A concurrent engineering approach for the development of medical devices

Abstract

Effective product development is one of the most critical issues facing medical device manufacturing today. There is a need for processes and methods that facilitate interaction between diverse groups and while focusing on the requirements for rapid regulatory approval. In this paper we propose an attribute-driven concurrent engineering (ADCE) process for the development of medical devices. The proposed process evolved from experiences with a large manufacturer of medical devices, and with other manufacturing firms. The ADCE process permits manufacturers to reduce design iterations and compress the development time. There are two key concepts in the ADCE process, the formulation of attribute drive specifications (ADS) and the attribute-driven design control. To facilitate the formulation of the ADS, three classes of attributes that are commonly used in the medical device industry are identified. These specifications are then monitored using three levels of performance: Ideal, target and limit. Design control is achieved via the weighted specification accomplishment score, which is derived from the specification performance level. Examples are presented to illustrate the concepts. The ADCE process is not limited to medical devices, and is easily expanded to other products in general. © 2000 Taylor & Francis Ltd.