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

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.

De novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response

“…The successful design, production and testing of a PAPR by a volunteer team comprising medical professionals, scientists, student engineers and concerned citizens (PanFab) demonstrates the potential for addressing pandemic-related shortages of relatively complex types of PPE using a rapid and iterative approach to prototyping and design 31 . The process generated near-final PAPR designs with full-time effort by three graduate engineering students, support from a clinical specification and testing team, access to standard academic laboratories and modest financial support.…”

“…For both the filter cartridge and the blower unit components, we describe a “PanFab Custom Design” and a “PanFab Commercial Design” to accommodate different scenarios with respect to shortages of materials. The custom design has less reliance on commercial products and supply chains and can be fabricated in large part using additive manufacturing (3D-printing) methods for low volume production or injection molding for high volume needs 31 . The commercial design relies on commercially available parts made for other products and requires fewer custom fabrication steps, facilitating rapid introduction of new, locally fabricated units.…”