A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic
Author(s)Antonini, Marc-Joseph; Plana, Deborah; Srinivasan, Shriya Sruthi; Atta, Lyla; Achanta, Aditya; Yang, Helen; Cramer, Avilash (Avilash K.); Freake, Jacob; Sinha, Michael S; Yu, Sherry H.; LeBoeuf, Nicole R.; Linville-Engler, Benjamin; Sorger, Peter K.; ... Show more Show less
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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 pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation.
DepartmentMassachusetts Institute of Technology. Research Laboratory of Electronics; McGovern Institute for Brain Research at MIT; Harvard University--MIT Division of Health Sciences and Technology; Massachusetts Institute of Technology. Department of Mechanical Engineering; System Design and Management Program; Massachusetts Institute of Technology. Institute for Medical Engineering & Science; Koch Institute for Integrative Cancer Research at MIT
Frontiers in Digital Health
Frontiers Media SA
Antonini, Marc-Joseph et al. "A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic." Frontiers in Digital Health 3 (March 2021): 617106. © 2021 Antonini et al.
Final published version