Digital diagnostics for smarter healthcare in Africa

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.

Our long-term goal is to make modern, digital diagnostics available to everyone - regardless of the economic situation in their country. By doing this through strengthening local capacity for biomedical engineering, we will not only overcome many of the infrastructural barriers that have hampered initiatives in the fast, but also deliver important economic benefits through the creation of skilled jobs, and a reduction of high value imports. Over the last few years, an increasing number of open-source hardware designs have been released, with the potential to transform medical devices through the use of digital fabrication and inexpensive, well engineered parts from mass produced consumer goods.

By engaging directly with regulators and appropriate international organisations, as well as drawing on the experience of network partners such as HTAF and Incas Diagnostics, we will make recommendations that can streamline the process of approving locally produced medical devices. It is of paramount importance that this does not result in a compromise to patient safety or standards of care, but it is also possible that there are ways to lower the barriers to certification without compromising on technical standards. Our initial scoping exercises and subsequent case studies and analyses will help us to identify key sticking points in the process of certification, and recommend ways that regulators and local businesses can modify their practices in order to work around these issues. We have already engaged with the Tanzanian Medical Device Authority, and will engage with other regulatory stakeholders such as the World Health Organisation (where Prof. Ansah serves as an adviser) to understand how we can craft business models that meet their requirements while also keeping the benefits of open source technology.

Building UK-African links and African-African collaborations will help create a community of biomedical engineers in Africa that is internationally respected. Joint projects in Phase Two of the network will also challenge the pervasive view that "imported products are superior" by enabling African scientists to co-create new digital diagnostics with international partners. This reluctance to trust locally made goods is one of the major cultural barriers to growing many African economies, and results in "donor dependence". This is particularly prevalent in high-tech or safety-critical industries such as diagnostics, so the ultimate impact of our work will be renewed growth of high value industry. Producing high-value goods locally, rather than relying exclusively on primary industries like agriculture, is key to the economic development of the whole continent. Certification, acceptance, and large-scale procurement of locally produced goods is needed to realise this benefit, and our work will take important steps towards achieving that.

One of the big promises of open source technology is rapid replication. By avoiding the need for licensing deals and vendor exclusivity, we can harness the huge entrepreneurial energy that exists throughout Africa to create a network of businesses able to produce, service, and customise digital diagnostics. However, this promise is only likely to be realised if we carefully understand how to adapt innovations to different local contexts. The implementation science aspect of our proposed research will help to address this, and allow technologies that are successful in one place to be adapted and re-used in another.

Finally, we will engage the wider community of makers and innovators in Africa and the rest of the world, through social media, high profile blogs and video series, and design-sharing websites. We will also continue to share our work through open hardware networks, such as the Gathering for Open Science Hardware, and the Africa Open Science and Hardware network to reach innovators and makers who can help take open digital diagnostics projects forward.