A biomedical engineering professor and director of several Duke organizations that apply an engineering framework to the world’s great health inequities, Robert Malkin has made himself known—both at Duke and across the planet. Malkin’s “Pratt Pouch,” a ketchup-like packet that facilitates the prevention of mother-to-child transmission of HIV, was recently named one the World Health Organization’s “Top 10 Most Innovative Technologies,” and was recently selected as an awardee of the “Saving Lives at Birth” Grand Challenge. In light of the upcoming World AIDS Day, Towerview’s Matthew Chase sat down with Malkin to discuss the role that biomedical engineers play in the field of global health.

Can you briefly explain how the Pratt Pouch works, and describe its design process?

The idea is that a mother who is HIV-positive would, if given no other HIV intervention, have an HIV-positive child, and then there would be no hope for curing the AIDS/HIV problem because each generation would simply inherit it from their parents. That cycle can be broken with pharmaceuticals. The problem is mothers… who end up delivering at home for any reason—because they go into labor very late or the labor is very quick, or they are many, many, many hours from a hospital—they don’t have access to the drugs for their child. And you do need to provide a drug to both the mother and the child to give you the highest probability of preventing the transmission of the disease from the mother to the child.

So the Pratt Pouch allows the mother to take the meds home with her, and if for whatever reason she can’t make it home to the clinic in time to have her baby there, she can just tear open the pouch and drip the medication into the child’s mouth, preventing the child from becoming HIV-positive, and then later on go back into the clinic and pick up a more consistent and steady set of meds for the child to prevent longer-term exposure and transmission to the disease. So essentially it’s a drug delivery system that allows the medication to be preserved so that the mother can deliver it to her baby appropriately and safely to her baby at home.

As you transition from design to implementation, what challenges are you facing?

We’ve been meeting with Ministers of Health of Tanzania, Zambia, Uganda, Ecuador, Namibia and Kenya to see whether they’d be interested in using the pouch in their systems, but there are many significant problems. First of all, we’re only looking to solve the problem for the very hard-to-reach mothers. Any mother who is near the clinic should go to the clinic to have the baby…. They often, even at those very remote sites, have some access to midwives or other traditional birthing assistants, but that does not mean they have access to medication. Those traditional birthing assistants are, in some locations, allowed to distribute medications; and in other locations, they’re not.

So that’s the first hurdle: how are we going to get medicine, legally, to somebody who actually distributes it to the mother, very far from a hospital or clinic or pharmacy? So for example, in Uganda, traditional birthing assistants and something called community health distributors are permitted to distribute certain medications. And so for Uganda, what we’re looking for is permission to add another medication to their list, and then those mothers whose status is known to be positive could have access to this medication through community health distributors.

In other places, like Tanzania, there is no authority given to community health workers or traditional birthing assistants to distribute medication, so in Tanzania we are looking at these vans which drive out from clinics to these very remote sites—sometimes 5 to 10 hours from the site, the pharmacy—with health workers once a month. So once a month they go to this very remote village which is when they do all of the antenatal care…to try to prevent the transmission.

In Ecuador, it’s completely different: there are enough clinics, but these clinics are relatively remote. So there is no question of legality: these are regular clinics, they are staffed by nurses who definitely have the authority to distribute, but they’re relatively remote, so the issue we are facing there is just training: how do we get the training all the way out to the end of the system there?

You’ve recently publicly spoken out against interventions that merely provide donations of medical equipment to developing countries. Given that this ideology may seem somewhat counter-intuitive, can you explain this belief?

I am a strong believer that donations do not help, at least in the realm of medical equipment. And just to give you a couple of quick facts, the Director-General of the World Health Organization, Margaret Chan, stated that 70 percent of critical donated equipment does not work, and 30-40 percent never worked. And in fact there is an interesting study that came out last year that found that 60 percent of donated equipment is known broken at the time of donation. I don’t know exactly what the right number is—our data show that the number is around 40 percent, actually—but the problem is if you go into these hospitals you see huge piles of donated, unused medical equipment. And there’s a cost associated with that, not only in terms of square feet in a building, which could be used for patient care, but also the proper disposal of medical equipment is not cheap. The hospital across the street here is using $100 to $200 per piece of medical equipment to dispose of the equipment…. And so every time you donate something which doesn’t contribute to the hospital, you’re placing a burden on that hospital.

The other end of the scale is that it’s really, really hard to donate something and make it work. We just completed a study… of almost 1,000 pieces of donated, not-used equipment…. And less than 50 percent of it is working two years later. Think about this for a minute: If I donated you a computer, but the keyboard was in Thai, or the keyboard was in Khmer, and so was the manual, could you really operate your computer, if every screen came up in Cyrillic or Mandarin? You know, we deal with populations all the time who don’t speak English, or English is their fourth or fifth language, so that’s one issue.

Or they simply can’t get the supplies…. If I give you a washing machine, but you can’t find laundry detergent, is there really any value to the donation of the washing machine? Of course, that was just a metaphor—medical devices have much more complicated supplies that are required. And also broken parts; everything breaks, but you can’t find the replacement parts…. And so for all of these reasons it is very hard to donate medical equipment and make it work.

What do you think of the role that biomedical engineers currently play in the global health community? Do you feel that your profession is under-represented?

Well the answer to this is very simple—just think about the last time you went to the doctor. Probably within about 10 minutes of being called back, they had weighed you, taken your temperature, probably your blood pressure and they may have taken a blood sample, which would have to be sent off to a lab somewhere.... Every single one of those measurements—and you’re only 10 minutes into your visit at the doctor—has required a piece of medical equipment.

The fact of the matter is that when you go into a developing world clinic, almost none of those things work. Simple things like taking your blood pressure may be impossible, taking your weight may be impossible, taking a blood sample and sending it off to a lab might be a dream. And so I think it’s very clear that biomedical engineers have a critical role for the future of global health, and I think we’re taking up the challenge. I think it’s slow, and I think the reason is fairly clear. Compared to other areas of biomedical engineering, there is relatively little funding for addressing global health challenges.

But I don’t think that’s the only reason: I also think we’re relatively late to the game. Public health officials have been working on questions of malaria for probably 100 years or even more, not that they have ignored biomedical engineers in addressing that—remember that building dams and other things is also a key part to fighting malaria. But biomedical engineers are relatively late to the game. It’s only in the past 30 or 40 years that you’ve seen biomedical engineers at all, and probably only in the past 10 to 20 that you’ve seen biomedical engineers focusing on global health.... And I think another issue its that, unlike the public health professionals which have realized for many, many years that they have to be on the ground to address the problem, biomedical engineers are just getting there, where we have key partnership in key locations on the ground.... Even the concept that an engineer would benefit from rotating through a developing world site for 5 to 10 months—or even 5 to 10 weeks for that matter—which is common in public health professionals that are interested in global health issues, even that concept is relatively new. So I think we need to give it some more time before we really develop a full head of steam in this area.

Four years ago, you accepted a role as a representative to the Executive Board of the World Health Organization. What was that experience been like, and in general what role should the WHO play in addressing global health challenges in upcoming years?

There are a few things that you need to understand to understand the role of the WHO. First of all, I was surprised—and I will take full blame for being ignorant—I was surprised at how political of an organization it is. It really is an organization of nations who are trying to cooperate and collaborate to solve these global health challenges, and there really is a huge range of views on these issues. So you end up with a really political body.

But I’ll tell you another thing that you need to think about when you think about the WHO: the entire budget is like $850 million. My son’s school district has a larger budget to serve the county that we live in than the WHO has to serve the entire globe. So this is actually a very small organization, and yet the challenges are enormous. From the point of view of medical equipment, which is really what I know and have interacted the most with the WHO, there basically is now one person at WHO who is focused on medical equipment, exclusively. So of the entire globe, there is one person. As you can imagine, this is a very talented person, but a huge amount of responsibility for a small amount of staff. So I would like to be able to say that the WHO is going to play a very critical role in health care technology, but the reality of the matter is that they are a relatively small player. I think that companies, nongovernmental organizations and private sector actors, like universities, are going to play a much, much larger role moving forward than the WHO is just able to.

I really want to encourage undergraduates to get involved in global health—they can make a difference right now, they don’t need to wait until they have an MD or a biomedical engineering Ph.D. or something like that. There are lots of programs on campus right now—from DukeEngage to the global health certificate and many others—that they can get involved in right now to make a difference.