Incorporating sustainability in decision-making for medical device development

Abstract The development and commercialization of contemporary medical devices are inherently multidisciplinary. Consequently, they have to undergo a stringent regulatory compliance procedure in conformity with an ever increasingly fierce and competitive business environment. Throughout the product life cycle, medical devices would significantly consume renewable as well as non-renewable resources and as a result exert a substantial social, economic and environmental impact(s). Sustainability from an overall perspective in terms of social, economic and environmental domains is crucial for decision-making during product development; nevertheless they have rarely been incorporated simultaneously. Both public and private institutions only focused towards economic and environmental sustainability without acknowledging the critical role of social sustainability that needs to be addressed concurrently so as to uphold the other two. Accordingly, it is imperative to consider the criteria of the aforementioned domains of sustainability in the initial phases of product development. The proposed conceptual multifaceted framework comprehensively explores a broader scope of sustainable product development, mainly from the pragmatic standpoint of systems engineering in comparison to the contemporary evaluation and development approaches. The underpinnings of the proposed framework encompass the critical role of a MultiCriteria Hierarchical Model (MCHM), which is in fact an extensive revision of the analytical hierarchy process decision making model. The MCHM mainly functions across the idea screening phase (Stage 2) up to the business and feasibility analysis phase (Stage 4). Moreover, unlike its predecessors, the MultiCriteria Hierarchical Model is less dependent upon numerical scores allotted by expert opinion and apparently broader in its scope of application. Furthermore, the proposed framework elucidates the active participation of the MCHM in product design and development by conjoining with an artificial intelligence based computer system known as expert systems. The principal objective of the proposed conceptual framework is to deliver a thorough assessment and a feasible roadmap for the development of sustainable medical devices.

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