At Jimma University, a team of researchers invents its own neonatal monitoring device

The project starts from a real unmet clinical need. The Jimma University team carried out a needs assessment across six Ethiopian health facilities in Jimma zone, covering around 1,912 neonatal admissions. “We found that there is a shortage of medical devices, especially functional medical equipment. And there is also limited staff training,” as Derartu Dereje explains. In many neonatal units, existing monitoring equipment is either missing or underused due to the constraints mentioned above. In fact, imported devices often reach physicians with limited training or none at all, and their interface is complicated: healthcare workers end up relying only on a few basic functions.

These challenges gave rise to very concrete engineering requirements. These include unreliable electricity, high equipment and spare part costs, unavailable spare parts, sensors that fail within a short period of time, and the size of the sensor for newborn babies. “Those challenges became engineering requirements in our design. We prioritized battery operation, simplicity, maintainability, affordability, durability, local manufacturability and ease of use with minimum training requirements for healthcare professionals,” sums up the researcher.

The first prototypes designed by the team relied on a finger-based sensor for pulse oximetry, a measurement that continuously tracks the oxygen level in the blood, heart rate. The device also monitors temperature. But healthcare workers quickly pointed out a difficulty: in a premature newborn, the very small finger size makes it difficult to obtain an accurate measurement. After collecting feedback from the healthcare workers, the researchers redesigned the device around a wrist-based sensor, better suited to the morphology of newborns.

This dialogue is anything but occasional: it is built into the team’s way of working. Being very close to the clinical environment, with Jimma University Medical Center nearby, the researchers work with pediatricians, nurses and neonatal staff from the earliest stages of design. “We are not only developing devices,” says Derartu Dereje. “We are also strengthening the local innovation ecosystem, because at every step, physicians are involved in the design process.”

The road from prototype to medical device is a long journey. Derartu Dereje outlines the engineering design process her team follows: clinical need assessment, engineering requirements, design specification, prototype development, end-user feedback from end users (from pediatricians and neonatal nurses), laboratory-based tests with different simulators (benchmark testing), then redesign. Standards and conformity testing and the pre-conformity assessment come next, which further improve the device.

This process taught the team a lesson it considers essential from the early stage: a prototype that works in the laboratory is not enough. “A prototype is not a product,” the researcher insists. If standards and regulatory pathways are not considered at an early stage of the design, even a very good prototype risks never leaving the laboratory shelf.

To use the device in the clinical environment, the team also learned that technical performance alone is not enough. In the laboratory, the focus is first of all on the accuracy of the devices, the electronics and the system integration. But in a real hospital setting, an accurate device can still fail: a poorly placed sensor, a complicated interface or insufficient staff training is enough to compromise its use. “We have to design a device which is accurate, affordable, and appropriate,” sums up Derartu Dereje.

It is precisely at this pivotal stage, when a prototype validated in the laboratory has to enter a genuine regulatory pathway, that FID’s support played a decisive role. It enabled the team to fund the conformity process and the pre-conformity assessment, and above all to move beyond a purely academic approach.

“Without FID support, maybe the device would still be on the shelf,” says the researcher. “FID support allows us to move from academic concept towards a real medical device development pathway and impactful innovation and also helps us identify the real infrastructure needed to start establishing the Neothiopia TRID Lab, which enables other researchers to develop innovations in a lab environment and strengthens the innovation ecosystem.”

For the researcher, the stakes go beyond the neonatal monitoring device alone: “Our aim is beyond manufacturing the neonatal monitoring system,” explains Derartu Dereje. “Shaping the local innovation ecosystem for medical devices in Ethiopia and other low-resource countries is one of our critical areas.”

Cost is a key lever. In Ethiopia, imported equipment accounted for approximately 96.5% of the medical-equipment market in 2023, according to the U.S. International Trade Administration. Many of these devices have complex interfaces and require specialized training, which can limit their effective use in resource-constrained healthcare settings. The NeoThiopia device developed at Jimma University is estimated to cost approximately US$150 per unit in small-batch production, compared with nearly US$3,000 for certain imported multiparameter patient monitors, although their functionalities differ. Locally developed devices also offer advantages in maintenance, calibration and spare-part availability, and allow healthcare workers to be trained in their own language, supporting more sustainable healthcare delivery.

The project is now entering its field phase. The team has started the process with Ethiopia’s regulatory authority, the Ethiopian Food and Drug Authority (EFDA), with a clinical protocol ready to be submitted. Between December 2026 and January 2027, the device will be deployed in six selected health facilities for a pilot evaluation. There, it will be used in real-world conditions by healthcare workers with hospitalized newborns, to verify its reliability and ease of use before any wider rollout.