Digital diagnostics for smarter healthcare in Africa

资金充足的医学实验室高度自动化；计算机化仪器记录详细的数字图像和结果。这改善了吞吐量、质量控制和记录保存，并将为缺乏专业技术人员的农村环境提供培训和远程医疗。目前，自动化诊断设备价格昂贵，而且是在富裕国家制造的。大多数南半球国家被抛在了后面，这不仅是因为高昂的前期成本，还因为由于专有技术、保守的法规以及备件和消耗品的糟糕供应链，设备无法在当地进行维护。该网络将与当地临床医生和工程师建立可持续和负责任的伙伴关系，为非洲各地的实验室和诊所带来数字诊断。我们的愿景是在当地蓬勃发展的生物医学工程师和开发人员生态系统的支持下，建立综合性、现代化的数字医疗实验室。我们的方法的关键是使用“开源硬件”，在这里，易于复制的高质量诊断工具的设计在允许其使用、销售和修改的许可下共享。至关重要的是，开源项目不仅分享技术知识，还分享创新成果的所有权。为了使用这些设计，当地企业家不需要签订昂贵的许可协议——唯一的条件是，他们分享对设计所做的任何改进，以使其他地方的类似公司受益。为了实现我们的愿景，我们必须建立一套知识和技能体系，使新一代医疗器械能够在不依赖少数富裕国家的情况下进行维修和定制。我们的目标是测试开源硬件作为一种新的商业模式的潜力，以在低收入国家建立和扩展数字诊断解决方案，使用OpenFlexure显微镜作为案例研究。我们在工程师、卫生保健科学家、医学专业人员和社会科学家之间建立的联系不仅将帮助我们实现这一目标，而且将提供地方的、泛非的和洲际的联系，帮助在最需要的地方建立诊断创新的能力。我们将在这个项目的第一年进行规划，确定开源创新的障碍，并形成本地连接网络来克服这些障碍。在接下来的几年里，我们将在三个不同的非洲国家研究将当地生产的3D打印显微镜从工作原型到可用产品的过程，用于疟疾诊断。我们将使用实施科学的框架来研究“创新的扩散”，因为技术通过监管批准并被医疗保健提供者采用。我们将参与其他一些项目，例如低成本的视网膜成像设备，来比较不同的技术，并与其他应用领域分享我们在疟疾显微镜方面学到的东西。我们的网络是高度跨学科的，这对其成功至关重要：虽然许多诊断设备是由物理科学家和工程师开发的，但这必须以临床医生的需求为主导，并考虑到使用这些设备的国家的基础设施、法规和政治环境。这种对背景的理解需要社会和政策科学家，以及与监管机构和政策制定者的接触。虽然工程师需要考虑与环境相关的重要问题（例如可靠的电源或数据连接的可用性），但创新的许多最大障碍来自文化、政治或监管。我们将努力开发一种可持续的商业模式，在遵守相关法规和标准的同时，利用开源技术赋予当地企业家权力——为世界上一些服务最欠缺的地区提供更好的诊断服务。

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.