The statistics are staggering: every 16 seconds, a family grieves the loss of a stillborn baby. While the medical community has made incredible strides in many areas, predicting and preventing complications in pregnancy remains a profound challenge, particularly since nearly a third of stillbirths occur without any identifiable risk factors. Stepping into this critical gap is a new partnership between Wellcome Leap, a leader in funding bold health initiatives, and Medicines360, an organization dedicated to developing accessible products for women. We’re joined today by Faisal Zain, a healthcare expert specializing in medical technology, to explore how this collaboration aims to revolutionize maternal care. We will discuss the innovative fusion of blood-based and imaging technologies, the immense challenge of designing diagnostics for low-resource settings, and how these new tools could fundamentally reshape prenatal care for mothers everywhere.
Your organizations bring different strengths to this partnership. How does Wellcome Leap’s research funding and Medicines360’s product development model specifically combine to accelerate these new tools? Can you walk me through the key stages from a lab breakthrough to a globally available diagnostic?
This partnership creates a powerful pipeline from pure science to real-world impact. Wellcome Leap acts as the catalyst, injecting significant capital—like their $50 million In Utero program—to fund groundbreaking, high-risk, high-reward research. They foster the initial breakthroughs, like the blood-based biomarkers from the University of Cambridge or the retinal imaging technology from the University of Edinburgh. That’s the lab stage. But a scientific discovery isn’t a medical tool. That’s where Medicines360 comes in, with its specialized expertise in taking these innovations and navigating the complex journey of product development, clinical validation, and global distribution. They are the ones who transform a lab concept into a reliable, user-friendly diagnostic, ready for deployment in diverse settings, from a London hospital to a rural clinic.
You are developing both blood-based biomarkers and retinal eye imaging. How will these two distinct technologies be used together to create a more complete risk profile for a patient? Please share a practical example of how this combined data could change a patient’s care plan.
These two technologies are incredibly complementary because they look at the pregnancy from different biological angles. The blood-based biomarkers give us a direct biochemical window into what’s happening with the fetus and placenta—detecting early signs of fetal-growth restriction or gestational diabetes. The retinal eye imaging, on the other hand, provides a noninvasive way to assess the mother’s vascular health, which is a key indicator for conditions like preeclampsia. Imagine a woman in her second trimester. A blood test might flag a biomarker for potential growth restriction. Simultaneously, a quick retinal scan shows her vascular system is perfectly healthy. This combined data tells a doctor to focus specifically on monitoring fetal growth and perhaps adjusting nutrition, without the immediate alarm for preeclampsia. This precision prevents unnecessary medical interventions and tailors the care plan directly to the patient’s specific risk profile.
The goal is to deploy these tests in rural and low-income countries. What are the main design and cost challenges in creating a diagnostic that is effective outside of a sophisticated lab? Describe the step-by-step process for getting these tools into the hands of local healthcare workers.
The primary challenge is moving away from what Dr. Andrea Olariu calls “sophisticated analytical systems.” We can’t rely on expensive, bulky equipment that requires constant calibration and a sterile lab environment. The design must be robust, affordable, and simple enough for a local health worker to use with minimal training. This means engineering for portability, stability in varying climates, and clear, unambiguous readouts. The step-by-step process starts with designing these user-centric devices. Next, we pilot them in target regions to get feedback. Then, we establish training programs for local healthcare workers and create a sustainable supply chain to ensure tests are always available. Finally, and most critically, we must develop clear clinical protocols so that when a test flags a risk, the health worker knows exactly what the next step is to get that mother the care she needs.
The clinical trial starting this summer focuses on first-time pregnancies. What specific outcomes and metrics will determine the trial’s success? Please describe the journey for a participating patient, from their first trimester to their last, and what you hope to learn from their experience.
The trial’s success will be measured by its predictive accuracy. We need to see how well our biomarkers and imaging technology can identify mothers who will later develop complications, especially compared to the current standard of care where so many risks go undetected. We are focusing on first-time pregnancies because that’s when the risks are often highest and least understood. For a woman in the trial, her journey will involve regular, noninvasive monitoring across all three trimesters. She will provide blood samples and undergo retinal scans at key points. From her experience, we hope to build a detailed, longitudinal dataset that shows us precisely when these predictive markers begin to appear, allowing us to pinpoint the optimal window for intervention—long before a complication becomes a crisis.
Given that nearly a third of stillbirths occur in pregnancies with no identifiable risk factors, how could these predictive tools fundamentally change routine prenatal care for every expectant mother? What steps would be needed to integrate these diagnostics into standard care protocols worldwide?
This could be a complete paradigm shift. Right now, prenatal care for many low-risk pregnancies is largely reactive. These tools would make it proactive. For the first time, we could screen every expectant mother for underlying risks that are currently invisible, which is crucial when about 30% of stillbirths happen in seemingly normal pregnancies. It would change the very definition of a “low-risk” pregnancy by giving us a much clearer, data-driven picture. Integrating these tools into standard care requires a multi-pronged approach: first, demonstrating clinical efficacy and cost-effectiveness through robust trials. Second, securing regulatory approval in key regions, starting with the U.K. and U.S. Finally, we need to work with global health bodies and national health systems to create new care guidelines and training programs, ensuring these life-saving diagnostics become a routine part of every mother’s journey.
What is your forecast for maternal health diagnostics over the next decade?
I believe we are on the cusp of a major transformation. Over the next decade, I forecast a move away from broad, symptom-based risk assessment toward highly personalized, predictive, and preventative care. We will see more noninvasive technologies like the ones in this partnership become standard, integrated into a continuous monitoring ecosystem that can be accessed from anywhere. The goal is a future where a simple, affordable test can give a mother in any part of the world the clear insights she deserves about her pregnancy health, empowering her and her care provider to act before complications arise. As Regina Dugan so powerfully stated, we can deliver these tools “before it’s too late.”
