Universally Friendly Obturator

Cervical cancer disproportionately affects low-income countries where most cases progress to later stages; these contribute to 311,000 deaths globally every year. Interstitial brachytherapy is the only curative treatment for late-stage cancer. Unfortunately, current methods rely heavily on the use of transcutaneous needles pushed through layers of skin and healthy tissue. These needles significantly increase patient morbidity and the risk of patient complications, making this procedure highly invasive, time-intensive, and difficult to perform. The UFO is a 3D-printed, reusable applicator that completely eliminates the need for transcutaneous needles by guiding all needles through its internal channels instead, entirely protected from skin and tissue. The device meets industry standards and fits easily into the current procedure. Furthermore, the UFO increases accessibility to treatment by making brachytherapy cheaper, safer, and easier to perform, bringing this life-saving treatment to the hundreds of thousands of women battling cervical cancer in low-resource settings worldwide.

Cervical cancer disproportionately affects low-income countries, where 80% of cases worldwide are diagnosed; cervical cancer is the leading cause of death from cancer amongst women. These patients often lack access to necessary prevention strategies, so their cases usually progress to later stages. Late-stage cervical cancer has a 5% survival rate, which contributes to 311,000 deaths globally every year. Late-stage cases are marked by their lateral progression, making the tumors difficult to access for treatment. 

Interstitial brachytherapy is the only curative treatment for such tumors. Unfortunately, current methods rely heavily on the use of transcutaneous needles, pushed through layers and layers of skin and healthy tissue, in order to irradiate the tumor. During the procedure, a physician must meticulously push each needle, carefully avoiding nearby organs, arteries, and nerves. These needles significantly increase the risk of patient complications, making this procedure highly invasive, time-intensive, and difficult to perform.

Our partnering physicians in Houston treat 40 patients with brachytherapy each year. In the U.S., brachytherapy accounts for 58.8% of all treatments for cervical cancer, resulting in 170,500 patients domestically. Globally, 570,000 cases are diagnosed every year (450,000 cases in low-income countries), making our potential impact tremendous.

The UFO is a 3D-printed applicator that addresses issues with current brachytherapy methods by completely eliminating the need for transcutaneous needles. To use the device, the physician places the obturator head of the UFO into the vaginal canal until the head rests against the cervix. The user interface, where the needles are initially inserted, sits outside of the vaginal canal. The physician places needles through the angled internal channels, which span the length of the entire UFO, until they reach the tumor. This unique design treats the full extent of a 9 cm tumor without the use of a single transcutaneous needle, minimizing patient morbidity typically associated with brachytherapy. Due to this approach, the cost, time, and expertise needed to complete the procedure are also lowered. 

To ensure broad implementation, the UFO is uniquely adaptable to both patient anatomy and compatibility with all brands of equipment. The length and width of the design can be optimized for the individual patient, and the central hole can be altered to provide comprehensive treatment to patients with or without a uterus. If necessary, the diameter of the channels can also be changed to accommodate different companies’ equipment, making the UFO universally adaptable.

The UFO makes cervical cancer brachytherapy cheaper, safer, and easier to perform, enabling more women to be treated using brachytherapy, especially in low-resource settings where it is needed most. The UFO is inexpensive and highly adaptable compared to current applicators. By using 3-D printing or injection molding, manufacturing costs for the UFO are low, and the simplicity of the design prevents high costs from labor and assembly. Its unique design eliminates the need for transcutaneous needles, making the procedure less risky for inexperienced physicians to perform. With the UFO, more hospitals can afford the device, more physicians can perform brachytherapy, and more patients can actually receive the treatment. 

Moreover, patients with complete hysterectomies and patients with more difficult-to-access tumors are currently unable to receive comprehensive radiation from brachytherapy due to the inadequacies of current equipment. The UFO is uniquely able to address this issue with its variety of adaptive options, providing these patients with treatment that they would otherwise not be able to receive.

Worldwide, hundreds of thousands of women battle cervical cancer, and many of them can benefit from life-saving brachytherapy treatment. The UFO increases accessibility to this procedure by offering these women the opportunity for this treatment.

Cervical cancer is the leading cause of death from cancer amongst women in low-income countries, and it has an immense effect on gynecological health. Worldwide, 570,000 cases are diagnosed and 311,000 women die from cervical cancer every year. Interstitial brachytherapy cures late-stage tumors, preventing the cancer from returning. The UFO increases accessibility to this treatment by making the procedure cheaper, safer, and easier to perform. Our device will have a tremendous impact globally on women battling cervical cancer not only by improving their outcomes from treatment, but also by protecting their future gynecological health from recurring cancer.

The UFO is unique in the ability to treat the full extent of late-stage cervical tumors without the use of transcutaneous needles. Current methods of brachytherapy may use up to 40 needles pushed through many layers of healthy tissue, risking damage to the vital structures that surround the cervix. The UFO eliminates the risk by guiding needles through channels in the obturator body, which sits within the vaginal canal, rather than forcing needles freely through tissue. The UFO guided needles are also able to treat areas of the tumor that are generally inaccessible in the current method by bypassing the structures that would block access. 

Additionally, the UFO is able to treat patients who do not have a uterus. In most current cases, patients who have had hysterectomies (often due to a previous cancer occurrence) are left with a radiation cold spot in the densest central part of their tumor due to the inability to use a tandem, a rod-like instrument used to irradiate the uterus in standard brachytherapy cases. However, the UFO comes with a central channel for either a tandem or a central needle. By using the central needle model of the UFO, the entire tumor can be irradiated for patients without a uterus. 

Finally, since the UFO simply houses the existing brachytherapy needles without directly interfacing with the radiation source, it can be used with any company’s equipment, making the UFO widely accessible for any brachytherapy center.

The UFO makes use of technology at every stage of the process of design and use. The design uses CAD software, specifically AutoCAD, to draw the prototype models and visualize the needle paths within the body. To manufacture the UFO models, the team has used a variety of 3D printing technologies including filament-based printers, multi-jet fusion (MJF), selective laser sintering (SLS), and sterolithography (SLA). Each of these 3D printing technologies offers different resolution, material compatibility, timeframe, and cost, which the team has optimized throughout the prototyping process. In the future, the UFO will be manufactured using injection molding technology to produce higher volumes of the device. 

Once in use, the UFO will aid in the current methods of dosimetry planning. Ultrasound will be used to guide the needles to the appropriate depth as they leave the head of the UFO and enter the cervical tissue. Then, the UFO, with the needles in place, will be CT scanned in order to visualize the needle arrangement in each specific patient. The CT scan is overlaid with an MRI image of the tumor in order to map the needle arrangement with the tumor shape. Existing model-based algorithms are then used to map out an individual dose plan to optimize radiation intensity and distribution in each needle for complete irradiation of the unique tumor.

CAD software, 3D printing techniques, and injection molding manufacturing are broadly used technologies for a wide variety of applications from children’s toys to car parts. CT, MRI, and ultrasound are used broadly within the medical field, especially for diagnostic applications, since they allow for visualization of internal body structures. 

Within brachytherapy, various algorithms for dosimetry planning exist. At a fundamental level, they combine known equations for radiation distribution as well as images from CT and MRI scans to optimize for the desired clinical target volume (CTV) for irradiating the tumor while avoiding organs at risk (OARs). Examples and further explanation can be found in these papers:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5509987/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453149/

In the U.S., brachytherapy accounts for 58.8% of all treatments for cervical cancer, resulting in 170,500 patients domestically. Globally, 570,000 cases are diagnosed every year (450,000 cases in low-income countries). Even though low-resource settings carry the burden of cases, brachytherapy is rare. Its widespread implementation is hindered largely because of its significant cost, high risk of complications, and difficulty to perform, resulting in the deaths of hundreds of women that could have survived otherwise. The UFO addresses these issues to make brachytherapy more accessible where it is needed most.

The primary output of the UFO is that it allows more doctors to perform brachytherapy. As mentioned, the current procedure requires a high level of expertise, time, and still poses a considerable amount of risk of complications to the patient. These issues discourage and even prevent physicians who are not extremely familiar with the procedure, from performing it at all. Since the UFO guides all needles through its internal channels and directly to the site of the tumor, it makes needle insertion less daunting and greatly reduces the risk of complications. Additionally, it reduces the needle insertion time from 2-2.5 hours to 1-1.5 hours, without compromising the precision of the placement. The time reduction for the procedure also makes the procedure more accessible for doctors, especially those in low resource settings, which are overwhelmed with their number of patients. This significant reduction in time also directly translates to money saved through operating room costs.

Since the UFO makes brachytherapy more accessible to doctors, particularly those with limited expertise, it means more doctors can perform the procedure and can even push their clinics or hospitals to adopt brachytherapy as a treatment. In the short term, this will make treatment viable in places and to women who previously had no access to brachytherapy. This will lead brachytherapy to be more commonplace and result in the curing of hundreds of women. Overall, lowering the burden of cervical cancer not only in low-resource settings, but worldwide.

Since the UFO is still in its testing phase, it is not being used to treat any patients. Within its first year of use we expect to implement the UFO across clinics in Texas. The Harris Health Systems currently treats around 40 patients per year. There are at least 3 other hospitals in Houston that perform brachytherapy. Assuming they all treat about 40 cases per year, our device would be able to serve at least 160 patients per year in Houston alone. We have identified at least 9 other brachytherapy clinics across the 3 other major cities of Texas. Assuming they each also treat 40 patients per year, we estimate the UFO will be able to serve a minimum of 13 clinics in Texas and 520 patients within its first year.

Within five years, we expect the UFO to be in use nationwide and internationally. We expect it to be rolled out nationwide within 2-3 years and be used to treat the annual 170,500 brachytherapy patients. Internationally, we plan to implement the UFO within 3 years in Brazil, Nigeria, and Tanzania, the countries where our partner organization, Rice 360˚ Institute for Global Health, already has connections. Assuming those countries also treat 58% of cases with brachytherapy, the UFO would serve about 12,151 women in Brazil, 39,768 women in Nigeria, and 19,599 women in Tanzania. By combining the domestic and international values after 5 years, we expect the UFO to treat 412,518 women.

Within the next year, we aim to finalize testing and design optimization and begin patient trials through partnership with radiation oncologists at the Baylor College of Medicine. Evidence collected through these trials will allow us to receive FDA exemption for the UFO. In this time, we will also work to seek legal protection for the intellectual property of the UFO design. Finally, we will begin to scale up production of the UFO in preparation for expansion of pilot testing within Texas, with the goal of expanding to the five largest cities in Texas within the next year. 

Within 5 years, the team will be working towards large-scale manufacturing and distribution of the UFO. In this timeframe, we will make the UFO available on a broader market, specifically increasing widespread access in the US, Tanzania, Brazil, and Nigeria, all countries where the team and our partners have existing relationships with radiation oncologists.

Within the next year, one of the biggest challenges for our team is continuing to push the project forward while working remotely due to COVID-19. Additionally, while both Rice University department of global health and Baylor College of Medicine continue to support our project, we are currently working as an independent project without financial support from any institution.

As we work to broaden the market for the UFO beyond our existing partners, the biggest barriers will be distribution and liability. Working with our partners will give us a foothold in each of the countries we are targeting, but gaining widespread distribution remains a challenge.

Our team has been working to overcome the challenges of working remotely by utilizing team organization software such as GoogleDrive and holding virtual meetings via Zoom. While it is not ideal, we have also been able to continue progress with the physical prototype by shipping it between team members and utilizing our partnership with doctors at Baylor College of Medicine to gain critical feedback on the design. To aid with funding we have been applying for grants and are in conversation with Rice University about continuing the project through one of their global health product development pipelines. 

To overcome long-term challenges of distribution and liability, we plan to find manufacturing partners who are willing to license our technology in different geographic regions where they have existing relationships and product distribution plans.

We are linked to the Rice 360 Institute for Global Health at Rice University but we are unregistered and still trying to formulate what type of company we hope to be. 

5 people are currently working on our solution team.

At Your Cervix was formed as a senior design team for Global Health Technologies minors at Rice University. Currently, we are continuing research and development on the UFO with support from our partners. 

Susannah Dittmar & Lauren Payne head our design team. Susannah brings her experience in bioengineering to our product design and development, while Lauren develops renderings of our prototype for manufacturing. Krithika Kumar serves as our communications manager, and she facilitates our contact with clients and publications. With her experience in engineering consulting, Elisa Arango oversees our financial strategies to determine how to make the UFO as accessible as possible. Sanika Rane leads business development, and with her expertise in graphic design and website development, she is able to establish appropriate marketing strategies for our brand. Susannah, Elisa, and Lauren have all worked on international internships with the Institute for Global Health, so they lead our efforts to implement the UFO abroad, especially in low-income countries. 

Our clinical efforts are led by our partnering physicians. Dr. Michelle Ludwig and Dr. Alexander Hanania are radiation oncologists in Houston with ample experience treating cervical cancer patients with brachytherapy. Together, they provide us with a physician perspective and offer us invaluable resources, like their clinics, patients, and radiology team. 

We also continue to receive the support of our faculty advisor, Dr. Andrea Gobin, Director of Invention Education at the Institute for Global Health. She brings her experience in product development, with over 20 publications and 3 patents in her name.

We are currently partnered with two organizations, the Rice 360˚ Institute for Global Health at Rice University and the Baylor College of Medicine. The Rice 360˚ Institute brought our team together and pitched the challenge to us in August of 2019. They have provided us with continual mentorship, access to a design kitchen, and funding. Since August of 2019, we have also been working side-by-side with two radiation oncologists at the Baylor College of Medicine, Dr. Michelle Ludwig and Dr. Alexander Hanania. They have shared their clinical perspective and insight with us and are heavily involved in the testing of the prototype.

Our business model follows the low-income client template. Licenses to use the UFO will be sold through an ecommerce website to hospitals, clinics, and radiation oncologists. We will obtain local partners to conduct licensing, manufacturing, and distribution. UFO’s will be manufactured and distributed locally.

Once we gain a strong foothold in the United States, we hope to leverage our connections in the United States with Rice University and the Rice 360 Institute for Global Health to scale up our production to low-resource settings with promising brachytherapy markets, such as Nigeria and South Africa. We want to make key relationships with manufacturers and distributors along the way and attend brachytherapy and cervical cancer conferences to market our device. We hope to maintain quality assurance and provide customer service support and user training to ensure that devices are delivered promptly and used correctly with the highest quality. Throughout this journey, the UFO will continue to be improved through rigorous research and development. 

Capital will initially come from grants, philanthropic funds, and prize money from competitions; gradually we hope to attract investors and raise funding. This will be used to fund research and development, manufacturing and distribution, insurance, ecommerce and web domain fees, and hiring important personnel such as attorneys, subject matter experts, and business consultants. We aim to incorporate and create an LLC as a hybrid for-profit and non-profit venture. The profits that come from licensing out the UFO comes back into the business to fund future initiatives.

Licenses to use the UFO will be sold through an ecommerce website to hospitals, clinics, and radiation oncologists. We will obtain local partners to conduct and manage licensing. We are aiming to create a hybrid for-profit and nonprofit venture in that the revenue from sold licenses will feed back into funding nonprofit ventures. Within the next couple of years, funding will come from applying for grants and loans, reaching out to philanthropic organizations, and participating in competitions. After that, we will pursue venture capital investments. There will be a higher upfront cost for UFO’s licensed in the United States than in low-resource settings to ensure that those who are not able to traditionally afford the treatment are still able to access it regardless of financial ability. This will enable us to expand into low-resource markets with more financial confidence.

Our team, mentors, and clinical partners truly believe the UFO has the ability to save the lives of thousands of women every year, especially given the little innovation in the field of brachytherapy and the significant burden of late-stage cervical cancer on women worldwide. The beauty of the design is in its simplicity and effectiveness, both of which we believe are key to widespread adoption. 

Although we believe the value of the device speaks for itself, we recognize that in order to continue moving forward, we must develop a comprehensive business model, manufacturing and distribution model, and obtain funding legal advice. We are a team of recent college graduates and one undergraduate that majored in Bioengineering, Kinesiology, and Psychology. We believe the interdisciplinary nature of our team, in addition to the collaboration with our clinical partners, has contributed to our successes so far. However, there are still many crucial aspects of our project that we lack knowledge of, primarily on the business, financial, implementation, and legal side. Besides providing funding to keep our project going, becoming Solvers would open up doors to a community of experts that will be able to provide guidance and tangible recommendations for our team on these topics based on their experiences in the field. Additionally, it will be an opportunity for our team to develop connections and partnerships across the US and abroad that will help us achieve our mission of making brachytherapy accessible for all women.

We are seeking guidance to develop a strong business model which includes a financial plan that will keep us funded and at least allow us to break even. Additionally, we are seeking legal advice for legal matters related to setting up our business and IP protection.

The current manufacturing method for the UFO is high resolution 3D printing. We have explored alternative manufacturing methods, such as injection molding that would allow us to scale up the device. However, we have limited knowledge in choosing the best paths and partners to scaling up our device. More importantly, we lack knowledge on how to distribute our device locally and abroad and the recommended method for ensuring accessibility, especially in low resource settings.

We would like to partner with a range of organizations and individuals to best fit our needs. Specifically, we are interested in partnering with other Solve members and with philanthropic organizations such as the Bill and Melinda Gates Foundation, global health non-profits like PATH, and MIT innovation centers such as the Tata Center, MIT Africa, and the Legatum Center for Development and Entrepreneurship. 

We would like to partner with Solve Members because it is likely that we will come across similar challenges, considerations, and paths. We hope to discuss and learn from the unique experiences and perspectives of the other Solve Members to strengthen our initiative.

Through a partnership with philanthropic organizations like the Gates foundation we hope to secure funding that will help us hire and maintain a legal advisor, consultants and subject matter experts, acquire distributors and manufacturers, and continue to scale-up our device. Additionally, through this partnership as well as that with global health non-profits like PATH, we hope to benefit from the reputation and connections of the organizations in low resource settings to implement our own device.

Through a partnership with innovation centers at MIT, we hope to establish connections with their teams and faculty so that we can learn from their previous ventures and use their programs as a framework for our business.

The UFO is focused on making access to brachytherapy more equitable. It not only has the potential to save the lives of hundreds of thousands of women every year, but also gives women who might otherwise be treated with a hysterectomy, a second chance to become mothers. The UFO improves the quality of life for women diagnosed with cervical cancer by lowering the invasiveness and pain associated with brachytherapy treatment, lowering the risk of post-procedural complications, and increasing the chances of survival. Ultimately, allowing women to defeat their cancer and continue contributing to their families and their communities. 

The UFO's implementation model is centered on identifying partners and hospitals that will help treat the greatest number of women. To achieve this goal, we also intend to explore large-scale manufacturing techniques, such as injection molding, that will meet the demand and lower the cost of the UFO. We will use the prize to fund this exploration and conduct testing. Specifically, we plan to conduct material testing to identify the safest and cheapest material for the UFO for larger scale production, including material compliance with sterilizability and biocompatibility standards, as well as to complete pilot testing of the device with patients.

Cervical cancer disproportionately affects low-income countries where most cases progress to later stages, which only have a five percent survival rate. The UFO is focused on making access to brachytherapy, the only curative cervical cancer treatment for late stage cases, more equitable. It not only has the potential to save the lives of hundreds of thousands of women every year, but also gives women who might otherwise be treated with a hysterectomy, a second chance to become mothers. Simply put, the UFO’s mission is perfectly aligned with the Bill & Melinda Gates Foundation’s belief that every life has equal value.

The UFO's implementation model is centered on identifying partners and hospitals (public and private) that will help treat the greatest number of women. To achieve this goal, we also intend to explore large-scale manufacturing techniques that will meet the demand and lower the cost of the UFO. We will use the prize to fund this exploration and conduct testing. Specifically, we plan to conduct material testing to identify the safest and cheapest material for the UFO for larger scale production, including material compliance with sterilizability and biocompatibility standards, as well as to complete pilot testing of the device.