Lifecycle extension of single-use medical device sensors: Case study of an engineering sustainability transition program

Abstract

Medical devices and consumables are contributors to the known, highly negative ecological impacts of healthcare provision. Medical device manufacturing organizations are increasingly met with pressures to convert thousands of their existing, post-market products to be more sustainable, yet there is limited knowledge of how these transition projects are achieved. This case study examines the execution of a large medical device manufacturer's sustainability transition program of a post-market single-use sensor. We provide both a detailed synthesis of the design verification steps and a review of the key challenges which were identified during a customer-driven lifecycle extension program of a single-use medical device sensor; the case study sensor was released with a doubled shelf life, thus increasing the time of safe and effective use plus decreased scrapping needs. This paper contributes to the knowledge for the practical development of the required design verification efforts of released, highly regulated single-use medical device sensor products during sustainability transition programs. This paper increases knowledge related to the complexities and challenges technology ecosystem sustainability programs face in the post-market medical device consumable space during reverification of legacy products to meet sustainability challenges. Additionally, the paper identifies six phases of waste during a single-use medical device sensor's lifecycle.