Integrated Multilayer Architecture with Multi Interface Entity Model for Risk Management in Modular Product Design

Abstract

The purpose of this paper is to propose a framework where risk management is a living, decision-driving process in a Product Lifecycle Management (PLM) supported product development environment. This is especially relevant in the realm of the medical devices industry where products have a direct impact in customer’s health. The challenge is finding a methodology where risk management is a living, concomitant process throughout the lifecycle, which is cumulative, so the risk assessments refine with the product’s definition while adhering to a tightly regulated environment for medical devices. This process needs be fully embedded in the PLM processes so it is able to accompany the product at any change throughout its life. To achieve this goal we narrow the definition of risk to fit our purposes. We introduce the Multi Interfaces Entity Model (MIEM) as method to do a scalable and summative product decomposition. The results of the MIEM will be translated in a multilayered architecture that recognizes the functional, the modular, the generative and the physical view. In the next step, we evaluate the possible solutions to these modules creating a bridge the configurable products in PLM. From the decomposition throughout the design until the configuration, different risk assessment will be performed with the goal to accumulate them at the point of configuration to choose the best product based the lowest possible risk. The results lay the ground for a recursive methodology that supported with a PLM integrated risk management, which can be automated to make sure the risk assessment is complete, re-usable and configurable as an additional PLM function. This allows the creation of a configured design structure, applying recursively the same cumulative properties of the risk assessment. Further investigation is needed on how to implement this framework in an open source environment that is still compatible with proprietary PLM systems.

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