On June 12 at the Kiira Motors Corporation offices in Ntinda, I met a team of youthful designers and engineers brainstorming around the recently-unveiled Bulamu ventilator.
It was surrounded by different types of wires and gadgets; from laptops to scientific calculators and pipes, among others. Here, the team was putting final touches on the second ventilator prototype before it undergoes clinical trials in a few days. Thatcher Mpanga, the lead product designer, says her team has been working on the prototype since April.
“We are still testing it and we hope to have a product that can be approved by the National Drug Authority (NDA) within the next six weeks,” she says.
HEALTH MINISTRY SET
The unveiling of Bulamu ventilator last week came hot on the heels of government’s plan to host Covid-19 patients at Namboole stadium. During the unveiling, Dr Jane Ruth Aceng, the Health minister, noted that the swelling figures of positive Covid-19 patients have forced government to gazette them a special place of treatment where Bulamu ventilators can be used.
“If many of you have been following closely what is happening in other countries, you see that not all patients are managed in a hospital setting. About 80 per cent of Covid-19 cases are mild and moderate, while 20 per cent progress to severe,” she said.
“If our set up was in such a way that we had homes that are self-contained, we would actually manage patients at home. It is better to remove patients from communities to prevent infections. So, Namboole will accommodate mild patients.”
BACKGROUND
The Bulamu ventilator is a brainchild of Dr Vincent Sembatya, the director for Quality Assurance at Makerere University, who wanted the institution to develop a medical innovation in response to the Covid-19 pandemic.
Developing a mechanical ventilator would be one of the ways in which the institution could contribute to the control of the pandemic, which has affected more than 700 people in Uganda.
So, the university, through its affiliate Resilient African Network (RAN), approached the ministry of Science, Technology and Innovation for support and in turn, the ministry brought on board Kiira Motors Corporation to apply its experience in innovation, engineering and product development on the project.
Under this arrangement, RAN provides the medical expertise and personnel while Kiira Motors provides the design, engineering development and production capacity, including prototyping and manufacturing the products.
Emmanuel Fred Mugunga, the ministry of Science, Technology and Innovation undersecretary says the push to have a ventilator ready in the shortest time was based on the need for Uganda to have the machinery necessary to meet the demand in the event Covid-19 patients reach the stage called Acute Respiratory Distress Syndrome.
“We also wanted to find a way to deliver a product that is affordable in Uganda, considering the high cost of the ventilators on the market,” he says.
“I know someone who imported a ventilator at Shs 75m [about $20,000] but it is a burden to the hospital. That is too expensive for Ugandans, even for government, yet that ventilator can only serve one person at a time. So, this is an opportunity to kill two birds with one stone by making our own ventilators at a low cost that can serve as many patients regardless of their financial capacity.”
Mpanga adds that after intense discussions with various stakeholders, it was realized that a low-cost ventilator is possible because there are international researchers and engineers making low-cost ventilators in response to the Covid-19 pandemic.
“We realized most of them are universities which have collaborated with hospitals and clinicians to provide designs that can be used by innovators worldwide to stem Covid-19 pandemic,” she says.
“So, we benchmarked a number of these open source designs from the University of Florida, the Massachusetts Institute of Technology and other open design ventilator technology developers. We realized we could shorten the product development cycle by adapting the open source design and building upon it to realize a low-cost ventilator that is fit-for-purpose in Uganda with emphasis on supply chain localization.”
SHAKY START
Mpanga admits the first few weeks were tough because no one on the team had ever developed a medical device before.
“We spent a lot of sleepless nights, we were working tirelessly through the weekends as well,” she says.
“When we were working on the very first engineering prototype, we wanted to prove that the software we based on works; so, we developed a prototype with basic respiratory functions but it wasn’t to the point where we could say this is a finished product. A lot more work needed to be done to improve it. Since the ventilator architecture, operational mechanism and underlying technology are similar to vehicular powertrain systems from a technology perspective, the team had the core competencies to realize a ventilator that is fit-for-purpose in Uganda.”
BREAKTHROUGH
It was at that point that a team of experts was formed to include anaesthesiologists from the college of Health Sciences, Makerere University, researchers, product designers, engineers and software developers from Kiira Motors as well as quality assurance personnel from government.
So, that team was able to work tirelessly and come up with an improved prototype designed for use in an intensive care unit or as an emergency ventilator with three respiratory units. The team now has a few more weeks left before final testing to move to the next stage.
“Currently, we are validating and doing some engineering tests on it. The design and specifications have been completed and the next stage will be to undertake animal tests which will be led by a team from the college of Veterinary Medicine, Animal Resources and Biosecurity at Makerere and will not take more than two weeks,” says Mpanga.
Thereafter, the team will start randomized clinical trials on human subjects led by anaesthesiologists and epidemiologists from the college of Health Sciences, Makerere.
The studies will commence with patients who are moderately ill, then scale to patients who are severely ill. These assessments will be conducted at the Uganda Heart Institute. Alongside all these tests, the engineering team will receive continuous feedback to optimize the design and develop a production intent unit.
According to Dr Sembatya, the production intent unit will have to meet all the requirements of a mechanical ventilator without any errors. “When we finish that trial, that’s when we will apply for approval from NDA and thereafter, we plan to make 40 units for the human trials then after we apply for registration of the device still under NDA.”
Mugunga adds that it is everyone’s prayer that the Health ministry succeeds in containing Covid-19 pandemic before it goes out of control but nonetheless, he is hopeful the Bulamu ventilators will be ready to work on any patient who needs respiratory assistance.
COST EFFECTIVE
A website search shows that top-end ventilators cost between $15,000 and $25,000 but according to Mpanga, the Bulamu ventilator will cost about $3,000 [Shs 11m] after production.
“We will have the final pricing after completion of validation and verification stages but our target is a price point of $3,000 and that will definitely go lower as we scale up production.”
BEYOND COVID-19…
Dr Sembatya says the ventilators will remain useful because there are many Ugandans suffering from lung-related diseases which require the use of ventilators. “Tuberculosis patients, for example, greatly need respiratory assistance and, therefore, Bulamu will come in handy to save lives,” he says.
Mugunga adds that production of ventilators will have a ripple effect in that it will create opportunities for anesthesiologists while also reducing patients’ cost on anesthesia.
“We have a lot of brain drain of anesthesiologists due to limited opportunities here. The fact that the Bulamu ventilator will cost thrice less than those on the global market offers many people jobs while also saving lives,” he says.
“You’ve heard stories where a poor patient is removed from a ventilator and it is given to a rich person…that would be eradicated.” He also said plans are underway to do a feasibility study to find out how the ventilators would reach patients in rural areas.
On the other hand, Mpanga is not ruling out venturing into other medical equipment.
“There have been discussions about how we could go beyond ventilators and make more medical devices and equipment in Uganda. That has already proven to be possible. This is being considered by the collaborating entities involved in Bulamu,” she says.
“So, a company may be formed to start making these medical devices in Uganda and the ventilator will be the first product. It’s true the health sector needs a lot of innovations in order to meet the technological needs of our health centres and save countless lives of Ugandans.”
It is early days but Bulamu ventilator could be the wakeup call to increase collaboration of Uganda’s medical and engineering sector for the betterment of our life.