Interested in learning more? Enjoy this CNN documentary on the A-Lite vein locator on African Voices: Changemakers.
Tell us about your innovation. What is the problem? What solution are you offering? What populations are you serving?
I am the CEO and co-founder of A-Lite Uganda Limited. A-Lite is for-profit social venture and our mission is to improve the quality of healthcare in Sub-Saharan Africa through innovation and applied research. We’re doing this by driving the design and development of context-specific medical device innovation.
Globally, up to 80% of all children admitted into hospital wards require intravenous cannulation for admission of fluids or blood products. However, it becomes a difficult task, even for the most experienced clinicians, to locate a proper vein at the first attempt especially for fat babies or for those whose veins are collapsed. This can result in delayed, failed, or multiple pricking. Clinical studies show that for a health worker to establish a successful intravenous line among children takes an average of two needle sticks over a period of 2 to 13 minutes, with difficult venous access requiring as many as nine cannulation attempts and up to 30 minutes to access.
In an emergency situation, every minute counts. Additionally, even in non-emergent situations, repeated attempts at cannulation are associated with pain, stress, trauma and damage to arteries and nerves. We have even seen patients whose skin has peeled off because the medication has been delivered into the skin instead of the vein, for example. This compromises both patient safety and care, potentially leading to substantial patient discomfort, prolonged hospitalization, increased costs of treatment and even additional downstream morbidity.
"A-Lite has a vision to introduce a medical device to the market that takes into consideration African skin pigmentation. It is only by being on the ground and seeing the difficulties that healthcare providers encounter that the innovators were able to develop this vision."
– Wambui Nyabero, Chief Technology Officer
There are already various devices on the market that have been developed to improve detection of veins, but these options are often not available in this region, are prohibitively expensive, and are not designed for the context and situation of low- and middle-income countries. With this in mind, our team has developed the A-Lite Vein Locator, a lightweight blood vessel illuminator designed to alleviate the clinicians’ work burden associated with finding a patient’s vein. We would like to see far more cases where the vein is found on the first attempt in order to save critical treatment time, spare patients unnecessary trauma, and get the medicine to those who need it as quickly as possible.
What is a recent example of progress? What are you currently celebrating?
We have achieved great progress to date and have so much to celebrate. We are lucky to have been shortlisted among the top 10 ideas to be supported by the United Nations Development Programme (UNDP). It is an honor to be shortlisted for the Youth Ideathon Award and we look forward to the benefits that come with this recognition.
Additionally, we have also been able to acquire approval from the necessary regulatory bodies to clinically test the A-Lite Vein Locator among patients in four health facilities in Uganda. The testing so far has gone through three phases. Phase 1 was a laboratory-based preclinical trial, which was successfully accomplished at Gearbox in Kenya. The device was exposed to conditions that are similar to those in the intended environment.
The second phase was the interventional clinical trial, which was to assess the safety and efficacy of the A-Lite Vein Locator, first on adults. Phase 3 was the comparative clinical trial, which assessed the performance of the A-Lite Vein Locator as compared to the existing standard of care. Some adolescents were cannulated using the standard of care without any assistance, while others were cannulated using our device. The results showed that the A-Lite Vein Locator was able to perform very well as compared to the standard of care, with the clinician able to access the vein in between one and three minutes. Our immediate next step, which is Phase 4, will be performing tests on children and collecting data regarding the device’s performance.
What are the primary challenges you’re currently facing?
Along with the many challenges involved with starting a business, understanding the process of commercialization of medical devices in the Ugandan context is something we’re currently navigating. We are receiving support from Villgro to understand the regulatory compliance required (especially after conducting clinical trials), the regulatory bodies responsible for the approval of medical devices in Uganda and the documentation required to obtain approval, and of course, knowing the CE marking and certification requirements.
Over the course of developing your innovation, what is something you have learned that might help other innovators?
We’ve learned so much. One of our biggest lessons is the importance of documentation, especially in engineering. When we’re doing things like building circuits and other tasks we see as basic, we didn’t know that we actually needed to document every process. If you want to produce a successful product, documentation from the first stage of development is critical.
How has Villgro impacted your growth?
Through Villgro, we have been connected with their huge network of different mentors with different skills. They connect each innovator in their portfolio with someone who knows what you need to know. They have really helped us understand the steps to move us from the prototyping stage to where we currently are in terms of design, development, manufacturing, the regulatory approval processes and eventually reaching the end user.
Additionally, Villgro has funded our project and also connected us to other investors. Within a year of Villgro’s investment, they had already connected us to other funding, which has really supported us moving forward – and they are still supporting us in this way in the background as we continue to grow. We believe that working with Villgro has been essential for us in terms of growth, access to impact investors and access to mentorship. It really has been a very good journey with Villgro.
"Villgro Africa provided seed funding and technical assistance to enable A-Lite’s hardware development, which will take several years to get to market because of the nature of medical device development. This kind of patient capital and assistance is what is needed to develop a thriving medical device industry in Sub-Saharan Africa."
– Wambui Nyabero, Chief Technology Officer