Integrated Fuzzy-Based Modular Architecture for Medical Device Design and Development

In this impel we present an integrated collaborative modular, architecture method lot medical device design and development The methodology is focused on analyzing the input of stakeholder data from existing products and components to achieve an optimal number of modules The methodology starts by defining a product s functional and physical decompositions Product parameters are selected such as quality reliability ease of development and cost These are prioritized using analytical hierarchy process (AHP) to determine the medical device manufacturers focus area The parameters subsequent metrics are selected for performance requirements Next we evaluate the candidate modules by acquiring stakeholder data and converting them to crisp values by applying the Sugeno fuzzy based method Finally we determine the subsequent optimal module values using a multi optimization goal programming model We present here a proof of concept using a typical glucometer The implication of tins work is the determination of the optimal number of product modules based on stakeholder constraints Hence an original equipment manufacturer (OEM) can work on fewer components per module without adversely affecting the integral, quality and reliability of the final product Next is the improved quality of patient care by enabling cost reductions in product design and development thereby improving patient safety This methodology helps reduce product cycle tune thereby improving market competitiveness among the, factors [DOI 10 1115/1 4002323]