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12 August, 2015 - 07:51 By Tony Quested

The milk of life: a wearable device that could save millions of lives

the JustMilk NSDS contains a tablet pre-dosed with an infant’s medication

A Cambridge-California social enterprise has devised a novel nipple shield that could safely deliver drugs and nutrients to infants during breastfeeding without spreading potentially fatal diseases.

JustMilk is a not-for-profit venture bidding to develop the life-saving device to the point where a pharmaceutical partner could take it to global rollout. For the moment it is having to manage on one seed grant and donations but hopes engagement with global universities will further raise profile and finances.

The low-cost Nipple Shield Delivery System (NSDS) JustMilk is developing is currently in the initial testing and fundraising phases. The team hopes the shield will soon be a major tool in the global fight against diarrhoea & malnutrition, malaria, HIV/AIDS and other health crises.

New drug delivery methods for infants are needed in low and middle-income countries: 2.9 million babies die each year within the first month after birth, with the risk of death highest during the initial hours and days. 
Many of these deaths are easily preventable by early administration of drugs or nutrients. 

JustMilk believes its NSDS provides a unique, user-informed solution to this challenge and that a wide-range of active pharmaceutical ingredients (APIs) could be delivered to infants using the NSDS such as antibiotics, antimalarials, antiretrovirals, vitamins, nutrients, and probiotics.

Development of the NSDS brings together a diverse array of fields including chemical engineering, microbiology, and public health. 

To use the NSDS, a mother places the device, containing a pre-loaded tablet insert, over her breast before breastfeeding. As her infant suckles milk passes through the device, causing the APIs to be released directly from the tablet into the breast milk and passed to the infant. The NSDS will be pre-loaded, disposable, and will minimise material thickness while maximising skin-to-skin contact with the infant.

Currently, the most common infant drug delivery devices are measuring spoons, dosing cups, and oral syringes, all of which deliver liquid formulations and can lead to dosing errors. There are other issues such as cold chain and refrigerated storage requirements, unpalatability, and the potential presence of harmful excipients. Alternatively, solid dispersible tablets must be dissolved in potable water in a clean container before being administered with the same devices.
  
To address dosing issues, the NSDS contains a tablet pre-dosed with an infant’s medication. Since the sterile device utilises human milk as the tablet’s dissolving agent, potable water is not required to dissolve a dry tablet.

Using the device could also encourage the natural and healthy practice of breastfeeding - suboptimal breastfeeding practices lead to 800,000 child deaths annually. 

JustMilk president and CEO, Geoff Galgon, told Business Weekly the concept originated in 2008 at an International Development Design Summit at MIT. Since then the team has formed collaborations with several academic and public health institutions.

Galgon said: “Our team was given the design challenge of preventing mother to child transmission of HIV during breastfeeding. We quickly realised that the concept of a wearable device (a modified nipple shield) which could administer compounds into breast milk could potentially be used as a more general drug and nutrient delivery device for infants.

“In resource-limited settings in particular, there are many challenges to delivering these essential therapeutics to infants, including shelf-life limitations and the non-availability of potable water. We hope that our technology will be able to help tackle some of these challenges.”

JustMilk as a nonprofit entity has existed as a 501(c)(3) venture in California since 2013 but the team and partners are located internationally.

There are currently four members on the board of the nonprofit organisation. After 2008, another one of the inventors, Stephen Gerrard, took the project forward technically, studying the drug delivery aspects of the device for his PhD at the Department of Chemical Engineering and Biotechnology at the University of Cambridge. During the course of his PhD, and subsequently, the inventors formed a partnership with the University College London School of Pharmacy and other institutions for technical development and acceptability studies. 

They then met Aspen Flynn who helped co-found the US nonprofit. She recently completed an acceptability study in collaboration with the University of Venda in South Africa, where she received positive feedback about the technology from mothers in resource-limited settings. In 2013 JustMilk received a Saving Lives at Birth Seed Grant which Galgon says “greatly helped propel the project forward.”

The current technical development of the project is led by Rebekah Scheuerle, a chemical engineering PhD student at the University of Cambridge.

Galgon said Cambridge remains heavily involved with multiple graduate-level students working on the project in the Department of Chemical Engineering and Biotechnology. 

“We are also active in the Judge Business School Accelerate Cambridge Programme,” he adds. 

Both Galgon and Aspen are located in California and say they receive substantial support from the University of California, Berkeley. “Having two geographic centres has its challenges as you might imagine, but it also has benefits – including the diversity of perspectives, talent, and resources that we can work with.”

JustMilk has reached a landmark point in the development of the new device, as Galgon explains: “Up until this point our validation tests have primarily included user acceptability studies and an array of lab-based experiments based largely on simulations of various aspects of breastfeeding. We are currently planning our first clinical investigation to determine how an infant and mother dyad would respond to using the device in a clinical, controlled, safe environment.

“We are seeking donations – and as a nonprofit organisation are eligible to receive tax deductible charitable gifts – to boost funding for this study. We then hope to partner with a pharmaceutical company to initiate clinical trials with the device.

“Generally, we are investigating what the most judicious scale-up strategy for us will be and are fortunate to be in close contact with knowledgeable advisers.”

Donations in any currency are accepted and can be made online through Paypal via their secure site. JustMilk is also happy to take donations by other means – visit the website at http://www.justmilk.org

• The JustMilk product is made possible through the generous support of the Saving Lives at Birth partners: the United States Agency for International Development (USAID), the Government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada, and the UK Government. This interview does not necessarily reflect the views of the Saving Lives at Birth partners.

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