Well-funded medical labs are highly automated; detailed digital images and results are recorded by computerised instruments. This improves throughput, quality control, and record-keeping, and would enable training and telemedicine for rural contexts where an expert technician is not available. Currently, automated diagnostic devices are expensive, manufactured in rich countries. Most of the Global South is left behind, not only because of the high up-front cost, but because equipment cannot be maintained locally, due to proprietary technologies, conservative regulations, and poor supply chains for spare parts and consumables. This network will bring digital diagnostics to laboratories and clinics across Africa, in sustainable and responsible partnership with local clinicians and engineers. Our vision is of integrated, modern, digital healthcare laboratories that are supported by a thriving local ecosystem of biomedical engineers and developers.
The crux of our approach is the use of "open source hardware", where designs for easily replicated, high-quality diagnostic tools are shared under a license permitting their use, sale, and modification. Crucially, open source projects share not only technical know-how, but also ownership of innovations. Local entrepreneurs are not required to enter costly licensing deals in order to make use of these designs - the only condition is that they share any improvements they make to the design, for the benefit of similar companies elsewhere.
To reach our vision we must build a body of knowledge and skills that enable a new generation of medical instruments that can be repaired and customised without relying on a handful of rich countries. Our aim is to test the potential of open-source hardware as a new business model to establish and scale digital diagnostic solutions in LMICs, using the OpenFlexure Microscope as a case study. The links we build between engineers, healthcare scientists, medical professionals, and social scientists will not only help us achieve this aim, but will provide local, pan-African, and intercontinental links that help to build capacity in diagnostic innovation where it is needed most.
We will spend the first year of this project planning, identifying barriers to open source innovation, and forming networks of local connections to overcome these barriers. In the following years, we will study the process of taking a locally produced, 3D printed microscope from working prototype to usable product for malaria diagnostics in three different African countries. We will use the framework of Implementation Science to study the "diffusion of innovation" as the technology is taken through regulatory approval and adopted by healthcare providers. We will engage with a number of other projects, for example low cost retinal imaging devices, to compare across different technologies, and to share what we have learned in malaria microscopy with other application areas.
Our network is highly interdisciplinary, and this is crucial to its success: while many diagnostic devices are developed by physical scientists and engineers, this must be led by the needs of clinicians, and informed by the infrastructure, regulations, and political environment of the country where it is to be used. This understanding of context needs social and policy scientists, as well as engagement with regulators and policymakers. While there are important points for engineers to consider relating to the context (such as the availability of reliable power or data connections), many of the biggest barriers to innovation are cultural, political, or regulatory. We will work to develop a sustainable business model that uses open source technology to empower local entrepreneurs while complying with relevant regulations and standards - bringing better access to diagnostics to some of the most underserved regions of the world.