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.
Highlights
Rapid Product Development to Meet Emergent Shortages of Medical SuppliesIn the face of a global COVID-19 pandemic, widespread disruption of international supply chains and local distribution networks has led to severe shortages in personal protective equipment (PPE) and other medical equipment such as ventilators [1]
Numerous international collaborations have been formed, anchored in open-source designs, rapid dissemination of pre-prints and repositories such as the National Institute of Health’s 3D Print Exchange [2]. Such non-traditional fabrication of medical equipment is made feasible by the widespread availability and low cost of manufacturing techniques including 3D printing and laser cutting. These approaches are ideal for low-volume production of face shields, masks, frames for N95 filtering facepiece respirators (“N95 masks”), swabs for diagnostic kits, and potentially more complex medical products such as ventilator parts [3, 4]
We propose that the capacity for crisisresponsive local manufacturing be further developed so that it can contribute to resilience to pandemics and healthcare emergencies at local, national, and international levels
Summary
In the face of a global COVID-19 pandemic, widespread disruption of international supply chains and local distribution networks has led to severe shortages in personal protective equipment (PPE) and other medical equipment such as ventilators [1] These shortages have spurred numerous local efforts to supply alternative products. Numerous international collaborations have been formed, anchored in open-source designs, rapid dissemination of pre-prints (on medRxiv or bioRxiv) and repositories such as the National Institute of Health’s 3D Print Exchange [2] Such non-traditional fabrication of medical equipment is made feasible by the widespread availability and low cost of manufacturing techniques including 3D printing and laser cutting. Local repair and rebuilding capacities have long been recognized as critical aspects of resilience to natural disasters [5]
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