Marissa Chmiola

PATH/Dan Chang New rapid diagnostics are urgently needed to prevent unnecessary use of antibiotics and curb the growing problem of antimicrobial resistance, according to a new report from the United Kingdom’s Review on Antimicrobial Resistance (AMR). The report calls for greater investment to develop and support adoption of quicker and more precise diagnostics tests. Antibiotic overuse and growing resistance The rise of drug-resistant bacteria poses a significant health threat to people around the world. Unnecessary use of antibiotics is helping drive this rise in resistance, but since the 1940s, there has been little improvement in the way bacterial infections are diagnosed. The report points out that most antibiotic prescriptions are issued by medical professionals who are making a diagnosis empirically without using a diagnostic test. The fact that diagnostic tests are relatively expensive but antibiotics are cheap means it is less expensive for doctors and their patients to skip the test and issue the antibiotic prescription in case it proves helpful. Diagnostic tests are also time-consuming. It can take 36 or more hours to identify whether a person has an infection, so doctors often put sick patients on a treatment before a diagnosis can be confirmed. The scale of this problem can be quite dramatic: The report highlights one study on patients with respiratory problems which found that more than two-thirds of courses of antibiotics were likely to have been inappropriately prescribed for conditions other than infections or for infections caused by viruses, which aren’t responsive to antibiotics. Rapid diagnostic tests—which will allow doctors to identify within minutes whether an infection is present—can prevent unnecessary prescription, and more refined tests—which enable doctors to identify the exact strain of the bacterial infection and the antibiotics to which it is resistant or susceptible—will enable doctors to more precisely prescribe narrow-spectrum antibiotics, which will help slow the development of resistance. Incentivizing development of diagnostics A CDC scientists examines antibiotic resistant bacteria. CDC/ Melissa Dankel While new rapid diagnostics are urgently needed, the report points out that there is little commercial incentive for drug developers to invest in diagnostics, since their use would lead to decreases in the number of antibiotics purchased. The report proposes the use of “Diagnostics Market Stimulus pots” that would provide a revenue stream for developers of products that meet a recognized area of need. These developers would receive “top-off” payments when products are purchased by healthcare providers, thus raising the commercial benefit of investing in diagnostic development to match the societal need for these products. The report also calls for greater investment in early stage research, referring to its previous report which called for an AMR innovation fund of US$2 billion over five years to boost funding for such research. “For far too long we haven't recognized the huge cost to society of increasing resistance when we use antibiotics that we don’t need—such as antibiotics for flu which have no effect except to increase the chances of superbugs developing," said Lord Jim O'Neill, chairman of the AMR review. "To avoid the tragedy of 10 million people dying every year by 2050, the world needs rapid diagnostics to improve our use of antibiotics. They are essential to get patients the right treatment, cut down on the huge amount of unnecessary use, and make our drugs last for longer." A diagnostic “wish list” To inform investment efforts in diagnostic research and development, the report includes a “wish list” of diagnostics that could be game changers in curbing antibiotic resistance. Below are of few of those identified in the report: Rapid diagnostics that could be used at home to indicate bacterial or viral infections. These would potentially reduce visits to the doctor and so reduce healthcare resource consumption. Biomarker panels to distinguish whether patients admitted via A&E [accident and emergency] for pneumonia or fever have bacterial infections or not. A bedside test that would reliably exclude any infection. This should reduce the empirical use of antimicrobials and could also often be used as part of the treatment protocol for sepsis.

Maximilian Geigenmueller, advocacy officer at the Berlin office of DSW, answers questions about the German PDP funding call. Earlier this month, Germany’s Federal Ministry of Education and Research (BMBF) the renewal of the German funding program for product development partnerships (PDPs) conducting research and development (R&D) for health technologies to combat poverty-related and neglected diseases (PRNDs). The call for proposals for €50 million over five years (2016–2021) is expected to be published shortly. GHTC Breakthroughs blog is joined by Maximilian Geigenmueller, advocacy officer at the Berlin office of Deutsche Stiftung Weltbevoelkerung (DSW)—an international development organization that conducts global healthR&D advocacy—to learn more about this funding call and its importance in advancing R&D for lifesaving global health technologies. Q: Why is this funding call significant among efforts to advance global health R&D? A: This funding call is very significant in the sense that it ensures the continuation of German PDP funding. The first funding round was considered to be a pilot, and it was by no means a given that there would be a second one. Germany was late in joining the group of governments funding PDPs in 2011, when the United States and United Kingdom had already been funding the model for years. Germany also started out at a small scale—€20 million over four years. Over the duration of this time, it was gradually increased to over €26 million, which I think was an indication that the German government began to understand and increasingly appreciate the PDP model. This was further reinforced by an independent evaluation of the first funding round which was very positive. I think with this second call Germany has established itself as a PDP supporter in the medium and long term—albeit at a still rather modest funding level. Q: How does this second funding call differ from the first? A: First of all, there will be more money: €50 million over five years from 2016 to 2021, which is still not quite what we had hoped for but almost double the first funding round. Secondly, this call will be open for proposals not only on the 17 neglected tropical diseases (NTDs) and malaria, which were included in the first funding round, but also HIV and AIDS and tuberculosis (TB). Q: The announcement of this funding call occurred at the G7 Research Ministers conference which Germany chaired. How does this funding call reflect Germany’s broader global health priorities? And how does it align or differ with the priorities agreed upon at the G7 conference? Photo: PATH/Jennifer Fox A: I think the German government finally decided it was time to take on a leadership role in global health that appropriately reflects the country’s economic and financial standing in the world. I am sure the Ebola crisis—an outbreak of an infectious disease spreading at a breathtaking rate with no immediate treatment available and relatively close to home—had a lot to do with it. The prioritization of PRNDs/NTDs, antimicrobial resistance, and Ebola on the G7 agenda has given a lot of visibility to health issues in the international debate this year. For a while it looked like the G7 were leaving out the big three diseases of poverty—HIV and AIDS, malaria, and TB—and would only discuss NTDs, particularly as the G7 leaders’ summit communiqué only referred to NTDs. Fortunately, at the G7 Research Minister Conference in Berlin on October 8–9, the ministers of research included not only NTDs but also explicitly mentioned malaria, tuberculosis, HIV and AIDS, and several other infectious diseases. There are some interesting commitments in the communiqué, such as better coordination of research efforts. Germany’s Minister of Research Johanna Wanka has offered to host a brainstorming workshop on this in 2016. Also, the communiqué states the intent to develop a joint G7 pilot research activity for R&D projects to build research capacities in high PRND/NTD burden countries. Combined with the Japanese 2016 G7 presidency which is very likely to have health as one of its priorities as well, I think we have a good chance that health is going to stay at the center of the international agenda for a while. Q: As a global health R&D advocate, what excites and disappoints you about this funding call? A: I am excited about it being out and that there is significantly more budget available this time. It is of course not enough, not by a long shot, but maybe there will be some top-ups to the second funding round, as was the case in the first funding round when Germany started out with €20 million and ended up with €26 million. There is also the prospect of institutionalizing German PDP funding, moving away from providing limited funding for a number of years to making it a permanent feature in the German budget, but this is most likely only going to happen at the end of the second funding round. What was also really exciting was the process of ensuring this second funding round happened. I think all advocates—PDPs, nonprofits, philanthropic organizations, and others—did a great job in keeping global health R&D in the political debate. For example, during the summer the All Parliamentary Group on Population and Development of the German Bundestag wrote a letter to Chancellor Angela Merkel voicing their support for global health R&D and the PDP model, which was signed by 19 members of parliament (MP). I think nineteen MPs coming together from three out of the four parties in the Bundestag to sign a letter in support of a measure which represents only a minuscule share of the research ministry’s annual budget is fairly remarkable.

Moderator Lisa Cohen and panelist Tony Pipa. With the Sustainable Development Goals (SDGs) freshly adopted, the Global Health Technologies Coalition (GHTC) gathered representatives from the private, public, and nonprofit sectors on Capitol Hill this past Wednesday to discuss what it will take to achieve the global goals. One message rang loud and clear during the briefing: health innovation will be critical to achieving the SDGs, and it will take political commitment, funding, partnerships, and accountability mechanisms to deliver the next generation of health innovations needed to get us there. The panelists agreed that the SDGs—which set ambitious targets to end poverty, infectious disease epidemics, and preventable maternal and child deaths—are an important device for catalyzing political commitment and driving collective action to improve global health. Anthony Pipa, the US special coordinator for the Post-2015 Development Agenda, called the SDGs “a very optimistic global moment” and noted the power of the 193 United Nations member states coming together to agree on a set of goals, a point reinforced by moderator Lisa Cohen, executive director of the Washington Global Health Alliance. Pipa explained that the success of the Millennium Development Goals (MDGs) demonstrates the power of goal setting in advancing global health, and that the SDGs must build on that success. But he also clarified that “the SDGs are not just the MDGs 2.0,” as the SDGs are broader and more ambitious than the MDGs when it comes to health—they set goals to eliminate disease and preventable deaths, not just reduce them. He also described the inclusivity of the development process and the universality of the agenda, which promoted a sense of ownership among member states that are now starting to integrate the SDGs into their own national agendas. In the case of the US government, Pipa explained that the SDGs closely align with US priorities in global health and reflect the government’s longstanding commitment to health research and development (R&D). Panelists Dr. Dean Jamison and Kaitlin Christenson The need for strong and sustained investment in global health R&D to reach the SDGs was highlighted throughout the briefing. Dr. Dean Jamison, co-chair of the Lancet Commission on Investing in Health, explained that “we benefit today from investments in R&D of products made decades ago” and that health innovations have driven significant progress in global health over the past few decades. Jamison noted the Lancet Commission report’s conclusion that it is possible to achieve the ambitious SDG vision, but not without greater investment in R&D for new health technologies. He emphasized that, although health R&D can be a long and expensive process, it delivers huge returns on investment. The panelists all underscored that, because the SDGs are so ambitious, no one sector alone can ensure their success. Instead, it will take partnerships between the public, private, academic, philanthropic, and nonprofit spheres to reach the targets, particularly for health. Kaitlin Christenson, acting director of Advocacy and Public Policy at PATH, discussed the importance of product development partnerships (PDPs) in advancing the development of health technologies. Christenson remarked that PDPs leverage resources, expertise, and financing from across sectors and help “multiply” the impact of public sector investment. Gary Cohen Gary Cohen, senior vice president at BD, echoed this sentiment, noting that “so much of what we’ve achieved in health is due to collaboration, we couldn’t see doing it any other way.” Moving a promising idea through product development, regulatory approval, scale up of manufacturing, and market strengthening, in order to ultimately get the health innovation into the hands of patients who need it, is a daunting process. It’s not possible to do this, Cohen explained, without the involvement of the private sector. Cohen noted that throughout the process of developing the SDGs, it was widely acknowledged that the private sector would be critical to their successful implementation. Christenson pointed out that, while it is clear new health tools are needed to reach the global goals, it is not just about designing any technology, but the right technology. She explained that developers must stay focused on the needs of the end user and ensure that the product is affordable and contextually appropriate in order to achieve the desired health impact. She also noted that the community must be diligent in identifying health technologies with the greatest potential to drive dramatic improvements in health and rally the necessary investment and political support to bring them to scale. As an example, she highlighted PATH’s Innovation Countdown 2030 initiative, which identifies 30 innovations with the greatest promise to accelerate progress toward the SDGs. Attendees check out health technologies funded by US government investment. Pipa also emphasized that reaching the SDGs will require “doing business differently” and pointed to innovation within the US government to promote new thinking in global health, like USAID’s Saving Lives at Birth Grand Challenge. In the same vein, Christenson pointed out that “innovation comes from everywhere, not just white-coated scientists” and called for systems and policies that support a broad view of innovation. Cohen said that “innovation in business models will be just as important as innovation for technologies” and called for greater collaboration among key players to ensure that R&D investments are translated from the development of new tools and technologies to the ultimate delivery and use of lifesaving products. An audience member from PATH pointed out that, despite the importance of new health technologies to achieving the SDGs, the agenda does not currently include any indicator to measure progress in global health R&D, citing concern that “unless something is measured, it doesn’t necessarily happen.” Panelists agreed that data and measurement is a critical part of ensuring we are on the right track to reach the health targets. Pipa highlighted the expanded availability of data and the need to leverage data from different sectors, while Jamison cited the importance of data and monitoring in holding actors accountable to their SDG commitments. Though it will be a challenging road ahead to reach the SDG targets by 2030, the panelists were optimistic it could be done. Cohen emphasized that “these seemingly intractable problems are solvable.” Pipa agreed, saying, “the political consensus around ending extreme poverty is really powerful, and we shouldn’t underestimate that power.”

Female condoms. Photo: PATH/Patrick McKernTake a stroll through any pharmacy and you’ll see shelves stacked with male condoms of many varieties, but look for a female condom and you aren't likely to find one for sale. Though first introduced more than 20 years ago, female condoms are remain an unknown or inaccessible option for many women. But thanks to the efforts of dedicated product developers, public health professionals, and female condom advocates, that’s changing, as a slew of new female condom products are emerging and expanding the market. Today, in celebration of Global Female Condom Day, we look back at the history of the female condom and look ahead at what’s next for this female-initiated prevention tool.A game changing product with a slow start When the first female condom—known as the FC1—was introduced on the US market in 1993 by Wisconsin Pharmaceuticals (now the Female Health Company), it was hailed as a game-changer in sexual health. It checked off all the requirements for what product developers had heard women wanted—it had comparable effectiveness to male condoms, it could be inserted prior to sex allowing for less disruptive love-making, it was less physically restrictive for male partners, and most importantly, it was female-initiated. FC2 female condom. Photo: Female Health Company In spite of these advantages, the female condom never really caught on among American consumers. Many women were hesitant to try it because of its unfamiliar size and shape—it is larger than a male condom and doesn’t come neatly rolled up in a small package. Among those women who did try a female condom, many found it was difficult to insert and uncomfortable or noisy during sex. The FC1 was also many times more expensive than a male condom, which deterred some women and couples from trying it out.While the product received a tepid reception in the United States, women’s health and rights groups in middle- and low-income countries—where rates of unplanned pregnancy and STIs/HIV are alarmingly high and women may have few options to negotiate protection—saw the female condom as an important new tool to save women’s lives. Pilot introduction programs took off in countries including Brazil, Ghana, South Africa, and Zimbabwe. In response, the Female Health Company optimized the product, changing the material from polyurethane to nitrile to reduce production costs, and introduced the world to FC1’s successor—you guessed it: the FC2. In 2007, the FC2 was prequalified by the World Health Organization (WHO) making it eligible for bulk procurement. Today, the FC2 is available in 144 nations. Expanding choice in the female condom market Cupid Female Condom. Photo: Female Condom Market IntelligenceSpurred by increased advocacy to expand options for female-initiated prevention, researchers and product developers went to work on new female condom designs. In recent years, consumers have begun to see the fruits of this labor, as several new female condoms, each with different design variations, have emerged on the market. In 2012, the Cupid female condom—which uses a foam sponge on one end rather than a ring to provide stability—joined the FC2 as the second female condom to receive WHO prequalification.The female condom market is on the cusp of further diversification, as additional female condoms are awaiting WHO prequalification decision or soon to be submitted for review. Phoenurse female condom. Photo: Female Condom Market Intelligence Each of these options offers a different approach to addressing the drawbacks of the FC1. For example, the Air female condom contains an air bubble to help keep the product stable during sex, while the Phoenurse comes packaged with an insertion stick for optional use when inserting the product. The Velvet condom is similar to the FC2 design but made of natural rubber latex, while the VA w.o.w, like the Cupid, contains a sponge for internal stability, but instead has a rounded triangular outer ring to keep it secure.Another second generation female condom in early introduction is the Woman’s Condom, developed by GHTC member PATH. As a nonprofit product developer focused on user-centered design, PATH set out in the late 1990s to create a female condom that would be easy to use and comfortable for both partners. The product development team began by examining acceptability studies of existing female condoms and hosting focus groups with men and woman in several countries to better understand what users wanted from a product. Their design objectives became clear: “create a product that would be easy to handle, easy to insert, stay stable in the vagina during sex…[and] provide good sensation for both the male and female partner,” explained Maggie Kilbourne-Brook, program officer at PATH, adding “and if possible, users wanted it be more aesthetically pleasing.” The Women's Condom. Photo: PATH/Glenn Austin  PATH developed and tested more than 50 prototypes before freezing design development. To increase the ease of insertion, the Women’s Condom’ main pouch is compressed into a narrow, rounded capsule which women insert like a tampon. Within 30-60 seconds, this capsule dissolves, allowing the condom to expand within the vagina. To provide stability, four small foam pieces are used which adhere gently to the interior of the vagina. And unlike other female condoms, the Woman’s Condom is not pre-lubricated; instead it is packaged with separate lubricant users can apply following insertion.New designs under development The Origami Condom. Photo: Female Condom Market IntelligenceAs these aforementioned female condoms are introduced and vie for market share, additional female condoms are advancing through the research and development (R&D) process. Next to market will likely be the Origami Condom, which is moving into phase 2 clinical trials. The Origami female condom is quite a dramatic reimagining of the female condom. It’s a conical shaped device that is folded during insertion and expands like an accordion during sex. It’s made of a durable, flexible silicon material designed for wash and reuse. The Bill & Melinda Gates Foundation is also giving a boost to female condom development. Last year as part of its initiative to develop “next generation condoms,” the Gates Foundation announced grant funding for three early-stage female condom development projects. Researchers from Indiana University received funding to advance their “female pleasure condom” which has ribbed siding to increase stimulation and enhance sexual experience, while another grantee is developing an “air-infused female condom” that is “inflated and positioned using air pressure” to enable easier and quicker insertion. The third grant recipient is approaching the insertion challenge in an entirely different way, designing a sliding, easy to use, re-usable applicator for female condoms that works like a tampon applicator.The many challenges of female condom development and access  A woman demonstrates use of a female condom at a community meeting in Kenya. Photo: PATH/Eric Becker Studies have shown that including female condoms in condom promotion programs leads to increased levels of protected sex, meaning certain men and women are using female condoms in circumstances where male condoms would have otherwise not been used. And qualitative studies have found that having female condoms available as an option can help some women negotiate condom use with their partners. “It can shift the conversation,” explains Kilbourne-Brook, “It’s not male condom or nothing—it’s male condom, female condom, or nothing.” Even though female condoms deliver improved health outcomes, they are still a challenging value proposition for global procurers who purchase over 90 percent of female condoms. While prices are expected to drop as new products come to market and production volumes increase, female condoms will always cost more because of their design. Today, at bulk procurement prices, a buyer can purchase roughly 17 male condoms for the price of one FC2 female condom. And the fact that demand is so driven by price-sensitive bulk procurers changes the nature of the market, discouraging developers and manufacturers from investing in R&D to enhance consumer-experience or spending on marketing to increase appeal. Instead, it encourages companies to focus on developing the lowest cost product possible that meets the health need.Developers hoping to bring a new female condom into the US market also face an additional hurdle. Because female condoms were a new product category at the time the FC1 underwent regulatory review, the US Food and Drug Administration (FDA) decided to regulate female condoms as Class III medical devices—a classification typically reserved for higher risk medical products (male condoms are classified as Class II devices). Because Class III devices require more data and evidence for approval, it creates a more costly and lengthy process for developers. Most other regulatory authorities classify female condoms as Class II devices, and female condom advocates are calling on the FDA to down classify female condoms to pave the way for expanded choice. The path forward  Many advocates argue that for female condoms to make the leap from niche product to a staple in the bedroom worldwide, concerted marketing, education, and awareness campaigns are needed to demystify and destigmatize female condoms and boost their consumer appeal. To build momentum, Global Female Condom Day was launched in 2012 as an international day of action focused on increasing knowledge, availability, and use of female condoms. And this year, advocates will Dance4Demand to urge policymakers, donors, and health providers to increase their support for female condoms. While the female condom may have been slow to catch on, its supporters believe it can make such a leap. After all, many people forget that male condoms were at one point stigmatized as products used only by people engaged in morally questionable activity. It took a concerted effort from public health professionals, governments, and the private sector to bring them into the mainstream and make them the ubiquitous, widely-used product they are today. If the hopes of female advocates are realized, pharmacies everywhere may soon have to make some extra room on their shelves. ReferencesHoke TH, Feldblum PJ, Van Damme K, et al. Temporal trends in sexually transmitted infection prevalence and condom use following introduction of the female condom to Madagascar sex workers. International Journal of STD and AIDS. 2007; 18(7):461–466. Latka M, Gollub E, French P, Stein Z. Male-condom and female-condom use among women after counseling in risk-reduction hierarchy for STD prevention. Sexually Transmitted Diseases. 2000;27(8):431–437. Barbosa RM, Berquo E, Kalckmann S. Acceptability of the Female Condom in Different Social Contexts: Final Research Report. Brasilia, Brazil: Ministry of Health, Secretariat for Health Policies, National STD/AIDS Coordinating Office; 2000. Artz L, Macaluso M, Brill I, et al. Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics. American Journal of Public Health. 2000;90(2):237–244. Macaluso M, Demand M, Artz L, et al. Female condom use among women at high risk of sexually transmitted disease. Family Planning Perspectives. 2000;32(3):138–144. Musaba E, Morrison CS, Sunkutu MR, Wong EL. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sexually Transmitted Diseases. 1998;25(5):260–264. Gollub EL, French P, Latka M, Rogers C, Stein Z. Achieving safer sex with choice: studying a woman’s sexual risk reduction hierarchy in an STD clinic. Journal of Women’s Health & Gender-Based Medicine. 2001;10(8):771–783.

An injectable HIV and AIDS treatment that could offer HIV-positive individuals an option other than taking daily pills is entering late-stage clinical-trials. In previous studies, the drug—PRO140—was shown to be successfully in suppressing viral loads to an undetectable level for at least one month in 98 percent of patients. Most HIV-positive patients take nearly 30 antiretroviral pills every week. In some patients, these pills cause kidney and liver damage as well as resistance to further treatment. The developers of this new treatment hope PRO140 could become available in once-a-week, two-dose treatments by 2017, pending success of clinical trials. Former US Treasury Secretary Lawrence Summers and Lancet Commission member Gavin Yamey write in a Huffington Post op-ed that the development of game-changing health technologies will be critical to reaching the health goal in the Sustainable Development Goals (SDGs). They argue that reaching the SDG health targets is not possible with today’s health tools and that new medicines, vaccines, diagnostics, and other innovations will be required. To spur such innovation, they call for increased investment in global health research and development from all nations. A new observational study suggests that taking daily pills to prevent HIV infection—known as pre-exposure prophylaxis (PrEP)—is working to prevent HIV infection in the real world. Kaiser Permanente of San Francisco announced last week that none of its 657 clients receiving PrEP have become infected over a period of more than two years. When PrEP was introduced, many critics predicted that it could decrease condom use, in turn leading to more HIV infections. Advocates of PrEP say this study shows that such concerns were unwarranted, as PrEP is proving effective in nonclinical settings. CNN reports in-depth on the global spread of Dengue and efforts to control and treat the disease. While Dengue fever was once a problem only in pockets of South America and Southeast Asia, today more than 100 countries harbor risk of infection. Currently, there is no treatment or vaccine against for the disease and no effective prevention options; because the mosquitoes that carry Dengue bite during the day, bed nets that have been critical in preventing malaria are not effective for Dengue prevention. New mosquito control interventions, drugs, and vaccines are needed to tackle the disease.

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.