Breastfeeding has served as the primary method for a mother to feed her infant since the dawn of humanity, but could it also be a way for her to administer life-saving medicines to her baby? The answer is yes—if a group of researchers from the United States and United Kingdom have their way.
The researchers—who have formed the nonprofit JustMilk—are developing a nipple shield device that allows a breastfeeding mother to administer drugs or nutrients to her infant through her breast milk. The device is easy to use—a mother would simply place the shield—which contains a rapidly dispersible tablet potentially containing antimalarials, antiretrovirals, antibiotics, or micronutrients—on her breast while feeding her child. As the milk passes through the device, it breaks down the tablet and delivers the medicines or nutrients to the infant.
The “eureka moment”
According to JustMilk’s cofounder Dr. Stephen Gerrard, PhD, the idea for the device emerged out of a design challenge—how to prevent HIV transmission during breastfeeding in developing countries—that his team was issued at the 2008 International Development Design Summit. The team had an idea to create a wearable device that deposits HIV-inactivating compounds into breast milk. After discovering the existence of both potential compounds and a wearable device—a nipple shield—the team realized it was on to something. “The eureka moment was that we could combine the two, and then you have a way of depositing antimicrobial compounds into milk,” said Gerrard. “The second point straight after that was—hang on—this could be a general drug and nutrient delivery device for infants.”
Since then, the JustMilk team has focused on the broader potential of the device as a drug or nutrient delivery system. “Over 4.8 million infants under the age of one die each year from conditions like pneumonia, malaria, diarrhea, and HIV,” said Gerrard. “And an overwhelming majority of those conditions can be treated, and the deaths can be avoided by appropriate administration of agents to the infant….We’re trying to tackle those big issues, and we’re looking to make a major impact.”
Overcoming the challenges of drug delivery in low-resource settings
Gerrard believes JustMilk’s device offers advantages over conventional methods for administering drugs to infants, which often create challenges in low-resource settings. Liquid drug formulations can have a limited shelf life and require refrigeration; while powdered or dry formulations require reconstitution with potable water and can create accurate dosing issues. Gerrard believes a prefilled, disposable version of the JustMilk nipple shield could address many of these challenges, as well as empower a mother by allowing her to personally administrator medicine to her baby in a natural context.
A work in progress: Putting users first
JustMilk, which received a grant last year from the Saving Lives at Birth Challenge, is still in the early stages of product development and is currently conducting research to inform the design, marketing, and eventual delivery of the device. In the next two months, JustMilk will begin user acceptability studies with mothers at the University of Venda in South Africa to answer questions like: should the device be disposable or prefilled with medicines, how should it be packaged, and would its use generate stigma for users—and if so—how can that be prevented? JustMilk also plans to conduct a study examining how infants react to intermittent use of the nipple shield to determine if the breastfeeding process is impacted by the infant using the shield once or twice a day.
Gerrard sees that these studies are vital to the development process. “You have to have your end user right there from the beginning of the design process,” he said. “You have to get all these things right in the first place; otherwise, if you’re going through the clinical trial approval process and you’ve got something wrong, you’re going to have to go back again.”
Gerrard acknowledges that the next six months will be a critical time period for the organization as it seeks to establish the viability of the product, mitigate any risks during its development, and potentially attract the involvement of medical device manufacturers. He explained, “Our goal with this device is to establish feasibility, demonstrate that it can confer a health benefit to infants, and hope the market reacts.”
Marissa Chmiola is GHTC’s communications officer.
JustMilk received a funding grant in 2013 from the Saving Lives at Birth Challenge—which is supported by the US Agency for International Development, the Bill & Melinda Gates Foundation, the Norwegian Ministry of Foreign Affairs, Grand Challenges Canada, and the UK Department for International Development. JustMilk has also received support from the Clinton Global Initiative, public health charity FHI 360, the University of Cambridge, and the National Collegiate Inventors and Innovators Alliance.