Docs-as-Code for Open-Source Medical Hardware & PPE's

The advent of the COVID-19 pandemic created a global demand for accessible, reliable, & affordable medical devices & personal protective equipment (PPE). However, as the pandemic progressed throughout 2020 and into 2021, the inventory of commercially available medical devices and PPE was severely restricted across almost all medical establishments throughout the world. This supply chain failure demonstrates the need to produce reliable and cost effective medical equipment and PPE without extensive dependencies on remote manufacturers. Volunteer groups formed in order to create PPE for medical workers, and others began to design PPE with a focus on local manufacturing and open designs. open-source organizations formed in order to fascilitate global volunteer efforts and contributions for developing medical devices and PPE for medical workers. The tight regulatory environment dictates standards for the design, manufacturing, & certification of medical devices and PPE's. Such regulations commonly require a complete set of bill of materials, change management, and quality assurance processes. Meeting such regulatory requirements, while adhering to the principles of open-source hardware, poses its own set of technical challenges. This talk tells the story of how Tetra Bio Distributed (TBD), a volunteer-founded 501(c)(3) non-profit organization, developed medical devices and PPE as open-source hardware, using a docs-as-code approach.