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

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.

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

“…Finally, a hose adapter was designed to form air-tight connections between the ends of the plastic hose, the housing outlet, and the facepiece inlet. While all custom-made parts, including the custom housing, were 3D printed for prototyping, these designs were also optimized for injection molding to facilitate future high volume production ( Antonini et al, 2021 ). The CAD files for all custom and 3D printable/moldable parts, as well as printing instructions, are in Supplementary Material S4 .…”

“…The successful design, prototyping, and testing of a PAPR by a volunteer team comprising medical professionals, scientists, student engineers, and concerned citizens (the PanFab team) demonstrates the potential for addressing pandemic-related shortages of relatively complex types of PPE using a rapid and iterative approach to prototyping and design ( Antonini et al, 2021 ). 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 provided in part by the MIT COVID-19 Emergency Fund and the decision of the US National Institutes of Health to allow individuals paid by Federal research grants to devote time and effort to pandemic mitigation.…”

“…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 ( Antonini et al, 2021 ). 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.…”

Can the Profitability of Medical Enterprises Be Improved After Joining China's Centralized Drug Procurement? A Difference-in-Difference Design

“…The problem in the global drug market is that governments try to bear only the marginal cost of domestic drug consumption and rely on other countries to pay for the globally shared innovative achievements in drug R&D. From the perspective of cooperative organizations, with the reduction of the number of individual members, it is less difficult to punish the “free rider” behavior in the organization, and the uncooperative behavior is easier to be detected. Therefore, the level of voluntary supply of public goods is higher ( 28 , 29 ).…”

Resilience and Protection of Health Care and Research Laboratory Workers During the SARS-CoV-2 Pandemic: Analysis and Case Study From an Austrian High Security Laboratory

“…The role of supply chains, equipment procurement, and the dependency on manufacturers and suppliers of PPE components, disinfectants, and laboratory material was grossly underestimated by healthcare systems and research organizations (Burnett et al, 2022). HCWs and RLWs faced the additional situation of global delivery stops and delays of several months for PPE components in the early stage of the pandemic (Antonini et al, 2021;Best and Williams, 2021;Kothakonda et al, 2021;Ogbuoji et al, 2021;Pillai et al, 2021;Plana et al, 2021;Weaver et al, 2021;Loibner et al, 2021b). The three major problems of PPE unavailability, unprecedented rise in prices and maintenance of safety are described in Table 4.…”