In 2009, pediatricians at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi partnered with bioengineering professors at the Rice 360˚ Institute for Global Health at Rice University in Houston, Texas.
The pediatricians were facing a problem afflicting many families in Malawi: high numbers of preterm babies were dying because they had difficulty breathing. Jocelyn Brown, a graduate of Rice 360˚, explained, “In order to survive, these babies need specialized care and equipment, but this requires resources that most developing countries do not have.”
The World Health Organization reported that as of 2010 Malawi topped the list of countries with preterm birth rates over 15 percent. As Brown described, nearly one in five babies are born before 37 weeks of gestation, and complications from prematurity - including difficulty in feeding, breathing, and regulating body temperature - constitute the largest causes of neonatal death.
Brown was at the fore of a team effort to design a low cost, high impact device uniquely suited to the needs of preterm babies in hospitals like QECH: the Pumani bubble Continuous Positive Airway Pressure device (bCPAP). The Pumani device delivers therapeutic air pressure into the lungs of newborns to treat respiratory distress.
In the developed world, CPAP devices are often used to treat sleep apnea in adults. These devices typically feature a motor and tubing that deliver enough air pressure to keep airways in the lungs open. CPAP is also used to treat respiratory distress in newborns, and this type of neonatal CPAP can often cost thousands of dollars. The Pumani device was designed to be made of durable and affordable parts so that it could deliver the same pressure as traditional CPAP devices at a fraction of the cost. Today, the Pumani device, kit, and training materials can be purchased for a third of the cost of any other bubble CPAP on the market
Brown is now a product manager at 3rd Stone Design, a design firm for medical equipment based in San Rafael, California, where she oversees the production, sales, distribution, and customer support of affordable medical devices, including the Pumani device. Over the last seven years, the Pumani device has gone from a simple prototype to a low cost, commercial-grade technology used by pediatricians in hospitals in multiple countries, and the 3rd Stone Design team has been involved in the design and refinement of the product since its conception.
Brown explained that the clinicians at QECH asked the professors from Rice to create a long-lasting CPAP system. The clinicians had been working with a homemade version of a CPAP machine made from a vacuum pump and spare tubing. However, the clinicians knew that their homemade device was a short-term solution and that it was considered difficult to operate
Brown and other students began designing a replacement CPAP device that would be easy to use and built to last. They started with the basics, looking at what Brown described as the “the parts that would be necessary.”
Their prototype included a plastic box, a Nalgene bottle, and tubing submerged in water. A simple Nalgene bottle provided enough space for the tubing, a crucial feature of an effective CPAP device because the depth the tubing determines the net amount of air pressure. The simple, back-to-basics design allowed the team to create something that could theoretically be effectively introduced in places like QECH. After refining their prototype, the team had to test their device against traditional CPAP machines to determine if it could indeed deliver an adequate amount of therapeutic pressure and treat respiratory distress.
“We routinely went over to Texas Children’s Hospital to test ours and their CPAP systems,” said Brown. “We learned that their systems were delivering the same pressure [as the Pumani device].”
“After completing the lab testing, we applied for IRB approval to begin a clinical study in Malawi in 2012. Clinical results showed that the Pumani device led to a 27 percent improvement in survival rates compared to newborns given nasal oxygen.”
In addition to being low cost and durable, the refined Pumani bubble CPAP device introduced in Malawi had its own built-in air pump, a bonus feature specially suited to the needs of the clinicians at QECH who had no way to pump in the air needed for CPAP therapy.
The promising results from the study helped the Pumani team win transition-to-scale funding for a country-wide rollout in Malawi. After collaborating with the Pumani team for many years, 3rd Stone Design decided to license the Pumani technology from Rice University, so that it could manufacture and distribute the Pumani around the world. Some of the original aspects of the prototype were further refined so that the Pumani device could be introduced in more places.
“We knew the plastic box and the Nalgene bottle were not going to be long-term solutions,” Brown explained. “3rd Stone Design came in and brought the Pumani up to a manufacturable product.”
Brown and her colleagues had begun working with pediatricians in Queen Elizabeth Central Hospital and at Texas Children’s Hospital before the clinical study in order to develop an initial user manual and training materials. Hadleigh Health Technologies, a subsidiary of 3rd Stone Design, helped to oversee manufacturing for the rollout. Thanks to these partnerships, all 27 public hospitals in Malawi now have Pumani bCPAP devices.
Currently, 3rd Stone Design maintains a structure point in its license agreement for the Pumani device, which requires the company to sell the Pumani at a significantly reduced cost for GAVI-eligible countries. The current Pumani device is designed to run for five years, though Brown expects they could last even longer. It has received CE marking recognized in the European Union as well as many African and Asian countries, and it is the same standard as any European medical device that has to go to market.
Brown explains that 3rd Stone Design intends to build off its recent successes to scale use of the Pumani system in sub-Saharan Africa.
“We have sold to 60 customers in 19 countries, and we are continuing to work with major newborn health [organizations] in Nigeria,” she said. “We are also working on rollouts in Tanzania, South Africa, and Zambia.”
In total, Brown views the longevity of the device and its high impact aspects as two of the most important features. “That’s two of our main concerns: durability and the effectiveness of use,” Brown said “We have had to add to the design, despite trying to keep the costs as low as possible. Where we are now is we have a Pumani bCPAP that is durable, affordable, and long-lasting, so that it can help babies breathe for years to come.”