PregnanSEE
2021
PregnanSEE is a project I worked on over four months in a team of 6. Our aim was to design and build a prototype of a device that meets an unmet, pressing health need in an innovative way.
PregnanSEE is a minimally invasive, portable POC device that can measure the levels of 4 different biomarkers (Vitamin B9, Vitamin B12, Ferritin and Hemoglobin) simultaneously in one test. We were awarded with the "Best Innovation Award" in 2021 by Columbia University.
One of our main motivations to develop the product is that the results of a conventional lateral flow assay test does not give enough resolution to be quantified by the human eye. We wanted to give the results in a quantitative manner in order to figure out the next steps in the treatment process and motivate the patient to follow through with recommended treatment leading to improved health outcomes.
Prototype of "PregnanSEE"
MOTIVATION:
The healthcare infrastructure in rural India is not very accessible as we can see displayed on the map on the left. 73% of villages do not have access to a health center with doctors, nurses and lab tests. And about 90 million people have to travel more than 10 km to reach the nearest health center.
In order to bridge this gap the Ministry of Health and Family Welfare (MoHFW) has appointed accredited social health activists known as ASHA workers in each village. ASHA workers are women who live in these villages and are trained in performing basic health check ups and disseminating important health information. They move door to door keeping track of the community’s health and connecting them with the public health system. Lastly, they assign each pregnant patient an antenatal card where the patient's vitals, supplementation and future check ups are recorded and tracked.
LIMITATIONS IN CURRENT CYCLE OF CARE:
When it comes to caring for the pregnant populations ASHA workers provide pregnancy tests and give out iron, folate supplements. Unfortunately, there is a lack of motivation on the patients part to keep up with the recommended supplementation. We believe this is where we can fit in with a personalized diagnosis to incentivize keeping up with the recommended intervention. ASHA workers also perform an initial hemoglobin check using a color scale. This hemoglobin test has low visual resolution, and oftentimes the results from this test contradicts hospital lab tests.
We arrived at our need statement after validation and refining through a variety of stakeholder interviews spanning from patients to healthcare professionals and community health workers like the aforementioned ASHA workers.
MORE ABOUT THE PROTOTYPE
Our idea is based on lateral flow assay principle. We wanted to use a single test strip, such as the one shown in, to quantify all the four biomarkers. The blood traveling to the test strip used to quantify the biomarkers would be received by the sample pad. The blood would travel through the strip by capillary action until it reaches the conjugate pad. The conjugate pad, which stores the conjugated labels and antibodies that will bind to the target and continue to migrate along the strip. As the sample moves along the device, the binding reagents situated on the nitrocellulose membrane will bind to the target at the test line. A coloured line will form. Depending on the concentration of the biomarker, the density of the line will be different. Some targets may require quantification to determine target concentration. Combining a reader with this technology will allow us to provide quantitative results to the patient or healthcare professional. Finally, the sample will pass through the nitrocellulose membrane into the absorbent pad, which will absorb the excess sample.
We aimed to quantify the biomarkers with a lateral flow assay. This assay is commonly used by people to obtain binary results. A common example is a pregnancy test, which tells you whether you are pregnant or not. Research supports the idea of quantifying this information using the intensity of the line in the test strip. In the case of pregnancy, this wouldn’t be of use, because you just want to know if you are pregnant or not. However, for our biomarkers we do want to know the quantification of this deficiency. Quantification is preferred because the visual resolution of the color code used to qualitatively measure deficiency is not appreciable (top right) and because the treatment is administered according to the quantification.
To quantify the intensity of the test strips, we designed this proof of concept. Due to time constraints, we were only able to generate a calibration curve for iron, but we would have to repeat this process for all of our biomarkers. As a first idea, we prepared different solutions with different iron concentrations and used an RGB sensor that is connected to the microcontroller to create a calibration curve. In the future, once we design our 4-in-1 detection test strip, we would calibrate it using our sensor and solutions of known concentrations of our specific biomarkers of interest
We next aimed to identify the cost of developing our prototype. In our research we found that each assay costs only 7 cents and together with electronics and device housing, the total prototype cost is about $11
Our device provides significant value to three main stakeholders. We can improve the health outcomes of pregnant mothers by providing them with a means to test their potential deficiencies, empower ASHA workers by increasing efficiency and enabling personalized care, and reduce the burden of the healthcare system in India at large.
We have also identified the great market potential of innovating in this unmet need. Currently, the total available market revenue for lab-based biomarker testing during pregnancy in India has been estimated at $1.2B; the serviceable available market, which is defined by the rural population, is estimated at $832M. We predict to capture about ~4% of the rural market revenue, or $36.6M, by distributing 5 PregnanSEE devices at a combined cost of $55 to each of the 665,000 villages in rural India over the course of the initial rollout
This is a snapshot of how we envision our business to grow in the next 5 years.
We are going to spend the first 2 years doing market research and prototyping, followed by preclinical research
Next, in the third year, we would do human trials to evaluate the safety and efficacy.
Our focus for the following 2 years would be on securing approval from the Indian government and the regulatory agencies, working on the manufacturing and distribution and partnering with the ASHA workers
In collaboration with Ragini Kothari, Albert Fernández, Will Kadison, Delfina Rodriguez and Shiv Patil