Breakthroughs Blog: Maternal health

Many infants have difficulty breastfeeding and must rely on cup feeding. Photo: PATH/Amy MacIver Breast milk is the perfect first food for newborns; it provides nutrients and energy that infants need and contains substances that strengthen their immune systems. Ideally, newborns are breastfed within their first hour of life with breastfeeding continuing for their first several months of life. However, some babies are not able to breastfeed—preterm babies often do not have the fine motor skills and babies born with facial anomalies like cleft palates cannot breastfeed. And in some cases, babies who are orphaned or have mothers too sick to breastfeed who must be fed with donor milk. In high-resource settings, these infants could have breast milk fed to them through feeding tubes or specially-designed bottles, but in low-resource settings these solutions are impractical and often unsafe in areas where reliable clean water is not available. Tubes must be inserted by a trained medical professional and are often not available in low-resource settings; while bottles are expensive—particularly those that adapted for use by infants with cleft palates— and difficult for mothers to keep free of bacteria due to their crevices. For infants in low-resource settings who cannot breastfeed, the World Health Organization recommends hand expression of breast milk and use of a small cup to feed newborns. Cups are easier to clean so reduce the risk of infection, and cup feeding has been shown in some studies to improve the transition of preterm infants to exclusive breastfeeding. The problem? There is no cup designed specifically for the job, and the household cups many mothers use have some serious drawbacks that can put their baby’s health at risk. A solution? A group of innovators from the University of Washington, Seattle Children’s Hospital Craniofacial Center, and PATH have invented the NIFTY™ cup—a simple-to-use, easy-to-clean, inexpensive cup designed specifically for delivering breast milk to infants. Your average cup won’t do for breastfeeding Because there is no standard cup designed for the purpose, mothers who need to cup feed typically use whatever small cups or devices they have on hand. For example, in India mothers typically use a miniature gravy-boat like device called a paladai—originally used to burn oil during religious ceremonies—that have sharp-edged metal spouts and can cause oral cuts or injuries to an infant. A young infant being cup fed with a mug in Kenya. Photo: PATH/Evelyn Hockstein In other areas of the world, mothers use coffee mugs, shot glasses, medicines cups, or whatever small cups they can find. Unfortunately, the relatively wide rims of these cups can make it difficult for a mother to maintain a consistent flow of milk to her newborn which can be problematic and even dangerous. Too much milk too fast can cause a newborn to aspirate, while too little milk can mean the baby does not get sufficient nutrition. “These infants are getting an erratic, inconsistent, sometimes too rapid flow [of milk] or not enough access to milk while they are feeding,” explained Christy McKinney, PhD, MPH, a clinical assistant professor at the University of Washington who helped design the NIFTY™ cup, “So the infants don’t get enough nutrients within the short amount of time to grow and fight infection.” During lengthy cup feedings, an infant can actually expend more energy trying to feed than it takes in, which can lead to a rapid decline in health. Another problem with standard cups is spillage. “About a third of milk is spilled at each feeding, said McKinney, “If you are trying to feed and hand expressing your breast milk, it’s a pretty painful experience to have a third of that spilled and wasted every time you are feeding, which can be 12 times a day for a newborn.” The NIFTY™ cup: a game changer for cup feeding A demonstration of feeding using the NIFTY cup. Photo: Marissa Chmiola/GHTC McKinney and her collaborators kept these drawbacks in mind as they set out to create the perfect cup for cup feeding. The NIFTY™ cup was designed with a unique reservoir that can hold a bolus of milk at its end. McKinney called this reservoir a “game changer.” It reduces spillage and allows the milk to be constantly available to the infant. McKinney explained that unlike a spout which only allows milk to be poured into an infant’s mouth, the unique reservoir of the NIFTY™ cup enables cup feeding to become a two-way street just like traditional breastfeeding or bottle feeding. “The mother is making sure that the reservoir is filled and then the infant gets to help pace the feed,” said McKinney, “That pacing results in a much calmer infant. They don’t run the risk of aspirating from too much milk poured into their mouth; instead, they can get the milk they need at the rate they want it, which allows for a calmer, integrated feeding experience between mother and infant.” The NIFTY™ cup inventors also made the cup out of silicone, which offers several advantages: The cup is soft and easy to squeeze, it prevents mouth injuries, it’s durable, and it can be boiled, which makes it easy to sterilize. Because the NIFTY™ has a reservoir that controls the flow of milk, the cup can be sized much larger than other cups used for cup feeding. This allow mothers to directly hand express the milk into the NIFTY™ cup rather than using multiple cups which in turn reduces spillage and opportunities for contamination. In addition, the NIFTY™ cup contains tracking markers on the side to monitor milk intake, it’s ergonomically designed for comfort, and it can be affordably produced at less than $1.00 per cup. In short, the NIFTY™ cup offers more advantages for mothers and infants than any other available cup. The long road to innovation For McKinney it has been over a five-year odyssey to turn the NIFTY™ cup from idea to reality. Inspired by her time as a Peace Corp volunteer in Ethiopia and having just completed her PhD studying craniofacial anomalies and beginning her new post-doctoral position, McKinney was looking for ways she could help children in low-resource settings with oral clefts. She saw feeding as the most problematic area and an area most in need of innovation. “So I just thought it would be nice to come up with an idea to feed these infants with,” said McKinney. With this concept in mind, McKinney began searching for a partner who could help make such an idea possible. She discussed the idea with Dr. Michael Cunningham, the director of the Seattle Children’s Hospital Craniofacial Center, where she completed her PhD, and they approached GHTC member PATH, based in Seattle. “We reached out to PATH…and there was sufficient interest to say let’s try and make this work,” said McKinney. Together they developed a design team which included McKinney (an epidemiologist); Dr. Cunningham (a craniofacial pediatrician); a social scientist, engineer, and commercialization officer from PATH; and an occupational therapist/lactation consultant from Seattle Children’s Hospital. Together, with funding from PATH and the Seattle Children’s Hospital Craniofacial Center, the team designed their first prototype cup. A product can only have impact if it meets end-user needs and people are actually interested in obtaining it. To make sure both applied to the NIFTY™ cup prototype, the team set out to test drive the cup in low-resource settings. With support from a nonprofit Transforming Faces—which supports care for children with oral clefts in South India—and additional funding from the University of Washington CoMotion, McKinney and the team took the NIFTY™ cup to Sri Ramachandra University in South India to do formative design work in both the cleft center and the Neonatal Intensive Care Unit. They introduced the cup to mothers and health providers including lactation consultants, watched the product in use, and conducted surveys to gauge interest in the product and to inform design. The NIFTY™ cup was a big hit. “I was really excited that they liked it more than what they were using,” said McKinney, “I didn’t quite know what to expect on that, but they are really excited to get it commercialized.” Armed with valuable feedback from South India, McKinney and the team regrouped and are doing a minor redesign of the product which will be complete this summer. Last month, the team won a grant from the Saving Lives at Birth Challenge. With this funding, the NIFTY™ cup developers plan to conduct a clinical study in Ethiopia to evaluate the product’s effectiveness compared to standard cups being used, and also develop a market shaping strategy for introducing the product. While it could still be some time before the product is widely available to those who need it, McKinney and the rest of the team are energized by the NIFTY™ cup’s lifesaving potential and the support they are receiving to continue development and introduction. “I’m so excited. This little idea has percolated so long, and people have finally seen the value it can bring,” said McKinney.

In this guest post, Heather Ignatius—senior policy and advocacy officer at PATH—writes about a new bipartisan piece of legislation to accelerate progress towards ending preventable child and maternal deaths. More than 30 diverse organizations including PATH are calling on members of Congress to support the legislation, and you can add your voice to the call by joining their virtual “chain” of people around the world who believe we must do all we can to #SaveMomandKids. The Reach Act aims to accelerate an end to preventable maternal and child deaths. Photo: PATH/Gabe Bienczycki Today Senator Susan Collins (R-ME) and Senator Chris Coons (D-DE) introduced a new bipartisan piece of legislation that could help save the lives of women and children around the world. This legislation—the Reach Every Mother and Child Act (Reach Act)—aims to end preventable maternal, newborn, and child deaths within a generation by putting into place US policies to reach more women and children with lifesaving programs and support the development, introduction, and scale-up of high-impact interventions in low-income countries. Reach Act reaffirms America’s commitment to end preventable maternal, newborn, and child deaths In 2012, the United States, the governments of Ethiopia and India, and UNICEF led the Child Survival Call to Action, committing to end preventable child and maternal deaths by 2035—a commitment that has since been endorsed by 175 partner governments around the world. The Reach Act would make it the policy of the United States to make good on that promise and put in place a coordinated, whole-of-government strategy to achieve it. The legislation calls for the US to set ambitious, outcome-based targets for reducing child and maternal deaths and track and report progress toward them annually. It also calls for improved coordination across US government agencies, establishes a maternal and child survival coordinator position at the US Agency for International Development (USAID) to oversee activities, and would expand the use of innovative financing mechanisms that will help countries overcome financial hurdles and obtain more resources to strengthen health programs, ultimately moving countries towards greater self-sustainability in confronting their own health challenges. Reach Act ensures innovation is part of the US government strategy to achieve this aim Improvements in maternal and child health have been one of the greatest success stories in international development. Since 1990, deaths of mothers and children under the age of five worldwide have been nearly cut in half—meaning every day 17,000 more children live and 700 more mothers survive childbirth compared to just two decades ago. Central to that progress has been research and development (R&D) of new and innovative health products. For example, new vaccines, drugs, diagnostics, and other health innovations have led to 4.2 million fewer child deaths in 2013 compared to 1990, according to a report by the Institute for Health Metrics and Evaluation. Advances in maternal and child health have been driven by the development of new approaches and innovative technologies. Many of these breakthroughs—such as bed nets to prevent malaria, oral rehydration therapy to treat diarrheal disease, and antiretrovirals to treat HIV and AIDS—were supported or piloted by US government funded programs, demonstrating the power of US investment in innovation to save the lives of mothers and children. Ending preventable maternal, newborn, and child deaths is an ambitious goal, but it’s also an achievable one—and investing in health innovation can help us get there. According to the Lancet Commission on Investing in Health, the world can achieve a “grand convergence”—reducing maternal and child deaths in low-income countries to low levels within a generation—by increasing investment in the R&D of new technologies and the scale-up of existing technologies. The Reach legislation would ensure that R&D is a critical part of the US approach to ending preventable maternal, newborn, and child deaths. As the lead US agency working in maternal, newborn, and child health, USAID has long placed global health R&D and innovation at the core of its activities to end extreme poverty and build resilient societies. The agency has helped to support the development and introduction of a range of affordable and cost-effective technologies including easy-to-use diagnostic tests for HIV and AIDS, malaria, and tuberculosis; innovative contraceptive technologies; treatments to reduce neonatal infection and postpartum hemorrhage; and vaccines against leading childhood killers like meningitis. The agency has sought to harness expertise and resources across sectors and geographies to catalyze the development of health technologies to improve maternal and child health. Through programs like the Saving Lives at Birth: A Grand Challenge for Development, USAID has advanced innovative solutions for maternal and child health, such as simple pouches to deliver drugs to reduce mother-to-child transmission of HIV and AIDS and devices to help babies take their first breath. The Reach Act challenges policymakers at USAID and other US agencies to continue to think long-term about the role innovation could play in achieving an end to preventable maternal, child, and newborn deaths. The GHTC staff has joined the global chain to #SaveMomsandKids Innovation will be necessary to bend the curve Last year in its Acting on the Call report, USAID articulated a roadmap to achieve the vision of ending preventable and maternal deaths in 24 priority countries, setting an interim milestone of saving 15 million children and 600,000 women by 2020. If achieved, meeting this milestone would mean that US programs would be exceeding the impact targets set in 2012. The development and introduction of new health technologies can further accelerate progress toward this goal—helping us bend the curve more steeply and saving more lives, more rapidly. Now is the time for Congress to turn ambition into action. The Reach Act can help us realize a world where every kid everywhere lives to celebrate his or her fifth birthday and no mother dies as a result of pregnancy or childbirth. Read a fact sheet about the legislation. Watch a video of Sen. Collins and Coons introducing the legislation. To support the legislation, join the social media campaign using the hashtag #SaveMomsandKids.

Wendy Taylor of USAID introducing the other event partners. Photo: Marissa Chmiola/GHTC Last Wednesday 53 teams of innovators gathered at the International Trade Center in Washington, DC, for the Saving Lives at Birth DevelopmentXChange—an event resembling a cross between a science fair and an episode of Shark Tank. There were no baking soda volcanoes or smiley sponges to be found, rather innovative ideas to advance the health of pregnant women and newborns in poor communities around the world. And at stake was not a blue ribbon or a chance to take home Mr. Wonderful’s money, but something much more important—the chance to save the lives of mothers and their babies. Saving lives at birth through innovation This DevelopmentXChange served as the final stage of competition in the 5th annual Saving Lives at Birth Grand Challenges Program, a contest sponsored by the US Agency for International Development (USAID), the government of Norway, Grand Challenges Canada, and the UK Department of International Development, which aims to identify and advance groundbreaking and cost-effective solutions to improve maternal and newborn health. Innovators from around the world compete for grants to develop, test, and bring their ideas to scale. The competition covers three areas—technology development, service delivery, and demand creation. The program started in 2011 as a way to “leapfrog” solutions in the underserved area of research. “We recognized that the area of maternal and neonatal health is an area that had really not seen the type of innovation we need to save the lives of mothers and newborn around the time of birth and in the hardest to reach areas,” said Wendy Taylor, director of the Center for Accelerating Innovation and Impact at USAID. “So we put together the Saving Lives at Birth Grand Challenge…and called on the brightest minds across the world, engineers and entrepreneurs, scientists and students, to come up with new, groundbreaking ideas, new ways to prevent and treat mothers and newborns and save their lives in the most risky time—the 48 hours around the time of birth.” The response to this call has been tremendous. Since 2011, the program has provided over US$47 million in funding to 81 innovative tools and approaches, and many of the program’s successes are already having an impact as they begin to scale. To date, Saving Lives at Birth–supported innovations have been delivered to over 1.5 million women and newborns, saving at least 4,000 lives. This year the Saving Lives at Birth competition received more than 750 submissions, over half of which came from low-and middle-income countries (LMICs). Fifty-three teams were chosen to compete as finalists at the DevelopmentXChange. At the conclusion of the event, 17 award nominees were selected with additional nominees in the transition-to-scale category to be announced later this year. GHTC member projects featured as finalists Among the 53 finalists were 10 projects from GHTC member organizations: Validation of low-cost, user-friendly strip test for preeclampsia/eclampsia screening PATH Brandon Troy Leader showcases his team's innovation. Photo: GHTC/Courtney Carson Dr. Brandon Troy Leader and his team at PATH are developing a low-cost, easy-to-use strip to test for proteinuria—a key indicator of preeclampsia/eclampsia—during pregnancy. Preeclampsia is a serious health risk to both mothers and infants and accounts for at least 16 percent of maternal deaths in low-resource settings. Current diagnostics are either time-consuming and expensive—requiring 24 hour urine analysis—or inaccurate—relying on analysis of protein levels in urine which can fluctuate with fluid intake. Both of these tools are impractical for use in secondary health centers, where most women in LMICs receive treatment. The team’s innovative dipstick promises to deliver a quick, low-cost, and highly accurate test that will allow more women in low-resource settings to be diagnosed and appropriately monitored for preeclampsia/eclampsia. The strip tests for a new protein-to-creatinine (PR/CR) marker and uses a product specifically designed for this single application. It is available at less than $0.10 a strip—the current cost of the inaccurate protein-urine analysis diagnostic. In lab tests, the PR/CR strips showed 85 percent sensitivity, indicating that with appropriate clinical trials, the product could be quickly rolled out to communities in need. The team was seeking a Saving Lives at Birth validation award to test the PR/CR strips in a clinical trial with over 20,000 women and accelerate the product’s introduction into low-resource settings. Advancing introduction of new screening test for preeclampsia PATH To address the unmet need for effective screening and treatment of preeclampsia in low-resource settings, PATH is preparing for a large-scale evaluation of its innovative glycosylated fibronectin (GlyFN) test. The test targets the GlyFN biomarker, which occurs at higher concentration in the blood than other preeclampsia biomarkers and offers excellent sensitivity and specificity. Small scale tests indicate that the GlyFN test predicts preeclampsia in the third trimester of pregnancy with a sensitivity of 97 percent and specificity of 93 percent. The GlyFN test is innovative not only for its use of an easier to detect biomarker, but also for its accuracy and sensitivity in diagnosis. The PATH team was seeking a Saving Lives at Birth award to perform the first operational evaluations of the GlyFN test, refine training materials with users in the field, and implement a prospective-cohort study in Karnataka, India. Developing a model for national scale-up of the Pratt Pouch to prevent mother-to-child HIV transmission Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) A syringe typically used to measure ARV dosage and the Pratt Pouch which could replace it. Photo: GHTC/Marissa Chmiola Dr. Edward Bitarakwate and his team at EGPAF Uganda are seeking to develop a model for the national scale-up of an innovative product to prevent mother-to-child HIV transmission known as the Pratt Pouch. About 1.5 million HIV positive women give birth each year. It’s possible to prevent mother-to-child HIV transmission if antiretrovirals (ARVs) are administered during labor and for several weeks following delivery. Unfortunately, many mothers don’t give birth in health facilities so their infants fail to receive ARVs during this critical period, and those who do are currently sent home with bottles of liquid ARVs and a syringe to measure appropriate doses to administer to their child. Keeping these syringes clean can prove difficult for new moms in low-resource settings, and the viscosity of the liquid ARVs makes it challenging to measure accurate doses. The Pratt Pouch addresses these challenges—it’s an easy to tear open package containing a premeasured dose of ARVs which can be stored safely for up to 12 months at any temperature. Dr. Bitarakwate described the pouch as a “ketchup packet” for ARVs, noting that the pouch is an adaptation of technology used in the food industry to package ketchup. The pouch was developed by a team of engineers at Duke University with support from a previous Saving Lives at Birth grant. Small pilot tests of the product in individual health care settings have demonstrated promise, so Dr. Bitarakwate is seeking funding to work with the Ugandan government to integrate the product into the country’s health system and create an effective model for national scale-up of the product. Reducing birth complications by increasing access to noninvasive, cloud-connected anemia screening diagnostic device PATH Masimo's Pronto-7 anemia screening device. Photo: PATH/Patrick McKern Iron-deficiency anemia affects half of all pregnant women in LMICs and can lead to poor pregnancy outcomes including preterm births, low birth weight, and maternal mortality, contributing to one-fifth of maternal deaths. However, anemia often goes undetected, as methods commonly used throughout sub-Saharan Africa require a blood draw, which can be prohibitive to patients and must be administered by highly-trained health professionals. PATH consulted more than 100 nurses, doctors, and other health professionals in sub-Saharan Africa, hearing repeatedly “noninvasive is the future” of diagnostics. PATH has partnered with California-based diagnostic manufacturer Masimo to create a noninvasive, easy-to-use, cloud-connected diagnostic device, using the “FDA-approved guts” of Masimo’s Pronto-7 hemoglobin test. Rather than drawing blood, the health worker merely asks the patient to place their finger on the sensor (see photo) and the results are available within a minute. PATH will use Masimo’s equipment and technology, but will develop a device that is more durable and even easier to read—enabling use by lower-skilled professionals. Andy Beddoe, a product development officer at PATH, explained that diagnostics that require disposable parts are more dependent on a robust supply chain. This device, however, will require no such disposables, and will use cloud-enabled software, allowing the manufacturer to “sell tests like you would cell phone minutes,” troubleshoot, or calibrate it remotely. Beddoe believes each device could last three to four years, administering more than 50,000 tests. The software could also be used for data collection and could be adapted for use in other diagnostics. A pediatric-friendly ARV dosage form: validation of palatability, flexibility, and accurate dosing of LPV/r PATH “[We’re] targeting the most vulnerable population infected with HIV,” explains Dr. Manjari Lal, senior research officer in Vaccine and Pharmaceutical Technologies at PATH, in discussing her project. Less than a quarter of HIV-positive children in LMICs are receiving ARVs, and for most families, the current treatment method involves breaking adult doses into two, crushing up one half, and mixing it with food. Lal’s team is working to transform lopinavir/ritonavir (LPV/r)—the first-line treatment for pediatric HIV—into a product that is palatable, heat-stable, and that allows for flexible dosing. The team is developing a freeze-dried, fast-dissolving tablet, which allows a parent to mix the medicine with water—as children often struggle with pills that must be swallowed. According to Lal, palatability is a major consideration for pediatric treatments, as infants won’t hesitate to spit out bitter medicines. The treatment is currently in the preclinical phase, and must go through animal studies and clinical trials with human adults before it is ready for use in children. Scaling an Integrated Human Milk Bank and Breastfeeding promotion program in Kenya PATH Human milk provides important nutritional and disease-preventing properties for infants and is particularly critical for those who are born preterm or have low birth weight. Unfortunately, some mothers are unable to produce milk or do so in the quantity needed to feed their newborn. While it’s preferable for infants to receive their own mother’s fresh milk through breastfeeding or hand expression, in cases when that is not possible, the World Health Organization recommends the administration of human donor milk. The idea of milk banks were developed to meet this need. These banks accept donor milk, screen and process it for safety, and disseminate it to mothers in need. PATH was seeking a grant to scale-up and evaluate the impact of an innovative and integrated human milking banking approach known as Mother and Baby Friendly Initiative Plus (MBFI+). Unlike stand-alone milk banks, the MBFI+ approach creates “hubs” that provide both lactation support and milk banking at the same facility. Kimberly Amundson—program officer on PATH’s Maternal and Child Health and Nutrition Team which is leading the project—describes MBFI+ as a “self-reinforcing cycle of supporting breastfeeding for all infants.” Mothers come into the facilities for lactation support, and are then able to donate any excess milk they may produce to those who need it, and those infants who receive donor milk often go on to be able to breastfeed just fine with their own mother. The team hopes to introduce the approach at two hospitals in Kenya, evaluate its effectiveness and potential cost savings, and position the approach for national adoption. Clinical validation of a novel, affordable uterine balloon tamponade, developed in Africa, to reduce maternal deaths due to postpartum hemorrhage. PATH Postpartum hemorrhage, or severe bleeding after childbirth, is the leading cause of maternal mortality, resulting in 125,000 deaths annually. However, with just a condom and a catheter—materials readily found in health clinics—the risk can be drastically reduced. The condom—connected to the catheter—is inserted into the uterus and slowly filled with water, inducing uterine contractions and ultimately slowing or stopping the bleeding. While such a device, known as a uterine balloon tamponade, is readily available in high-income countries, it can be used just once and can cost as much as $400. PATH and partners have worked to develop a device—designed and manufactured in Sou Africa with input from health professionals—that costs just a few dollars. While condoms work well, they vary greatly and the thickness of  a condom can impact the pressure exerted by the device. This uterine balloon tamponade involves a reusable bag that is filled with water and held at a certain height—depending on how much pressure is needed—connected to a reusable catheter which is in turn connected to the disposable, standardized balloon. The device has been successfully tested and with widespread introduction, an estimated 169,000 deaths could be prevented over the next fifteen years. PATH was seeking funding to conduct a clinical validation study of the product and develop a commercialization strategy to increase access to the product in LMICs. Use of a low-cost simulation model to expand postpartum intrauterine device services Jhpiego The Mama-U simulator at the Jhpiego display. Photo: GHTC/Marissa Chmiola Over 90,000 maternal deaths can be prevented each year through family planning use. Yet, many women who have just given birth don’t receive access to long-acting family planning methods like intrauterine contraceptive devices (IUCDs) because there are not enough health providers trained to properly administer IUCDs to women with postpartum bodies; and many women incorrectly believe the product may not stay in place given the changes to their bodies resulting from birth. Under a previous grant, Jhpiego found that using a postpartum body simulator called the Mama-U was effective for training workers and improving service delivery. According to Dr. Fauzia Assad, a medical doctor working with Jhpiego Pakistan, the Mama-U offers benefits over existing approaches to training for postpartum IUCD training. “It’s cost-effective, just $50 versus $600 for the usual model, culturally appropriate, easy to take along, very portable, easy to understand, and it offers the same level of difficulty one would experience with an actual patient because it has a similar feel and tension.” In earlier testing, Jhpiego found the product was not only helpful in training providers, but counselors found it helpful in educating patients, dispelling patient concerns, and increasing client use of IUCDs. Jhpiego was seeking a grant to build on past learning and show that the Mama-U can improve quality of services and patient uptake and change the way postpartum IUCD training, counseling, and services are delivered. Projecting Health India PATH People typically find it easier to learn a process if they see it demonstrated, rather than just hearing or reading about it. This is why the Projecting Health India program is using video as a medium through which to promote health behaviors. Projecting Health India a community-based, video education project, which trains communities in India to create and produce videos addressing a variety of health topics—including birth preparedness, breastfeeding, and family planning—which are shown at community mothers’ groups and village health days. The videos feature local actors and health workers and aren’t distributed outside the district for which they were produced. Michelle Desmond, a monitoring and evaluation officer at PATH involved with the program, described the approach “as hyperlocal” which is key to the program’s effectiveness. “Literature on behavior change shows that if you can empathize with a person you see practicing a healthy behavior, you are more likely to practice it yourself,” said Desmond. “So in these videos women are seeing people who sound like them, who look like them, who are in the same situation as them practicing these health behaviors.” After realizing that the videos were so popular that women were finding ways to transfer them onto their mobile phones to rewatch and share, Projecting Health partnered with mobile phone vendors in India to allow the videos to be easily loaded onto phones, providing an additional way for these videos to be distributed to harder to reach mothers. PATH was seeking a Saving Lives at Birth grant to scale up this project in government systems throughout the state of Uttar Pradesh. NIFTY: A Neonatal Intuitive Feeding Technology for preterm infants who have difficulty breastfeeding PATH A demonstration of feeding using the NIFTY cup. Photo: GHTC/Marissa Chmiola In high-resource settings, infants who struggle with breastfeeding can be fed with breast milk through tubes or bottles, however such technologies can be expensive, difficult-to-use, or unsanitary in low-resource settings. In LMICs, the World Health Organization recommends the use of small cups for infants with feeding difficulties, including preterm infants, infants who have lost their mother due to complications in pregnancy or childbirth, and children with cleft palates. There is currently no product on the market specifically designed for this purpose, and the metal or glass cups that are often used can be inefficient, or can cause injury to the infant’s mouth including cuts. To address these limitations, PATH and its partners created the NIFTY™ cup which is made of silicone, making it soft and durable. The cup can also be boiled without causing any damage—making it easy to sterilize. The cup also has a reservoir on the lip of the cup, making it easy to control the amount of milk delivered and prevent waste. The NIFTY™ cup costs just $1.25 to produce. This innovation was chosen as one of the 17 competition award nominees. The team at PATH will use the funding to test the NIFTY™ cup in hospital settings in Ethiopia and work with private-sector partners throughout the sub-Saharan market to commercialize the cup. Innovation is happening around the world In visiting the DevelopmentXChange, it was clear that innovation is happening in all corners of the globe and lifesaving ideas can come from anywhere and anyone. Saving Lives at Birth demonstrates the power of bringing governments, foundations, academic institutions, and for-profit companies together to address our most pressing health challenges. GHTC congratulates both our members and the other teams who were selected as finalists and award nominees—your work continues to inspire us. Authored by Marissa Chmiola, GHTC’s communications officer with support from Courtney Carson, senior policy and advocacy associate, and Kat Kelley, senior program assistant.

In this post, Amie Batson, MBA—chief strategy officer at GHTC member PATH—discusses a new PATH-led initiative to identify and showcase lifesaving innovations with the promise to transform global health by 2030 and offers insights into what it will take to accelerate the impact of innovation. This post originally appeared in the Innovation Countdown 2030 Report: Reimagining Global Health. What if the solutions to the greatest health challenges of our time were within reach? Imagine if the world came together around those solutions and worked to accelerate the ones with the most potential to transform health. How might the world source, assess, finance, and coordinate investment in the highest-impact innovations and dismantle the barriers that keep them from reaching the very people who need them most? This is the intriguing premise behind the PATH-led Innovation Countdown 2030 (IC2030) initiative. With support from the Norwegian Agency for Development Cooperation, the Bill & Melinda Gates Foundation, and the US Agency for International Development, we set out to identify, evaluate, and showcase health technologies and interventions with great promise to accelerate progress toward solving the world’s most urgent health issues. We turned to experts and innovators all over the globe, crowdsourcing transformative ideas and innovations that could dramatically increase the affordability, accessibility, or effectiveness of health care compared to the current standard of care. Reimagining Global Health, the inaugural report of the IC2030 initiative, features 30 innovations that experts believe could quicken the pace of progress toward the health targets in the proposed UN Sustainable Development Goals (SDGs), along with commentaries from health, technology, and business leaders. These 30 innovations are presented in four categories mapped to the proposed health targets: maternal, newborn, and child health (MNCH); infectious diseases, including malaria, HIV and AIDS, and tuberculosis (TB); reproductive health; and noncommunicable diseases (NCDs), including diabetes, cancer, and chronic respiratory and cardiovascular disease. We cast a wide net in our search because innovation is truly diverse and global. Our call for nominations brought in more than 500 ideas submitted by people in nearly 50 countries across five platforms: devices; diagnostics; drugs and therapeutics; systems and services, including digital health; and vaccines. We then tapped more than 60 health experts to evaluate and rank those innovations, selecting the final set featured here. For a detailed look at our methodology, please see pages 37–41 of the Reimagining Global Health report. Four strategies to accelerate the impact of innovation Our list of 30 promising innovations and our dialogue with experts and innovators around the world offer important insights into what it will take to harness the power of innovation to save lives. 1. Tap and support innovation wherever it occurs. Innovators are everywhere, not just in well-funded labs and technology companies in wealthy nations. Today’s innovation ecosystem is diffuse, with smart ideas coming from every corner of the globe and across every sector and discipline. The world increasingly sees the importance of user-centric solutions that are demand-driven, relevant, and affordable. The opportunities for accelerating innovation—wherever it comes from—have never been greater, empowered by digital platforms where new ideas, data, and approaches can be shared, developed, and deployed. Our crowdsourcing approach for gathering innovations is one example of the new tools that are redefining health innovation. Nearly 30 percent of the 500-plus submissions received by IC2030 came from people in low- and middle-income countries, giving voice to their growing role in health innovation. There were many more promising ideas than we could feature in this report. Strengthening the capacity of low- and middle-income countries to identify, develop, adapt, produce, regulate, assess, and share innovations is critical for a robust innovation pipeline. Investments in countries’ innovation ecosystems will catalyze better overall global health while ensuring that innovations are appropriate for low-resource markets and local contexts and cultures. Innovators with direct experience working with limited resources may be the best source for frugal innovations—cost-effective solutions to address the needs of the poor, wherever they live. 2. Assess and advance innovations that deliver the most health for the money. Rigorous and transparent assessment of an innovation’s health impact, market size, and technological feasibility compared to alternatives in the pipeline is important for informing decisions about where to invest precious health resources. Low- and middle-income country governments are requesting assistance in evaluating the potential health and economic value of introducing one innovation versus another amid a burgeoning supply of new tools and interventions. Investors are also demanding more and better data on which to base investment decisions. However, comparing innovations across diseases and conditions is a challenge. Health experts frequently focus on specific conditions and make decisions with a single health outcome in mind. A key feature of IC2030 is the health and cost impact modeling process we developed to quantify lives saved, cases of disease averted, and costs for a subset of MNCH innovations. This model could provide a common framework to assess innovations with the greatest potential to address the SDG health targets. Our impact modeling results for select maternal, newborn, and child health innovations are featured on pages 13–19 of the Reimagining Global Health report. The data provide new insights into prioritizing global health investments for greatest impact. For example, we found that new tools for community-level water treatment to prevent diarrheal disease and the scale-up of a low-cost drug to prevent newborn infections could save more lives over the next 15 years compared to other innovations we modeled. Measuring the impact of crosscutting innovations is equally important. These health systems and platform innovations, including digital tools and broad diagnostics, have the potential to address multiple SDG health targets simultaneously. About one in five of the innovations submitted to IC2030 was crosscutting in nature. Yet assessing their impact is particularly challenging because of the complexity of linking multiple health outcomes to the foundational structure of the health system that supports them. In this first year of IC2030, we did not systematically evaluate crosscutting innovations, but they will be a focus going forward. New assessment tools and more comparable, comprehensive, and reliable financial and technical data are critical to help spotlight and advance innovations with particular promise that might otherwise be overlooked. A clear and rigorous framework to gauge the best value for money in a range of low- and middle-income settings is needed to inform national and subnational purchasing decisions and the decisions of those purchasing on behalf of countries. This will also help innovation investors more accurately assess potential impact, markets, and revenue flows. Zeroing in on health solutions that offer the greatest value for money is the essential next step in reaching the millions of people still waiting to share in the gains of our progress. 3. Develop new financing mechanisms for global health innovation. The pool of public and private funds to invest in health innovations is large and evolving. Funds from traditional R&D and development donors—typically dedicated public funds from wealthy countries—are being augmented by resources from philanthropies, social impact investors, private-sector mechanisms, and domestic sources. This new mix of innovation funding creates both opportunities and challenges. Domestic funding to introduce and scale up health innovations is becoming central to innovation funding. As low- and middle-income economies grow and countries graduate from aid, they are expected to finance their own health expenditures, creating new markets for affordable health tools and interventions. Sustainable financing of innovation will depend on the decisions of domestic stakeholders, including governments, insurance entities, corporations, and individuals. As more viable markets emerge, we will see a rebalancing of innovation from being primarily supply-side driven by donors and the R&D community to being more demand-side driven by countries and markets. Supporting country decision-makers to buy or, in the case of insurance mechanisms, cover or reimburse cost-effective health innovations must be at the heart of a new and improved financing model. Global funding mechanisms, including the Global Fund to Fight AIDS, Tuberculosis and Malaria and the new Global Financing Facility at the World Bank, may be well-positioned to act as intermediaries, as Gavi, the Vaccine Alliance, currently does for vaccines. These mechanisms can increase the certainty that funds will be readily available to purchase high-priority innovations if countries demand them. To play this role, they will need a window into the innovation pipeline and a means of engaging with eligible governments to identify high-impact innovations. The next generation of health financing mechanisms must also be responsive to the increasing requirements of social impact and private investors who base their investment decisions on not only the potential health impact of an innovation but also its probable market in low- and middle-income countries. While traditional funders have always understood the importance of having a clear “line-of-sight” to the market, it was often discounted. The assumption has been that if an innovation demonstrated significant public health value, a donor would eventually support it. New financing mechanisms must spotlight and bridge the critical links between R&D decisions, market uptake, and health impact. Innovators will respond to incentives that encourage them to maintain a focus on the market from the beginning of the development process to ensure the creation of sustainable and affordable innovations. New financing mechanisms must also provide more efficient and effective models for making and executing investment decisions. Over the past decade, the evolving spectrum of innovation funders has led to increasing fragmentation of investment decisions and growing transaction costs. Each investor—whether a public agency representative, a social impact investor, or a minister of health—brings a unique mix of risk tolerance, due diligence processes, data sources, expected returns, and interest in specific platforms, geographies, or health areas. For any investor, the difficulty and risk of investing alone is high, but today, the transaction cost of coordinating decisions and investment can be even higher. Global health investment funds try to address this challenge but require all investors to align on risk/reward preferences. The growing diversity of funders, while currently a challenge, has the potential to be a benefit if investors can leverage their different interests and risk tolerance. If actively coordinated, mixed sources of funding can be structured to finance different stages in the innovation cycle with a focus on the market. This means recognizing the growing role of purchasers in establishing a market, as well as finding new ways to align the decisions of investors and purchasers. All parties would make better decisions if they knew, and could count on, what others were doing. 4. Coordinate investments to ensure a strategic approach to health innovation. Coordinated investments in innovations across the continuum of care, including prevention, diagnosis, treatment, and disease management, have the potential to ensure a comprehensive suite of health tools and services designed for the greatest possible impact. The proposed SDGs provide the opportunity for investors to work toward shared health targets and better coordination in how they source, assess, and invest in innovations that achieve those targets. Yet we found potential inefficiencies in investment approaches that may underscore the current lack of coordination. In certain health areas, for example, we received nominations for multiple devices all taking a similar approach to address the same health condition. While competition might result in better tools at better prices, it also raises the question of whether donors are aware of what others are investing in and whether scarce resources could be more strategically targeted. In maternal health, we received many submissions for diagnostics to predict and detect preeclampsia/eclampsia—the second leading cause of maternal mortality—but few innovations for the treatment of these life-threatening conditions. In many low-resource settings, the existing treatment, magnesium sulfate, is underused, incorrectly administered, or unavailable. Diagnostics will have limited value unless innovations in new treatments and delivery systems are developed in parallel. A broader understanding of where investments in innovation are high—or very low—is also warranted. NCDs now account for about two-thirds of global deaths, yet we received very few innovation nominations. Donors may assume others are funding NCD innovations while they focus on infectious diseases. Will they be surprised when they pivot to NCDs and discover the lack of appropriate innovations for people in low-resource settings? Could investments in preventive innovations today allow countries to effectively leapfrog developed nations and avoid creating the huge treatment burdens associated with NCDs? Conclusion The robust and growing innovation pipeline presents an exciting opportunity to accelerate high-impact solutions that can create better health and opportunity for all. Ensuring the best ideas are surfaced—wherever they come from—is the first critical step we must take to deliver on the promise of the SDG health targets. This should include investing in the innovation ecosystem in low-resource countries to enable local entrepreneurs to develop, produce, and share their ideas. It also means using new crowdsourcing tools to gather ideas and data visualization to make the comprehensive pipeline more visible to national and global investors, policymakers, and innovators. Developing and adopting assessment methodologies that provide common, consistent, and comparable evaluations of innovations is the second step. Countries are in great need of health technology assessment tools that allow governments and insurance entities to decide which of the many innovations available today and in the future should be procured, covered, and reimbursed. These tools also will improve the quality of market estimates, one of the most critical and yet weakest components of innovation assessment for all investors. The third step is to develop innovative financing mechanisms that both recognize the growing importance of domestic finance in determining markets in low- and middle-income countries and benefit from the growing diversity of investors. Financiers have the potential to leverage their investments by aligning with other funders while maintaining a strategic focus on the market. Aligned investment across the different stages of the innovation cycle, from development to production, commercialization, purchase, and wide-scale use, has the potential to dramatically accelerate our progress. The fourth step may be the most essential—coordinating the resources and attention of investors, innovators, and policymakers on innovations with the greatest potential value for money. Our progress depends on decision-makers sharing information to ensure that collectively, the world is investing in the portfolio of innovations that will allow us to achieve our shared goals embodied in the SDGs. Innovation is the key to sustainable health impact. But innovation isn’t a random set of ideas and inventions. High-impact innovation is more likely to result from the kind of sourcing, assessment, financing, and coordination described above. It is our hope that one or more of the innovations highlighted in this report will become a game-changer for global health over the next 15 years. But beyond the success of any single innovation, we hope IC2030 will be a platform to catalyze discussion, collaboration, investment, and momentum toward the day when everyone has an equal chance for a healthy life. Photo: PATH/Gabe Bienczycki.