Values

The way in which we decided what values to prioritize came down to a few factors. How did we want to conduct ourselves in a spirit that represented our university, our labs, and ourselves? Where did we feel we could make the most impact? To answer these questions, we had several conversations as a team. As a result of these discussions, we recognized the capability of our project to be misused. There are many cases where users do not use the device as intended and expose themselves to hazardous material. This is why we valued safety at every step to not only guarantee that our device was not harmful to humans, but also take actionable steps to prevent any dangers from arising in the first place. We recognize that our team’s at-home solution to monitoring BV could in fact create a problem of discouraging doctor advisory altogether. Through our human practice conversations, we learned how to actively work towards solving this problem. While we believe synthetic biology is a powerful tool, we insist that our project is a way of empowering individuals to monitor their health and it will not and does not serve as a replacement for medical expertise. We do not want to isolate people from proper medical care. Because we are individuals working towards improving human health, we can deeply reckon with the dangers that come along with this work, and place a high value on understanding our community to ensure safety. Because of the safety and availability of the lab spaces we had access to, we had to compromise on the options of what synthetic biology tools we would create. We therefore chose to work with whole cell biosensing. Before we had even decided on our genetic circuit, we spent time researching the current status quo of BV diagnosis. Was a solution even necessary? As it stands, there are no widely available tools that provide continuous monitoring of the vaginal microbiome. We would also like to discuss our use of the term ‘woman’. We recognize that not all people with uteruses and or vaginas are women and not all women have uteruses and vaginas. We use the term ‘woman’ to refer to anyone who has a vaginal microbiome. We acknowledge the imprecision of language and we aim to be as inclusive and accurate as possible. A lot of at home tools capture single snapshot views of the vaginal microbiome, which highly oversimplifies the complexity of the vagina. Furthermore, the tools that do exist, like OSOM Blue and Evvy are costly, and require users to send their samples to their labs for processing. When we spoke with doctors and clinicians alike in our human practices conversations, we understood that there are standards for effective BV testing that they provide, but this can be inaccessible to patients who cannot see a physician, and can take time to send results to a lab. We strive to make daily, accessible, and immediate results to reduce barriers for care. Our approach fits in a niche that science has typically not gone into. By structuring our work with empathy, integrity, and safety, we will innovate to continuously do good for our community.

Value 1: Empathy

We believe that in order to connect with our community and truly listen to their needs, we need to make every choice with empathy. To see and listen from an angle that is not our own, is an incredibly powerful ability that we strive to embody in our project development. We must listen to our community because otherwise we create a tool that, while it may be of scientific interest and value, it is not helpful to those that we are dedicated to serving. The communities most impacted by the development of our project are women who have recurrent BV and BV associated symptoms. We hope to reach rural communities in particular where point of care diagnostics are tricky to come by. We understand that if we do not communicate the goals and impacts of our project to the right audience, it may cause harm. If women who have asymptomatic BV use our device, the results could create unwarranted stress because they have no symptoms. We of course would always recommend they see a physician, but we ultimately cannot control a user’s actions. Because we valued empathy, by asking doctors who work with BV on the daily, we learned that overdiagnosis of BV is a big problem, and because BV treatment has severe drawbacks, it is critical to avoid overdiagnosing BV with our device. This is why women with asymptomatic BV would be better off consulting with practiced experts to discuss their health. Use of our device for this community of women can cause dangerous negative impacts including a recurrent cycle of BV and yeast infection. We uncovered this through acting on our value of empathy, and it is our top priority to market and communicate our product correctly. Furthermore, we consulted with our own community of women on campus who face BV, by conducting a survey, to ensure that what we prioritize is what they need.

Value 2: Integrity

By engaging in the iGEM competition, all 5 of us deeply recognized the power of this platform for synthetic biology. We recognize that we are very fortunate to have the privilege of developing and working with synthetic biology tools to make real translatable technology for our community and for the world. We understood that everything from research to communication and education demands to be held to a high standard of honesty because of the respect it gains in the scientific community. Because we are dedicated to holding ourselves responsible for honesty, we ensured that at every step in our process, we interpreted data and the results ethically, and each of us documented the work we did daily in high detail. To ensure that others can build upon what we start, we made sure to well detail all experiments and protocols. We understood that null results, while disappointing, are vital pieces of science to communicate to fellow scientists where not to go, which can be equally as useful as positive results which point towards breakthroughs. Consequently, we ensured that we showed and documented every experiment we ran no matter what the outcome was.

Value 3: Safety

Engaging safely in every aspect of our project is an unshakeable belief we hold. Whether it is with our community or in the lab we prioritize safety in every step we take. We are dedicated to guaranteeing that our technology does not in any way harm human health or the environment by closely understanding any and all safety regulations and biocontainment problems that arise.

OAI Cycle

Observe, Ask, Implement

Designed to structure our human practice conversations, our integration cycle, OAI, connects insights from experts to actionable changes on our project. Through iteration of our concise cycle, we first observe key details necessary for our project, ask thoughtful questions to experts, and lastly, implement changes based on reflection of their feedback.

Observe:

Noticing the world is a key step to changing it. Understanding and observing the needs of our community allows us to properly tailor our solution for them. When we recognize the details of our user requirements, we can create a more consumer-based, thorough and usable solution that actually works for the community that we designed it for.

Ask:

After we have gathered information about the status quo, then we will engage with experts to gain guidance on how to best fit our user needs to our solution. Formulating thoughtful questions is a key part of uncovering the details of a good solution. Before we discuss with experts, we start by meeting as a team to discuss the topics we want to bring up, ensuring we’re well‑prepared for an engaging conversation and able to gather the information we need.

Implement:

Thereafter we gather necessary information, our goal is to implement it effectively in solution design. We will firstly reflect upon and analyze the information that we were given by experts to understand how to best create actionable change in our solution. Then, after thoughtful discussion amongst the team, we will create a plan to start implementing the changes we deem most necessary amongst all the information we have. Our implementation step is our way of ‘closing the loop’ between what we choose to act on in our design and what our HP meetings have suggested is necessary for our users.

Introduction

Our project is based in women’s health, and so our primary motivation for discussing with stakeholders was to understand the needs of a woman in her day to day life and be able to apply them to our product design. Although our team members included a majority of women, we wanted to gain a wider perspective that was representative of women worldwide, especially considering the high prevalence of BV globally. We had known that we wanted to use whole-cell biosensor technology to detect BV, but were unsure as to how best to proceed. There is only so much one can learn simply by reading papers, therefore, knowledge from experts in the field was required to provide a personal insight into the lives of a multitude of women. This came in many forms, from doctors, to industry experts, to professors who had worked on women’s health research. Compiling all their expertise allowed us to gain an understanding of the variation in a woman’s experience with Bacterial Vaginosis which was then incorporated into genetic circuit design and our form factor. We subdivided all of our human practice conversations into sections, organized by general theme of why we spoke with those professionals based on where we were in the project.

Section 1: Understanding BV in Practice

Our first major collection of stakeholders was a variety of doctors that were associated with our campus and our medical school. Societally, women’s pain is often marginalized and ignored, so to be cognizant of the real world experiences women have with BV, we wanted to understand every stage of the disease. At this point in the project, BV had come to the forefront of our ideation, but we were still unsure about how vividly it impacted women and what use a potential diagnostic device for BV would have. Narrowing our scope was the primary goal of our discussions with these doctors. Diseases have a long path of progression, and understanding each aspect from prevention, to symptoms, to long term effects, to treatment and its aftereffects are all vital to gain a complete comprehension of the way the disease presents itself.

Section 2: Applications and Proof of Concept

Once we had an understanding of the personal aspect of BV and had identified key targets for diagnosis, we needed industry expertise on how to feasibly incorporate our ideas into a point-of-care diagnostic device for women. This included a series of conversations with individuals who had worked on incorporating research and healthcare with real world applications. There were various challenges we encountered in our attempts to integrate our hardware with biology. While the focus of our project was on synthetic biology, we wanted to capture as many aspects as we could of the guiding diagnostic criteria, Amsel’s criteria, in our device. In our project, we struggled with how best to incorporate a pH sensor into our device and how to keep our whole-cell biosensor alive. Uncovering this information was the primary goal of our conversation with our industry experts.

Section 3: Revalidating with Doctors

Once we had a firm grasp of our project, we then wanted to validate that our data would be useful for doctors and practitioners. By revisiting a doctor’s perspective, we aimed to ensure that the data we would be providing, pH and putrescine amount, would be useful for clinicians. This section of our conversations grounds our product in real world scenarios so that we can better serve and uplift our community. This was to ensure that our science was responsible and good for the world.

Section 4: Data and Data Communication

Science and data communication grows ever more important in our world and to create an effective and usable device, we need a strong user interface. We wanted to learn how to bring our science to the general public in a way that is understandable and doesn’t require advanced knowledge of synthetic biology. Being worthy of a user’s trust needs to stem from well thought out explanations of our science and honest reflection of our accuracy. The primary goal of this section was to understand more closely how to analyze our data, and then how to convey those complexities to our users. We wanted to learn how to market our product in the most accurate way possible to guarantee it finds the right audience.

Timeline of Conversations

Hover to see the main takeaway and click on each person for more detail!