DO Medical Team Achieves Breakthrough Developments in Wound Therapy Device Design & Establishes New Healthcare Partnerships in Kenya
“He heals the brokenhearted and binds up their wounds.” Psalm 147:3
In the past year, our DO Medical team made breakthroughs in the design of the negative pressure wound therapy (NPWT) device, which will provide an affordable, reliable, and electricity-free option for treating severe wounds that take far too many limbs and lives in developing countries.
A Year of Great Progress
In 2023 alone, our engineers developed a working design concept, built a proof-of-concept prototype, and completed a feasibility study on healthy subjects in collaboration with our partner, Malamulo Mission Hospital in Malawi.
During the feasibility study, which was completed in November, the team gathered quantitative data on the prototype’s performance and qualitative data pertaining to human-centered design and ethnographic factors. The goal was to observe how users interact with the device and gather their feedback.
As part of the study, our engineering team connected the device to dressings on mock patients without wounds and allowed the medical team to interact with the prototype device with minimal instruction to collect information on usability. The team also captured pressure data, the main benchmark of functionality.
Feedback from physicians, nurses, and medical technicians using the device was so positive that they indicated they would immediately request 25 to 30 units, and several nurses asked if they could keep the prototype. While leaving a proof-of-concept prototype to be used on patients was not possible, the request was proof that the project is moving in the right direction. “That was really encouraging to hear them say that,” said Hannah Tilley, Project Engineer II who facilitated the study at Malamulo. “It highlighted that they really need this product and put an urgency on us.”
The medical team also commented on how quiet the device is, emphasizing that “it will be so relaxing for the patient.” With limited resources, rural medical facilities are forced to resort to devices not originally designed for wound therapy. At Malamulo, they rely on a suction machine intended for use in surgery, which is loud and has a motor that burns out when used for NPWT. “But that’s the best they can do for a wound vac,” Tilley says.
The feasibility study was also a critical step in the FDA-approval process.
“The team succeeded in developing a wound vacuum device that can hold the required vacuum for the required amount of time without an electric motor,” says Mark Heldreth, DO Medical Engineering Fellow who has been involved in medical device development for the last 35 years. “That’s really important, of course, for the market we’re targeting because in central Africa only 10% of the population has any access to electricity, and it is really not very dependable at all. It often shuts down or there are huge voltage spikes that destroy the medical equipment hospitals have. Every hospital we’ve spoken to has lost equipment due to voltage spikes.”
A Critical & Urgent Need
During the process of developing this device, the DO team has heard heart-wrenching stories about the critical needs in under-resourced hospitals—stories that push our team to keep working tirelessly to see this project to completion even in the face of multifaceted design challenges and the complexities of FDA compliance.
“These people don’t have the fundamentals,” Heldreth says. “One of our clinicians who works at a mission hospital in southern Niger said they take sterile gloves, wash them out, put them on a clothesline to dry, and use them the next day. One of the doctors we work with in Kenya says they have no dressings to use (for wounds) so she goes to the local market and looks for seat cushions. She’ll breathe through the seat cushion to make sure the air passes through so it’s usable. They cut it up into pieces and then sterilize it. That’s what they are using to cover wounds.”
The needs are great, and DO is committed to meeting them with excellence.
New Partnerships for Greater Impact
The physician in Kenya Heldreth is referring to is Dr. Celeste Adrian, a wound care expert and a surgeon at Kapsowar Mission Hospital where DO team members Tilley, Jonathan Kalala, and Matt Reimink visited in August 2024 to establish a partnership with the hospital and further advance the NPWT device project.
Design Outreach chose Kapsowar Mission Hospital as our newest healthcare facility partner because of their expressed need for reliable NPWT devices, their ability to support a partnership, and Dr. Celeste’s passion for wound care in Kenya.
“Dr. Celeste’s makeshift NPWT devices, with dressings made from seat cushions, have saved several patients from limb amputations,” Tilley says. “Many of the other hospitals would have gotten to the point of needing to amputate because they just couldn’t get the wound under control.”
With the right equipment, like the device DO is developing, Dr. Celeste and her team could save many more limbs and lives.
As a result of DO’s recent trip to Kapsowar Mission Hospital in Kenya, Dr. Celeste will be joining DO’s Healthcare Advisory Panel, we have new inroads for potential clinical testing, the team received valuable insight into international regulations, and we further validated user needs.
Doctors, surgeons, and nurses alike at Kapsowar were enthusiastic about DO’s device, and they are eager to begin using it regularly in their care of patients with severe and chronic wounds, Tilley says. Most encouraging, however, was hearing from patients at Kapsowar Mission Hospital and recognizing what a valuable partnership this will be both for improved medical care and for the care of souls in need of the hope that comes only from Jesus Christ.
“Patients are very thankful for the care they receive at Kapsowar,” Tilley says. “One man had received a Bible and prayer from the chaplain there, and he said after he gets healed he wants to join a church because he wants to follow God when he leaves the hospital. For us to be able to come alongside Kapsowar with tools they can use for ministry to help better their care of patients would be huge because they are healing people, saving limbs and preaching the word of God. So that would be a great opportunity for us to live out exactly what DO’s goal is: to come alongside partners and advance the Gospel through our technologies.”
The next steps in the NPWT device development are a formative usability study, clinical trials, and final FDA approval.
