A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic
Name
fdgth-03-617106.pdf
Description
Published version
Size
766.87 KB
Format
Adobe PDF
Checksum (MD5)
dc685906c6639f7aae0b6028476cab99
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.
Date Issued
March 2021
Journal
Frontiers in Digital Health
Publisher
Frontiers Media SA
Citation
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.
Version
Final published version
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 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.
MIT Department
Massachusetts 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
Massachusetts Institute of Technology. Institute for Medical Engineering & Science
Koch Institute for Integrative Cancer Research at MIT
Terms of Use
Creative Commons Attribution 4.0 International license
Persistent DSpace Link
DOI of Published Version
https://doi.org/10.3389/fdgth.2021.617106
