Non-Invasive HPV Screening Device Wins 2024 Global Health Competition

Healthcare

From left to right: Dr. Joe Kolars, the founding director of the Center for Global Health Equity, professor of Medicine and Health Professions Education in the U-M Medical School and professor of Health Management and Policy in the U-M School of Public Health; Claire Hogikyan, Vice President of Administration at WDI; Dr. Lee Schroeder, Associate Professor, Chemical Pathology at Michigan Medicine, Dr. Thiyagarajan, Dhanalakshmi; Ioan Cleaton-Jones, Director of Healthcare Delivery at WDI; U-M undergraduate student Natasha Mehta; Noel Watson, CEO and Chief Executive Officer of Southerly Pharma; and Dr. Shane Quinonez, Clinical Associate Professor at C.S. Mott Children's Hospital. Kolars, Schroeder, Cleaton-Jones, Watson and Quinonez served as judges for the pitch competition.
Judges listening and taking notes during the presentations.
Dr. Thiyagarajan, Dhanalakshmi (left) and U-M undergraduate student Natasha Mehta (right) during their presentation.
The case competitions winners Dr. Thiyagarajan, Dhanalakshmi (left) and U-M undergraduate student Natasha Mehta (right) holding an oversized check for the award of $30,000.
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The William Davidson Institute and the Center for Global Health Equity at the University of Michigan are proud to announce the winning project of the 2024 Global Health Commercialization Pitch Competition — an innovative screening device designed to detect high-risk strains of human papillomavirus (HPV), especially tailored for use in low- and middle-income countries (LMICs) where such health resources are scarce. The winning team, led by Dhanalakshmi Thiyagarajan, MD of the U-M Department of Obstetrics and Gynecology, will receive funding and additional programmatic support over the next year to further develop the device. The team will actively engage in field feasibility studies over the coming year in partnership with Korle Bu Teaching Hospital, which not only serves as a major medical hub in Ghana but also stands as a key institution for healthcare provision and innovation across sub-Saharan Africa.

The innovative HPV screening device is the brainchild of a diverse and interdisciplinary team at the University of Michigan, comprising experts drawn from a range of fields and institutions. Collaborating with Thiyagarajan are co-investigators Julia Kramer, who brings a mechanical engineering perspective with her PhD and Master of Public Health background, and Kwaku Asah-Opoku, MD, contributing insights from his experience in obstetrics and gynecology at Ghana’s Korle Bu Teaching Hospital. Additionally, the research efforts benefit from the fresh perspective of a group of dedicated students from the Michigan Health Engineered for All Lives (M-HEAL) student organization: Suraj Menon, Ariana Layne, Natasha Mehta, and Alyssa O’Brien.

“Our team is mindful of the myriad challenges faced by women in LMICs when it comes to accessing healthcare,” shared Dr. Kwaku Asah-Opoku, a co-investigator in the project based in the department of obstetrics and gynecology at Korle Bu Teaching Hospital in Ghana. “With our device, we aim to alleviate some of those barriers, although we know there’s still a long journey ahead of us.”

In low-income settings, traditional HPV screening methods such as pap smears and self-swabbing face numerous obstacles. Pap smears can be costly and require a clinic with a trained professional to administer the test, factors that impede access in resource-limited regions. Furthermore, these procedures can be invasive, causing discomfort and dissuading women from participating in essential screening. While self-swabbing offers a less invasive option than traditional pap smears, some preliminary research suggests that women in low-and middle-income countries have reservations about their ability to self-collect samples accurately without the supervision of a healthcare provider. Additionally, these women reported difficulties in finding a private and comfortable space to perform self-swabbing.

The team’s device presents a promising solution to overcome these barriers. Unlike standard urine collections which are often too diluted for accurate HPV detection, this device specifically collects the first 20mL of urine—a concentration increasingly shown to yield HPV detection rates comparable to self-swabbing. This method is economically advantageous, with the cost approximately halved from the standard $42 to around $21, making it a more feasible option for individuals in impoverished areas.

The device’s design embraces non-invasive, patient-centered principles. Women can use it within the comfort of their usual settings, as it neatly integrates into existing toilet facilities. The simplicity of the collection process means that women can gather the sample themselves at local health posts, significantly increasing screening accessibility. It’s also a boon for women with physical disabilities, eliminating the need for a speculum examination.

“We’re under no illusion that our work is a panacea, but we do believe it represents an important advancement in making HPV screening more accessible,” said Thiyagarajan. “Our hope is that this device can be a part of a larger solution to safeguard women’s health, opening doors to preventative care for women who need it the most.”

For the second consecutive year, the William Davidson Institute and the Center for Global Health Equity collaborated to present the Global Health Commercialization Competition, a pioneering initiative that invites faculty visionaries from across the University of Michigan’s three campuses to contribute groundbreaking healthcare solutions for the global stage. This annual competition is a beacon for innovative thinking in the face of daunting health issues prevalent in under-resourced regions of the world. Embracing an interdisciplinary methodology, the competition encourages the fusion of technical expertise and market-driven strategies to create interventions that are sustainable within the communities they aim to serve.

Claire Hogikyan, Vice President of Administration at the William Davidson Institute and programming leader for the competition, emphasized, “This collaborative environment is what propels innovators to traverse the last mile in healthcare delivery, ensuring that our efforts reach, and more importantly, resonate with those in need. It is this cross-sector synergy that ignites sustainable change, and we believe it’s a cornerstone for achieving global health equity.”

The passionate work of the U-M community, fortified by strategic partnerships and a shared vision for a better world, is truly lighting the way towards a healthier tomorrow that promises equity and accessibility for all.

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.

About CGHE

The University of Michigan has a long tradition of international engagement and individual global health programs that have often been centered within its numerous colleges and institutes. The Center for Global Health Equity aims to enhance the ongoing work of these existing efforts by fostering connectivity to increase cross-campus initiatives and programming. Global health leaders from across our academic units provided input to help define the Center’s thematic priorities and overall approach to impact.

Media Contact:

Scott Anderson, WDI Communications Manager

seander@umich.edu

WDI’s Senior Director of Healthcare Delivery, Ioan Cleaton-Jones, is an independent director on the board of Shifa International Hospitals (Shifa), which is publicly listed on the Pakistan Stock Exchange. He was nominated to the board by the International Finance Corporation, which owns 12% of Shifa. Shifa’s flagship operation is the 550-bed Shifa International Hospital, an advanced teaching hospital treating complex medical conditions, located in Islamabad. This hospital is one of only four in Pakistan that are quality accredited by Joint Commission International (JCI), the international arm of the US Joint Commission which does quality assurance in US hospitals. It also serves as the teaching hospital for the private, nonprofit Shifa Tameer-e-Millat University, which has colleges of medicine, nursing, pharmacy, dentistry, medical technology and other healthcare-related disciplines. Additionally, Shifa has a second hospital in the city of Faisalabad, with another under construction in the same city. It also has outpatient medical centers, medical labs and pharmacies.

2024 Global Health Commercialization Competition

The William Davidson Institute at the University of Michigan is excited to announce the call for applications for the 2024 Global Health Commercialization Competition. This innovative competition serves as a dynamic platform for U-M faculty visionaries based on the Ann Arbor, Flint, and Dearborn campuses, who wish to contribute their scientific and technological solutions to the most pressing global health challenges of our time.

Co-hosted by the U-M Center for Global Health Equity (CGHE) and the William Davidson Institute (WDI), the competition showcases U-M’s commitment to global health equity, with a unique market-driven approach. The competition relies on interdisciplinary collaboration to create sustainable and impactful innovations, aiming to improve healthcare in low- and middle-income countries around the world.

Competition participants will present their business case within a 15-minute timeframe to a panel of industry experts, followed by an informative 10-minute Q&A session. The winning team will be awarded substantial funding of $30,000, provided jointly by the CGHE and the WDI. Additionally, the winning team will be eligible for further consultative services provided by MBA students from our Ross School of Business, as a part of the Multidisciplinary Action Projects (MAP) Program.

The competition also provides extensive proposal review, guidance, and mentorship to all its participants, increasing their likelihood of success. Each shortlisted team is also entitled to a one-on-one consultation session with a member of the Fast Forward Medical Innovation (FFMI) team, who will review the project and provide constructive recommendations to enhance its prospects.

Proposals are due by April 5, 2024, providing an opportunity for team participants to fine-tune their pitches and maximize their chances of success. Application forms, template presentations, and more information about the event is available on our website.

Read more about last year’s competition

 

Healthcare

A patient using the Grip Forté rehabilitation device at a clinic in India. 

the Grip Forté hand and wrist rehabilitation device is a lesson in partnership. WDI connected U-M students, faculty and healthcare providers

The Grip Forté is a reasonably simple device to use. Created using a 3D-printer, the 8 inch square collapsible cube is powered by springs and the patient’s strength. It was developed to help patients to rehabilitate hand and wrist strength, flexibility, and control.

And while the Grip Forté itself isn’t complicated, the road from concept to construction wound through a series of partnerships – between teams around the globe, various departments at the University of Michigan, and engineers and healthcare professionals. Every step required a cooperative approach to problem-solving, medical support, and economic strategy. These are familiar commercial crossroads for the William Davidson Institute at the University of Michigan (WDI).

Developing a new medical product is a complex process and developing one for use in low- and middle-income countries (LMICs) is even more complicated. In these settings, creators must grapple with challenging supply chain resources, few investors, and limited knowledge of how best to commercialize a new product. Doing so demands a strong collective effort, and WDI relied on its deep well of partners to move this product forward. As its development progressed, the potential impact of Grip Forté became clear.

Finding a market, filling a need

The Grip Forté journey began with a course through the Global Health Design Initiative at the University of Michigan. Led by Kathleen Sienko, professor of mechanical engineering, and Julia Kramer, assistant professor of mechanical engineering, the immersive experience trains student engineers to work with stakeholders to identify up to 100 unmet medical needs with potential engineering solutions.

After narrowing down the possibilities, the student engineers landed on just such a pairing:  A mobile, small-scale device for patients needing to build strength and control following a hand or wrist injury. The WDI team decided to field test the device with both Dr. Abena Tannor, a Ghanaian clinician who recently completed specialist training in physical medicine and rehabilitation, and Dr. B. Shibu, Chief Medical Officer & Consultant Physiatrist at Poovanthi Rehabilitation Institute in India. WDI first began working with Poovanthi’s founders in 2010 when the organization was still in the planning stages and has continued the partnership since the organization was founded in 2011.

Learn more about Tannor’s story here.

Once they gained a good understanding of the specific therapy requirements, the students  designed a device to fit the need. The initial prototype showed promise but was set aside when the course came to completion and the students moved on. It was at this point in the project that Professor Sienko approached WDI to see about the business possibilities for the product.  WDI has worked with hundreds of organizations on business plans and models over the years and it began to take a lead role in investigating the commercial prospects for this device.

“At WDI, we understand and appreciate the power of collaboration in moving our mission forward and making things happen when it comes to launching new businesses and products,” said Claire Hogikyan, WDI Vice President of Administration, who has led the commercialization efforts. “As an independent nonprofit we have the ability and privilege to seamlessly reach out to other institutes and departments at the University to find projects that support their goals — while expanding economic and social freedom in LMICs. Grip Forté is one of those projects.”

Claire Hogikyn

At WDI, we understand and appreciate the power of collaboration in moving our mission forward and making things happen when it comes to launching new businesses and products.

WDI tasked two U-M Ross graduate students to determine the device’s potential business path forward, including possible price points, the likelihood of local manufacturing, and an assessment of the market. They determined there was a space for the product to thrive and, as importantly, a space for it to serve.

The students from the Global Health Design Initiative course had identified the need — a population in Ghana that required physical therapy but was underserved. Their prototype had potential, but there were challenges to overcome in the Ghanaian market. It was made of wood, which is heavy. It also relied on rubber bands for resistance training. However, the rubber bands necessary for that function are nearly impossible to find in Ghana. Considering the need, the commercial prospects, and the design issues, the WDI team set about to transform the initial prototype into a more viable product for the region.

Grip Forté in use.
Grip Forté in use.
Grip Forté in use.
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Leaning on Critical Connections

Building out a functional product wasn’t something WDI could do alone, so the Institute turned to its vast network of connections to bring the concept into existence. The first step was with Anthony M. Waas, a professor in the Aerospace Engineering department of the College of Engineering. He laid out a starting point for the team: 3D printing. It was the perfect solution to the production and supply chain challenges in most LMICs.

Tannor agreed with the assessment and was glad to lean into the technology. “Traditional rehabilitation methods and devices can be expensive and inaccessible. Grip Forté’s 3D printing technology provides a more cost-effective and easily accessible solution,” Tannor said via email.

WDI went on to enlist the work of Avin Vijay, an assistant research scientist also in the aerospace department. Vijay works closely with the mechanics of structures, 3D printing and design optimization. Vijay and his students created a prototype that could be completely manufactured in Ghana and around the globe. They built the Grip Forté using common thermoplastic polyester, with 3D-printed springs to replace the rubber bands and metric bolts that are small, sturdy and readily available.

On the production side, Colin Hunter, a student in the Penny W. Stamps School of Art & Design who collaborates with the Department of Aerospace Engineering helped WDI select the best 3D printer for the job — one that would effectively and efficiently print the product and be readily available for a reasonable price in locations outside the U.S.

Once they began the printing process, the next step was to test the product. WDI leaned on its connections at Saint Joseph Mercy Health System to find local physical therapists to conduct some initial experiments. The staff determined the product had potential uses in LMICs, where patients need convenient access to these low-cost therapies. The WDI team decided to field test the device with both Dr. Tannor in Ghana and Dr. B. Shibu,  Chief Medical Officer & Consultant Physiatrist at Poovanthi Rehabilitation Institute in India.

This widespread evaluation and analysis was essential to developing the most effective design, explained Vijay. “WDI gave us critical global contacts for this project,” he said. “We now have a global market for the product and are receiving feedback from patients within those markets.”

WDI gave us critical global contacts for this project. We now have a global market for the product and are receiving feedback from patients within those markets.

This widespread evaluation and analysis was essential to developing the most effective design, explained Vijay. “WDI gave us critical global contacts for this project,” he said. “We now have a global market for the product and are receiving feedback from patients within those markets.”

Tannor and Shibu tested the products with patients in their centers and received mostly positive reviews. There was one issue: Patients were using the device for an additional exercise that it wasn’t built to support, breaking two of the springs. Vijay had a new task ahead of him: redesigning those springs to manage that new movement.

“WDI is co-located and affiliated with a major research university. We know there are other ideas out there languishing on shelves that could become commercialized products in LMICs. If there are other people with an idea, with a prototype, but who don’t know what to do next, WDI might be the place to go to,” said Hogikyan. “We have the skill and importantly, the connections to move ideas forward.”

An assembled Grip Forté and one ready for shipping.
3D rendering of the Grip Forté as a wood prototype.
3D rendering of the Grip Forté plastic prototype.
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Taking It a Step Further

As the Grip Forté continues to undergo field testing, it also continues to evolve. While Vijay and his students are tackling the issue of adjusting the springs, they’re also working on an avenue to turn its creation into a circular economy.

The team is developing ways to recycle plastic bottles into the filament needed to print the device. Using opensource code, the group is using the 3D printer to print a machine that will function as a recycling tool. This will add even more value to the local economy while also reducing the cost of 3D printing. Plastic bottle collectors could earn money by selling the material to device builders, enabling device builders to broaden their business by printing additional items.

“If we can put together a model where the endgame is both helping to improve the health and wellbeing of individuals while also repurposing plastic waste, that is a nice win,” Hogikyan said.

The Grip Forté is the most recent WDI commercialization project, but it’s far from the only one underway. WDI and the Technological Institute of the Philippines recently began a six-month effort to commercialize technologies produced through funded research and special projects. At the same time, WDI is supporting the second annual Global Health Commercialization Competition. Co-sponsored by Fast Forward Medical Innovation (FFMI), the Center for Global Health Equity, and WDI, the competition will create and support a community of U-M faculty innovators actively working on technical solutions to healthcare problems in emerging markets. The program will include two key components: A professional development course and a pitch competition where the winning team will receive $30,000 to advance their concept to the marketplace.

The Global Fund plays a significant role in global markets for health products related to HIV and AIDS, tuberculosis (TB) and malaria, both as a financing institution and by negotiating procurement terms for a portion of the health products that it finances. To support the Global Fund’s Health Finance Department in its work with Supply Operations, WDI used the Global Fund’s influence as a major purchaser of HIV, TB and malaria commodities to collaborate with suppliers, research institutions and external partners to analyze pipelines, create incentives and apply strategic purchasing to drive down the price and drive up the quality of key commodities.

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 provided ad hoc support to Global Fund teams working with countries. Examples of this support include estimating the costs of providing specific types of services and developing frameworks that countries can use as they prepare to transition away from donor support.

Poovanthi is a rehab facility that was started over 10 years ago. At that time, WDI supported work on developing the business plan. This year, WDI supported a team of MBA students in developing a five year strategic plan to support Poovanthi’s expansion plans. In addition WDI had an MBA student work at Poovanthi for the summer to determine unmet medical needs that may be addressed with engineering solutions. This is in partnership with the College of Engineering.

WDI’s Senior Director of Healthcare Delivery, Ioan Cleaton-Jones, is an independent director on the board of Grupo OSME in Mexico. OSME is constructing a new private hospital in the city of San Luis Río Colorado in Northern Mexico. OSME currently operates a large medical clinic that offers primary care, 24-hour urgent care, medical imaging, selected specialist consultations, and a pharmacy.

Develop a protocol for establishing seven Vision Centers around Kisii and develop recommendations on location of Vision Centers. Kisii Eye Hospital is also expanding into Kisumu with a second hub hospital. A second project this year is designed to put together an execution plan complete with financial and market analysis for the Kisumu market.

ICL has been operating a successful lab in Ethiopia since 2004. In partnership with Cerba Lancet Africa and ICL, this project evaluated the feasibility of setting up a manufacturing hub and supply hub in Addis Ababa Ethiopia for diagnostics laboratories located throughout the continent.

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