A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic.

ABSTRACT: The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pande

SUBMITTER: Antonini MJ 

PROVIDER: S-EPMC8064560 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature