(r)Evolve: A Modular Centrifuge for Diagnostic Testing

A novel, modular centrifuge to enable blood diagnostic testing with or without electricity, designed for and with emerging markets

Infectious diseases pose a high burden on health and economics in the developing world and other low-resource settings. Appropriate diagnostic testing is essential not only to administer the appropriate treatments for diseases, but also to efficiently utilize limited supplies of treatments, ensure safe blood transfusions, monitor and control the spread of disease, and prevent overtreatment that may lead to antibiotic resistance. Rapid diagnostic tests (RDTs) using simple paper strips are routinely used to diagnose diseases such as malaria, syphilis, and hepatitis B. However, a major barrier for adopting RDTs in resource-poor regions (e.g. those lacking electricity) is the need to separate whole blood to extract plasma or serum. Centrifuges are also essential for diagnosing communicable diseases and providing safe blood during a natural disaster, and can help to ensure the safety of “buddy transfusions” in military settings (fresh whole blood transfusions between soldiers) by allowing testing for communicable diseases that soldiers may be exposed to in war zones.

Sisu Global Health has identified a significant niche market for a manually operated centrifuge to increase access to diagnostic testing in resources-poor regions. We are developing (r)Evolve, a patented, modular centrifuge that can be used with or without electricity, and which can effectively, affordably separate blood for downstream diagnostic testing. Created from on-the-ground research in India as well as secondary resources throughout Africa, we have demonstrated that with an earlier prototype, laboratory technicians in Ghana could achieve the necessary speed (3,500 RPM over an equivalent time as an electric centrifuge) with manual cranking to successfully separate blood. As a small business that develops and commercializes medical devices for emerging markets, Sisu Global Health has already successfully taken Hemafuse, a manual autotransfusion device, from a concept to a fully manufactured device with regulatory clearance in Ghana and Kenya, with distribution contracts secured in these markets. Our team includes expertise in business, medical device design for emerging markets, and public-private partnerships in Africa, as well as in regulatory affairs, clinical analysis, and engineering.

There is tremendous potential and growth in the market for RDTs that require blood separation in low-resource settings. Eleven of the 20 fastest growing economies are located in Sub-Saharan Africa, and as these emerging markets grow, healthcare will be in greater demand. In fact, expenditures on healthcare in Sub-Saharan Africa have risen from $16.7 billion in 2005 to around $35 billion in 2016, and is projected to be $200 billion in 2020. Medical device spending is expected to reach $16 billion by 2020. With this knowledge, Sisu Global Health is focused on private sector laboratories as the main customer segment, but is also targeting local government sources, non-government organizations (NGOs) operating in the region, and local/regional hospital systems. Our ultimate goals are to increase access to diagnostic testing compared to electric centrifuges, increase efficiency of diagnostic testing compared to existing manual centrifuges through faster sample processing and increased sample throughput, and improve the quality of RDT results by separating blood properly, thereby reducing misdiagnoses and the need for additional testing.

Our solution is an application of existing technology to effectively, affordably separate blood for downstream diagnostic testing in low-resource settings. Although other electric and manual centrifuges exist, (r)Evolve will have its own market niche due to several advantages that address issues unique to low-resource users, including safety, efficiency, robustness, and affordability, with an option to upgrade to electric power. Instead of paring down US and European technology, we design for and with emerging markets, taking into account their unique spending habits, needs, and limitations that do not overlap with typical Western sales structures.

Following three generations of prototypes, a feasibility study, and third-party validation in several low- and middle-income countries (LMICs), the current version of (r)Evolve can achieve 3,500 RPM tube speed with 35 RPM user input, and features a sample capacity of six vials, enclosed base to contain samples in case of spills, and a planetary gear system linked to the drive shaft to achieve the necessary speed. We have shown that laboratory technicians in Ghana could achieve sufficient RPM with manual cranking to separate blood, and generate clinically equivalent results to an electric centrifuge for a cholesterol assay.

We plan to gather feedback from additional stakeholders in LMICs, modify the prototype to address their needs, and perform a usability test in Ghana to finalize the design for manufacturing and regulatory approval. Specifically, we will test for safety using a battery of industry standard tests, and test for efficacy by comparing performance in a cholesterol assay to that of a standard electric centrifuge. We plan to initially implement (r)Evolve in Ghana due to the in-country advocates and traction we have built through another device in our pipeline, as well as interest that we have established with an early prototype.

We plan to implement ten units of (r)Evolve in Ghana, and test for technical function, ease of use, and integration with other equipment. We will also analyze the impact of our device on the capacity of the clinics, including the number of diagnostic tests performed, expansion of clinic locations, and accuracy of test results. These user validation trials will take the place of a full clinical trial, and we will prepare for regulatory submission in Ghana. After Ghana, we plan to expand to Rwanda, Kenya, Tanzania, Ethiopia, and Nigeria, followed by the rest of Sub-Saharan Africa and India.

There is tremendous potential for growth in the market for diagnostic tests that require blood separation in low-resource settings. In Ghana, we have established interest and need with an early prototype in 2014, and have since made connections spanning interested distribution partners, government support (Ministry of Health and National Health Service), and advocates in multiple hospitals. We will sell (r)Evolve through wholesale distributors with a local team, similarly to our first portfolio product. We will leverage our network of clinicians across West, East, and Southern Africa, who are willing to collaborate, seek clinical solutions, and enable adoption of our device.

This solution has not yet been deployed. However, we are targeting private sector laboratories as the main customer segment, as well as local government sources, NGOs operating in the region, and local/regional hospital systems to increase access to diagnostic testing in resources-poor regions. We plan to initially implement (r)Evolve in Ghana, followed by Rwanda, Kenya, Tanzania, Ethiopia, and Nigeria, and the rest of Sub-Saharan Africa and India. Because (r)Evolve can be used with or without electricity, it reduces the load on difficult electrical infrastructure in low-resource urban settings, while granting rural locations greater access to diagnostic testing.

We plan to perform a pilot launch with ten units in Ghana in the next 12 months, and introduce (r)Evolve into the African market in 2020. We project a $300 million market for (r)Evolve in Africa and a $1.3 billion market across all emerging markets, based on an assessment of existing laboratories and blood collection centers across private, government, and NGO sectors. We expect (r)Evolve to be financially sustainable within two years of sales (three years from now), and reach 5,800 laboratories and collection centers and impact over 3.4 million lives.

Our team includes expertise in business, medical device design for emerging markets, and public-private partnerships in Africa, as well as in regulatory affairs, clinical analysis, and engineering. As a small business that develops and commercializes medical devices for emerging markets, we have already successfully taken Hemafuse, a manual autotransfusion device, from a concept to a fully manufactured device with regulatory clearance in Ghana and Kenya, with distribution contracts secured in these markets. We will utilize the strong partnerships we have created through our initial product to guide the development and distribution of (r)Evolve.

Eleven of the 20 fastest growing economies are located in Sub-Saharan Africa, and as these emerging markets grow, healthcare will be in greater demand. In fact, expenditures on healthcare in Sub-Saharan Africa have risen from $16.7 billion in 2005 to around $35 billion in 2016, and is projected to be $200 billion in 2020. Medical device spending is expected to reach $16 billion by 2020. With this knowledge, we are focused on private sector laboratories as the main customer segment, but are also targeting local government sources, NGOs operating in the region, and local/regional hospital systems. We project a $300 million market for (r)Evolve in Africa and a $1.3 billion market across all emerging markets, based on an assessment of existing laboratories and blood collection centers across private, government, and NGO sectors. We expect (r)Evolve to be financially sustainable within two years of sales, and reach 5,800 laboratories by the second year. Sisu will sell a portfolio of devices through wholesale distributors, and we expect >50% profit margin at scale. We plan to initially implement (r)Evolve in Ghana, followed by Rwanda, Kenya, Tanzania, Ethiopia, and Nigeria, and the rest of Sub-Saharan Africa and India.

We are seeking to form strategic partnerships with leaders in the medical device industry as we prove our pipeline in Sub-Saharan Africa, and expand in both region and products in emerging markets. In addition, we are seeking laboratory space and academic partners for prototype development and testing of (r)Evolve before conducting a usability study, finalizing the design for manufacturing and regulatory approval, and establishing the first sales. We believe Solve can help to connect us with key partnerships to develop and launch our solution.

While we are building a robust network and sales channels with African hires to launch our first product, our barrier to develop (r)Evolve has been bandwidth, resources, and finding the right partners. We see Solve as an opportunity to establish a partnership with resources at MIT to build and test (r)Evolve, and potentially other products as we scale in future. With the right mentors, Solve can support us in becoming a platform company, rather than just a one-product company. As we begin sales of (r)Evolve in Africa, we will also benefit from an industrial partner with established local sales hubs.