Investments in this strategy aim to improve access to innovative medical devices and diagnostics to better suit low-income populations or address challenging health systems context. Improving access can be by either enhancing existing tools and devices or inventing new ones that are better tailored to the context. The sections below include an overview of the strategy for achieving desired goals, supporting evidence, core metrics that help measure performance toward goals, and a curated list of resources to support collecting, reporting on, and using data for decision-making.
Health care personnel in emerging markets often lack access to adequate diagnostic technology, preventing them from making reliable diagnoses. Health care facilities can also serve large geographic areas, so low-cost, portable medical devices and rapid point-of-care diagnostics can make delivering high-quality health care services possible even in remote settings.
There is a known gap (referred to as the “10/90” gap) between developing and industrialized countries, whereby 90% of the research money in genomics and related biotechnologies is focused on the health needs of only 10% of the world’s population (1). Current state-of-the-art laboratory medicine is highly dependent on complex platforms that assume advanced infrastructure, including reliable electricity, and cold storage; it also requires a sterile environment, large sample volumes, and highly trained personnel to perform the tests.Low-infrastructure sites often lack these characteristics. As such, high-impact diagnostic tools must be tailored to such settings to meet existing need.
Multiple diagnostic tests have recently been developed for many pathogens, including many that primarily affect low- and middle-income countries, such as HIV, malaria, and tuberculosis. Still, innovative medical devices and point-of-care diagnostics have not yet been deployed widely, especially in low- and middle-income countries. This presents many opportunities to improve health outcomes by:
Medical devices and diagnostics that perform as well as the technologies currently used in laboratories and hospitals would have a greater impact if they could be implemented outside of traditional brick-and-mortar healthcare facilities. Gains from wider implementation would far exceed those from merely improving the performance of current tests. A 2006 research study showed that improving test accuracy for bacterial pneumonia detection in advanced health care facilities led to only 119,000 more disability-adjusted life years (DALYs) saved per year, compared to 263,000 more DALYs saved by expanding access to health care sites minimal resources (11).
Lack of access to innovative medical devices and quality diagnostics at the point of care also contributes to the enormous disease burden in emerging markets. Progress is occurring, but has been slow. Medical devices and diagnostics are largely inefficient, and evidence needed to move these tools to sustained distribution is lacking. In many emerging markets, expenditure on diagnostics is often a negligible proportion of healthcare spending: a World Health Organization (WHO) report showed that only 6% of health expenditure at a district hospital in Malawi is on diagnosis (12).
Diagnostic tests often take 5–10 years to develop with an investment ranging from $2 million to $10 million (13). For products with a viable commercial market, this is driven, funded, and managed largely by the private sector, drawing on appropriate expertise as needed. However, in developing countries, there has been little interest in investing in diagnostic product development because of a perceived lack of return on the investment. Besides requiring low cost, diagnostic tools for these countries must also cope with environmental challenges, such as heat, dust, and high humidity, as well as unreliable electricity supplies and refrigeration facilities. Much of the population may live far from health centers with laboratory facilities, even as test results must be delivered fast enough to influence clinical decision-making.
Implementing point-of-care medical diagnostics also presents some practical challenges. Made available must be not only a test itself but also any accessory materials (e.g., chemicals, swabs, or gloves) required to use a test safely and accurately, and any essential consumables must not exceed their shelf lives. The skills required to use a test must match those likely available in the local context—or effective training must be designed and delivered.
Below are some of the stakeholders most critically and directly impacted by innovations in medical devices and point-of-care diagnostics:
Providers: Healthcare providers who continually face shortages of essential supplies and diagnostics due to any of the conditions described could greatly benefit from innovative product delivery models.
Women and Other Marginalized Groups: Due to economic and social disadvantages, women and other vulnerable populations may have less access to innovative point-of-care technologies and diagnostics. For example, Access to improved prenatal syphilis point-of-care diagnostic testing has been shown to enable same-day testing and treatment for pregnant women and their partners, which has positive impacts on newborn health (15, 16).
Uninsured People: At the point of delivery, diagnostic tests are rarely free and can often be expensive.
People in Rural Areas: Geographic remoteness presents one large, persistent obstacle to universal health coverage (3). Innovative medical devices and point-of-care diagnostics can improve the quality of health services in remote areas, improving health outcomes for rural populations.
People in Geographically Inaccessible Areas: Distance is not the only geographic barrier to universal health coverage; untraversable terrain also prohibits access to quality healthcare. Innovative medical diagnostics and point-of-care technologies can help reach populations in these previously inaccessible areas.
Point-of-care medical devices offer improved access to diagnostic and monitoring laboratory tests in many emerging marketsa where centralized/referral laboratories are unavailable. Thus, patients living in remote areas with limited access to the healthcare system have the most to gain from investments in this strategy. Distance from the patient’s home to ta healthcare facility is directly correlated to the direct and opportunity costs borne by the patient, particularly in rural and remote areas (14). As such, increased access to innovative medical devices and point-of-care diagnostics will have the most impact in the areas that central laboratory testing systems cannot efficiently service. These are also the most challenging areas in which to introduce new technologies.
Accurate diagnostics can affect health-care decisions well in excess of their cost. Diagnostics only account for an estimated 2% of the cost of global health care but affect 60–70% of treatment decisions (6). In resource-limited settings, meanwhile, the alternative to diagnostic tests offered at the immediate point of care might be no diagnostic support at all.
Research undertaken to estimate the global health benefits of new diagnostics for the developing world clearly indicates that the right tools could save millions of lives if they are made widely accessible and if appropriate treatments are available. A few examples that the research found possible with new diagnostics are (7):
Most of the benefit of reducing the disease burden would occur in Africa, where access to tests and antibiotic treatments for bacterial pneumonia is currently limited. Most of the benefit of reducing over-treatment of bacterial pneumonia would occur in Latin America and especially Asia, where overuse of antibiotics is a significant problem. Similar results were found for many other diseases, most notably in the case of malaria, for which a new, widely available point-of-care diagnostic would avert as many as 450 million unnecessary treatments per year (17).
Access to point-of-care diagnostics is often binary: patients either receive or do not receive a certain diagnostic test. Tests, if received, may directly save lives. Consider an example:
UE LifeSciences’s flagship point-of-care innovation, the iBreastExam (iBE), is a clinically validated, handheld, non-invasive, and radiation-free device that can help community-health workers identify breast lesions early, at the point of care. The iBE has screened more than 100,000 women and identified more than 100 cancers at a cost of USD 1–5 per test (8). In a clinical trial, the iBE performed with significantly better sensitivity, by 19%, than the standard clinical breast exam.
Risk factors for this strategy include:
While they should be considered, the risks above are more likely to dilute potential impacts than produce negative ones. Devices play an important role in modern health care. Although cutting-edge medical devices are often seen as significant cost drivers for healthcare providers operating within limited budgets, these devices may offer considerable long-term cost savings, improve patient outcomes, and create more efficient and effective health practices. They can promote less invasive procedures, reduce patient recovery time, shorten the length of hospital stays, and enhance health system sustainability.
In under-resourced settings, hypothermia at birth is one of the most important risk factors for newborn infants. Incubators and radiant warmers are often unsuitable for these settings. There is an incredible need for low-cost, scalable solutions for neonatal hypothermia. The EMBRACE Nest Infant Warmer is an easy-to-use, portable infant warmer that does not need a continuous power supply, costs a fraction of a standard incubator, and is portable, hygienic, and reusable. Designed for hospitals and ambulances in low-resource settings, the EMBRACE Nest Infant Warmer can be used in either homes or hospitals, works without electricity, and is intuitive enough for proper use by healthcare workers or mothers in emerging markets. Since their introduction in 2010, EMBRACE warmers have been distributed in 12 countries and kept more than 90,000 vulnerable newborns warm (10).
Davey, Sheila. The 10/90 Report on Health Research 2003-2004. Global Forum for Health Research, 2004. http://announcementsfiles.cohred.org/gfhr_pub/assoc/s14791e/s14791e.pdf.
Yin, Yue-Ping, Evelyn Ngige, Chukwuma Anyaike, Gbenga Ijaodola, Taiwo A. Oyeladec, Rui Gama Vaz, Lori M. Newman, and Xiang-Sheng Chen. “Laboratory Evaluation of Three Dual Rapid Diagnostic Tests for HIV and Syphilis in China and Nigeria.” International Journal of Gynecology and Obstetrics 130, suppl. 1 (June 2015): S22–S26. https://doi.org/10.1016/j.ijgo.2015.04.004.
Wong, Joseph. "Achieving Universal Health Coverage." Bulletin of the World Health Organization 93, no. 9 (August 2015): 663–4. http://www.who.int/bulletin/volumes/93/9/14-149070/en/.
International Fund for Agricultural Development (IFAD). Rural Poverty Report 2011—New Realities, New Challenges: New Opportunities for Tomorrow's Generation. Rome: IFAD, 2010. https://www.ifad.org/documents/10180/c47f2607-3fb9-4736-8e6a-a7ccf3dc7c5b.
Peeling, R.W. and D. Mabey. "Point-of-Care Tests for Diagnosing Infections in the Developing World." Clinical Microbiology and Infection 16, no. 8 (August 2010): 1062–9. https://doi.org/10.1111/j.1469-0691.2010.03279.x.
McNerney, Ruth. "Diagnostics for Developing Countries." Diagnostics (Basel) 5, no. 2 (June 2015): 200–209. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4665590/.
Urdea, Mickey, Laura A. Penny, Stuart S. Olmsted, Maria Y. Giovanni, Peter Kaspar, Andrew Shepherd, Penny Wilson et al. "Requirements for high impact diagnostics in the developing world." Nature (2006): 73.
UE Life Sciences. http://www.uelifesciences.com/.
“Xpert HPV.” Cepheid Solutions. http://www.cepheid.com/en/cepheid-solutions/clinical-ivd-tests/sexual-health/xpert-hpv.
Embrace Global. http://embraceglobal.org/
Urdea, Mickey, Laura A. Penny, Stuart S. Olmsted, Maria Y. Giovanni, Peter Kaspar, Andrew Shepherd, Penny Wilson et al. "Requirements for high impact diagnostics in the developing world." Nature (2006): 73. https://www.nature.com/articles/nature05448.
World Health Organization Task Force on Health Economics. "Cost Containment and Cost Analysis of TB Control Programmes: The Case of Malawi." 2003.
Kettler, Hannah, Karen White, and Sarah J. Hawkes. "Mapping the landscape of diagnostics for sexually transmitted infections: key findings and recommendations." (2004). http://apps.who.int/iris/bitstream/handle/10665/68990/TDR_STI_IDE_04.1.pdf;jsessionid=66126CAD0035FCFC4FF2C7F302918278?sequence=1
Gerlach, Jay, Magda Sequeira, Vivian Alvarado, Christian Cerpas, Angel Balmaseda, Alcides Gonzalez, Tala Santos, Carol E. Levin, Juan Jose Amador, and Gonzalo J. Domingo. "Cost analysis of centralized viral load testing for antiretroviral therapy monitoring in Nicaragua, a low-HIV prevalence, low-resource setting." Journal of the International AIDS Society13, no. 1 (2010): 43. https://jiasociety.biomedcentral.com/articles/10.1186/1758-2652-13-43.
Mabey, David C., Kimberly A. Sollis, Helen A. Kelly, Adele S. Benzaken, Edward Bitarakwate, John Changalucha, Xiang-Sheng Chen et al. "Point-of-care tests to strengthen health systems and save newborn lives: the case of syphilis." PLoS medicine 9, no. 6 (2012): e1001233. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001233.
Bonawitz, Rachael E., Julie Duncan, Emily Hammond, Leoda Hamomba, Jane Nambule, Kennedy Sambambi, Victor Musonda et al. "Assessment of the impact of rapid syphilis tests on syphilis screening and treatment of pregnant women in Zambia." International Journal of Gynecology & Obstetrics130, no. S1 (2015). http://onlinelibrary.wiley.com/doi/10.1016/j.ijgo.2015.04.015/full.
Girosi, Federico, Stuart S. Olmsted, Emmett Keeler, Deborah C. Hay Burgess, Yee-Wei Lim, Julia E. Aledort, Maria E. Rafael et al. "Developing and interpreting models to improve diagnostics in developing countries." Nature (2006): 3.
This mapped evidence shows what outcomes and impacts this strategy can have, based on academic and field research.
Joos O, Silva R, Amouzou A, Moulton LH, Perin J, Bryce J, et al. (2016) Evaluation of a mHealth Data Quality Intervention to Improve Documentation of Pregnancy Outcomes by Health Surveillance Assistants in Malawi: A Cluster Randomized Trial. PLoS ONE 11(1): e0145238.
McConnell M, Ettenger A, Rothschild CW, Muigai F, Cohen J. Can a community health worker administered postnatal checklist increase healthseeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya. BMC Pregnancy Childbirth. 2016 Jun 04;16(1):136.
Mitchell M, Hedt B, Msellemu D, Mkaka M, Lesh N. Improvement in Integrated Management of Childhood Illness (IMCI) Implementation through use of Mobile Technology: Evidence from a Pilot Study in Tanzania. BMC Med Inform Decis Mak. 2013;13:95.
Haberer JE, Musiimenta A, Atukunda EC, Musinguzi N, Wyatt MA, Ware NC, et al. Short message service (SMS) reminders and real?time adherence monitoring improve antiretroviral therapy adherence in rural Uganda. AIDS. 2016;30(8): 1295.
Biering-Sorensen S, Andersen A, Ravn H, Monterio I, Aaby P, Benn CS. Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial. BMC Pediatr. 15, 137 (2015).
Mbonye AK, Magnussen P, Lal S, Hansen KS, Cundill B, Chandler C, et al. (2015) A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria. PLoS ONE 10(7): e0129545.
Das J, Chowdhury A, Hussam R, Banerjee AV. The impact of training informal health care providers in India: A randomized controlled trial. Science2016;354:aaf7384.
Nyqvist, M. B., Guariso, A., Svensson, J., Yanagizawa-Drott, D. Effect of a Micro Entrepreneur Based Community Health Delivery Program on Under-Five Mortality in Uganda: A Cluster-Randomized Controlled Trial (CEPR Discussion Paper Series DP 11515). London: Centre for Economic Policy Research.
Sharma S, Van Teijlingen E, Belizán JM, Hundley V, Simkhada P, Sicuri E. Measuring What Works: An impact evaluation of women’s groups on maternal health uptake in rural Nepal. PloS one. 2016;11(5):e0155144.
Boston Consulting Group (BCG). The Advance market commitment pilot for Pneumococcal Vaccines: Outcomes and impact evaluation, 2015.
Ross, et al, 2013. A Low-Cost Ultrasound Program Leads to Increased Antenatal Clinic Visits and Attended Deliveries at a Health Care Clinic in Rural Uganda. PloS One. 2013.
Each resource is assigned a rating of rigor according to the NESTA Standards of Evidence.
(Number of days or hours the identified critical equipment was utilized) / (Number of days or hours the identified critical equipment of installed capacity)