WDI conducted a review for the Global Fund with the goal of leveraging ongoing Diagnostic Network Optimization initiatives, as well as performance metrics in selected countries and other existing data sources on investments in GeneXpert technologies, to support robust cross-country comparisons, and develop a conceptual framework for addressing cost efficiency questions for multi-disease integrated testing platforms. The work entails developing a Theory of Change that recognizes the complex relationships between cost-efficiencies and other components of the Global Fund’s Value for Money concept, including effectiveness, equity and sustainability.
WDI is partnering with the U-M School of Engineering’s Global Health Design Initiative, the Aerospace Engineering department and a doctor in Ghana to iterate on a design of a hand rehabilitation device with an eye toward commercialization in a Ghana Rehabilitation facility. The latest prototype was produced using 3D printing and the new “Grip Forté” is currently being field tested in Ghana. The team is expanding the project building a 3D printed PETG recycling device.
Just over the border with Yuma, Arizona is the town of San Luis Río Colorado in Sonora, Mexico. Like many border communities, agricultural jobs dominate the local economy. In this community of around 200,000, Grupo OSME is a privately run medical clinic business, founded by Dr. Raúl Payán, focused on serving the health needs of agricultural workers and their families. Despite the success of the business, Payán explains that securing the necessary financing to expand OSME into a hospital has been a major challenge. But in early 2023, the North American Development Bank (NADB) and Grupo OSME signed a US$14.2 million loan agreement to finance construction of the medical complex. The deal was completed after WDI conducted due diligence on OSME’s expansion and business plans, which gave NADB the expert advice it needed to proceed with financing. The project includes the design, construction and operation of a private hospital with space for 67 beds, an emergency room, operating rooms, intensive care unit, medical imaging and laboratory, along with a medical specialties center. As the following video feature explains, at the time of this project, WDI was also developing a Healthcare Delivery Management Training program, following a request from the World Bank Group’s International Finance Corporation. Following a positive experience of the due diligence process, OSME requested training for its management team from WDI. As a result, OSME and a Ghanaian hospital were the first two businesses to participate in the course.
Pressing global health concerns, from undetected cancer to untreated psoriasis, require innovation to find powerful, lasting solutions. Often, that kind of innovation comes from small teams, start-up companies, and underfunded research groups — but, for these teams to be successful, they need support.
The William Davidson Institute (WDI) and the Center for Global Health Equity (CGHE) at the University of Michigan (U-M) came together recently to assist with filling in that piece of the equation.
“There is a lot of research happening at the University of Michigan that could lead to impactful products or services in low- and middle-income countries,” said Paul Clyde, President of WDI and professor at the Ross School of Business. “Assisting and accelerating that work, through both funding and technical assistance, is very much in line with our mission.”
To support that growth, Fast Forward Medical Innovation, a department at the U-M Medical School, offered a professional development course with a focus on key business commercialization principles, which began in January 2023. For the first time this year, WDI and CGHE followed this course with the Global Health Commercialization Competition. The competition invited faculty innovators to share their work on technical solutions to healthcare problems in emerging markets. Responses to the request for proposals were due on April 1, 2023. Four finalists were selected from the group, and each one presented their pitches to judges on May 22.
Ultimately, one team took home a $30,000 prize and a chance to work with MBA students at the Ross School of Business to refine their plans.
Each proposal was centered on a clearly defined, unmet need in low- and middle-income countries (LMICs) and an innovative solution to enhance the lives of people in these regions. These solutions had to be commercially viable, and teams were required to outline market timelines.
In line with similar pitch competitions, presenters had the chance to highlight the significance of their work — and their own enthusiasm for the solutions. “These pitch competitions give the proposers the opportunity to sell their idea. Sometimes, when we’re reading proposals, we’re missing some of the passion. We’re missing the background about what makes these approaches exciting and relevant,” said Dr. Joseph C. Kolars, founding director of the Center for Global Health Equity and Senior Associate Dean and Professor at the University of Michigan Medical School.
“It’s an easier way for us to understand the ‘why’,” he explained.
The first of the four teams to present at the competition, Saratani, is working to improve outcomes for cancer patients in Africa and taking aim at the lack of effective diagnostics. “One of the most important tools in ensuring better cancer outcomes is ensuring early cancer detection,” said Geoffrey Siwo, Research Assistant Professor of Internal Medicine at the U-M. His team also included Robert Karanja, Co-Founder and Chief Innovation Officer at Villgro Africa, and Deogratias Mzurikwao, AI Lead at Villgro Africa.
Saratani, named after the Swahili word for cancer, aims to diversify the biological data used to create the reference genome for molecular diagnostics, which is currently designed on Caucasian genetic data. This leaves massive gaps in the data, making it ripe for problematic diagnoses in Africa. Biobanks in Africa hold the information to fill this gap, but the bridge between them and pharmaceutical companies is missing. That’s where Saratani plans to step in. It would function as a marketplace, avoiding the overhead of running a biobank and capitalizing on the potential widespread deals that could be built between small biobanks and large pharmaceutical organizations.
While Siwo acknowledged that these biomarkers are not yet widely used for detection in Africa, he encouraged support for their preemptive and proactive work. “If we wait until these biomarkers are widely used, it will be very difficult to change, and we know they are inaccurate,” he explained.
Penicillin allergies riddle medical records across the U.S., but it could be that up to 90% of people with this notation have been mistakenly diagnosed. This particular allergy marker keeps patients from treatments that protect against site infections during surgeries and superbug infections during hospital stays. In LMICs, false penicillin allergies could make certain treatments totally inaccessible.
EpiSLS aims to make allergy testing simpler, from correcting those false positives to providing clear answers about food allergies. Parker Martin, an MD and MBA student at the U-M, and Cory Cooney, a 2023 U-M MBA graduate, created a novel optical sensing technology that is compact, portable, and safe for any patient who might get an in-office allergy test. For clinics in emerging markets, the tool — which is currently patent pending — could mean bringing sustainable allergy testing to regions where there has not ever been an allergy specialist.
Through their easy-to-administer and even-easier-to-read technology, the team is set on “bringing allergy testing into the 21st century across the world.”
Psoriasis is a chronic disease that causes psychological and physical suffering when left untreated — and, in LMICs, this is often the case. While medications can treat many symptoms of the condition, they aren’t available in emerging economies. The costs are prohibitive, the production is not available, and the administration is a challenge. The Psoriasis RX team, led by Tom Kerppola, Professor of Biological Chemistry and Biophysics at the U-M, has set its sights on changing that dynamic.
“The problem is enormous,” Kerppola explained. There are about 100 million people suffering from psoriasis at the moment, and a substantial number are not finding any relief. “Regrettably, the only drugs used in low-income countries have very low efficacy, barely better than placebos,” he said, explaining that that’s not the case in high-income countries. “It’s clear we can do better.”
His research is centered on the Keap 1 protein, which could suppress inflammatory responses in skin fibroblasts without the risks of systemic infection that often come with immunosuppressant drugs. “This is not an untreatable condition,” Kerppola said, and he’s on his way to finding a treatment that works for patients regardless of geography.
Over 70% of women around the world have not been screened for cervical cancer, and part of the reason is access to and comfort with the current medical tools required for these screenings. At the moment, the exam for cervical cancer screening requires a vaginal speculum, an exam table with stirrups, and a person who is physically and emotionally able to handle the exam. For many around the globe, those requirements just cannot be met.
In search of a way to reach these women, Marilyn Filter, a Certified Nurse Midwife and Associate Professor at the University of Michigan – Flint, and Lyn Behnke, Board Certified Family Nurse Practitioner, Psychiatric Nurse Practitioner, and associate professor at the U-M – Flint, built a new tool. The Femscope Calm Collect system is a slim cell-collection device with a scope that would replace the speculum and swab typically used. Providers can learn to use it in under an hour, it connects to a smartphone or computer, and patients can receive the exam without an exam table.
“We have made it our mission in life to improve patient outcomes,” explained Filter. Their accessible tool is less expensive, easier to use, and more comfortable for many patients — all traits prioritized to improve screening rates for people around the globe.
The team is on its way to completing its pilot study to ensure biopsy results are of the same caliber as a traditional exam, then the product will move to a full clinical trial and eventually head to market around the globe, Filter said.
Judges Ioan Cleaton-Jones, Senior Director of Healthcare Delivery at WDI, Pascale Leroueil, VP of Healthcare at WDI, Amy Conger, Managing Director for the Center for Global Health Equity, Kolars, Brad Martin, Managing Director of Fast Forward Medical Information, and Dr. Lee Schroeder, Associate Professor of Chemical Pathology at the University of Michigan, faced the difficult task of choosing a winner. They considered the presentations, asked questions of the teams, and came to a decision: The Femscope team took home the prize.
Filter and Behnke plan to use the funds to purchase a 3D printer and fund its pilot test — the first essential steps to get the life-changing product into the market. Once there, “it will certainly save lives,” said Filter.
Medicines for Malaria Venture (MMV) is a nonprofit organization that works with partners to discover, develop and deliver new, effective, and affordable antimalarial drugs. One of MMV’s current projects is to develop a long-acting injectable product to protect children at risk of malaria. To ensure the product would achieve its goals, MMV needed clear guidance on what was most important to clinicians treating pediatric patients in malaria endemic countries. Getting there required understanding the business and real-world clinical side of taking a health product to market. This is familiar territory for WDI’s Healthcare team.
To find the best path forward for its injectable, MMV sought answers from the drug’s final users. As it updated the injectable’s Target Product Profile (TPP)[CA1] , which is a compilation of the desired characteristics that will make up a product or device, MMV wanted to know what aspects of the new product would create the most value for clinicians administering it to children.
“When you develop a product, there are a number of elements that you can act on, and we wanted to know, from the local stakeholders, that is the people in the field, the decision-makers in the countries, what matters to them,” said Céline Audibert, Director of Market Research, Access & Product Management at MMV.
Audibert enlisted WDI’s help to better understand those elements. WDI’s Healthcare group wrote and carried out a survey in six African countries — some of the places that would benefit most from such a product. It was sent to healthcare professionals and public health officials, including those in charge of maintaining nationwide malaria-related efforts, in Cameroon, the Democratic Republic of Congo, Senegal, Ghana, Mali, and Nigeria. The survey covered a series of characteristics in an injectable product, including duration of protection, efficacy, number of injections, volume per injection, needle size, and tolerability. It laid out various options with different levels of each characteristic and asked participants which ones they would choose.
This method of choosing various combinations of parameters, rather than simply asking for a ranking, was intentional. It forced a choice, thereby providing a deeper understanding of the importance of various elements. When a large enough group of participants are pushed to make trade-offs, researchers can uncover what truly matters to the population.
Uncovering preferences for the product characteristics was the objective of the study — and key to developing an injectable that would be both adopted and effective. “In the past, there wasn’t a focus on the needs of a particular group of people, at the country or regional level,” said Pascale Leroueil, Vice President of Healthcare, who led the research. “The more we build Target Product Profiles specific to the countries where we’re introducing new products, the better.”
WDI didn’t need to reinvent the wheel to develop its survey and methodology. The Institute has been gathering and analyzing data for decades to support business-centered solutions that drive economic growth and social freedom in low- and middle-income countries. In this case, it applied a well-tested system in a space where it had been rarely used.
“There are tried-and-true methods that are utilized in the private sector that we can apply to this area, and WDI does that better than most,” said Leroueil.
Leroueil and Ben Davis, WDI Senior Research Fellow, proposed the methodology to Audibert, who was familiar with it from her previous private-sector work. They both understood the core purpose behind the answers they sought. “There are reasons people want something,” explained Leroueil. Supply issues, cultural preferences, and geographic needs can drive the acceptance or denial of treatment — and no amount of after-the-fact adjustments will bring the same benefits as early-stage consideration.
The results were promising. “This research has confirmed some of the things we believe. There were characteristics where we had a lack of understanding internally and needed information from the field, so we had very clear answers on what matters and what doesn’t,” Audibert said.
The value of getting these answers at the start of the development process is broad and inclusive. Investors and donors can be sure their money is being put to effective use, drug development teams can focus their energy on the aspects of a product that matter most, and patients can get the drugs that serve them best.
Efficiencies in development matter to nonprofits like MMV. “When you have a restricted amount of money to invest, you need to know where you’re going to put that money,” said Audibert. MMV is currently working on funding for the continuation of the project, so this information will be used, in part, to demonstrate how the injectable can better meet the needs of the populations they plan to serve.
The research also makes a major difference for scientists, developers, and those in the business of drug delivery. Audibert expects that having these answers will help optimize the time and investment spent on drug development and support better-informed decisions. With a focus on what counts, researchers can create the best possible product for the population.
Finally, patients are more likely to accept treatments that fit their needs, and that acceptance can support healthier families, communities, and countries.
“Businesses that know how their customers will use their products usually have the edge over those that wait for feedback after a product is launched,” Leroueil said. “It’s exciting to see organizations like MMV take this approach.”
Henry Ford Health (HFH) has been doing work in the international space for more than 8 years. Expanding their international portfolio is part of the HFH strategic vision. This project provided research on t he regions t hat offer t he most opportunities and fit for W DI to pursue additional projects and partnerships that align with WDI’s existing portfolio of international projects.
The Global Fund works closely with countries to help them achieve long-term sustainability of health programs, so they can maintain progress and continue to expand services after Global Fund support ends. WDI is conducting an in-depth desk review for the Global Fund with the objectives of strengthening guidance for Global Fund countries to effectively implement Performance for Results (PfR) modalities, supporting the development of a PfR modality that is appropriate for the Global Fund context, and developing an approach that would provide support to the Global Fund countries and ensure that the National Strategic Plans for the next round of funding are appropriately costed.
FIND promotes affordable diagnostic tests for poverty-related diseases. WDI is creating a conceptual framework for them that describes their current and future areas of work, including many of the elements typically found in a strategy. To do so, WDI is digesting existing documents, meeting with the organization’s leadership and stakeholders and synthesizing this information to be understandable to a broad audience. The WDI team will deliver a short document and slide deck outlining the conceptual framework.
WDI is partnering with the U-M School of Engineering’s Global Health Design Initiative and the Aerospace Engineering department to iterate on a design of a hand rehabilitation device with an eye toward commercialization in a Ghana Rehabilitation facility. The initial prototype was constructed of wood and the next iteration will be produced using 3D printing. The team is exploring working with Hewlett Packard in Africa.
Q&A
with Pascale Leroueil, WDI Vice President for Healthcare
As the pandemic has revealed, vaccine coverage in low- and middle-income countries is well below that of higher-income countries. And while global attention tends to focus on a vaccine’s efficacy through R&D and clinical trials, there is less understanding about what factors lead to people ultimately receiving a vaccination. This knowledge discrepancy led WDI Healthcare Vice President Pascale Leroueil and fellow researchers to hone in on the role a particular technology may have in the overall success of a vaccine in terms of population coverage. This can include factors such as how vaccines are administered (needles versus orally administered vaccines, for example), and cold-storage supply chains. In a recent study, Leroueil and co-authors present a method for estimating the impact of vaccine technologies on vaccination coverage rates. They designed the method to help decision makers better assess the most value for their money, with the goal of improving vaccine coverage for vulnerable communities.
We wanted to help donors think about the potential impact of their research, manufacturing and deployment decisions related to vaccines. The wonderful thing about research and product development is that the options of where to invest are nearly endless. But money and time aren’t endless, even for donors. We had been asked by a global donor to help them think about the relationship between a given vaccine technology and its associated vaccination coverage rate. For example, if countries had access to a microarray, patch-based vaccine delivery system that could replace the standard syringe and needle delivery system, what might that do to vaccination coverage rates across the world? As a first approximation you might answer, “not much.” However, if you start to think about the operational implications of what it means to move from something that requires a mid-level skilled healthcare worker such as a nurse to a less skilled healthcare worker such as a community health worker, then you can start to see how changing the delivery system could lead to higher vaccination coverage rates. We thought an approach that could quantify the potential vaccination coverage rates that could be achieved with different vaccine presentations would be useful to many types of stakeholders, including donors, manufacturers and country-level decision makers.
We started with the assumption that vaccination coverage rates are a function of two things: (a) the barriers to vaccination in a given environment and (b) the characteristics of the vaccine presentation. As I alluded to earlier, some vaccine technologies could mitigate or remove some barriers in some contexts. For example, one barrier in a given context might be lack of refrigeration. Therefore, a vaccine that doesn’t require refrigeration would remove this barrier to vaccination for the people in this context. We ended up defining six barriers to vaccination that we felt could be overcome by changing the vaccine presentation, or how it’s administered to a patient. From there, we had to think about how we would turn our relatively simple assumption into numbers that would allow us to say something to the effect of, “If Country X had access to Vaccine Presentation Y, they could achieve a vaccination coverage of Z%.” We turned to something called, “probability theory,” which is something you likely learned in middle school. Basically, it says if the probability of A happening is a, and the probability of B happening is b, the probability of both A and B happening is a x b. The math we used is slightly more complicated, but the general idea is the same. Namely, the probability of a person in Country X with access to Vaccine Presentation getting vaccinated is the product of the probabilities of a person overcoming each of the six barriers we defined.
One of the neat things about our approach is that it can be used at any point along the vaccine development pathway. From someone thinking about research & development to someone considering vaccines, this approach allows them to estimate the maximum demand for a particular vaccine presentation.
The quick answer is that it could help vaccine manufacturers forecast potential demand for a particular vaccine presentation. Vaccine manufacturing is a complex and expensive business that relies heavily on scale to make it work. Realistically, a manufacturer needs to have a pretty good understanding of how many vaccines they will be able to sell and at what price before they decide to start manufacturing. This approach allows them to understand the former, while another approach we are developing allows them to understand the latter.
Donor organizations in the vaccine-related space would use this approach to guide their investments, whether that’s at the research and development stage, or manufacturing stage. For example, say a donor has five vaccine presentations in the pipeline, all against the same disease. Now say they want to move only two of those vaccine presentations forward. How do they make the decision about which vaccine presentations to move forward? While there are probably a few parameters that go into that decision making process, one of them is most certainly the potential vaccination coverage that each of the vaccine presentations could yield. In many ways, the Ministries of Health are making similar decisions—for a given disease, which vaccine presentation should the country purchase? Again, there are likely a few parameters that go into that decision making process but one of them is most certainly the potential vaccination coverage.
Absolutely. The approach we outlined in the paper can be used as-is for any vaccine-related technology. In principle, one could extend this approach to almost any product or service, whether it is health-related or not. What would need to change is the ‘barriers.’ For example, if we’re talking about an ultrasound, access to refrigeration is probably not a barrier to treatment but access to power probably is a barrier to treatment. Although vaccines are near and dear to our heart, we intentionally developed an approach that could be adapted to other products or services.
The importance of considering the contexts in which a vaccine presentation will be deployed. I want to be clear and say what was done in terms of vaccine development, manufacturing and deployment was nothing short of a miracle. Having said that, the pandemic shined a huge spotlight on the barriers to vaccination that exist for many people across the world. The refrigeration requirements for some of the presentations were a significant barrier in many countries, as was the need for multiple doses and access to skilled health workers. The result? Staggering levels of Covid-19 vaccine inequity. That vaccine inequity would exist at all is terrible, but that it still exists is unforgivable. Those with resources in the vaccine space should be actively developing more platforms that help reduce the barriers to vaccination for those with the fewest resources. Although our approach could help decision makers estimate the potential impact of doing this, I can only hope it’s now self-evident that identifying ways to address these barriers before the next pandemic is critical to our survival.
About WDI
At the William Davidson Institute at the University of Michigan, unlocking the power of business to provide lasting economic and social prosperity in low- and middle-income countries (LMICs) is in our DNA. We gather the data, develop new models, test concepts and collaborate with partners to find real solutions that lead to new opportunities. This is what we mean by Solving for Business — our calling since the Institute was first founded as an independent nonprofit educational organization in 1992. We believe societies that empower individuals with the tools and skills to excel in business, in turn generate both economic growth and social freedom — or the agency necessary for people to thrive.
WDI’s Education team works with world-class instructors from leading universities — including our home at the University of Michigan — to develop and deliver programs. Through our rich faculty network, cultivated over the past 25+ years, we deploy experts with both deep subject matter expertise and relevant regional experience.