Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

A Crisis-Responsive Framework for Medical Device Development during the COVID-19 Pandemic

Version 1 : Received: 23 September 2020 / Approved: 24 September 2020 / Online: 24 September 2020 (10:45:53 CEST)

How to cite: Antonini, M.; Plana, D.; Srinivasan, S.; Atta, L.; Achanta, A.; Yang, H.; Cramer, A.; Freake, J.; Sinha, M.S.; Yu, S.H.; LeBoeuf, N.R.; Linville-Engler, B.; Sorger, P.K. A Crisis-Responsive Framework for Medical Device Development during the COVID-19 Pandemic. Preprints 2020, 2020090577 (doi: 10.20944/preprints202009.0577.v1). Antonini, M.; Plana, D.; Srinivasan, S.; Atta, L.; Achanta, A.; Yang, H.; Cramer, A.; Freake, J.; Sinha, M.S.; Yu, S.H.; LeBoeuf, N.R.; Linville-Engler, B.; Sorger, P.K. A Crisis-Responsive Framework for Medical Device Development during the COVID-19 Pandemic. Preprints 2020, 2020090577 (doi: 10.20944/preprints202009.0577.v1).

Abstract

The disruption of conventional manufacturing, supply, and distribution channels for medical supplies during the COVID-19 pandemic has caused widespread shortages and 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 utilizes extensive stakeholder engagement, comprehensive and dynamic needs assessment, local manufacturing, and product testing for the accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing and discuss relevant regulatory policies. We highlight the applicability of the crisis-responsive framework to a successful local program that designed and supplied face shields for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing and changes in regulatory policy that strike a balance between rigidity and uncontrolled innovation.

Subject Areas

personal protective equipment (PPE); COVID-19; manufacturing; prototyping; 3D-printing; biocompatibility; sterilization; face shields; regulatory sciences; local resilience

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