The OpenFlexure Microscope is an open source laboratory-grade digital robotic microscope. As a robotic microscope, it is able to automatically scan microscope slides creating, enormous multi-gigapixel digital representations of samples. The microscope is already undergoing evaluation for malaria and cancer diagnosis in Tanzania, Rwanda, and the Philippines. As an open project our key goal is to support local manufacturing of microscopes in low resource settings. But, how can an open source project empower local manufacturers to make hardware certified for diagnostic use?

Collaborative hardware design is notoriously difficult without complex Product Lifecycle Management (PLM) systems. However, Git provides more powerful version control than the most expensive proprietary PLM systems, especially if you use a code-based CAD package. Platforms like GitLab give clear records of project management through issue and merge request threads. Also, CI pipelines give us the ability to perform regular code quality checks, automate the generation of print-ready 3D models, and to generate detailed always-up-to-date assembly documentation and diagrams.

This high-quality consistent documentation has enabled thousands of microscopes to be built around the world, in over 50 countries. Microscopes have been used on all seven continents, from the Antarctic sea ice to the rainforest in Panama. They have been used for educational workshops in Sweden and Ghana, and even built by mobile makerspaces in wartime Ukraine. Hospitals already use the microscope to for remote consultancy and training, however without certification it cannot be used for diagnosis.

Combining good documentation with accessible calibration routines, gives manufacturers and users confidence that their locally-manufactured device performs as well as the thousands of other OpenFlexure Microscopes around the world. Building in robust calibration is crucial in our push towards medical certification.

This talk will involve live microscopy demonstrations, give an overview of the microscope and its applications, as well as diving into deeper questions of open source workflows for managing diagnostic device design.