Three-Dimensional Printed Devices for Health Care in Response to the Coronavirus Disease 2019: Lessons Learned to Date.

During the first surge of the coronavirus disease 2019 (COVID-19) there was a tremendous global response from three-dimensional (3D) printing communities and individuals to support local health care systems and staff. The responses involved a range of 3D printer users from amateur makers to conglomerate manufacturers creating personal protective equipment (PPE) and other supplies of which there were shortages. These new supply chains resulted from the democratization of 3D printing, open source file sharing, mass production of desktop machines, and the relatively cheap cost of 3D printers. The democratized state of 3D printing facilitated an altruistic movement of makers with ranging experience, to work alongside traditional manufacturers to make medical supplies. With the critical nature of the shortages and the sharp increase in COVID-19 infections, many standards and regulations were bypassed, and good manufacturing processes disregarded, in cases. The outcomes from this article is a set of six lessons learned from the authors perspective regarding the use of 3D printing during the initial phase of the COVID-19 pandemic. We note challenges experienced around volume manufacturing, infection control requirements of produced parts and the cleanability of devices, mechanical strength considerations, good manufacturing practices, product and intellectual property (IP) liability, and the role of involving clinical stakeholders.