD. Basically, the model serves as a conceptual framework and provides a set of formalisms to define the development landscape for medical devices. Specifically, the model describes the phases of MDD and their relationships, including the testing and approval environment that impacts this process. The Food and Drug Administration (FDA) is an essential part of this environment, acting as the regulatory agency for medical devices in the USA. FDA approval is a significant milestone which industry developers must achieve before the actual release of their devices in the US market. In this article, the relevant literature addressing the regulations and the MDD process models are reviewed. The development and organisation of the model are discussed in detail with descriptions of the building process, concepts, granularity, utility and overall contribution. The model is the result of a documentation analysis and is supported by a content validation survey and a case study. The model is proposed as an aid for designers to proactively use in handling the complexities of MDD.