“ALMOST HALF OF THE WORLD’S POPULATION DOESN’T HAVE ACCESS TO DIAGNOSTIC INFORMATION, WHICH MAKES IT IMPOSSIBLE TO GET QUALITY HEALTHCARE.”
Interview with Patti White, CEO, Hemex Health, Portland, Oregon
Being able to identify an illness or disease is the first step toward treatment. But as Patti White, CEO of Hemex Health, explained in an interview with IFC, diagnostic tools are generally not being designed for use in emerging markets. Listening to the needs of healthcare providers in developing countries and seeing their facilities firsthand are an effective way to build medical devices that function successfully even in unpredictable environments. Meanwhile, focusing on keeping costs down at every stage of development ensures that high-quality medical solutions remain affordable.
What led you to focus on designing and manufacturing affordable medical devices for underserved communities?
After two decades running medtech startups, my cofounder Peter Galen and I knew our way around researching, developing, and bringing a range of medical devices to market. We had visited medical facilities around the world and seen that there was a gap in terms of medical devices designed for low- and middle-income countries. People in these communities needed reliable, accurate, easy-to-use, and affordable equipment that could operate in the toughest environments. Since companies were not designing instruments and technology to work in rugged, unpredictable spaces, we knew there was an opportunity to fill a need that wasn’t being met.
Our core competency is identifying strong technology solutions in the development phase at places such as university laboratories. We then leverage these to build simple, innovative, and affordable medical devices. What we do is we operate from both sides. We both look at what’s in development, and we also ask users what would work for them. For example, for our first product, which identifies sickle cell anemia, we started in India and asked clinicians, users, and administrators what they wanted from their diagnostic devices. We built prototypes of what eventually became our diagnostic reader, the Gazelle. We saw we could make such a difference for many people, which really inspired us.
We were also energized by the opportunity to run a sustainable business. We continue to see phenomenal growth in healthcare in emerging markets, like India and African countries, and are excited to be part of it. Fortunately, having a social impact and making a profit are not mutually exclusive.
What are some of the big challenges in operating medical equipment in low-resource environments?
Medical equipment often requires a climate-controlled environment, uninterrupted access to electricity, and trained technical experts to operate the technology. Even most point-of-care instruments stop working around 86°F [30°C], which is problematic in developing countries that can be hot and humid and have unreliable access to climate control. Remote communities in these regions may experience power outages and are generally not equipped to maintain pristine conditions needed for sensitive medical devices.
We designed the Gazelle and disease-testing cartridges to function in environments up to 113°F [45°C]. They were built to withstand dust, vibrations, and movement, and rigorously tested in harsh conditions. Our devices are intuitive to use, with automated interpretation of results so that entry-level healthcare workers can easily use them. Most importantly, they are affordable. Keeping costs down is always top of mind.
One issue in low-income countries is making sure people are trained properly and equipment is well maintained. How do you manage that?
Gazelle was designed with training assistance and maintenance built in. The device interface is similar to a smartphone. There are onscreen videos that walk users step by step through the process of preparing a sample obtained from the patient for the test. Gazelle analyzes the samples to identify errors and coaches users on corrections and possible errors made in the preparation process. Since the device provides the interpretation of results automatically and stores patient information and results digitally, we avoid many human interpretation and transcription errors. Customer training can be provided by in-country distributors, but many customers are up and running on their own using our written instructions and training videos available on the web.
User maintenance is not required other than keeping the device clean. The device was validated for a five-year life with high usage.
How big is the gap in early diagnosis rates for treatable conditions for developed versus developing countries?
Almost half the world’s population doesn’t have access to diagnostic information, which makes it impossible to get quality healthcare. Sickle cell anemia is a prime example of how important diagnostic services are. The World Health Organization says that 70 percent of children with sickle cell disease under age five in even the highest prevalence regions can survive into adulthood if diagnosed and treated with cost-effective regimes, such as nutrition, pneumonia vaccinations, and prophylactic penicillin. However, 90 percent of those with sickle cell disease live in regions without access to diagnostics.
Why does early detection matter?
Sickle cell anemia presents in babies as early as five to six months old. An early diagnosis means that children can be treated with prophylactic penicillin and a pneumonia vaccine. Parents would also know to protect their children from common illnesses that would be harder for them to fight. Doctors could administer hydroxyurea, a generic drug that can reduce pain crises associated with sickle cell anemia, which is the standard of care in the United States. Educating parents and initiating affordable, effective treatment dramatically changes the health outcomes for children, but that hinges on a diagnosis.
What’s been the impact of this device on sickle cell anemia care?
It is estimated that for every 100 persons tested in high-prevalence regions for sickle cell anemia, two will test positive for the disease and more than half will die by their fifth birthday. We have sold 170,000 individual testing cartridges in countries like India and Ghana with high disease rates. This translates to probably saving 1,700 lives and thousands of families who don’t have to go through the devastating loss of a child.
In regions like Sub-Saharan Africa, it is estimated that 2 percent of the population have the disease and 25 percent carry the genetic trait. If these individuals with [the] trait are made aware that they might pass down sickle cell anemia, they can make informed decisions about marriage and would know to have their children tested early. The potential to save lives is profound.
How did you design your product to be user-friendly and reliable in unpredictable environments?
We evaluated many innovative technologies and licensed two from Case Western Reserve University and miniaturized them to work with Gazelle. Before turning the technology into products, we spent time in India and Africa to understand the critical requirements so we could build the right solution. We focused on creating robust devices that were accurate, easy to use, and affordable. Part of making our products usable in a wide range of settings required advanced functionalities like image quantification and AI.
Our products also utilize consumer electronics components, like smartphone cameras and lights, because the parts are high quality, inexpensive, and durable. The Gazelle is battery-operated but can be plugged into a mobile phone charger because everyone has one. New diseases are added to the diagnostic reader and come through as software upgrades. Now for example, we can also read Covid in addition to sickle cell anemia and beta thalassemia. Users simply connect to the Internet or can upgrade manually via a memory stick. We look forward to seeing how medtech in developing countries evolves because it looks like the opportunities are limitless.
This interview has been edited for length and clarity.
Published in July 2022
Patti White is the CEO of Hemex Health, which designs diagnostic technologies for the real world by listening to the needs of healthcare providers including those in some of the most remote and challenging settings. Her career has focused on finding and building solutions that make a difference in people's lives. She started out as a pioneer in personal computers and then moved to medical, where she has commercialized medical technology, established global distribution channels, created strategic partnerships, and built new companies. White has an MBA from The Wharton School at the University of Pennsylvania and a BA in finance and international business from the University of Washington.