Robert Malkin, Ph.D., P.E.

It’s 1989. Five years after earning his bachelor’s degree in electrical engineering, Robert Malkin is designing cardiac pacemakers in Switzerland. It’s an important job, and he’s developing deep expertise and earning good money. But he’s unhappy. Very unhappy. “I decided I didn’t want to be an engineer,” he says. “Actually, I didn’t want to work anymore, period. I had a party, burned my time card, and disappeared into the sunset.”

Disappeared into the sunrise is more like it. Malkin headed southeast to Thailand, where he signed up with a YMCA-sponsored team that was trying to get poor Thai parents to stop selling their daughters into that country’s booming sex trade. “It was more or less sexual slavery,” says Malkin. “Despite being immoral and illegal, it was happening in large numbers.”

The group Malkin joined had a simple strategy: to give vulnerable girls some skills that would make them too valuable to sell off. His job was to teach the girls English so they could help customize and peddle the handicrafts the villagers were making for tourists.

Modeled after a ketchup packet, an invention made by a Pratt School of Engineering class could revolutionize the way antiretrovirals are delivered to newborns.

Robert Malkin, professor of the practice of biomedical engineering and director of Engineering World Health, and the students in his Design for the Developing World course developed the new antiretroviral delivery method—the Pratt Pouch—in 2011 and began testing it the following summer. Previously, the essential medication was delivered to developing countries in syringes, but the medication often dried up before reaching the pregnant mothers. By storing the medicine in the Pratt Pouch, the medicine does not dry up before reaching the developing countries.

The Pratt Pouch has gone through clinical trials, with 100 percent of mothers involved in the study reporting that they’d rather use the the pouch than other single-dose methods. The product has not yet been launched, but with increased funding it could be unveiled in China, Malkin said.

“If you buy a can of paint and put it on the wall, it is permanently a solid,” Malkin said. “It changes state because you change the surface to volume ratio. This is analogous to the problem the people are having with the syringe.”

HIV-positive mothers need to give drugs to their newborns immediately. But many give birth at home, far from hospitals. A Duke biomedical engineering class has developed the ideal solution.

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.

Engineering World Health (EWH) and the GE Foundation have signed an agreement with Instituto Nacional de Formacion Profesional (INFOP) in Honduras that lays the foundation for expansion of the BMET Training Program. Since 2010, EWH and Duke University have led a continuing education program for biomedical equipment technicians from 12 public hospitals in Honduras. The agreement represents a move toward sustainability in that the program will be locally managed and operated.

The three-party agreement establishes a new field of training in Honduras and will offer an intensive, full-time training program for hands-on medical equipment repair and maintenance. INFOP will also create an independent academic department with three full-time faculty members and construct laboratory facilities to support the program at its campus in Tegucigalpa. The training will be led by the Honduran public sector through INFOP, with the first group of students beginning study in February.

The BMET training curriculum was developed by Robert Malkin’s Developing World Healthcare Technology lab, with help from undergraduate students at the Duke Pratt School of Engineering. A similar training program has been tailored for use in Ghana, Rwanda and Cambodia.

The World Health Organization has selected the Pratt Pouch as one of the top ten innovative health technologies of the year for use in low-resource settings around the world. Developed by Duke’s Pratt School of Engineering and DGHI faculty member Robert Malkin, the Pratt Pouch helps stop the spread of disease from HIV-infected mothers to newborns. The innovative ketchup packet-like pouch has a pre-measured dose of antiretroviral medication that can be given to the newborn within the first 24 hours of life. When newborns receive antiretroviral drugs shortly after birth, their chances of contracting HIV are significantly decreased.

“We are really excited to be selected by the World Health Organization,” said Malkin. “We are actively discussing the wider dissemination of the pouch with Ministries of Health in several countries.  I know that we will be able to use this recognition to more convincingly explain the benefits of the pouch.”

Through Duke Global Health Plus, Duke is helping build capacity for skilled health care workers and hospitals outfitted with medical equipment to better treat patients in low- and middle-income countries. The program recycles surplus medical equipment and supplies from the Duke University Health System for use by Duke faculty or Duke-affiliated physicians on global projects that build capacity and improve health.

The latest recipient of GH PLUS support is Robert Malkin, a biomedical engineer and faculty member at the Duke Global Health Institute and Pratt School of Engineering.  As Director of Duke-Engineering World Health, Malkin is working with partners in Central America, Southeast Asia and Africa to train biomedical equipment technicians (BMET) on how to repair broken medical equipment.

This fall, Malkin will ship, deliver and install more than 200 pieces of Duke surplus medical equipment and supplies to Instituto Nacional de Formacion Profesional in Tegucigalpa, Honduras. The medical equipment will be used in the BMET Training Program to give technicians hands-on practice repairing broken medical equipment like patient monitors, defibrillators, microscopes, infant incubators, ventilators and diagnostic ultrasound machines.

Thousands of lives may soon be saved through an action as simple as tearing open a packet of ketchup.

Over the past three years, researchers at the Pratt School of Engineering have developed a small foil packet, called a “Pratt pouch,” that holds single drug doses to give to newborn babies of HIV-positive mothers—significantly reducing the babies’ chances of contracting HIV. In August the researchers received a $250,000 grant from the U.S. Agency of International Development to further research and implement the pouch, specifically in Tanzania in a two-year project beginning this Fall.

Since more than 50 percent of mothers in Tanzania deliver at home, they do not always have the opportunity to travel to a clinic to get anti-retroviral medicine, said Dr. Robert Malkin, leader of the research team and director of the Developing World Healthcare Technology Laboratory at Duke.

“An HIV-positive mother will receive the pouch and will be encouraged to return to the hospital, but if they can’t, they can give the medication to the HIV child themselves within 24 hours after birth,” said Malkin, professor of the practice of biomedical engineering.

Last week, nearly $14 million was awarded to innovations aimed at saving the lives of mothers and children around the world Thursday in a landmark event hosted by US Secretary of State Hillary Clinton and USAID Administrator Rajiv Shah. The innovative Pratt Pouch developed by Pratt School of Engineering and DGHI faculty member Robert Malkin was selected as an awardee of the “Saving Lives at Birth” Grand Challenge, the first in a series of Grand Challenges for Development led by the U.S. Agency for International Development (USAID), the Bill & Melinda Gates Foundation, the Government of Norway, Grand Challenges Canada, and the World Bank.

The ketchup packet-like pouch developed by Malkin and the DHT-lab at Duke, contains anti-retroviral drugs which help HIV-positive moms prevent transmission of the virus to their newborns. Malkin’s invention is the type of low-tech, high-impact device that can prevent the hundreds of thousands of newborns from contracting HIV at the time of birth.

In her remarks, Secretary Clinton said the Pratt Pouch is a good idea: “Now researchers are developing a pouch that can last for months and, apparently, looks like something that you get at a fast food restaurant, like one of those little ketchup containers. And then a mother can have it on hand and will be able to care for her child immediately. So we have lots of great ideas that are here.”