There are innumerable challenges to providing quality health care to the developing world, but this is one of the most critical: How do you deliver medication to HIV-positive mothers who have no immediate access to antiretrovirals (perhaps because they're performing a home birth) but need to give the drugs to newborn children in the first days of their life? If they can't get the medication in time, the children could also become HIV-positive.
That's the question that Robert Malkin, a biomedical engineering researcher at Duke University, posed to his students in a class called "Design for the Developing World." After a series of experiments, Malkin and his students came up with a solution: a small, single-dose foil pouch lined with plastic and filled with antiretrovirals that mothers can tear open and squeeze directly into their newborn's mouth. Think of it as a ketchup packet for HIV drugs.
In the past, researchers have experimented with other single-dose delivery methods, including cups and syringes. But for a variety of reasons (they don't last long enough, development costs are high), none have really taken off.
The Pratt Pouch--named after the Pratt School of Engineering at Duke--has a longer shelf life than other methods. It has been developed entirely by Malkin and his students, so drug companies don't need to worry about development costs.
Bulk shipments can be sent to countries in need, and local pharmacists can fill the pouch with drugs via syringes. Mothers would receive the pouches in advance of giving birth. The drugs contained in the pouch vary depending on a number of factors, including the health status of the mothers and whether countries follow updated World Health Organization guidelines.
Malkin and his team have tested the pouch with Duke patients as well as in clinical trials in Ecuador. After use, the pouches are inspected microscopically and macroscopically to measure every data point imaginable--how much force and velocity is used to tear it open, the number of seconds from when a mother grabs the pouch to when she makes the first tear, what percentage of the pouch is emptied, what percentage of the medication lands in the baby's mouth, and so on.
The clinical trial has been a big success, with 100% of mothers involved reporting that they would rather use the pouch than other single-dose methods. "The hospital wants to switch all anti-retrovirals for babies to [the pouch]," says Malkin.
At three to four cents per pouch, Malkin's product is cheaper to produce than a syringe--and cheaper than the antiretrovirals themselves. But it's still a little expensive for the developing world. "I don't predict it will drop further in cost," he says, unless there is a significant ramp-up in production. Funding will also be the biggest challenge in scaling up, since the product is never likely to see a significant profit. "People who are HIV-positive who deliver at home are poor. There's just no money," says Malkin.
Armed with $250,000 from USAID's Saving Lives at Birth: Grand Challenge for Development campaign, Malkin and his team plan on beginning a new pilot with mothers in Zambia this November. He's still deciding what the plan will be for scaling up; right now, he's leaning towards making the technology completely open-source. But licensing the Pratt Pouch isn't out of the question.
"A critical piece of the puzzle will be what funders are looking for," he says. "Some will be more familiar, more comfortable with the licensing approach."