Concern for the man himself and his fate must always form the chief interest of all technical endeavours. —— Albert Einstein
Overview Every year, millions of women courageously undergo mastectomies to combat breast cancer, reclaiming their right to life. However, for many, the loss of breasts is far beyond physical change, it’s also a challenge to self-identity, leaving invisible scars that are deeply felt and hard to heal. Especially, even after successful surgery, the shadow of cancer lingers: although following hospital check-ups could diagnose relapses, they often bring new anxiety. All the sleepless nights before examination and the agonizing wait for results make it extra hard for many to truly embrace life again even as a survivor. Synthetic biology is, after all, serving for human well-being, and our project ABCS is born to protect women’s health and relieve their anxiety. To achieve this goal, we know that science alone is not enough. This year, we actively engaged with diverse stakeholders such as industry experts, researchers, legal professionals and patient communities, whose insights inspired the initial concept of the project, guided us in refining its design, strengthening our modeling approaches, addressing ethical concerns and beyond. This iterative process ensured that ABCS truly resonates with society’s needs.
Map of stakeholders
We advanced our project through a stepwise pathway, enabling the transition of the project from public health needs to real-world application. In the stage of brainstorming, we began by exploring the potential of in vitro diagnosis and decided to utilize such a system to address the public health challenge of high breast cancer recurrence rates in Yanbian. Therefore, we focused on the real-time surveillance of breast cancer to enable post-surgical checkups without constant hospital visits. In the experimental design stage, we built up an in vivo input-sensor-output system through biomarker selection, sensors implantation in autologous adipocytes and output signal evaluation. During the stage of engineering and optimization, we received guidance from specialists on evaluating the rAAV viral vector and set up a model to assess the renal clearance efficiency of Gluc. For our ethical considerations, we established a quantative ethical risk assessment model to guarantee that every stakeholder is fully respected and protected throughout the process of the project. To ensure that interviews are effectively implemented, we utilized AI assistance to guarantee that these interviews are conducted under strict ethical restrictions. Finally, in the commercialization stage, we collaborated with experts from legal, medical, and other professional fields to design a comprehensive business strategy, accelerating the project’s transition from “laboratory” to “application”. Toolkits for Practice We believe that truly meaningful social practice should be scientific, inclusive, and ethically grounded. Throughout the project, we have gradually refined and integrated a set of complementary frameworks and approaches. We believe these tools has helped us align goals between technology development and society needs, as well as achieve shared value among stakeholders more systematically and effectively, putting technology to good use and serving society.
Frameworks for project practice
Dual-Track Framework: Connecting the Lab with Society For an iGEM project to succeed, lab innovations must be in tune with society’s real needs. To ensure our ABCS project effectively tackles real-world challenges, we developed a “dual-track” framework, which integrates our lab efforts with the outside world to achieve synergistic effects.
  • For the outer track, we gather authentic feedback through social surveys and interviews with public health professionals, bringing real-world needs directly into the lab. To be specific, we engaged in public Interviews, attended conferences, applied the BEAM ethical model, interviewed patients, and explored paths toward commercialization.
  • For the inner track, we collaborate closely with scientists, clinicians and other core stakeholders, continuously refining and deepening the project based on their lab and clinical expertise. In particular, We established the AFT, defined both input and output parameters, introduced AAV as the delivery vector, and simulated the GFB mechanism.
This approach ensures that our project maintains rigorous innovation in the lab while consistently responding to genuine societal needs, giving us a solid foundation to move forward.
Dual-Track Framework: Connecting the Lab with Society
Concentric Stakeholder Engagement: Working Together at Every Level We organize stakeholders into three layers:
Core layer decides the research objectives—the “what” we need to achieve;
Middle layer determines the implementation path—the “how” we do it;
Outer layer evaluates “whether it should be done” and “how to promote it”.
This layered approach ensures that all groups have a voice throughout the project lifecycle—from initial ideas and design, to ethics review and commercialization planning. In the ABCS project stakeholder network, each group has made a clear contribution: Clinicians (Dr. Lianbo Zhang, plastic surgeon): identified that the project could be extended to women opting for breast augmentation, expanding potential applications in aesthetic medicine; Ethics and social science experts (Prof. Yunsheng Dong, Prof. Yujiao Jia, Ms. Jun Wei): clarified ethical assessment protocols, focusing on validity and reliability, introduced life-history interviews to make patient conversations more respectful, and refined informed consent procedures; Technical and statistical experts (Prof. Wenbin Chen, mathematician): suggested using Bayesian networks to quantify risks, making the evaluation more statistically grounded. Business mentors (Prof. Jinshan Zhang, innovation and entrepreneurship advisor): encouraged us to run business simulations to enhance practical skills.
Concentric Stakeholder Engagement
Patients and high-risk groups Core Layer Core requirement: non-invasive, convenient, and real-time monitoring method Interactive strategy: collecting pain points through community interviews
Clinicians and administrators Core Layer Core requirement: accuracy of test results Interactive strategy: expert interview to optimize technical pathways
Expert in biotechnology Middle Layer Core value: provide crucial technical support Interactive strategy: participation in academic conferences and expert interviews
Ethicists and jurists Middle Layer Core value: assessing the ethical risks of synthetic biology technology Interactive strategy: building an ethical risk assessment model
The public Outer Layer Core value: understanding the public through Interactive strategy: designing popular science tools to lower the cognitive threshold of the public towards technology
Policy makers and disease control institutions Outer Layer Core value: providing epidemiological data Interactive strategy: participation in public health conferences and promote the inclusion of the proiect into the local "Supplementary Screening Program for Two Types of Cancer"
Investors and business partners Outer Layer Core value: providing commercialization path design Interactive strategy: participation in relevant professional conferences to learn business knowledge
Practitioners in the aesthetic medicine industry Outer Layer Core value: engineered fat cells are compatible with existing breast augmentation/reconstruction surgeries Interactive strategy: optimizing cell culture and transplantation through interviews
SCQAI: Structured Problem Analysis and Implementation Successful synthetic biology projects require not only problem analysis but also concrete actions. Therefore, based on the classic SCQA framework (Barbara Minto, The Pyramid Principle), we added an “I” for Implementation, forming the SCQAI framework, which guides the project throughout its lifecycle:
Situation Outline the background throughout the project development Complication Identify conflicts and barriers during the progress the situation Question Extract key issues from the conflicts Answer Propose targeted solu- tions to address the issues Implementation Translate ideas into con- crete actions, testing and adjusting them
This framework allows us to turn each piece of societal feedback into a clear set of problems and to ultimately implement practical improvements. BEAM: Ethical Risk Assessment for Synthetic Biology As synthetic biology advances, balancing technological innovation with ethical responsibility is essential. To address this, we created the BEAM ethical risk assessment model. This tool enables us to systematically identify and quantify ethical risks in specific contexts, providing a structured approach to analyzing the ethical implications of synthetic biology. Unlike traditional methods that rely on subjective judgment, BEAM offers a more scientific, data-driven approach, filling a gap in the tools available today. It not only gives us a clearer picture of the balance between innovation and risk but also provides a practical reference for exploring how social responsibility and technical progress can advance together in synthetic biology. We built the BEAM ethical model step by step in the following order:
  • Weighted Calculation using a Structural Equation Model (SEM).
  • Probability Assessment through Bayesian Network–based risk quantification.
  • Model Building by gathering public views on synthetic biology risks.
  • Application & Validation through feedback collection and validation tests.
Each stage was logically connected and guided by our IHP perspective, ensuring the BEAM model was constructed in a coherent and evidence-based way.
Buiding BEAM
In the dynamic landscape of synthetic biology, advancing technological innovation must go hand in hand with rigorous ethical risk assessment—this is a core belief that guides our team’s Human Practices efforts. To translate this belief into actionable tools for the iGEM community, we share the Usage Instructions of the BEAM model. Developed to address the pressing need for systematic, standardized ethical evaluation in synthetic biology projects, this instruction has two key purposes:
  • Serves as a clear, step-by-step guide to applying the BEAM model—from distributing Likert-scale questionnaires to calculating initial risk scores and selecting inference methods.
  • Shares details of the model’s core dimensions and their sub-dimensions, ensuring transparency in our ethical risk quantification.
We hope it empowers more teams to integrate ethical assessment into every stage of innovation, fostering a safer, more responsible synthetic biology community. Access the full BEAM Usage Instructions below to get started.
BEAM usage instructions
Deeply rooted in the fertile soil of these frameworks and tools, our human practices branched out and thrived.
Insight growth tree
Inspiration At this stage, we conducted surveys and interviews in Changchun communities, identifying breast cancer as a key public health concern and recognizing the need for more accessible, patient-friendly diagnostic techniques. A visit to the Yanbian CDC reinforced the urgency of long-term recurrence monitoring, inspiring us to explore a breast cancer surveillance system with in vivo monitoring and in vitro readout. We then gained further insights at the MedTech Summit 2025, where experts emphasized in vitro diagnosis (IVD) and real-time early warning, and finally confirmed the clinical relevance of this direction through our interview with Dr. Guang Sun.
Listening to the Community
S (Situation) At the beginning, we aimed to define a research direction with both scientific value and social impact. C (Complication) Before engaging the community, we lacked clarity on which health issues were most urgent and relevant to the public. Q (Question) What specific needs should our project address? A (Answer) Community surveys and interviews highlighted strong demand for breast cancer education and easier follow-up. I (Implementation) We produced a breast health handbook and set our project focus on improving breast cancer diagnostic techniques.
Amid the rapid progress in medical technology, we initiated the preparation of this year’s iGEM project. Our core goal was to identify a research direction with strong scientific potential, social value, and humanistic care. To achieve this, we turned our attention to several communities in Changchun, including Qunying and Huxi Community Health Centers and Nanling Baiyi Community. These communities represent residents across different ages, professions, and health conditions, providing us with a broad perspective on public needs. To better capture these needs, we designed and distributed a Public Health Needs Questionnaire, covering residents’ awareness of common diseases, accessibility of medical services, and the dissemination of health knowledge. The results revealed that nearly 80% of residents were concerned about cancer health education, with breast cancer ranking the highest at 88%. Notably, among all female cancer patients in the communities, breast cancer accounted for 15.6%. These findings pointed us toward an initial research direction. Building on this, we conducted in-depth, face-to-face interviews with residents. One breast cancer patient told us that if she had realized the importance of seeking medical care when she first noticed a lump in her breast, she might have avoided considerable suffering. Her experience made us aware that many people lack sufficient knowledge about the early symptoms of breast cancer. In response, we decided to create a Breast Health Awareness Handbook to help the public learn self-examination methods and strengthen self-care awareness. Another patient’s suffering left an even deeper impression on us. She explained that traditional follow-up examinations for breast cancer were not only cumbersome but also invasive, which discouraged her from undergoing regular screening. As a result, she delayed seeking medical care until symptoms became obvious, missing the optimal treatment window. Her story highlighted the strong public demand for breast cancer diagnostics that are less painful and more convenient. During our fieldwork in Nanling Baiyi Community, which has a younger demographic, we also interviewed a student from Jilin University. She shared that her hometown was in the Yanbian Korean Autonomous Prefecture, where many of her family members and friends had been affected by the threat of breast cancer. This motivated us to plan our next step: visiting the Yanbian CDC to further investigate the local situation. Taken together, the survey results and patient feedback underscored a clear public need. In response, we decided to focus our project on improving breast cancer diagnostic technologies, aiming to provide more scientific, accessible, and patient-centered solutions.
To turn community insights into actionable data, we designed and distributed our “Questionnaire on Public Health Needs”—a tool aimed at understanding residents’ awareness of common diseases, access to medical services, and gaps in health education. Below, you’ll find the full “Questionnaire on Public Health Needs” that started it all: a testament to how listening to communities can steer innovation toward what matters most.
Questionnaire on Public Health Needs
Understanding Public Health Needs in Yanbian
S (Situation) After identifying breast cancer as our focus, we sought to understand challenges in different regions. C (Complication) Before visiting Yanbian, we were unsure how regional health disparities affected breast cancer follow-up. Q (Question) What obstacles exist in breast cancer care in resource-limited areas? A (Answer) Local CDC staff revealed the lack of reliable, long-term monitoring tools. I (Implementation) We adopted a technical model with long-term in vivo monitoring and convenient in vitro readout.
Through the student we met in Nanling Baiyi Community, we learned that her hometown—the Yanbian Korean Autonomous Prefecture—faces considerable challenges related to breast cancer. Motivated by this, we traveled to Yanbian and interviewed staff members at the local Center for Disease Control and Prevention. They explained that: as a minority region, Yanbian’s unique geographic environment, lifestyle patterns, and distribution of medical resources give its public health issues distinctive regional characteristics. The area is currently facing multiple challenges, in some remote counties, resources for disease prevention and control are insufficient; primary healthcare institutions lack adequate diagnostic equipment and trained professionals; and surveillance networks for certain diseases have yet to achieve full coverage, with data collection and analysis still limited in timeliness. We started our discussion with staff at the local CDC by presenting the breast cancer health education booklet we had developed. They were highly appreciative of our efforts, and explained that while the government has implemented initiatives such as the ”Two Cancer Screening” policy, which aims to promote the early detection and prevention of cervical cancer and breast cancer through advanced diagnostic methods, a more pressing challenge is the development of technique for convenient follow-up examination of breast cancer. On the one hand, existing diagnostic methods often fail to reliably detect early recurrences, which can result in delayed diagnoses—or, conversely, lead to false alarms that cause unnecessary trauma and psychological stress. On the other hand, breast cancer recurrence risk varies among individuals, spans long periods, and sometimes occurs before the next scheduled follow-up. They noted that if a technology could be developed to both alleviate patients’ anxiety about recurrence and enable long-term dynamic monitoring, it would be of great benefit to the public. Inspired by this, we decided to pursue the development of a technology capable of long-term in vivo monitoring with convenient in vitro readout, allowing patients to conduct preliminary follow-ups at home.
Strengthening Our Idea at the MedTech Summit 2025
S (Situation) With our technical model in place, we needed to refine the approach through industry insights. C (Complication) Before the summit, we struggled to identify which technologies could best meet patient needs and stand out in the field. Q (Question) Which solutions are practical and patient-friendly? A (Answer) Experts’ insights inspired us of integrating IVD with implantable sensing to enable real-time early warning. I (Implementation) We refined our design by incorporating real-time warning functions and prioritizing patient comfort.
After establishing breast cancer “in vivo monitoring with in vitro readout” as the core of our project, we faced a new challenge: identifying the right technologies that could not only address patients’ real needs but also enable our project to stand out in the industry. To explore potential solutions, we attended the MedTech Summit 2025. The conference, centered on the themes of Medical Device Innovation and Digital Transformation, brought together experts, industry leaders, and researchers from across the globe. Discussions revolved around frontier technological applications, industry development trends, and evolving patient needs. During the event, we systematically visited multiple company exhibitions and interviewed experienced professionals. Through these exchanges, we learned that with the growing influence of precision medicine and rapid technological advances, in vitro diagnostics (IVD) has become a hot topic due to its speed, convenience, and cost-effectiveness. As one industry practitioner explained, IVD refers to the testing of samples such as blood or tissue outside the human body, providing critical information for disease prevention, diagnosis, and treatment. Compared with traditional imaging or invasive procedures, IVD offers greater convenience and scalability. When combined with implantable, in vivo sensing and non-invasive, in vitro readout, IVD enables continuous or periodic monitoring inside the body, with results easily retrieved through simple external devices. This model not only reduces the need for frequent hospital visits and complex procedures but also provides high-risk groups with a low-burden, rapid, and repeatable monitoring solution. We quickly realized how crucial this approach is in meeting the need for rapid follow-up in breast cancer care. Many patients, after initial treatment or surgery, must repeatedly undergo biomarker testing or recurrence monitoring. By integrating IVD with implantable sensing and in vitro readout, patients could perform regular check-ups more conveniently, significantly improving both efficiency and adherence, thereby meeting urgent clinical and public health demands for breast cancer follow-up. Another frequently emphasized concept at the conference was patient-friendly innovation, which highlights the importance of designing technologies that minimize discomfort, simplify procedures, and consider patients’ psychological well-being. This resonated strongly with insights we had gathered from earlier public needs assessments. In one exchange, an industry expert specializing in tumor monitoring devices introduced us to the concept of real-time early warning: “The essence of real-time early warning lies in the continuous data collection by in-body sensors, combined with intelligent analysis on the readout side, which allows abnormal fluctuations in tumor biomarkers to be detected at an early stage. Unlike traditional follow-up methods that rely on check-ups every three, six, or even twelve months—during which recurrence or metastasis may already have occurred—real-time early warning closes this dangerous ‘monitoring gap’. By issuing alerts at the first sign of abnormality, it shortens the time window for detecting recurrence and enables earlier medical intervention.” We came to understand that this model not only enhances medical monitoring in terms of sensitivity and timelines but also offers patients greater peace of mind. Instead of passively waiting for periodic test results, they can access timely health information through convenient in vitro readouts. This perfectly aligns with the “patient-friendly innovation” repeatedly highlighted during the conference. As a result, we resolved to incorporate real-time early warning functions into our design, combining IVD with innovative sensing technologies to reduce the discomfort of conventional methods while empowering patients with earlier detection of potential abnormalities.
Interview with Dr. Guang Sun, Breast Surgery Department
S (Situation) After shaping our technical framework, we sought suggestions from clinical experts. C (Complication) We lacked the professional expertise to confirm that our focus matched urgent clinical needs. Q (Question) How do clinicians view the key gaps in breast cancer monitoring? A (Answer) Dr. Sun stressed recurrence monitoring and long-term prognosis management as top priorities. I (Implementation) We confirmed our project direction aligns closely with frontline clinical challenges.
Guang Sun Chief Physician of Breast Surgery, China-Japan Union Hospital of Jilin University
  • Standing Committee Member of the Breast Cancer Professional Committee of Jilin Anti-Cancer Association
  • Committee Member of the Oncology Clinical Research Professional Committee of the Chinese Medical Education Association
After determining our primary technical approach, we sought to gain deeper insights into how clinicians perceive our solution, as well as to draw upon more frontline clinical experience. To this end, we interviewed Dr. Guang Sun from the Department of Breast Surgery at China-Japan Union Hospital of Jilin University. In the interview, Dr. Sun provided a systematic overview of the current landscape of breast cancer screening and treatment, drawing on his extensive clinical experience. He noted that with the increasing adoption of imaging modalities such as mammography, ultrasound, and MRI, the early detection rate of breast cancer in China has improved significantly. In certain regions, screening programs are now able to cover most women aged 40–69. However, in primary care settings and less developed areas, screening coverage remains limited. Among high-risk groups in particular, both patient compliance and accessibility of services continue to be pressing challenges. Regarding treatment, Dr. Sun explained that current treatment for breast cancer are relatively well established, typically involving multimodal approaches such as surgery (breast-conserving or mastectomy), chemotherapy, radiotherapy, endocrine therapy, and targeted therapy. Clinical guidelines have evolved into a fairly standardized stage-based treatment framework. With the introduction of newer therapies such as HER2-targeted drugs and CDK4/6 inhibitors, survival outcomes for some patients have been significantly extended. Nonetheless, he highlighted two major ongoing challenges: Risk of recurrence and metastasis—Even after completing standardized initial treatment, patients still face a considerable risk of recurrence. Five-year disease-free survival rates vary greatly by subtype, with triple-negative breast cancer presenting the highest recurrence risk. Inadequate long-term prognostic management—Current follow-up systems for breast cancer patients are insufficient. In many regions, monitoring tools are limited, patient adherence is poor, and primary care facilities lack effective diagnostic methods. This leaves substantial gaps in risk monitoring during the postoperative and long-term rehabilitation phases. Dr. Sun concluded that the clinical focus of breast cancer has gradually shifted from “how to achieve early detection” toward “how to reduce recurrence risk and improve long-term quality of survival”. He therefore strongly supported our emphasis on recurrence monitoring and long-term prognostic intervention as both timely and clinically meaningful.
Project Design Building on these insights, we began to translate clinical needs into technical solutions. Expert interviews refined our project direction. Dr. Wan Wang confirmed adipocytes as feasible carriers via mature fat grafting. Dr. Lianbo Zhang broadened our vision by suggesting cosmetic fat augmentation as an additional application. Dr. Bin Yang guided us to prioritize Gaussia luciferase over melanin for better psychological acceptance and stressed the need to monitor high-risk groups between check-ups. Professor Walter Bodmer highlighted rigorous biomarker validation through both literature review and database analysis. These insights grounded our design in clinical practice while expanding its impact to wider populations.
Interview with Dr. Wan Wang, Breast Surgeon
S (Situation) Postoperative breast cancer patients face both the psychological pressure of recurrence monitoring and stressful traditional hospital check-up. C (Complication) It was unclear how to integrate our diagnostic system into routine medical procedures to meet these needs. Q (Question) Could our system be integrated into standard treatment processes, and is adipose tissue a suitable carrier? A (Answer) Dr. Wan Wang affirmed that autologous fat transplantation technology in China is mature and could be effectively used. I (Implementation) We chose adipose cells as carriers and planned to implant engineered adipocytes during breast reconstruction surgery.
Wan Wang Associate Chief Physician of Breast Surgery Department, China-Japan Union Hospital of Jilin University
  • Committee Member of the Breast Cancer Professional Committee of the Chinese Medical Education Association
  • Committee Member of the Breast Reconstruction and Repair Professional Committee, Innovation & Organ Reconstruction Branch of the Chinese Association of Plastics and Aesthetics
At the initial exploration stage, we noticed that breast cancer patients after surgery face challenges both psychologically and physically: on the one hand, they must live with the lifelong pressure of recurrence; on the other hand, traditional imaging and biopsy methods are difficult to achieve non-invasive and real-time alerts. Meanwhile, we learned from studies that the number of breast reconstruction surgeries is increasing annually, this led us to question whether a diagnostic system could be integrated into standard breast cancer treatment, so that patients could benefit from both non-invasive monitoring and psychological recovery. To explore this idea, we consulted Dr. Wan Wang from the Department of Breast Surgery at China-Japan Union Hospital of Jilin University. During the conversation, we introduced our concept of using engineered adipocytes as a technical carrier and sought her opinion. Dr. Wang explained that autologous fat grafting is already a well-established technique in China, widely applied in many clinical fields. She gave the example of her center’s experience with DiEP flap surgeries, where, despite the lack of intraoperative vascular imaging tools such as SPY, the team relied on microsurgical skills and achieved a high survival rate. This gave us more confidence in the feasibility of implanting engineered adipocytes during reconstruction, while also reminding us to pay attention to technical requirements that ensure cell survival after surgery. Currently, the national breast-conserving surgery rate remains below 20%. At Dr. Wang’s hospital, the rate is about 40%, which is relatively high in comparison with the average. However, the proportion of immediate reconstruction after mastectomy is still low—around 10% in large medical centers nationwide, and even below 5% in Jilin Province. These figures suggest that while integrating a diagnostic system into reconstruction surgery could provide solutions for some patients, we must also consider how to extend the benefits of this technology to the much larger group who do not undergo reconstruction. Based on Dr. Wang’s insights, our team clarified the technical direction and decided to use adipocytes as the carrier. By implanting engineered adipocytes during breast reconstruction, we aim to develop an integrated strategy combining diagnosis and treatment.
Interview with Dr. Lianbo Zhang, Plastic Surgeon
S (Situation) When planning the project audience, we always paid attention to the suggestion of Dr. Wan Wang that non-reconstruction patients should also benefit from our project. C (Complication) Limiting our technology to this specific patient group would significantly narrow its clinical value and potential impact. Q (Question) How could we expand the system’s use to a wider group? A (Answer) Dr. Lianbo Zhang noted that autologous fat transplantation for cosmetic breast augmentation is both clinically safe and increasingly in demand. I (Implementation) We expanded our project design to include women undergoing breast augmentation.
Lianbo Zhang Director of the Department of Plastic Surgery, China-Japan Union Hospital of Jilin University
  • Young Committee Member of the Plastic Surgery Branch of the Chinese Medical Association
  • Young Committee Member of the Medical Cosmetology Specialty of the Chinese Association of Integrative Medicine
From the very beginning, we kept in mind Dr. Wan Wang’s reminder: while integrating our diagnostic system into breast reconstruction surgery could benefit some patients, we also needed to consider the many women who do not undergo reconstruction. With this in mind, we looked at the use of autologous fat grafting in cosmetic breast augmentation as a possible extension of our project. Restricting our system to post-mastectomy patients would mean a relatively small user base. To fully assess the potential of this technology, we interviewed Dr. Lianbo Zhang, a plastic surgeon, focusing on the clinical outcomes and market acceptance of autologous fat grafting. From a clinical perspective, she explained that fat grafting offers unique advantages because the tissue comes from the patient’s own body. It avoids complications such as capsular contracture and the foreign-body sensation that often occur with implants. The reconstructed breasts also look and feel more natural, which appeals to patients who prefer minimally invasive and harmonious with their own body procedures. From a market perspective, she noted that as consumer attitudes toward aesthetic surgery evolve, more patients are seeking “natural results” without artificial implants. Combining Dr. Wang’s earlier advice with Dr. Zhang’s insights, we broadened our project’s scope. In addition to breast cancer survivors, we decided to include women who actively choose cosmetic breast augmentation. By leveraging fat grafting, a well established and widely accepted cosmetic procedure—as our entry point, we could expand the reach and impact of our diagnostic technology.
Designing Our Output Signal During the development of our project, one teammate got inspiration from fireflies. The glow of fireflies comes from luciferase, an enzyme that catalyzes its substrate, luciferin, under specific conditions to emit visible light. This sparked an idea: could we engineer adipocytes to express and secrete luciferase upon sensing breast cancer signals, allowing the disease to be detected by examining fluorescence in urine? To evaluate this concept, we conducted an extensive literature review and discovered that firefly luciferase (Fluc) is not an ideal urinary reporter protein and is rarely used for this purpose. The main reasons are:
  1. Lack of an efficient natural secretion signal peptide.
  2. Large molecular weight, limiting secretion into the extracellular space and blocking passage through the glomerular filtration barrier.
We then systematically examined other luciferases and soon turned our attention to Gaussia luciferase (Gluc), another bioluminescent enzyme. Widely used for in vitro signal reporting, Gluc possesses properties that overcome the limitations of Fluc, with a much smaller molecular weight and a natural signal peptide for secretion, we considered it an ideal urinary reporter protein. Gluc uses coelenterazine as a substrate and does not require ATP for its catalytic reaction, making the assay simple to perform. It has high luminescence efficiency, producing strong signals, often surpassing Renilla luciferase (Rluc) and rivaling or even exceeding humanized Fluc. Based on these advantages, we decided to use genetic engineering to introduce Gluc into adipocytes. When these engineered cells detect breast cancer signals, they would efficiently express and secrete Gluc. Gluc would then enter circulation, filtered through kidney, and accumulate in urine. For detection, the addition of coelenterazine, a substrate for Gluc, to a urine sample would be required, and the luminescent signal in urine would directly indicate cancer status.
Output determination (Gluc)
During our literature review, we identified another potential way to generate an output signal—melanin synthesis. We envision engineering cells to produce melanin when cancerous changes occur, causing visible pigmentation on the skin and providing a direct, intuitive warning signal. Compared with fluorescence or chemiluminescence, melanin offers several advantages: first, it is visibly apparent, requiring no extra detection equipment, so patients can notice it with the naked eye; second, its precursor comes from tyrosine, a naturally occurring amino acid in the human body, making it highly biocompatible and safe; third, melanin deposits in the skin are stable and long-lasting, less affected by environmental factors, and can provide sustained risk indications; additionally, the visual nature of pigmentation makes the warning easier for patients to understand and accept, reducing reliance on instruments or numerical readings. In terms of implementation, we plan to couple cancer-related signals with the tyrosine metabolic pathway, activating tyrosinase and related enzymes to convert tyrosine into dopaquinone and further polymerize it into melanin, forming visible deposits in the skin or subcutaneous tissue. This mechanism effectively acts as an in-body visual alarm, turning potential cancer signals into clear color cues that help patients detect health risks in time.
Output determination (skin melanin)
Interview with Dr. Bin Yang, Breast Surgeon
S (Situation) We needed to evaluate the possible output strategies, Gaussia luciferase and melanin. C (Complication) Both strategies had pros and cons in terms of psychological acceptance, convenience, and technical feasibility. Q (Question) Which output signal has the best balance of feasibility and acceptance? A (Answer) Dr. Bin Yang suggested that the melanin approach could worsen body image concerns, and Gaussia luciferase was more feasible. I (Implementation) We kept Gluc as our main output.
Bin Yang Associate Chief Physician of Breast Surgery Department, China-Japan Union Hospital of Jilin University
  • Having been engaged in breast surgery for more than a decade, he/she is committed to developing minimally invasive and refined treatments for benign and malignant breast tumors.
At the stage of evaluating possible output options, Gaussia luciferase and melanin, we began to weigh how to ensure both the convenience of at-home monitoring and the psychological comfort of patients. To explore this, we interviewed Dr. Bin Yang from China-Japan Union Hospital of Jilin University. His analysis gave us valuable guidance. Regarding the melanin approach, he pointed out that a permanent visible mark on the body might worsen patients’ body-image concerns, running against our original goal of easing psychological stress. Meanwhile, this approach faces several challenges, including the potential irreversibility of melanin deposition, poor visibility when expressed in subcutaneous adipose tissue, and possible interference from the surrounding tissue microenvironment. As for the other option, he noted that Gaussia luciferase is a relatively common and technically feasible output. Based on his advice, we decided to keep Gaussia luciferase as the primary output. Dr. Yang also emphasized the importance of identifying high-risk groups. He noted that people with a family history of breast cancer, pregnant women, and women going through menopause are at higher risk. In particular, during pregnancy, hormonal fluctuations can accelerate tumor progression, making the cancer more aggressive, harder to treat, and quicker to metastasize. This underlined the urgency of home monitoring: our system could provide real-time alerts during such critical periods, gaining precious time for treatment. In addition, Dr. Yang explained the routine check-up schedule for post-surgery patients: every six months within the first three years, once a year in years 3-5, and once every two years after five years. The focus is usually on detecting lung and bone metastasis through CT, bone scans, abdominal and gynecological ultrasound, and tumor marker testing. From this, we realized that our monitoring system should complement clinical follow-ups by covering the intervals between check-ups. This would reduce the risk of missed recurrences and further strengthen our determination to develop an effective monitoring technology that contributes to improved survival rates. We selected Gluc as a secreted reporter, enabling convenient luminescence-based detection. Signals were robustly measurable from culture supernatant with a detection limit of ~10³ cells, detectable as early as 6 hours and increasing up to 48 hours. This non-invasive extracellular output highlights its potential for clinical detection via easily collected body fluids like urine.
Interview with Professor Walter Bodmer, Fellow of the Royal Society
S (Situation) We were reviewing public databases to find genes differentially expressed between cancer-associated adipocytes (CAAs) and normal adipose tissue (NAT). C (Complication) Direct comparison datasets were limited and sample sizes too small, reducing statistical power. Q (Question) How could we obtain valid data to find the high expression genes in CAAs? A (Answer) Professor Walter Bodmer recommended starting with a thorough literature review to confirm the specific link between candidate genes and breast cancer. I (Implementation) We first verified the specificity of candidate genes through literature review, then moved on to database screening and validation.
Walter Bodmer Head of the Cancer and Immunogenetics Laboratory, MRC WIMM
  • Fellow of the Royal Society (UK)
  • Foreign Associate of the National Academy of Sciences (USA)
We aimed to identify highly expressed genes in cancer-associated adipocytes (CAAs) compared with normal adipose tissue (NAT). To achieve this, we systematically searched public databases. However, we soon found that datasets directly comparing CAAs and NAT were extremely scarce, and the available ones had very limited sample sizes (fewer than 100 cases). This presented two major problems: the statistical power was too weak, and the results were not reliable enough to support candidate gene selection. We then consulted Professor Walter Bodmer, Fellow of the Royal Society. He pointed out that the “high expression” we observed in CAAs might not be breast cancer-specific, but rather a general response of adipose tissue under inflammatory conditions. Based on his advice, we adjusted our strategy. Instead of relying solely on large-scale database screening, we decided to first conduct a thorough literature review. Only genes whose upregulation was strongly supported in the literature as breast cancer-related, and not simply driven by inflammation, would move forward into database validation. This way, we could make sure our candidate genes were both biologically meaningful and clinically relevant before further analysis.
Project Optimization Expert interviews shaped our project’s technical and clinical direction. The DIRUI project manager stressed accuracy in biomarker selection, leading us to adopt a combined strategy and finally choose LIF and PLOD2. We consulted Dr. Hongyu Wu, who guided us to use adeno-associated virus (AAV) for safer, long-term expression. Our Model group built a model assessing the renal clearance efficiency of Gluc, and refined it with advice from professionals. Professor Haoran Yu suggested parameter inference for missing renal data, enabling reliable simulations of Gluc clearance, and Senior Researcher Rui Yin recommended adding a steric hindrance correction, which improved our diffusion model’s accuracy. Together, these insights ensured that our system is scientifically rigorous, clinically feasible, and user-friendly.
Interview with Project Manager at DIRUI
S (Situation) Our team needed to select suitable cancer biomarkers. C (Complication) Without clear selection criteria, choosing among the many potential candidates was difficult. Q (Question) What standards should guide the choice of our biomarkers for breast cancer? A (Answer) A project manager at DIRUI, a medical technology company, emphasized that accuracy is the top priority, and suggested exploring combinations of markers. I (Implementation) We screened candidate genes through literature review, tested their combinations in our model group, and eventually selected LIF and PLOD2.
As a leading enterprise in the IVD industry, DIRUI Medical Technology Co., Ltd. has been deeply engaged in the industry for over 30 years. The company boasts a full industrial chain business covering the R&D, production, marketing and services of high-quality medical testing products, enabling it to provide comprehensive product solutions and services for medical laboratories.
One pressing issue for our team was how to select the most appropriate biomarkers to detect breast cancer. To address this, we turned to DIRUI Industrial Co., Ltd., a company with extensive expertise in tumor marker detection, aiming to obtain valuable insights from well-established practices of this enterprise. During our visit to DIRUI’s product exhibition hall, we reviewed their tumor marker product lines and received a detailed introduction from a project manager specializing in this field. Drawing on years of industry experience, he explained key considerations in optimizing screening workflows and reducing false positives. These insights not only confirmed the feasibility of focusing our research on monitoring breast cancer prognosis, but also provided concrete references for improving the performance of our detection system. When asked about the key factors in biomarker selection, he emphasized that accuracy must come first. Guided by this principle, we decided to explore a combined biomarker strategy. Through literature review, we identified four candidate gene pairs associated with cancer-associated adipocytes: PAI-1/PLOD2, CXCL3/LIF, TGFβ/Fam3c, and IL1β/IL6. HP to Experiment Differentiated adipocytes treated with tumor-associated cytokines showed upregulation of PLOD2 and LIF, confirming biomarker responsiveness. Co-culture with MDA-MB-231 cells led to higher luciferase signals, demonstrating that our dual-input sensor detects cancer cues in a tumor-like environment. Therefore, we confirmed the feasibility of using LIF and PLOD2 as our core biomarker pair for breast cancer monitoring.
Interview with Research Scientist Hongyu Wu
S (Situation) We initially planned to use adenovirus as a vector to achieve long-term stable expression of our target genes in adipocytes. C (Complication) Although adenovirus shows high infection efficiency, it cannot maintain stable expression over time. Q (Question) Was adenovirus the right choice, or should we consider a better option for sustained and safe gene delivery? A (Answer) Dr. Hongyu Wu suggested using adeno-associated virus (AAV), which has lower immunogenicity and stronger potential for long-term expression. I (Implementation) We shifted our design to AAV, while also planning adipose cell-specific optimization and validation experiments.
Hongyu Wu Research Scientist of Department of Integrative Biology and Pharmacology, University of Texas Medical School at Houston
  • She has more than 15 years of research experience in the gene expression regulation and protein function. As the first author or the co-author, she has published a series of papers on the high-impact journals, such as J. Am. Soc. Nephrol, Cancer Res, Mol.Cell.Bio, Blood, Sci Rep, Nat Communication, Circulation, Cells etc.
We initially planned using adenovirus as a vector to achieve stable, long-term expression of target genes in adipocytes. To evaluate this choice, we consulted Dr. Hongyu Wu, a research scientist with extensive experience in molecular biology and gene delivery systems. She told us that adenoviruses offer higher infection efficiency, even in hard-to-transfect cells, and can infect both dividing and non-dividing cells—an advantage when working with metabolically less active adipocytes. However, she also pointed out several challenges. Adenoviruses generally do not integrate into the host genome, they tend to remain predominantly in a free form within the cell, meaning that gene expression mediated by them is often short-lived. In her past work with hepatocytes, she observed effective expression, but not lasting stability. The highly differentiated nature of adipocytes could further shorten expression duration. She also mentioned that adenoviruses can trigger immune responses, potentially leading to clearance of transduced adipocytes and reduced persistence of gene expression. Moreover, the unique microenvironment of adipose tissue, rich in lipid droplets and extracellular matrix, might reduce viral diffusion and infection efficiency compared to other tissues, thus affecting overall expression. Drawing on her own research, particularly her experience with multiple vector delivery systems, Dr. Wu suggested that adeno-associated virus (AAV) may be a more promising alternative for long-term expression, due to its lower immunogenicity and more stable persistence in non-dividing cells. Still, she emphasized that vector optimization for adipocyte specificity will be essential, and further experiments are needed to confirm performance in adipocytes. HP to Experiment CCK-8 assays showed that AAV infection did not affect adipocyte viability, confirming our system is safe while functional. A multi-scale model predicted that Gaussia luciferase (Gluc) can pass the glomerular filtration barrier and reach detectable urine levels within hours, supported by an ODE-based kinetic model simulating its production and secretion.
Interview with Professor Haoran Yu, Department of Mathematics
S (Situation) We needed to evaluate Gluc’s renal clearance, but data on its filtration rate was missing. C (Complication) While modeling, we found no data on the basement membrane’s pore size. Q (Question) We asked Professor Haoran Yu how to estimate these unknown parameters. A (Answer) He suggested using normal distribution modeling, optimization, and data from similar membranes. I (Implementation) With his guidance, we filled the data gap and advanced our Gluc clearance model.
Haoran Yu Associate Professor, Department of Basic Mathematics, Jilin University
  • Once presided over the Youth Science Fund Project of the National Natural Science Foundation of China
  • Postgraduate student majoring in Fundamental Mathematics at the School of Mathematical Sciences, Peking University, and holds a Doctor of Science degree
For the future application of ABCS on patients, we needed to assess the renal clearance efficiency of Gluc. However, existing literature lacked data on the specific filtration rate of Gluc through the glomerular filtration barrier. To address this, our model group considered simulating Gluc transport across the three structural layers of the filtration membrane: endothelial fenestrae, basement membrane, and podocyte slit diaphragm. Yet we quickly encountered another obstacle—there was no available data on the pore size distribution of the basement membrane. We then consulted Professor Haoran Yu from the School of Mathematics at Jilin University. He pointed out that stochastic structures in biological systems often follow normal distribution patterns. He suggested leveraging such statistical laws, along with known physical parameters of the filtration barrier, to make reasonable assumptions about basement membrane pore sizes. For example, by assuming correlations with the other two structural layers, we could build a joint probability model to narrow the parameter range. He further recommended coupling macro-level renal clearance data with micro-level structural modeling. By using optimization algorithms to adjust assumed pore parameters until simulation outputs aligned with observed clearance data, we could deduce plausible distributions. He also proposed drawing on pore distribution data from biologically similar membranes as references, adapting them through similarity measurement modeling. These professional insights helped our team overcome critical data gaps, paving the way for the next step to assess the renal clearance efficiency of Gluc.
Interview with Senior Researcher Yin Rui
S (Situation) We were studying the renal clearance efficiency of Gluc and reviewed that the glomerular filtration barrier (GFB) is typically divided into three layers. C (Complication) However, we found major inconsistencies in the reported physical parameters of the third layer across different studies. Q (Question) We asked Senior Researcher Yin Rui why such discrepancies existed. A (Answer) He explained that many papers define the third layer differently and that it can actually be divided into the Podocyte Layer and the Split Membrane. I (Implementation) Following his advice, we refined our model by reconstructing the traditional three-layer GFB into a four-layer structure to better simulate Gluc’s renal clearance.
Rui Yin Senior Research Fellow of Stepan Company, Northfield, IL
  • Years of experience in nanotechnology synthesis and application
  • Nearly 40 products commercialized
Based on the previous interview, we further explored the renal clearance efficiency of Gluc. During the literature review, we found that the GFB is traditionally divided into three layers of membranes, including endothelial fenestrae, basement membrane, and filtration slit diaphragm. After establishing the physical parameters of the first two layers, we continued to search for the physical parameters of the third layer. In this process, we discovered significant discrepancies in the reported physical parameters of the third layer across various studies, which fell outside the margin of error. Therefore, we conducted an interview with Senior Researcher Yin Rui. During the interview, he acknowledged our exploratory approach. From the perspective of his daily experimental work, he pointed out that many studies differ in their specific definitions of the third layer. He mentioned that the third layer, as referred to in conventional literature, is divided into two sub-layers: the Podocyte Layer and the Split Membrane. He advised us to delve deeper into the literature to investigate the specific physical parameters of these two sub-layers. Inspired by his insights, we successfully conducted preliminary physical modeling. Subsequently, the Model group, building on this inspiration, revised the conventional three-layer GFB structure and reconstructed it into four layers based on distinct membrane functions. Ultimately, this led to the successful development of a model for the renal clearance efficiency of Gluc.
Ethics Model To address the growing need for scientific evaluation of complex ethical issues in synthetic biology, we designed the BEAM ethical risk assessment model. At the beginning, we faced two main challenges, unbalanced subjective judgment and objective criteria in quantitative assessment, and a lack of systematic depth in existing frameworks caused by the multi-dimensional complexity of ethical risks. To move our model forward, we interviewed Professor Yunsheng Dong, whose idea of scenario-based evaluation inspired us to break down the ethical issues in our project and establish specific risk indicators for each. To overcome the bottleneck of quantification, we followed the advice of Professor Wenbin Chen and introduced a Bayesian network model, allowing us to integrate multi-dimensional information through probabilistic reasoning and carry out dynamic risk assessment. Building on this, we applied a structural equation model (SEM) to further refine the framework. We conducted an online public survey to gather data for validation and analysis. This allowed us to identify key risk patterns and design tiered response strategies. Eventually we developed a systematic, data-driven ethical risk assessment solution that is adaptable across multiple scenarios.
Interview with Professor Yunsheng Dong
S (Situation) As we began building an ethical evaluation framework, we realized synthetic biology applications involve complex ethical risks. C (Complication) Before consulting experts, we struggled to balance subjective judgments and objective criteria, leaving the framework unreliable. Q (Question) How can ethical evaluation be both systematic and context-sensitive? A (Answer) Prof. Dong stressed that ethical risks vary by scenario and must be assessed with tailored indicators. I (Implementation) We refined our model into a scenario-based system with differentiated dimensions for clinical, monitoring, and cosmetic applications.
Yunsheng Dong Professor, Department of Sociology, School of Philosophy and Social Sciences, Jilin University
  • Mainly engages in research in the fields of social stratification, economic sociology, and network sociology.
  • Teaches undergraduate courses such as "Social Survey Research Methods" and "Data Analysis," as well as the postgraduate course "Research on Social Stratification."
As our project progressed, we became increasingly aware that the application of synthetic biology involves highly complex ethical dimensions. Without reliable methods for quantitative evaluation, these applications could carry hidden ethical risks once implemented. At the early stage of building our evaluation framework, we faced a dilemma: how to balance subjective judgment with objective criteria. Relying simply on theoretical reasoning risked becoming unrealistic, while depending only on expert experience made it difficult to establish a systematic and consistent standard, leaving the reliability of the assessment in question. To address this challenge, we consulted Prof. Dong, an expert in philosophy and sociology. He emphasized that ethical evaluation in synthetic biology must be closely tied to specific application scenarios, since the ethical concerns vary widely across contexts. For example, clinical monitoring focuses on patient safety and privacy, while cosmetic applications emphasize bodily integrity and social acceptance. Therefore, a single universal model cannot capture these differences, instead, we should design tailored evaluation dimensions and indicators for each scenario. Guided by Prof. Dong’s advice, we refined our scenario-based model. We broke down the various application areas of our project, such as clinical diagnostics, health monitoring, and cosmetic product development, identified their ethical risk focal points, and designed corresponding evaluation methods. This made our framework more targeted, practical, and adaptable.
Interview with Professor Wenbin Chen
S (Situation) We had established a multi-dimensional evaluation system using SEM to weigh influencing factors. C (Complication) Before this interview, we lacked a method to transform these weights into a practical tool for assessing uncertain risks. Q (Question) How can structural weights be linked to probabilistic risk assessment? A (Answer) Prof. Chen recommended using a Bayesian network to model causal and probabilistic relationships. I (Implementation) We integrated SEM with Bayesian reasoning, creating BEAM—a framework that enables dynamic, quantitative ethical risk assessment.
Wenbin Chen Professor, School of Mathematical Sciences, Fudan University
  • Research direction: Numerical Solutions of Differential Equations
  • Research findings have been published in journals such as Numerische Mathematik and SIAM Journal on Numerical Analysis.
In developing our ethical risk assessment framework, we first established a multi-dimensional evaluation system, covering aspects such as ecological security, technology governance, and public acceptance. To capture the structural relationships among these dimensions, we applied a Structural Equation Model (SEM), which enabled us to determine the relative weights of different influencing factors. However, when it came to the stage of quantitative risk assessment, we encountered a major challenge: how to make use of the established dimensions and their influence weights to evaluate potential and uncertain risks. To address this issue, we consulted Professor Wenbin Chen. He pointed out that the solution lies in uncovering the causal logic and probabilistic relationships among influencing factors, and recommended adopting a probability-based correlation model. Guided by this advice, we further optimized our framework by introducing a Bayesian network model. With its advantage in probabilistic reasoning, the Bayesian network complements SEM by dynamically updating risk probabilities, adapting to complex ethical risk scenarios, and enabling more precise quantification. By integrating SEM and Bayesian networks, we ultimately developed BEAM (Bio-ethical Assessment Model)—a novel framework that not only clarifies the structural weight of influencing factors but also allows probabilistic inference and dynamic risk evaluation.
Survey on Ethical Perceptions of Synthetic Biology
S (Situation) After identifying scenario-specific issues, we needed data beyond expert perspectives. C (Complication) Without public input, our framework risked being overly technical and disconnected from social expectations. Q (Question) What ethical concerns does the public prioritize in synthetic biology? A (Answer) The survey revealed public concerns about privacy, safety, fairness, and new applications like home monitoring and cosmetic uses. I (Implementation) We used this data as a core input for model training, ensuring our framework reflected both experts' advice and needs of the public.
After breaking down the ethical issues in different scenarios, we realized that the perspectives of experts and researchers alone were not enough to build a complete evaluation system. Ethical risks are not just topics for academic debate, they are also influenced by public perception. For this reason, the next step in developing our model was to design a questionnaire that could widely capture public opinions and provide us with real, comprehensive data input. We carefully designed a survey that covered multiple ethical dimensions, including questions about traditional concerns such as privacy, safety, and social fairness, as well as the public’s attitudes toward emerging applications of synthetic biology such as home monitoring devices and cosmetic enhancements. This became the first core dataset for building our model. The results we obtained not only highlighted the ethical issues most people care about but also provided essential quantitative data for the next stage of model training. Through this process, we gradually came to see public feedback as a bridge between expert reasoning and social perception, helping us prevent the model from becoming overly technical or disconnected from expectations of the society. This step also laid the foundation for the next challenge, which is finding ways to translate complex ethical concerns into data.
This survey was designed to understand public perceptions of ethical issues related to synthetic biology. We used a Likert-scale questionnaire, with each question carefully crafted, we managed to translate subjective opinions into actionable data. Below, you’ll find the full “Survey on Ethical Perceptions of Synthetic Biology” questionnaire that helped us bridge expertise and public perception.
Survey on Ethical Perceptions of Synthetic Biology
ABCS Ethical Risk Assessment
S (Situation) With BEAM established, we needed to test its applicability to our own project. C (Complication) Before conducting a targeted survey, we did not know how different stakeholders would evaluate our system’s risks and benefits. Q (Question) How do patients, clinicians, and the public perceive the ethical risks of our project? A (Answer) The survey showed experts focused on biosafety, while patients emphasized privacy, medical safety, and affordability. I (Implementation) We developed the ABCS Ethical Risk Assessment, a tailored tool aligned with BEAM, bridging universal theory with project-specific practice.
After constructing the initial BEAM framework and validating its feasibility with the first public survey, we recognized that the next step was to test whether this model could be effectively applied to our own project. While the first questionnaire mainly focused on general public perceptions of synthetic biology, the second one was specifically designed to evaluate our project within a real-world context. In this stage, we distributed a targeted survey centered on the actual applications and ethical challenges of our system. The goal was to examine how different stakeholders—including patients, healthcare professionals, and the general public—perceive the potential risks and benefits of our project. We designed the survey questions to correspond directly to the evaluation indicators within the BEAM model, such as patient privacy, long-term biosafety, social fairness, and accessibility. Through this process, the model was no longer a purely theoretical construct but became an applicable tool for ethical assessment in practice. The data collected from this second survey not only helped us measure the ethical risks of our own project but also served as a validation test for the adaptability of the BEAM model. The results revealed interesting differences: while experts tended to emphasize biosafety and long-term ecological effects, patients showed greater concern for privacy, medical safety, and affordability. These findings allowed us to refine our risk weights and build an ABCS Ethical Risk Assessment—a project-specific ethical evaluation aligned with the BEAM framework. This step marked the transition from a universal ethical model to a tailored assessment tool, bridging theory with application.
This survey was designed to assess our project within real-world contexts, focusing on the practical applications and ethical challenges of the ABCS system. Presented below is the complete “Ethical Risk Assessment of the ABCS Project” questionnaire, which served as the foundation for this crucial step forward in responsible innovation.
Ethical Risk Assessment of the ABCS Project
Patient Insights We strengthened the ABCS project in both ethics and practice: Director Jun Wei of the ethics committee guided us to ensure compliance through informed consent; philosophical advice from Professor Yujiao Jia helped us design respectful, patient-centered interviews; Dr. Zijun Zhou revealed patients’ psychological challenges and communication needs; AI simulations allowed us to refine questioning; in-person interviews confirmed high acceptance but raised safety and cost concerns; and online surveys showed clear preference for a test kit format. Together, these insights enabled us to align our design with patient needs while maintaining ethical rigor.
Interview with Director Jun Wei of the Ethics Committee
S (Situation) We planned to interview breast cancer patients to improve the ABCS. To ensure the process was ethical and protected patient rights, we consulted Jun Wei. C (Complication) Unstandardized interviews can cause misunderstandings about the purpose, privacy, or other details, leading to trust issues or legal risks. Q (Question) What steps should be taken before the interview, and what documents should be signed to ensure patients are fully informed, their privacy is protected, and the interview is legal and compliant? A (Answer) Mr. Wei advised that a written informed consent form is required. It should clearly explain the interview’s purpose, content, privacy protection, and participants’ rights before the interview starts. I (Implementation) We created an informed consent form.
Jun Wei Member of the Ethics Committee, China-Japan Union Hospital of Jilin University
  • Committee Member of the Clinical Research Management Group, Medical Science Research Management Branch of the Chinese Medical Association
  • Inspector for National/Jilin Provincial Drug Clinical Trials and Medical Device Clinical Trials Projects
As we optimized the ABCS project, we identified that firsthand insights from breast cancer patients were vital to refining its design and meeting their needs. However, we faced a critical challenge: patient interviews involve sensitive personal and medical data. Oversights in the interview process or documentation could leave patients uninformed about the interview’s purpose and privacy protection, expose the project to trust crises or legal risks, and compromise the validity and reliability of collected information—ultimately undermining project optimization. To address this challenge and ensure ethical compliance while protecting patients’ rights, we consulted Wei Jun, a member of the Ethics Committee, whose expertise proved invaluable in strengthening our process. He emphasized the importance of standardizing interview procedures and, in particular, improving the informed consent document to ensure clarity, transparency, and completeness. Following his guidance, we revised the informed consent form in detail: it explicitly outlined the interview’s purpose, the scope of topics to be discussed, how the information would be used, and the measures in place to protect privacy. Moreover, Wei Jun advised us to incorporate patient-friendly language and a clear structure, enabling participants to easily understand their rights without being overwhelmed by technical terms. Ultimately, this collaboration with the Ethics Committee ensured that the ABCS project advanced in a compliant and patient-centric manner.
We developed a comprehensive Informed Consent Form, refined with insights from ethics experts to prioritize transparency, accessibility, and patient autonomy. It clearly outlines the purpose of the interview, how data will be used, privacy protections, and emphasizes that participation is voluntary with the right to withdraw at any time. By using clear, jargon-free language and standardizing the process, we ensure ethical compliance and foster trust with the patients at the heart of our work. Here is the complete “Informed Consent Form”.
Informed Consent Form
Interview with Professor Yujiao Jia
S (Situation) We sought guidance on how to ensure our patient interviews respected participant autonomy and encouraged equal dialogue. C (Complication) During interviews, patients' autonomy may be overlooked, and the interviewer's role might make them feel “scrutinized,” making it difficult to get honest feedback. Q (Question) How can we design interviews to make patients feel respected and heard, not just “investigated”? A (Answer) Prof. Jia recommended the life history interview method based on narrative cognitive theory, using three-dimensional questions and narrative coding to focus on the patient’s experience and autonomy. I (Implementation) We developed a communication style that encourages equal dialogue, better meeting patients’ real needs and strengthening the humanistic care in our project.
Yujiao Jia Professor, Professor of the Department of Sociology, School of Philosophy and Social Sciences, Jilin University
  • Director of the Social Governance Research Professional Committee of the Chinese Sociological Association
  • Standing Director of the Chinese Social Security Association
  • Deputy Secretary-General of the Chinese Sociological Association
As we deepened the ABCS project’s patient interview phase, we faced new challenges beyond ethical compliance and psychological communication: how to truly respect patients’ subjectivity and build equal dialogue. To resolve these confusions, we consulted Professor Yujiao Jia, professor of philosophy and social sciences, who specializes in interpersonal communication and ethical research. Prof. Jia has long explored the balance between “investigation” and “respect” in humanistic research, and her professional perspectives could help us break through the current bottleneck. Drawing on academic theories and practical experience, Prof. Jia offered targeted guidance. She first recommended the narrative cognitive theory-based life history interview method, which guides patients to sort out disease-related life experiences. Specifically, the three-dimensional questioning method (event, emotional, meaning layers) can be used: the event layer asks about specific experiences, the emotional layer explores inner feelings, and the meaning layer digs into life concept impacts. She also suggested building a narrative coding tree to sort out institutional factors behind patients’ experiences in later analysis, avoiding reducing complex experiences to “symptom descriptions” and fully respecting patients’ subjectivity as life experience narrators. From a philosophical perspective, Prof. Jia emphasized that building equal dialogue requires the interviewer to suspend their perceived identity as medical authorities. She advised that we should approach the conversation from a position of humility, acknowledging our “incomplete cognition of the disease’s social and psychological mechanisms.” This means recognizing the patient’s authority over their own life experience, abandoning medical jargon, and fostering an open, interactive dialogue.
Interview with Dr. Zijun Zhou, a specialist in breast surgery
S (Situation) To better empathize with breast cancer patients, we hoped to understand the common psychological challenges they face. C (Complication) Breast cancer patients often experience complex psychological challenges due to the disease and treatment process. Interviews could potentially increase this psychological burden. Q (Question) What are the common psychological states among breast cancer patients? What communication skills should be employed during interviews to facilitate effective communication? A (Answer) Dr. Zhou pointed out that breast cancer patients often feel incomplete after having their breasts removed, and the anxiety about recurrence can make follow-up examinations stressful. I (Implementation) We conducted practice sessions with AI simulations before interviewing real patients.
Zijun Zhou Director of the Breast Surgery Department, Jilin Provincial Cancer Hospital
  • Committee Member of the Breast Cancer Special Committee of the China Health Promotion Foundation
  • Committee Member of the Oncology Internal Medicine Branch of the China International Exchange and Promotion Association for Medical and Healthcare
As we advanced the ABCS project and prepared for in-depth interviews with breast cancer patients, we quickly realized technical preparation alone wasn’t enough for successful interviews. Our core goal was to gain authentic insights into patients’ needs, but we faced a major obstacle: breast cancer, tied to physical image and long-term health, often leaves patients with complex, sensitive psychology. Failing to grasp these traits or using poor communication could cause two problems: patients being unwilling to open up and awkward communication triggering negative emotions, adding to patients’ existing psychological burden. This dilemma made us realize understanding patient psychology and mastering communication skills were as essential as ethical compliance for interviews. To fill this gap, we consulted experienced local hospital breast surgeons—professionals with long-term in-depth interactions with breast cancer patients and valuable insights into their psychological needs and communication preferences. During consultations, the surgeons outlined three common psychological states of these patients: first, identity confusion and low self-esteem after mastectomy due to feeling “physically incomplete”; second, widespread anxiety about recurrence, which makes follow-up examinations stressful; third, social withdrawal and frequent mood swings. They also gave communication tips: use a gentle, empathetic tone, avoid judgmental language; prioritize active listening; and take time with sensitive topics rather than rushing for answers. Inspired by this expert advice, our team revamped interview training to integrate these psychological insights and communication skills. Before each interview, we held briefings to remind members of the three common psychological states and practice empathetic language. During interviews, we intentionally started with casual topics to build rapport before moving to sensitive ones: when patients mentioned post-surgery “incompleteness”, we validated feelings instead of dismissing them.
AI Evaluation of Patient Interview Questions
S (Situation) Before interviewing real patients, we worried our approach might cause unintended emotional harm, so we utilized Doubao AI to evaluate our presupposed interview questions. C (Complication) Sensitive questions could trigger distress or misunderstandings. Q (Question) How can we gather genuine patient needs while minimizing emotional risk? A (Answer) The AI evaluation revealed potential pitfalls in our interview style. I (Implementation) We will avoid sensitive questions in real interviews.
Doubao AI Doubao is an AI assistant developed by ByteDance based on the Skylark model. It supports multi-platform use, including web-based, desktop client, and mobile terminals, and provides functions such as chat interaction, text generation, and English learning. It won the 2024 Smart Future·AI Application Benchmark Excellent Artificial Intelligence Product Award.
Before actually interviewing patients, we were still concerned that our approach might not be mature enough and could unintentionally cause secondary emotional harm. So, we decided to use Doubao AI to help us assess whether our interview style met the requirements suggested by the experts we consulted.
Below are excerpts from our conversations with the Doubao AI, where we asked questions and had the AI evaluate whether they might cause any harm to patients and whether they aligned with the experts’ previous recommendations.
Thanks for sharing. This talk is voluntary, you can stop anytime, and your privacy is safe. Would you like to tell me about your treatment experience?
Respects autonomy and privacy, builds trust.
Could you share an experience that impressed you most, and maybe how it felt or affected your life?
Open-ended, narrative style, encourages genuine sharing.
Do you feel incomplete after surgery? Do you regret it?
Sounds negative and may hurt. Better ask an open-ended question.
In-person Patient Interviews
S (Situation) We planned in-person interviews to learn patients’ real needs. Before starting, we got ethical approval from the hospital to ensure informed consent and protect participants’ rights. C (Complication) Without face-to-face, in-depth communication, it is difficult to capture patients’ potential concerns about ABCS. Q (Question) What is the overall patient acceptance of the ABCS concept, and what are their primary concerns and expectations regarding its cost and related services? A (Answer) Overall, patient acceptance was high. Their main concerns were the safety of cell modification, urine test accuracy, and risks of physical burden or false results. I (Implementation) Regarding the patients’ concerns about safety, we planned to strengthen the safety verification of the project and improve the accuracy of urine testing.
In-person interviews can deeply explore the actual needs, potential concerns, and emotional demands of patients regarding post-operative monitoring technologies in real-world medical treatment scenarios, providing a more targeted basis for technological research and product optimization. The primary prerequisite for conducting these interviews is to ensure ethical conduct and protection of patient rights. To this end, we first submitted an application to the ethics committee of China-Japan Union Hospital of Jilin University. The ethics committee conducted a strict review of the application, and we finally successfully obtained the hospital’s ethical review approval, laying a legal and compliant foundation for the in-person interview activities. In the patient screening stage, we collaborated with the hospital’s breast surgery doctors to select 25 breast cancer patients of different ages and at different postoperative recovery stages. These participants had stable post-operative recovery, a history of regular follow-ups, and were willing to participate in the research. Before the formal interviews, we scheduled the times in advance with the patients and conducted the interviews in a quiet and private meeting room specially set up by the hospital to avoid external interference. On the day of each interview, our team members first showed the hospital’s ethical review approval document to the patients, and then explained each item of the informed consent form in detail. After ensuring the patients fully understood and had no questions, we asked them to sign the informed consent form to confirm that their participation was voluntary and fully informed. A total of 25 valid interview records were collected through this offline interview. After sorting and analyzing the data, we found that patients have a high acceptance of ABCS, especially recognizing its “home-based testing” and “non-invasive and convenient” features, believing it can effectively reduce the inconvenience and psychological pressure of regular follow-ups. However, they also raised clear concerns for technical safety, detection accuracy, cost, and ease of use. This provided us with direct and crucial guidance for subsequent technological optimization and product design.
Ethical Approval Document
Online patient interviews
S (Situation) To ensure our final product meets patient needs, our project required extensive feedback on different potential testing methods. C (Complication) If the product’s form was determined solely based on our internal design, we might overlook the actual needs of patients. Q (Question) Which potential product format do patients prefer for at-home monitoring? A (Answer) Approximately 68% of the patients prefer the test kit approach, due to its similarity to familiar pregnancy tests, convenience for at-home use, the safety of sterile disposable tools, and lower cost. I (Implementation) Based on this feedback, we prioritized the development of the test kit as our primary product format.
"Mijian" is a rehabilitation communication community and post-hospital management software for cancer and severe disease patients, launched by Xiamen Cobblestone Network Technology Co., Ltd. in 2013. It aims to help patients alleviate psychological stress, access medical resources, and improve rehabilitation management capabilities through its online platform.
“Dancing with Cancer” is an anti-cancer communication forum founded in 2010, positioned as a grassroots anti-cancer hub and a warm community for cancer patients. Guided by its core philosophy of "Dancing with Cancer, Dancing with Love", the platform mainly provides diagnosis and treatment information sharing and patient mutual assistance services for more than ten types of cancers, including lung cancer, liver cancer, and breast cancer.
We have been well aware that the final product form must closely align with the actual needs and psychological acceptance of breast cancer patients, in order to truly address the pain points of post-surgery monitoring for patients. While our in-person interviews were valuable, their coverage was limited. Recognizing that online platforms can provide a more relaxing and autonomous environment for patients to share their thoughts, we decided to engage with a broader community online. We chose the well-known patient platforms “Mijian” and “Dances with Cancer” to post bilingual (Chinese and English) research surveys, and solicit opinions from breast cancer patients on the final product form of ABCS. These two platforms host a large number of patients with direct experience in post-surgery monitoring, making their feedback invaluable to our project’s direction. In terms of the design of the post content, we first clearly introduced the team background and the project’s original intention, and explained the core technical principles in plain language, avoiding excessive use of technical jargon and ensuring that patients with different knowledge backgrounds could understand the technical logic. Subsequently, we presented in detail two specific detection schemes based on the urine test principle: The first is the test kit scheme, which includes a special urine cup, EP tubes, and test reagents, and can be operated at home; the second is the automatic detection toilet scheme, where an ordinary toilet is modified to install a detection device, automatically collecting samples and displaying the results on a dedicated display screen, with strict privacy protection. After our post was published, we logged in to the two platforms regularly to monitor the patients’ messages and responses, and promptly answer the patients’ questions regarding the technical principles and detailed schemes. After sorting and analyzing the collected feedback, we found that the majority of patients (about 68%) preferred the kit solution. Patients who chose this solution generally believed that the operation steps of the kit were similar to familiar home pregnancy test strips, requiring no learning of complex operations, and could complete the test at home, suitable for daily home scenarios; the one-time sterile tools also eliminated their concerns about hygiene and safety, and compared to automatic detection toilets, the kit had a lower cost, did not require the renovation of existing living facilities, and had a higher psychological acceptance.
Entrepreneurship To enable ABCS to truly reach every woman who needs it and translate technological breakthroughs into accessible health resources, we further explored the commercialization of the project. This is not only a response to the needs of millions of breast cancer patients worldwide but also a crucial step in bridging the gap between innovative technologies in the laboratory and their clinical application. Market Positioning and Target Populations
Postoperative Breast Cancer Patients Breast cancer is the most common cancer affecting women worldwide, forcing millions to undergo surgery each year. For many, life afterward is marked by frequent medical check-ups, the emotional impact of physical changes, and the constant worry about the cancer coming back. ABCS changes that. It offers long-term, real-time monitoring that reduces the need for regular hospital visits and helps ease the fear of recurrence. What’s more, it works hand-in-hand with breast reconstruction techniques, allowing women to retain a natural breast shape after surgery. In doing so, it helps patients not only protect their long-term health but also reclaim their self-identification.
High-risk Populations Research shows that breast cancer is influenced by a range of risk factors. Women with a strong family history of the disease are 2 to 3 times more likely to develop it compared to others. For those who carry BRCA1 or BRCA2 gene mutations, the lifetime risk can soar to 60–80% — that’s 5 to 7 times higher than the average woman. The ABCS system offers long-term monitoring that can detect the earliest signs of breast cancer, enabling timely alerts and early intervention when it matters most.
Breast Reconstruction and Augmentation Populations For many women, breast reconstruction is the first step toward rebuilding their bodies after breast cancer surgery. In 2024, the global breast reconstruction market reached $515.3 million, with a projected growth rate of 4.9% from 2025 to 2034. At the same time, breast augmentation surgery remains the most popular cosmetic plastic surgery worldwide. According to the 2024 Annual Global Cosmetic Plastic Surgery Report, there were 1.658 million breast augmentation procedures performed globally in 2024. However, implants can interfere with traditional methods of breast cancer detection, such as mammography, ultrasound, and physical examination. The ABCS system addresses this challenge, offering not only a reliable solution but also long-term health protection for this growing group of customers in the future.
Exploring Commercialization Paths
Attending the Symposium on Clinical Research and Overseas Expansion of China’s New Drug R&D in the New Environment
S (Situation) In biomedicine, new technologies face many challenges moving from lab research to clinical use and commercialization. C (Complication) Our team needed to understand potential issues ABCS might face in practice to prepare effective solutions. Q (Question) How to bridge the gap in the “R&D-clinical-commercialization” process? A (Answer) From the symposium, we learned that project commercialization requires efforts in marketing, legal compliance, investment, talent development, and more. I (Implementation) We consulted experts in various fields to gain commercialization knowledge, helping us design the business plan.
As the ABCS project moves toward commercialization, it faces a common challenge: bridging the gap between research, clinical application, and market readiness. To address this, we participated in the Symposium on Clinical Research and Overseas Expansion of China’s New Drug R&D in the New Environment, aiming to learn from others’ experiences in overcoming the “research–clinical–commercialization” divide and to explore practical pathways for bringing our project to market. The conference helped us outline a comprehensive, multi-dimensional strategy to guide ABCS from technology R&D to real-world application. On the technical and clinical front, we plan to carry out small-scale clinical trials to enhance the stability of the ABCS system and ensure the technology aligns more closely with actual clinical needs. In terms of market engagement, we adopted a tiered approach—working with both hospitals and consumer-facing channels—and plan to co-develop supporting equipment to make the product better suited for practical use in diverse scenarios. To further refine our strategy and gain professional insights, we also conducted interviews with experts in marketing, investment, human resources, legal affairs, and business development. These conversations offered valuable perspectives on commercialization best practices and have helped shape a clearer, more actionable roadmap for bringing ABCS successfully to market.
Attending the International Academic Exchange Conference on Plastic Surgery, “China-Korea Plastic Surgery Academic Salon”
S (Situation) We needed to promote ABCS and explore its clinical application scenarios. C (Complication) We lacked a clear understanding of the business models, technical needs, and clinical requirements of public hospitals’ plastic surgery departments, making it difficult to identify a focus for project promotion. Q (Question) How can we find a feasible path for the promotion and clinical application of ABCS? A (Answer) Dr. Zhang explained the development models of plastic surgery departments in public hospitals, while Dr. Qin’s presentation showed that combining ABCS with breast augmentation offers both body shaping and breast cancer marker monitoring benefits. I (Implementation) We decided to enhance our connections with public hospitals, refine our cooperation plans based on specific clinical scenarios.
We set out to promote the ABCS project and explore its potential for clinical application. However, we realized that we lacked a deep understanding of the business models, technical development trends, and specific clinical needs of plastic surgery departments in public hospitals. This knowledge gap made it difficult to identify a clear entry point or focus for introducing the project effectively. To address this, we participated in the China-Korea Plastic Surgery Academic Salon. During the event, Dr. Lianbo Zhang’s presentation offered valuable insights into how plastic surgery departments in public hospitals operate, including their development models and technical requirements. His talk helped us understand that public hospitals place strong emphasis on clinical practicality, evidence-based results, and alignment with existing medical protocols when evaluating new technologies. This made it clear that building scientific research partnerships and engaging in clinical studies would be key strategies for earning recognition within the public healthcare system. These collaborations would not only help validate the ABCS technology in clinical practice but also establish credibility and trust among medical professionals—laying the groundwork for broader promotion and adoption. Meanwhile, Dr. Haiyan Qin’s presentation reinforced our vision of integrating ABCS with medical aesthetics and helped us identify a viable technical pathway for achieving this. Her insights highlighted the potential of embedding ABCS technology into breast augmentation procedures using engineered adipocytes, opening up a promising direction that combines aesthetic benefits with ongoing health monitoring.
Interview with Dr. Zhao, president of the private medical aesthetics clinic Jingdian Medical Beauty
S (Situation) We needed to understand market demands and technical challenges of private medical aesthetics clinics. C (Complication) We lacked insight into the market and demands of medical aesthetics clinics, which hindered ABCS promotion in private clinics and our goal of transitioning from technology to market. Q (Question) How can we promote the actual implementation of ABCS in private medical aesthetics clinics? A (Answer) Director Zhao provided an overview of the breast augmentation market, highlighting that adipocyte survival rate is a key factor affecting surgical outcomes and customer satisfaction. I (Implementation) In the future, we intended to strengthen communication with private clinics and accelerate the progress of optimizing cell survival.
Since its establishment in 2016, Changchun Jingdian Medical Aesthetic Clinic has gradually established a good reputation in Changchun, Jilin Province, with its professional medical team and advanced technical equipment. It is committed to providing customers with a complete range of medical aesthetic services, covering many fields such as skin beauty, plastic surgery, and micro-plastic surgery.
To better understand the needs and challenges faced by private medical aesthetics clinics—and to advance our project more effectively—we conducted an interview with Dr. Zhao. She provided valuable insights into the breast augmentation market within the private medical aesthetics sector. Dr. Zhao emphasized that the survival rate of fat cells is a key factor influencing both surgical outcomes and patient satisfaction, making it a top concern for clinics. She also highlighted a common challenge in the industry: the survival rate of transplanted fat cells tends to be unstable. If this issue isn’t addressed, it will be difficult to promote ABCS in private clinics. At present, improving the survival of engineered fat cells during transplantation remains a significant challenge for our team. Moving forward, we are committed to focusing our research efforts on this critical problem. By refining existing methods, adapting them to suit the unique characteristics of engineered cells, and optimizing both cell culture and transplantation techniques, we aim to improve fat cell survival rates in procedures such as breast augmentation.
Interview with Professor Ling Ren from the School of Business
S (Situation) We needed to develop a clear roadmap and marketing strategy for our product. C (Complication) Confused about key marketing elements such as how to identify target customer groups, select promotion channels, and formulate pricing strategies. Q (Question) How to formulate an effective marketing strategy to drive the commercialization of the project? A (Answer) Prof. Ren shared professional insights into the ToB and ToC models. Based on this, she advised us to prioritize ToB technical services initially, followed by the rollout of ToC products. I (Implementation) Our team has developed a customized business canvas for ABCS based on both ToB and ToC models.
Ling Ren Professor of the School of Business and Management, Jilin University
  • Research fields: Innovation and Entrepreneurship, Industrial Economy, Knowledge Management
  • Courses taught: Macroeconomics, Research on Theories and Practices of Technical Economy, Economic Research
While working on the commercialization plan for ABCS, we faced some challenges in crafting a clear marketing strategy. Initially we weren’t certain how to turn our technical strengths into something that appeals to the market, how to define our target customer groups, pick the right promotion channels, or decide on the best pricing approach. To address these difficulties, we interviewed Professor Ren Ling from the School of Business. She provided valuable insights into the differences between ToB and ToC business models. Following her advice, we decided to focus first on ToB technical services, then gradually roll out ToC products. This guidance helped us shape a more organized and strategic path toward bringing ABCS to market. Building on this, we developed a market segmentation plan. Our initial focus will be the medical sector—specifically postoperative breast cancer patients and high-risk groups. Here, we’ll highlight ABCS’s accuracy in condition monitoring and explore options for medical insurance coverage. We also plan to partner with leading hospitals, especially their breast surgery departments. For the consumer side, we aim to collaborate with plastic surgery clinics to reach breast augmentation clients. We’ll position the engineered adipocytes as a “health-conscious breast augmentation upgrade” that blends cosmetic enhancement with ongoing health monitoring. Pricing will be set slightly higher than conventional breast augmentation procedures, in line with premium cosmetic services.
In the business world, ToB (business-to-business) and ToC (business-to-consumer) are two fundamental models. ToB operations typically focus on providing professional products or services to enterprises or clinics, aiming to support their production, operations, or management needs. This model emphasizes long-term partnerships, tailored solutions, and specialized services. In contrast, ToC businesses are geared toward individual consumers, focusing on meeting their personal needs in everyday life. They tend to prioritize user experience, convenience, and strong marketing efforts. Taking Professor Ren’s advice, we adopted the strategy of “ToB technology services first, ToC products next” as our commercialization roadmap. Guided by this approach, we created a customized business canvas for ABCS. The canvas offers a clear, structured framework that aligns our value proposition, customer segments, key activities, and revenue models. It gives us a comprehensive view of how to bring ABCS to market effectively and ensures that all aspects of our strategy are cohesive, targeted, and built for long-term success.
Businuss Canvas for ABCS
Interview with Kunyang Xue, Deputy General Manager of Dongguan Binhaiwan Industrial Investment Co., Ltd.
S (Situation) We wanted to understand how a biotech startup can attract investment to drive its development. C (Complication) As a team of students with limited business experience, we were unsure how to translate the project’s technical strengths into highlights that for investors. Q (Question) How to effectively attract the attention of investment institutions and secure financial support to accelerate our commercialization process? A (Answer) Mr. Xue suggested that we enhance investor confidence in the project by clarifying its technical advantages, emphasizing its social value and future potential. I (Implementation) We developed the “ABCS Brand Strategy House”.
Kunyang Xue Deputy General Manager of Dongguan Binhaiwan Industrial Investment Co., Ltd.
  • A regional development promoter with both industrial investment perspective and implementation capabilities, who focuses on leveraging market-oriented operations and professional services to build Binhaiwan New Area into an "innovation highland" and "talent paradise" for the agglomeration of the artificial intelligence industry.
We set out to understand how a startup rooted in innovative biotechnology could successfully attract investment to support its rapid growth. However, with limited business experience, we struggled to figure out how to present our technical strengths in a way that would resonate with investors and highlight the project’s commercial value. To gain deeper insight, we interviewed Mr. Kunyang Xue, who has extensive experience in investment consulting and biotech entrepreneurship. During the conversation, he emphasized that securing investment isn’t just about showing cutting-edge technology—it’s about telling a clear and compelling story. He advised us to distill the core technical advantages of ABCS into language that investors can quickly grasp, while linking those strengths to real-world needs and market opportunities. He also stressed the importance of highlighting the broader social value of our project—especially its potential to improve long-term health outcomes for breast cancer patients and promote innovation in medical aesthetics. In his view, demonstrating both commercial potential and positive social impact can significantly increase investor interest and confidence. Taking this advice forward, our team has developed the “ABCS Brand Strategy House” as a concrete step to systematize our value proposition and better position the project for investment attraction.
In the commercialization of ABCS, we are aware that a clear and attractive brand core is key to gaining market recognition and attracting investment. The Brand Strategy House is a systematic brand management tool that articulates the core elements of a brand. Through the Brand Strategy House, enterprises can define its unique market position, effectively convey its brand value, and enhance awareness and resonance among target audiences, thus providing strong support for both the commercialization and long-term business growth. To this end, we have constructed the “ABCS Brand Strategy House” to anchor the core value and development direction of our brand. Spanning from technological breakthroughs to value delivery, and from practical applications to emotional connection, it comprehensively outlines the brand image of ABCS. This will show investors the long-term value and market potential of the project, extending far beyond the technology itself.
ABCS Brand Strategy House
Interview with the Human Resources Manager of Guangzhou Wondfo Biotechnology Co., Ltd.
S (Situation) Understanding how medical enterprises recruit and develop talent could guide our team building. C (Complication) We lacked a clear understanding of how medical enterprises build talent systems based on business needs and develop talent for commercialization. Q (Question) How can we build a talent system adapted to the commercialization process? A (Answer) Wondfo executives suggested fostering interdisciplinary talent through cross-departmental communication and regular training that combines technical and business knowledge. I (Implementation) We developed a comprehensive talent development plan and a “dual-channel” development strategy in Chapter 5 of the Business Plan.
Guangzhou Wondfo Biotech Co., Ltd. focuses on the R&D and production of in vitro diagnostic (IVD) reagents and POCT products. Its products are sold to more than 150 countries and regions worldwide. In the first half of 2025, Wondfo Biotech achieved an operating revenue of 1.246 billion yuan.
Our team lacked a clear understanding of how medical enterprises build talent systems that align with business goals—especially when it comes to cultivating people who can thrive in both technical and commercial roles. We quickly recognized that learning from experienced companies in the pharmacy industry could offer valuable direction for our own team-building strategy. To that end, we spoke with executives from Wondfo, a biotech company with extensive experience in medical innovation and commercialization. During the conversation, they emphasized the growing need for interdisciplinary talent—people who can bridge the gap between science and business. As one executive put it, “It’s no longer enough to just have a strong R&D team. If you want to bring a product to market successfully, you also need people who understand market positioning, customer needs, and regulatory strategy.” They shared a number of practical approaches, including encouraging cross-functional collaboration, creating opportunities for team members to rotate between departments such as R&D, marketing, and compliance, and hosting regular internal workshops that blend technical knowledge with business insight. These steps, they noted, help foster a more agile, well-rounded team—one that’s better equipped to navigate the complexities of commercialization. Drawing on their advice, we developed a tailored talent development plan for the ABCS project. We also introduced a “dual-track” growth strategy that allows team members to pursue either a technical or managerial path, depending on their skills and interests. These initiatives are helping us build a talent system that not only supports innovation but also prepares our team to deliver on the broader goals of commercialization.
Interview with Lawyer Junling Bai
S (Situation) The future development and commercialization of the ABCS project would likely involve potential legal risks. C (Complication) We were short of professional legal knowledge, making it difficult to comprehensively identify potential legal issues. Q (Question) What legal issues are involved in ABCS? How to ensure the legal and compliant advancement of the project? A (Answer) Lawyer Bai suggested that we attach importance to intellectual property protection and systematically analyze the legal risks faced by the project. I (Implementation) We incorporated a patent module into our development plan and designed a risk control scheme in Chapter 6 of our Business Plan.
Junling Bai Practicing Lawyer at Shanghai Branch of Kangqiao Law Firm
  • During her years of professional practice, she has handled a large number of litigation cases and non-litigation legal service projects, accumulating rich practical experience. Meanwhile, she serves as a legal counsel for many large state-owned enterprises as well as medium and small-sized private enterprises, providing professional legal services to these entities.
Our team recognized that the ABCS project spans multiple stages—biomedical R&D, clinical application, and commercialization—each carrying its own set of potential legal risks. To ensure the project progresses in a legally compliant manner, we interviewed Lawyer Bai to seek professional legal advice and gain clarity on the legal considerations at each phase. From our conversation with Lawyer Bai, we developed a clearer understanding of the key legal issues across different stages of the project. During the R&D phase, compliance with the Biosecurity Law and regulations related to gene technology is essential to ensure that the modification and experimentation of engineered adipocytes meet established legal and ethical standards. In the clinical application phase, attention must be paid to medical device regulations and ethical approval requirements for clinical trials. Finally, in the commercialization stage, issues such as intellectual property protection and compliance with medical advertising laws become critical. Based on Lawyer Bai’s guidance, we plan to strengthen our legal risk prevention and control systems. This includes reinforcing legal reviews of our R&D planning, partnership agreements, and marketing strategies, as well as engaging legal consultants for long-term advisory support. These steps aim to help the ABCS project move forward steadily within a sound legal framework, minimize potential legal risks, and lay the groundwork for smooth implementation and sustainable growth.
Interview with Professor Jinshan Zhang from the School of Innovation and Entrepreneurship
S (Situation) We sought guidance on how to turn the research project into a real entrepreneurial venture. C (Complication) Lacking practical entrepreneurial experience, we had gaps in connections, funding, and industry knowledge. Q (Question) How can we improve the team’s entrepreneurial skills and develop systematic thinking to tackle real-world challenges? A (Answer) Prof. Zhang suggested creating an entrepreneurial capability matrix by shifting from "technical thinking" to "entrepreneurial thinking." I (Implementation) We created an iGEM Entrepreneurship Practice Simulation game and held internal workshops to strengthen our practical business skills.
Jinshan Zhang Professor of the College of Innovation and Entrepreneurship, Jilin University.
  • First Batch of Top 10 Entrepreneurship Mentors of Jilin Province.
  • Guiding Teacher for the Only "Best Creative Team" and three-time "Gold Award Team" in the 7th, 8th, and 9th China University Students' "Challenge Cup" Innovation and Entrepreneurship Competition
We wanted to figure out how to turn ABCS from a research project into a real entrepreneurial venture. To get practical guidance, we interviewed Prof. Zhang, a seasoned expert in startup incubation and innovation strategy. He emphasized the importance of shifting our mindset—from purely “technical thinking” to a broader “entrepreneurial thinking” that considers not just the product, but also the market, business model, and long-term sustainability. Prof. Zhang introduced us to the idea of an entrepreneurial capability matrix—a framework that outlines the key abilities a startup team needs to succeed. These include market awareness, execution, fundraising, regulatory knowledge, team management, and strategic planning. He explained that while individual team members don’t need to master every area, a successful team must collectively cover all of them. He also drew from his real-world mentoring experience, pointing out a common pitfall among tech-driven teams: they often get caught up perfecting the product and lose sight of market feedback and commercial viability. One piece of advice that stood out was the importance of simulating real startup challenges. Taking his advice to heart, we developed our own “iGEM Entrepreneurship Practice Simulation” game—a hands-on training tool that mimics the pressures and decisions of running a startup. It helped us uncover weaknesses in our approach, sharpen our business instincts, and, most importantly, start thinking like entrepreneurs. By embedding this kind of training into our routine, we’ve taken a meaningful step toward building a team that’s not only technically capable but also ready for the demands of the market.
The Simulated Entrepreneurship Practice Sandbox is an important teaching tool used by the School of Innovation and Entrepreneurship at Jilin University for practical instruction. We, under the guidance of Professor Jinshan Zhang, adapted it to develop our iGEM Entrepreneurship Practice Simulation training game. Through comprehensive sandbox-based simulations, it helped our team members to be familiar with the entire startup process, including company registration, financing, and operations, and enhanced our decision-making capabilities through collaborative practice.
iGEM Entrepreneurship Practice Simulation
These hands-on exercises helped us break out of a purely technical mindset and start looking at the project through a broader lens—considering market trends, capital flow, and risk management. It’s been a valuable way to make up for our lack of business experience and limited exposure to resource integration. Through this process, we’ve gradually built up an entrepreneurship capability matrix, laying the groundwork for facing real-world startup challenges in the future.
Hands-on exercises
Development Plans ABCS must pass through several critical stages on its path from R&D to full-scale industrial application—including technology validation, clinical translation, and large-scale deployment. Each phase comes with tight timelines and clear execution requirements. To navigate this journey effectively, we’ve mapped out a ten-year development roadmap and created a detailed Gantt chart. Our goal is to guide the project toward full industrialization by 2035, with each step carefully aligned to ensure steady, strategic progress.
Entrepreneurship development plans
Business Plans The business plan helps us deeply analyze the commercial potential of the project and determine the implementation path. It is not only a systematic roadmap of the project from technology to the whole business chain but also a key blueprint for attracting resources and guiding practice.
ABCS Business Plan
DREAMS Value System To better fulfill our commercialization mission, we have established a value system centered on DREAMS, encompassing six key dimensions: Dignity-preserving, Responsible innovation, Equitable access, Adaptive to needs, Multistake-holder synergy, and Socially beneficial. This system serves as an all-round guide for ABCS to evolve into an enterprise that is both responsible and beneficial to the world.
DREAMS Value System
D (Dignity - preserving) We aim to safeguard the dignity of women by helping breast cancer patients maintain their sense of self-worth throughout the recovery process. Once the project is up and running, we plan to launch a comprehensive support program that includes mental health assessments and counseling, guidance on postoperative functional recovery, and a series of “Beautiful Rebirth” community events to foster connection and empowerment. To further protect patients, we will use blockchain technology to secure personal data and uphold privacy—ensuring that emotional well-being and personal dignity are respected just as much as physical health.
R (Responsible innovation) We are committed to practicing responsible innovation by aligning our work with ethical standards and broader social values. Looking ahead, we plan to launch the Green Medical Innovation Plan. This initiative will focus on ensuring the long-term safety of cell implantation through biosafety certifications, developing biodegradable carrier materials, and embedding environmental and ethical considerations into every stage of technological development. Through these efforts, we aim to strike a meaningful balance between advancing our business and fulfilling our social responsibilities.
E (Equitable access) We’re committed to making medical resources more accessible by lowering the monitoring threshold with portable detection technology, so that more women can benefit. As part of this, we’ll launch the “Pink Guardian Plan”. which includes a core initiative: for every 100 paying patients, one free transplantation spot will be offered. In resource-limited areas, we plan to provide discounted products priced close to cost, reflecting our strong sense of social responsibility. By creating a public welfare cycle of “detection - treatment - follow-up”, this plan aims to ensure that women from all income levels can equally access and benefit from these innovative medical technologies.
A (Adaptive to needs) We aim to respond flexibly to a wide range of needs by continually refining our technology. ABCS will develop a breast cancer risk stratification monitoring system that combines genetic and clinical data to build a personalized risk assessment model. This system will offer quarterly monitoring for high-risk individuals and annual check-ups for those at lower risk. By adjusting the monitoring schedule based on each person’s situation, we can avoid unnecessary medical costs while ensuring effective prevention and care, making the whole process more personalized and efficient.
M (Multistakeholder synergy) We plan to build a strong collaboration network involving multiple stakeholders to ensure the project develops responsibly. Looking ahead, we will work together with medical insurance agencies, hospitals, pharmaceutical companies, and insurers to create a Breast Cancer Prevention and Treatment Ecosystem Alliance. With the submission of the NMPA marketing application as a key milestone, this alliance will collaborate on designing clinical pathways, sharing data, ensuring fair value distribution, and combining resources. Together, we aim to strengthen and streamline the breast cancer prevention and treatment system for greater impact.
S (Socially beneficial) Create social value by integrating health management into everyday life through the “Medical Aesthetics + Medical” innovation model. Going forward, ABCS will launch the construction of a Global Breast Cancer Early Warning Database. The plan aims to collect 50,000 breast cancer monitoring cases worldwide within 10 years to develop a multi-dimensional risk prediction model, providing critical support for the precise prevention and treatment of breast cancer globally.
Closing the Loop At the end of this journey, what we built was not just a technical construct, but a living “demand–feedback–improvement” loop that connects science with people. Each experiment, interview, and field research became part of a wider rhythm—listening to patients, refining ideas, and sending them back into practice. The loop is therefore not a static framework, but a way of working that continues to grow with every voice we hear and every challenge we meet.
Demand - feedback - improvement cycle
Looking into the specifics, we started with the Public Cognition loop to understand public needs and define our focus on breast cancer recurrence monitoring. We then entered the Technology loop, where clinical doctors and research experts guided us in shaping and refining the project design. Finally, we moved into the Healthcare Ecosystem loop, ensuring ethical compliance, listening to patients, and planning for commercialization. In this way, we created a complete cycle that starts from public needs and ultimately returns to the public well-being. However, we are fully aware that our work has its limitations. Our understanding of patient needs, the scalability of our technology, and the integration across healthcare systems are all areas that require ongoing attention and improvement. There are challenges we cannot fully solve today, and insights we have yet to uncover. Yet, these limitations are not endpoints—they are invitations to continue. The loop we have built is a living framework precisely because it never stops; every challenge encountered, every gap discovered, fuels the next cycle of listening, refining, and improving. In this way, our work is never truly finished, but always moving forward, evolving alongside the patients and communities we aim to serve. In the end, our project is defined not by a single breakthrough, but by the “demand–feedback–improvement” loop we built around human care. When each iteration starts by genuinely caring for patients’ needs, and when every refinement reflects our goal of achieving gentler healthcare, what flows through this loop is no longer just data and technology, but our commitment to empower patients to once again embrace normal life, respect, and dignity.
Download
Drag to move the image · Scroll to scale