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.

What

Dimensions of Impact: WHAT

Investors interested in deploying this strategy should consider the scale of the addressable problem, what positive outcomes might be, and how important the change would be to the people (or planet) experiencing it.

Key questions in this dimension include:

What is the problem the investment is trying to address? For the people experiencing the problem, how important is this change?

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:

  1. improving existing devices and diagnostics at the point of care,
  2. developing new technologies to provide options for monitoring and controlling emerging diseases and diseases that are difficult to diagnose at the point of care, and
  3. addressing the severe lack of laboratory infrastructure in many low- and middle-income countries by increasing access to point-of-care medical devices.

What is the scale of the problem?

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.

Who

Dimensions of Impact: WHO

Investors interested in deploying this strategy should consider whom they want to target, as almost every strategy has a host of potential beneficiaries. While some investors may target women of color living in a particular rural area, others may set targets more broadly, e.g., women. Investors interested in targeting particular populations should focus on strategies that have been shown to benefit those populations.

Key questions in this dimension include:

Who/What is helped through this strategy?

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.

What are the geographic attributes of those who benefit?

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.

Contribution

Dimensions of Impact: CONTRIBUTION

Investors considering investing in a company or portfolio aligned with this strategy should consider whether the effect they want to have compares to what is likely to happen anyway. Is the investment's contribution ‘likely better’ or ‘likely worse’ than what is likely to occur anyway across What, How much and Who?

Key questions in this dimension include:

Is the investment’s contribution ‘likely better’ or ‘likely worse’ than what is likely to occur anyway across What, How Much and Who?

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.

How Much

Dimensions of Impact: HOW MUCH

Investors deploying capital into investments aligned with this strategy should think about how significant the investment's effect might be. What is likely to be the change's breadth, depth, and duration?

Key questions in this dimension include:

How many can receive the outcome through this strategy?

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):

  • A quick, easy-to-use test for bacterial pneumonia could save at least 405,000 children’s lives each year.
  • A widely accessible, easy-to-use diagnostic for antenatal syphilis would save at least 138,000 lives and avert more than 148,000 stillbirths annually.
  • A test for malaria that requires no laboratory infrastructure could save nearly 300,000 lives and avoid almost 450 million unnecessary treatments (resulting in more than 1 million additional lives saved) annually.

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).

How much change can beneficiaries experience through this strategy?

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

Dimensions of Impact: RISK

Key questions in this dimension include:

What risks do investments in this strategy run in terms of either people/planet experiencing impact or society as a whole? What is the probability that those risks happen?

Risk factors for this strategy include:

  1. Execution Risk: Investments in the strategy must consider that industry forces (e.g., patent expirations and achieving return on investment in high-growth therapy areas) and politico-economic forces (e.g., payers rewarding only true innovation and continuous health care reform) pressure the medical device industry in unprecedented ways. For instance, early adoption of a product depends largely on a manufacturer’s ability to increase physicians’ and patients’ uptake and to generate timely post-marketing real-life data customized for each stakeholder’s requirement and expectation.

    Further, in developing countries, health care personnel often lack proper training. In parts of Africa, a family member or a local community pharmacist may be the only health care provider. Therefore, health care providers should be appropriately trained on how to use and interpret the results of new medical devices and point-of-care diagnostic technologies correctly. Furthermore, continuing education courses should be provided to health care providers who use devices and dianostics on a routine basis, with updates on best practices, similar to those for drugs provided by the pharmaceutical industry.

  2. Stakeholder Participation Risk: Investments that seek to improve access to medical devices and diagnostics in emerging markets may fail if investors fail to consider that payers, physicians, and industry have yet to engage on a high level with medical devices because of the very fast market entry requirement for new products and the fragmented and often-evolving market access pathways, which can have a detrimental effect on commercial success.

  3. Drop-Off Risk: Investments in supply chain innovations in rural areas may have substantial initial impact. However, urbanization and infrastructure improvements may reduce the impact—or necessity—of these investments over time, as urban and rural populations grow more integrated. The impact of this risk is likely minimal, as rural populations will likely always benefit from improved access to innovative medical devices and diagnostics.

What are likely consequences of these risk factors?

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.

Illustrative Investment

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).

 

Draw on Evidence

This mapped evidence shows what outcomes and impacts this strategy can have, based on academic and field research.

NESTA: 3
Evaluation of a mHealth Data Quality Intervention to Improve Documentation of Pregnancy Outcomes by Health Surveillance Assistants in Malawi: A Cluster Randomized Trial

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.

NESTA: 3
Can a community health worker administered postnatal checklist increase health-seeking behaviors and knowledge?: evidence from a randomized trial with a private maternity facility in Kiambu County, Kenya

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.

NESTA: 2
Improvement in Integrated Management of Childhood Illness (IMCI) Implementation through use of Mobile Technology: Evidence from a Pilot Study in Tanzania

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.

NESTA: 2
Short message service (SMS) reminders and real-time adherence monitoring improve antiretroviral therapy adherence in rural Uganda

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.

NESTA: 2
Early BCG vaccine to low-birth-weight infants and the effects on growth in the first year of life: a randomised controlled trial

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).

NESTA: 3
Introducing rapid diagnostic tests for malaria to drug shops in Uganda: a cluster-randomized controlled trial

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.

NESTA: 3
The impact of training informal health care providers in India: A randomized controlled trial

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.

NESTA: 3
Effect of a micro entrepreneur-based community health delivery program on under-five mortality in Uganda: a cluster-randomized controlled trial

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.

NESTA: 1
Measuring What Works: An Impact Evaluation of Women’s Groups on Maternal Health Uptake in Rural Nepal

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.

NESTA: 4
The Advance Market Commitment Pilot for Pneumococcal Vaccines: Outcomes and impact evaluation

Boston Consulting Group (BCG). The Advance market commitment pilot for Pneumococcal Vaccines: Outcomes and impact evaluation, 2015.

NESTA: 2
A low-cost ultrasound program leads to increased antenatal clinic visits and attended deliveries at a health care clinic in rural Uganda

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.

Define Metrics

Core Metrics

This starter set of core metrics — chosen from the IRIS catalog with the input of impact investors who work in this area — indicate performance toward objectives within this strategy. They can help with setting targets, tracking performance, and managing toward success.

Additional Metrics

While the above core metrics provide a starter set of measurements that can show outcomes of a portfolio targeted toward this goal, the additional metrics below — or others from the IRIS catalog — can provide more nuance and depth to understanding your impact.