Problem to be solved:
How might we help women who are at risk for, or have experienced miscarriage have greater access to information about their health and the health of their baby during the first 12 weeks of pregnancy?
How did we get here?
Our journey to finding our people…
We began our project by asking a simple question: who should we be designing for? One of our main goals for our iGEM project is to create an IoT device that could one day be brought to market. Because of this, we knew it was essential to first identify a real, unmet need—before jumping to build a solution.
Firefighters
At the start of our discovery journey, we chose a population almost by chance: firefighters. We believed their line of work might involve unique biological and genetic challenges, so we began reaching out to fire stations in our local community and across the U.S. to better understand their daily experiences and uncover potential pain points.
Through these interviews, a striking theme emerged. Many firefighters told us about colleagues who had survived the immediate physical dangers of the job, only to later die from cancer. Some also shared concerns about bringing carcinogens home after a shift, potentially exposing their families.
This led us to consider developing a tool that could detect the presence and levels of carcinogen exposure. Such a device could help firefighters determine how thoroughly they needed to clean themselves and their gear, as well as track their cumulative exposure over time—potentially offering insights into long-term cancer risks.
At this stage, our team decided to explore aptamers as a biological tool for protein detection. We also decided to ask ourselves, who else is trying to detect and measure carcinogen levels that could benefit from this product?
Mines: In parallel to our interviews and conversations with firefighters, we began talking to some environmental specialists on the topic of carcinogen detection in water. We entertained this path for a short amount of time, until we realized that the scope of the project would be too large for our limited resources.
In our continued exploration and conversations with the firefighters, another issue surfaced. Many firefighters spoke about struggles with low testosterone levels. This shifted our thinking toward the possibility of hormone detection as another avenue for our project. We asked ourselves again, who else could benefit from a hormone detection tool?
Mothers and miscarriage
Inspired by the firefighters’ concerns around hormone monitoring, and by the personal experience of one team member’s mother, we turned our attention to progesterone detection.
Progesterone, sometimes called the “pregnancy hormone,” plays a critical role in supporting early pregnancy. We learned that if progesterone levels could be monitored during the first 12 weeks, there might be potential to detect, and even prevent, early miscarriages.
To better understand the audience that this tool would impact, we spoke with women who had experienced miscarriage firsthand. In these conversations, we discovered a number of pressing needs: clearer information about their hormone levels, more tools to monitor their pregnancies at home, and greater ability to advocate for themselves within a healthcare system that can often feel dismissive or unresponsive.
“Every pregnancy after the one that I had [miscarriage] I felt anxiety about whether it would take. I would do anything to give me peace of mind” – (interviewee)
From these insights, we knew our focus needed to shift. Our goal became to design a product that could help women detect potential risks of miscarriage before they occur, while also giving them data and confidence to advocate for their own care.
Our Journey to Producing a Solution
After months of interviews, we gained a clear understanding of who we were designing for, women who have experienced or are at risk of miscarriage, and the problem we wanted to solve: the lack of accessible, real-time knowledge about miscarriage likelihood.
To deepen our understanding of the tools, data, and biology already surrounding this issue, we turned to the experts.
Biologists
Our next step was to validate our concept, using aptamers for hormone detection and exploring the potential of progesterone monitoring in miscarriage prevention. Alongside reviewing relevant studies, we met with several experts, including Dr. Arroyo, a professor of Cell Biology and Physiology at BYU.
Dr. Arroyo’s research focuses on molecular signaling and cell invasion in complicated pregnancies. During our meeting, he helped us better understand how progesterone fluctuates during early pregnancy and how our proposed monitor could capture meaningful data.
Initially, we imagined a device that would take a single progesterone reading per day. Dr. Arroyo explained why this would be insufficient:
Progesterone is secreted in bursts, meaning a single daily reading could easily miss peaks or troughs and give a false sense of stability.
Time-sensitive conditions like miscarriage require more frequent data collection, ideally three or more measurements per day.
Every woman’s baseline levels differ. A continuous device could be worn even before conception, establishing personalized baseline data and allowing for tailored insights.
He also emphasized that clinicians prefer long-term hormonal trends rather than isolated readings, as continuous data could support better diagnoses and early intervention. Beyond patient use, Dr. Arroyo noted that a continuous progesterone monitor could significantly advance research in women’s reproductive health, an area where data remains limited.
Although conclusive research on progesterone therapy’s effect on miscarriage is still lacking, our proposed device could become a valuable research tool in itself. Our discussion with Dr. Arroyo refined our design direction and clarified the broader scientific contributions our product could make.
Doctors (OB/GYNs)
We also met with Dr. Ryan Ollerton, an OB/GYN at American Fork and Holy Cross Hospitals in Utah County. Dr. Ollerton described how doctors typically manage women at higher risk of miscarriage. Many providers prescribe progesterone supplements during the first 12 weeks of pregnancy, based not on lab data but on a patient’s history of miscarriage, since the supplements are generally considered safe.
He noted, however, that a continuous progesterone monitor would “not be super useful in generalist OB/GYN practice.” At first, this feedback felt discouraging, but it revealed an important truth: many women we had interviewed felt dismissed or unheard by their doctors.
Rather than discouraging us, Dr. Ollerton’s comments validated our mission. While such a device might not immediately fit into standard clinical workflows, it could empower women themselves, giving them data to advocate for their own health within a system that often overlooks them.
Our survey of 375 women across the United States reinforced this insight. The majority said they would be “likely to wear an in-arm monitor” if it could track hormone levels. This confirmed the desirability and relevance of our proposed solution for our target users.
Ethical Dilemmas and Challenges
As we developed our concept further, we encountered several ethical and regulatory challenges.
One major consideration was FDA regulation. Because our device could be classified as a medical tool, it would require FDA approval before market release, a process known for being lengthy (3–7 years), inconsistent, and often shaped by reviewer bias. Pregnancy-related devices in particular face heightened scrutiny and delays.
To ensure faster and safer accessibility, our team decided to pursue an alternative route: positioning our product as a personal health device rather than a medical one. This would allow us to bypass FDA medical-device approval while maintaining credibility and safety through LDT (Laboratory Developed Test) and IDE (Investigational Device Exemption) certifications.
This approach requires careful attention to ethics and communication. Our app’s design and marketing must make it clear that the device is not a diagnostic tool and that users should always consult healthcare professionals when interpreting their data, especially in urgent situations.
Another ethical challenge we identified involves potential psychological impact. During interviews, women who had experienced miscarriage described the tool as a source of comfort, something that could bring peace of mind during uncertainty. However, conversations with women outside this demographic revealed potential risks. For those prone to anxiety, frequent hormonal tracking might heighten stress rather than relieve it.
In a survey of 154 women, 52% said they often had “a lot of questions during pregnancy and preferred to research, plan, and prepare.” For these women, the device could unintentionally increase anxiety. While we believe the overall benefits outweigh this risk, our team remains mindful of how design choices and user education can help minimize negative emotional effects.
Societal Impact
As our conversations expanded, we began to see the broader potential of our device beyond miscarriage detection. In a recent survey of 212 women across the U.S., 56% said they would track their progesterone levels if given the opportunity. When asked for what purpose they would track progesterone levels for responses included:
- 7% to monitor miscarriage risk
- 17% for ovulation
- 19% for fertility
- 22% for irregular periods
- 17% for perimenopause
These findings opened our eyes to the diverse ways our product could support women’s health.
In one interview, a woman who spent four years seeking answers for irregular periods reflected on how this device could have transformed her experience:
“If I’d had something like this, maybe doctors would’ve believed what I was telling them, and the process would’ve been so much faster.” – (interviewee)
Stories like hers have reaffirmed our mission. By placing this tool directly into the hands of women, we are not only working toward miscarriage detection but also empowering personal health advocacy and contributing to the future of women’s hormone research.
Quantitative Data
Download Anonymized Survey 1 Results download
Download Anonymized Survey 2 Results download
People Interviewed:
- 11 Firefighters - 1-15-25, (1, UT firefighter) - 1-22-25, (3
firefighters, UT Valley location, Girl: 20s, Guy: 30s-40s, Chief: 50s) -
8 (UT Valley location, chief - 60s, engineer-truck - 30s to 40s, male -
50s, male - 20s, 2 others – 20s & 30s) - 2-7-25 (1 male UT
firefighter)
- 1 Environmental specialist:
- Brynn Howell
- 2 OB/GYNs
- 3-24-25 Dr. Ryan Ollerton (OB/GYN)
- Dr. Zarek
- 4 Women who have experienced miscarriage
- 3-28-25
- 3-20-25
- Two additional
- 2 Biologists
- Dr. Plaxco
- Dr. Arroyo
- Interested in using this tool for research
- In principles it could work to detect miscarriage
- Background in women’s health
Survey Responses: 587
1st Survey→ 375 Women - 97 of whom have experienced first trimester miscarriage
2nd Survey → 212 Women between the ages of 18-65
Survey Results:
1st Survey
- 81% (out of 81) would want to know about a miscarriage as soon as possible (before their next appointment)
- 51% (out of 154) felt that they had a lot of questions during their
pregnancy, and preferred to research plan and prepare
- Most difficult part of pregnancy journey (out ot 260) 45% dealing with physical pain / 25% mental health challenges / 17% dealing with pregnancy loss
- 66% would be likely or very likely to wear an on arm monitor if it could give them insights into their health and the health of their baby during the first 12 weeks
- 55% would be likely or very likely to wear an on arm monitor if it could detect pregnancy earlier than typical pregnancy tests
2nd Survey
- 56% women felt it was likely that they would track their
progesterone levels
- 34% felt it was unlikely that they would track their progesterone levels
- Why track progesterone levels (for those interested)
- Related to Periods: 58%
- Irregular periods: 22%
- ovulation: 17%
- fertility: 19%
- Menopause: 17%
- Diagnose miscarriage/early pregnancy issues: 7%
- Of those interested in tracking their progesterone levels…
- Likely to use our device: 51%
- unlikely to use our device: 37%
- Neither likely nor unlikely: 13%
- What would encourage you to buy this product?
- Data gathering
- Constant monitoring
- Ability to take personal control of health
- Not having to go in to get blood drawn all the time (convenience)
- An answer to my symptoms
- Discovering more about my fertility before trying to conceive
- What would prevent you from buying this product?
- Fear of Needles → 31%
- Price → 28%
Qualitative Data
Quotes:
“Every pregnancy after the one that I had [miscarriage] I felt anxiety about whether it would take. I would do anything to give me peace of mind”
“The more I talked to people the more I understood that it wasn’t anything that I was doing wrong, but that it was common [about miscarriage].”
“Something that I wish I knew at the beginning of her pregnancy journey is that, It’s okay to fight for myself”
“Following my miscarriage I would have liked to know if there were any issues [in subsequent pregnancies]”
“My doctor was more of an “its common type”, [they] were not as sympathetic”