Editor's note: On June 3, 2019, PATH and Sinapi Biomedical announced that the Ellavi uterine balloon tamponade (UBT) has achieved CE marking, signifying that the medical device meets European regulatory requirements. The low-cost, fully assembled Ellavi UBT is now cleared for sales in Europe, a pivotal step to mainstreaming use of this lifesaving emergency intervention in countries with high maternal mortality rates.
It’s dark out when the young woman arrives in labor. With the help of the clinic midwife, Motari, she delivers a healthy baby. There is a moment of joy. And then, things start to go wrong. The mother begins to bleed—profusely—and does not stop.
Motari works furiously, administering drugs, massaging the uterus. But still, the bleeding doesn’t stop. The mother’s blood pressure is dropping, and she’s going into shock. She could die any minute.
This is postpartum hemorrhage. Worldwide, it’s the leading killer of women and adolescent girls during childbirth, claiming more than 130,000 lives a year and accounting for roughly 25 percent of all maternal deaths. Postpartum hemorrhage can happen to any woman during any delivery, but 99 percent of the resulting deaths occur in low- and middle-income countries—particularly those in sub-Saharan Africa and South Asia.
In high-income countries, there are still huge racial and socio-economic disparities in pregnancy-related complications and deaths, but deaths from postpartum hemorrhage are rare because effective treatments are readily available. One particularly important intervention, a device called the uterine balloon tamponade, or UBT, is a standard in wealthy countries. But at a cost of hundreds of dollars for a single use, the version of the device used in high-income countries is far too expensive for low-resource settings.
A global injustice
“It’s simply unacceptable,” says Elizabeth Abu-Haydar, a UBT product manager and public health specialist at PATH who looks for ways to make childbirth safer. “No woman should die from postpartum hemorrhage. It’s treatable.”
That’s why Elizabeth and her colleagues at PATH have spent the last nine years tirelessly working to find a solution. The question isn’t how to treat postpartum hemorrhage—effective treatments like the UBT have existed for years.
The question is—how do we make those treatments affordable, accessible, and appropriate for any setting?
The journey begins
When Elizabeth began seeking answers to this question nine years ago, she found she wasn’t alone. Some health care providers had begun using an improvised device called a “condom catheter.”
Assembled with items that can be found in a clinic, a condom catheter costs one-tenth of the commercial UBT. A condom is inserted into the uterus and filled with water using a syringe and rubber tubing. The water-filled condom expands like a balloon and exerts pressure on the walls of the uterus, creating a tamponade that stops the flow of blood.
Elizabeth and the team at PATH championed the condom catheter as a wonderful short-term solution. Since the device was “self-assemble,” it could circumvent the costly, time-consuming review processes that govern commercial medical devices and start saving lives immediately.
PATH helped pilot the use of a condom catheter in facilities in Kenya, including the clinic in Western Kenya where Motari worked.
After midnight in a village clinic
Motari and the mom are exhausted and scared. This is their worst nightmare. The nearest hospital is two hours away, and right now every second counts.
Then Motari remembers the condom catheter. She hasn’t had to use it yet, and she’s nervous about whether it will be successful. She puts the catheter together, inserts it inside the mother’s uterus, and fills it slowly with water.
After what feels like ten excruciatingly long minutes, a miracle happens—the bleeding stops.
Leading the way to a long-term solution
While the condom catheter is being used to save lives, Elizabeth and the team at PATH have turned their attention to developing a long-term solution.
“The condom catheter is a wonderful stop-gap measure, but at PATH we want to be responsive to end-user needs,” says Elizabeth. “Midwives and health workers were saying the catheter was great, but during emergencies they still needed something preassembled and quality assured. So, we took all that feedback and committed to developing a medical device.”
At PATH’s Seattle product development shop, engineers got to work tensile testing plastics and polymers and designing a prototype. After years of iteration and user-centered design work, the team finalized the design for their UBT. The next challenge? Finding a manufacturer.
How hard could it be?
On the topic of finding a manufacturer, Dr. Patricia Coffey puts it plainly: “There’s no one clamoring to meet this need because it’s not a moneymaker.”
Dr. Coffey leads the PATH team responsible for developing maternal, newborn, and reproductive health technologies. A veteran of health product development, she knows how challenging it can be to bring new devices to market.
“Finding partners to fill these niches is incredibly hard,” Dr. Coffey continues. “When we do, it’s because the companies are committed to saving lives, even when profits are slim or nonexistent. Not every company is willing to do that.”
Thanks to four decades of experience, PATH has developed unique expertise in researching, evaluating, and selecting industry partners for products like these. In this case, an exhaustive search led them to Sinapi Biomedical—a midsize South African manufacturer that had already built a reputation by designing and producing medical products such as a low-cost chest drain to help treat gunshot victims.
Affordable, accessible, and appropriate
Sinapi took the initial PATH-created concepts and optimized them for usability, affordability, and manufacturability. Called the Ellavi uterine balloon tamponade, the final product is now set to launch in global commercial markets.
Best of all? Though the end-user price will vary with shipping, tariffs, and taxes, Sinapi has committed to a public-sector, out-the-door, per-unit price of US$7.50—putting this lifesaving device within financial reach for health systems in low- and middle-income countries around the world.
Dr. Coffey describes the journey so far: “We identified a need where a higher-quality device would be able to save women’s lives. We were able to stick to that vision. Now, we’re at the point where we can make it accessible at a price that’s affordable to the public sector. This is truly end-to-end product development.”
PATH is performing implementation research—finding the best way to put the product into health systems to minimize disruption and maximize uptake—and helping Sinapi make country-by-country plans to introduce and scale the Ellavi UBT.
For Elizabeth Abu-Haydar and the teams at PATH and Sinapi, the coming years will be just as important—and just as challenging—as the last. “Because of our persistence, we now have a long-term solution that will save lives. It’s so exciting!” Elizabeth says. “But we still have so much work to do to ensure women have access to this lifesaving device.”
With regulatory approval and widespread adoption, the Ellavi UBT is expected to save the lives of 169,000 women by 2030. The road to health equity is long and hard, but it can be paved with tenacity.