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

In this paper, we present an integrated collaborative modular architecture method for 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 this 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 integrity, 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 time, thereby improving market competitiveness among other factors.