Developing the OpenFlexure Microscope towards medical use: technical and social challenges of developing globally accessible hardware for healthcare

Abstract

The OpenFlexure Microscope is an accessible, three-dimensional-printed robotic microscope, with sufficient image quality to resolve diagnostic features including parasites and cancerous cells. As access to lab-grade microscopes is a major challenge in global healthcare, the OpenFlexure Microscope has been developed to be manufactured, maintained and used in remote environments, supporting point-of-care diagnosis. The steps taken in transforming the hardware and software from an academic prototype towards an accepted medical device include addressing technical and social challenges, and are key for any innovation targeting improved effectiveness in low-resource healthcare. This article is part of the Theo Murphy meeting issue 'Open, reproducible hardware for microscopy'.

Keywords: global health; microscopy; open source; pathology.

Figure 1.

An exploded view of the OpenFlexure Microscope version 6.1.5, reproduced from [1] under the CC-BY-SA licence.

Figure 2.

A map of the countries in which the OpenFlexure Microscope has been built or used, according to users in an OpenFlexure forum thread [15].

Figure 3.

Images of a squamous cell carcinoma from a vocal cord sample, captured on the OpenFlexure Microscope with a 40 ${\displaystyle \times }$ objective. Panel (a) shows a focused image with well-aligned optics, while panel (b) shows the same area out of focus and with misaligned illumination. A trained user can distinguish between these images, refusing to give a diagnosis based on poor data.