Figure 2 Impact v.s. Interest Graph

Figure 3 Stakeholder analysis

Our stakeholder engagement strategy was developed through a combined framework integrating both impact–interest mapping and stakeholder hierarchy analysis. Together, these visuals demonstrate how our team systematically identified, prioritized, and collaborated with diverse actors to ensure our project remained both scientifically feasible and socially responsible.

At the foundation, the Impact vs. Interest Graph illustrates the spectrum of influence and involvement across our stakeholder groups. On the high-impact end, governmental authorities such as the Drug and Drug Administration and Medical Insurance Bureau play crucial roles in determining regulatory feasibility and long-term accessibility. Equally influential are clinicians from multiple disciplines (ENT, dermatology, respiratory medicine, emergency) who provided clinical validation and ensured that our design met therapeutic and safety expectations.

In the mid-impact zone, investors and biotech professionals offered insights into commercialization potential and future scalability, while professors and researchers in synthetic biology and immunology strengthened our scientific grounding.

At the high-interest but lower-impact end, patients, parents, and the general public provided valuable real-world feedback through surveys and street interviews—helping us uncover unmet needs and test user acceptance. Medical students and cross-iGEM teams further extended our educational and outreach impact, fostering mutual learning within the broader iGEM community.

Complementing this mapping, the Stakeholder Hierarchy Diagram categorizes these groups into primary, secondary, and tertiary layers, based on their proximity and role in the project’s progression.

(1) Primary stakeholders (patients, public, parents, and children) shaped the early research direction by validating awareness, usability, and acceptance.

(2) Secondary stakeholders (clinicians, pharmacists, and microneedle experts) provided professional and technical input, directly influencing design optimization and biosafety decisions.

(3) Tertiary stakeholders (investors, biotech companies, global advisors) contributed strategic and commercial perspectives, ensuring long-term viability and regulatory readiness.

Figure 4 IHP Framework

This framework summarizes how our team systematically integrated Human Practices (IHP) into the development of our allergy microneedle therapy. It consists of five key components—Survey, Expert Interviews, Industry Visit, Public Engagement, and Integration & Evolution—each serving a distinct yet interconnected role in shaping both the technical a nd social aspects of our project.

1. Survey (Public & Patient): This stage established the foundation for our IHP by identifying real-world needs and awareness gaps. With 806 responses collected, we found that 71.3% of participants desired more effective therapies, and over half relied on social media for information. These insights directed our focus toward developing a painless, convenient microneedle-based therapy and improving science communication through public education.

2. Expert Interviews: Expert consultations provided scientific, medical, and industrial validation for our design. Specialists in allergy treatment, materials science, and commercialization (e.g., Dr. Chen, Dr. Lu, Dr. Zhang) helped confirm the feasibility, safety, and eco-friendly design of our therapy. Feedback also guided us to refine market entry strategies and align with SDG goals, ensuring both ethical and sustainable innovation.

3. Industry Visit: By visiting Creative Bioscience Company, we learned about the real-world translation of research into biotech products—covering R&D, pricing models, and regulatory processes. This highlighted the importance of stepwise verification, balanced cost structure, and hospital collaboration, informing how we plan to transition from lab-scale validation to commercialization.

4. Public Engagement: Through street interviews, school events, and adult lectures, we bridged the knowledge gap between synthetic biology and the public. This stage revealed misconceptions—such as underestimating the risks of certain allergies—and identified regional allergy triggers (pollen, seafood). Tailored educational materials for different age groups allowed us to enhance public understanding and refine our outreach content.

5. Integration & Evolution: This final stage represents the continuous feedback loop integrating insights from all prior stages. Survey, expert, industry, and public inputs were synthesized to refine both our product design (HA microneedle) and long-term education plan. This stage also established a global strategy for scaling the project—starting from FDA-first modular expansion—demonstrating how human practices actively drive project evolution.

Figure 6 Graph of Gender of Participants

Gender distribution: 67.2% of participants were female, and 32.8% were male. No non-binary participants completed the survey.

Figure 7 Graph of Age of Participant

Age distribution: 46.8% were teenagers under 18, 9.8% were between 18–30 years old, 36.4% were 31–50 years old, and the remainder were over 50.

Figure 8 Graph of Patient's Survey

Age of first symptoms: 28.5% of patients first experienced allergic symptoms between ages 0–5. Nearly 70% reported their first symptoms before age 18. This indicates that children and adolescents are disproportionately affected, likely due to underdeveloped immune systems and higher sensitivity to allergens. As individuals age, immune systems mature, leading to greater tolerance and fewer allergic incidents. These findings highlight the importance of early intervention and education to reduce risks and promote healthy development.

Figure 9 Graph of Ideas People Think How Allergy Management Can Be Improved

Perceptions of allergy treatment: 71.3% of respondents felt allergy treatments should be more effective, and 39.3% prioritized convenience. This shows dissatisfaction with current therapies. To address these issues, we designed hypoallergenic bivalent vaccine each targeting pollen, dust mites, and seafood. We incorporated self-assembling peptides to extend half-life and reduce injection frequency. Delivered via microneedles, our therapy aims to be painless, environmentally friendly, and compliance-friendly.

Figure 10 Graph of Percentage of People Being Allergic

Allergy prevalence: 75.8% of respondents reported being affected by allergies directly or indirectly. This confirms the urgency of allergy research and demonstrates its societal relevance.

Figure 11 Graph of Percentage of People Knowing Ways To Treat Allergies

Among respondents who do not have family members with allergies, a significant 35.4% admitted to not knowing how to treat allergies when asked about their approach in a hypothetical scenario. This lack of knowledge is concerning as it indicates a gap in the public's understanding of how to respond to allergic reactions. Only 23.2% chose desensitization therapy and 21.2% opted for dietary adjustments as potential treatment methods. This data underscores the need for comprehensive educational initiatives that inform the public about effective allergy management strategies. It is crucial to educate individuals on the appropriate use of medications such as antihistamines and adrenaline auto-injectors, as well as the importance of dietary adjustments and desensitization therapy in managing allergic reactions.

35.4% of the people answered, "don't know", this means that most of the people has no idea whatsoever if there's a harmful reaction caused by the allergens. It is essential for us to educate and show the people around the society about curing and saving themselves. Therefore, we designed and done some pretty successful Education activities for different age groups and divided them according to its target customers. For example, we created animated comic books just for elementary school students and held a campus activity to acknowledge basic to higher-level knowledge about biology.

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Figure 12 Graph of Percentage of People Recieving Allergy Education

For those respondents without personal experience of allergies within their families, the primary source of allergy education is social media, with 52% indicating they have acquired knowledge through this channel. This reliance on social media highlights the critical role of digital platforms in disseminating health-related information. But there are some real issues here, like whether the info you find online is actually accurate or worth your trust. It's important to make sure that information about allergy shared on social media is approve by science, otherwise false information could leads to misunderstanding and cause problems.

Figure 14 Interview with Dr. Chen

Problem Identified：

From surveys and early interviews, we found that while desensitization therapy (AIT) is clinically effective, it faces serious limitations: poor patient compliance, restricted availability of reagents, and potential risks of complications. At the same time, public awareness of allergy mechanisms and prevention remains low, creating barriers to effective management.

Expert Consultation：

To gain deeper insight, we interviewed Dr. Chen Liang, Chief Physician and Director of the Department of Allergy at Nanshan People's Hospital. Dr. Chen emphasized that the prevalence of allergic diseases in China is rapidly rising due to factors such as urbanization, pollution, and dietary changes—with more than 20 million patients affected by allergic rhinitis alone. In Guangdong's humid climate, dust mites are a particularly common allergen.

Dr. Chen also explained the immunological mechanisms underlying allergies: most cases involve IgE-mediated Type I hypersensitivity, where repeated allergen exposure triggers mast cells and basophils to release inflammatory mediators like histamine, leading to symptoms such as rhinitis, asthma, and skin allergies.

Proposed Solution：

Based on his insights, we recognized that our project has the potential to address the shortcomings of traditional AIT by providing a safer, less invasive, and more efficient delivery platform. However, Dr. Chen stressed that future research should focus on verifying the safety of recombinant allergens and improving delivery efficiency. Additionally, he noted the urgent need to improve public allergy education, especially among children and families.

Implementation Step：

Following Dr. Che's advice, we developed a series of educational activities targeted at different age groups. For younger children, we created illustrated comic books that explain allergy concepts through simple language and drawings. For schools and adults, we organized campus activities and public lectures that combined interactive games (e.g., allergen quizzes, placement games, original card games with prizes) with scientific explanations. These efforts not only increased public understanding of allergies but also enhanced the social impact of our project, reinforcing our commitment to bridging research with community needs. For more details, please visit the "Education" page for a comprehensive view.

Figure 15 Collection of photos for Implementation

Figure 16 Photo with Dr.Chen

Figure 17 Street interview towards the public

Problem Identified:

From both Dr. Chen's interview (3.1) and our team's questionnaire survey, it became clear that public knowledge about allergies is severely lacking. Many people hold misconceptions about allergy triggers and treatment, and very few understand the role of synthetic biology in prevention and therapy. This cognitive gap limits both disease management and acceptance of innovative solutions like microneedle-based AIT.

Proposed Solution:

We organized a street interview and outreach event at WanXiangHui Mall, combining rapid-fire quizzes, Q&A, and interactive demonstrations. The goal was to raise awareness, dispel misconceptions about allergies, and introduce the concept of synthetic biology in a simple, engaging way.

Implementation Step:

During the event, we:

• Corrected common misconceptions

• Collected qualitative insights (personal allergy stories, coping strategies).

• Gathered quantitative data (public expectations for the cost of microneedle therapy, common allergy triggers such as pollen and seafood).

• Engaged participants of all ages with quizzes and interactive voting.

This event both educated the public and provided us with valuable feedback to refine our solution design. It created a direct bridge between expert recommendations (3.1) and practical public engagement, ensuring our project remains both scientifically grounded and socially responsive.

Figure 18 Collection of the boards

Figure 19 Interview with Pharmacist

Problem Identified:

While medical experts and public feedback (3.1 and 3.2) highlighted the need for safer, more accessible allergy therapies, we realized that moving from concept to product requires a deeper understanding of formulation, dosing cycles, patient usability, and regulatory feasibility. Without this perspective, even promising technologies like microneedles risk failing in real-world adoption.

Expert Consultation:

To address this gap, we interviewed Dr. Lu, a pharmacist with extensive clinical experience in allergy-related drug development. Dr. Lu explained that in China, only two allergen vaccines—dust mite and Artemisia annua pollen—are currently approved, reflecting both the therapeutic demand and the strict regulatory environment. She shared that polyvalent vaccines, while attractive in theory, face major hurdles due to the complexity of immune responses and the lengthy biologics approval process.

On the formulation side, Dr. Lu discussed sustained-release technologies (e.g., microcapsules, controlled-release tablets, microspheres) and highlighted biocompatible materials such as hyaluronic acid, PLGA, and chitosan for microneedle applications. Importantly, she emphasized that painlessness and convenience are the two most critical factors for patient acceptance in long-term allergy therapy.

Proposed Solution:

From Dr. Lu's input, we refined our design priorities:

• Focus on biocompatible and eco-friendly materials such as hyaluronic acid, which align with both patient safety and environmental sustainability (linking to SDG 15: Life on Land).

• Emphasize on-demand, user-friendly formulations that account for variability in patients' skin conditions and dosing requirements.

• Recognize that while multi-allergen integration is promising, our near-term focus should be on validated, single-allergen formulations to meet regulatory and clinical feasibility.

Implementation Step:

Following the consultation, we conducted internal team meetings and literature research to evaluate different microneedle materials and delivery strategies. We also mapped potential product roadmaps that balance current feasibility (single-allergen solutions, patient-centered design) with future innovation (polyvalent formulations, controlled release). Dr. Lu's perspective also informed our sustainability assessment, ensuring that material choices minimize environmental harm compared to conventional injection-based therapies.

Figure 20 Screenshot Of Our team interviewing Dr.Lu Online

Figure 21 Interview with Expert Dr.Huang

Problem Identified:

Survey results showed that 35.4% of respondents were unaware of treatment methods for allergic patients, even if family members had allergies, and only 52% had received allergy education through social media. This highlighted a dual gap: the public lacks knowledge about both allergy management and microneedle-based therapies, which are central to our project. Ensuring safety and effectiveness in microneedle use is therefore essential before promoting this approach.

Expert Consultation:

We interviewed Dr. Huang, a doctor of Physical Chemistry, supervisor at Zhejiang Pharmaceutical Co., and iGEM Synthetic Biology Distinguished Expert. Dr. Huang provided detailed guidance on microneedle application, using biochemical minoxidil microneedles as an example:

• Proper site preparation and target selection.

• Post-use precautions (avoid water, acids, alkalis, and damaged skin).

• Needle size depends on injection layer; microneedles release drugs slowly over multiple applications.

• Potential risks: skin injury, infection, redness, swelling, bleeding, scarring for sensitive individuals.

He emphasized strict disinfection and recommended topical care for at-risk patients. Dr. Huang also connected microneedle safety and proper use to SDG 3: Good Health and Well-being, highlighting its contribution to public health and patient safety.

Proposed Solution:

Based on Dr. Huang's insights, we decided to adopt microneedle delivery for our allergy therapy to minimize tissue damage and improve patient compliance. We also recognized the need to create clear safety guidelines and educational materials for users to ensure proper application. This approach not only enhances therapeutic effectiveness but also aligns with global health goals (SDG 3).

Implementation Step:

Following Dr. Huang's guidance, we developed our microneedle prototypes, selecting appropriate materials and ensuring proper size, safety, and drug-release characteristics. In parallel, we designed school and campus activities to educate students and the public about allergies and microneedle therapy.

Figure 22 Screenshot Of Our team interviewing Dr.Huang Online

Figure 23 Microneedle picture

Figure 24 Interview with CEO of Haifa Baocheng Financial leasing Company

Problem Identified:

While our previous consultations and prototypes addressed scientific, technical, and public education aspects, the commercial viability and market adoption of microneedle allergy therapy remained uncertain. Understanding investor priorities and market hotspots is critical to ensure that our technology meets real-world needs and can be successfully implemented.

Expert Consultation:

We interviewed Mr. Antony Zhang, Chief Expert of the Pharmaceutical and Chemical Business Department at Haifa Baocheng Financial Leasing Co., Ltd., and a Financial Risk Manager (FRM). He highlighted:

• The market potential of microneedle technology due to its painless, home-usable nature and reduced cold-chain requirements.

• Its suitability for pediatric allergy, geriatric care, and community health applications.

• Investment priorities: technology accounts for 40%, market for 30%, and team for 30% in investment decisions, emphasizing the need for a solid technological foundation, market alignment, and capable team execution.

He also pointed out that although areas like cancer and neurology dominate investor interest, innovative solutions in the allergy field have strong potential due to unmet public demand.

Proposed Solution:

Based on Mr. Zhang's insights, we focused our project on enhancing treatment effectiveness and convenience, directly addressing the public pain points identified in our survey (70.9% wanted more effective treatment; 39.3% wanted more convenient treatment). We also considered scalability and commercialization strategies to ensure that the microneedle technology can meet both clinical and market needs.

Implementation Step:

We integrated these insights into our project by:

• Continuing to develop and refine our microneedle prototypes with effectiveness and convenience in mind.

• Conducting school-based educational activities to demonstrate the effectiveness and convenience of microneedle therapy.

• Participating in the Shenzhen South China iGEM Conference, sharing our project with other teams, and gathering feedback on market potential and public interest.

This consultation provided a market validation perspective, ensuring our microneedle project is aligned with both investor expectations and public demand, while highlighting its potential positive impact on the allergy treatment market.

Figure 25 Screenshot Of Our team interviewing Dr.Zhang Online

Figure 26 Field Visit to Creative Biosciences Company

Problem Identified

Even with validated microneedle prototypes and public/market feedback (3.1–3.5), our team recognized that transitioning from laboratory research to market-ready products involves complex R&D, clinical trials, hospital integration, and pricing strategy. Without a clear understanding of these stages, our microneedle project could face delays or reduced credibility in real-world application.

Expert Consultation

We interviewed Mr. Lv, R&D Engineer and Supervisor at Kangliming Biotechnology Co., Ltd., on World Allergy Day (July 8, 2025). He explained that biopharmaceutical products require multiple rounds of verification from laboratory research to clinical trials, with meticulous attention to stability and performance. Mr. Lv also emphasized the importance of:

• Early hospital partnerships for product trials, usage training, and problem-solving.

• Compliance with national pharmaceutical policies to accelerate approval and market entry.

• Balanced pricing strategies considering material costs, production scalability, market demand, and competitor pricing.

He highlighted that active participation in academic conferences, case competitions, and industry forums can increase product recognition and gain professional feedback.

Proposed Solution

Guided by Mr. Lv's insights, we structured a stepwise plan for our microneedle project:

• Establish a rigorous verification process at each stage from prototype to clinical trials.

• Engage hospitals early to provide product trials, training, and collect feedback to build trust and reliability.

• Optimize pricing and commercialization strategies to balance cost, value, and market competitiveness.

• Actively participate in professional forums to raise awareness and validate our product concept.

Implementation Step：

We integrated Mr. Lv's recommendations by:

• Refining our microneedle design and development process with clear verification checkpoints.

• Planning hospital collaborations for trial deployment and usage evaluation.

• Adjusting our pricing model based on production costs, demand surveys, and competitor analysis.

• Scheduling participation in academic conferences, competitions, and workshops to promote our microneedle project, enhance professional feedback, and increase public recognition.

For more details, please visit the "Entrepreneurship" page for a comprehensive view.

Picture 27 Photo of Our Team With Mr.Lv At Creative Bioscienes Company

Figure 28 Interview with expert Mr.Suzuki

Problem Identified

Although our microneedle allergy therapy had been validated technically, clinically, and commercially in domestic contexts (China), we recognized that expanding to international markets poses challenges including regulatory compliance, market differences, and regional patient needs. Without expert guidance, pursuing global application—particularly in Japan and the U.S.—could face significant hurdles.

Expert Consultation

We interviewed Mr. Yuji Suzuki, an expert in Japan's allergy market and regulatory landscape. He highlighted:

• The Japanese allergy drug market focuses on hay fever, dust mite, and pet allergies, while microneedle therapies remain largely unused. Demonstrating value and effectiveness is critical.

• Food allergies represent a fragmented but high-potential market.

• Regulatory differences across countries are significant; the U.S. FDA and China NMPA have the strictest approval processes, and foreign approvals require local clinical data and consideration of racial differences.

• Cross-regional expansion should prioritize markets by patient numbers and pricing, leveraging frameworks like ICH to simplify multi-country filings.

Proposed Solution

Based on Mr. Suzuki's insights, we refined our international strategy:

• Prioritize domestic (China) approval and market entry first, ensuring the microneedle therapy is safe, effective, and well-adopted locally.

• After establishing domestic success, expand to high-demand international markets such as allergies in Japan and the U.S., where competition is lower.

• Use FDA approval as a springboard for subsequent PMDA and other international regulatory submissions.

• Explore food allergy applications as a long-term growth opportunity, aligning product development with unmet global needs.

• Plan region-specific clinical trials and collaborations to meet local regulatory and patient requirements.

Implementation Step

We integrated these recommendations into our Business Plan by:

• Adjusting our microneedle project roadmap to focus first on high-demand international markets.

• Detailing actionable steps for FDA approval and future PMDA submission.

• Expanding R&D and marketing plans to include food allergy treatment applications, backed by market analysis and regulatory strategies.

• Establishing potential collaborations with local institutions in target countries to ensure compliance, credibility, and adoption.

Figure 29 Screenshot Of Our team interviewing Mr.Suzuki Online

Building on our current educational initiatives, we plan to expand outreach programs to reach broader and more diverse audiences. For children, future comic books and interactive digital content will continue to introduce basic allergy concepts and prevention methods. For students and young adults, we aim to develop campus workshops and gamified learning platforms that integrate allergy science with hands-on synthetic biology experiments. For adults, public lectures will evolve to include emerging therapies and policy discussions, empowering communities to make informed health decisions.

We also envision extending street-level and community-based outreach, combining interactive science communication with real-time feedback collection. Future initiatives will incorporate digital surveys and mobile engagement tools to track public understanding, misconceptions, and expectations for treatment accessibility, allowing iterative improvement of educational content.

Our microneedle immunotherapy platform will continue to undergo iterative optimization, emphasizing safety, convenience, and environmental sustainability. Future work includes:

• Expanding allergen coverage, starting with pollen, dust mites, seafood, and extending to food allergies based on market demand.
• Developing modular microneedle systems with interchangeable allergen components for global adaptability.
• Enhancing delivery efficiency and drug stability through material innovation (e.g., hyaluronic acid, self-assembling peptides) and advanced formulations.
• Conducting clinical validation and hospital partnerships to ensure real-world feasibility, integrating expert guidance and regulatory compliance.
• Scaling commercialization strategies informed by investor and industry input, balancing pricing, patient demand, and sustainability.

Looking ahead, our project aims to maximize public health impact and scientific outreach by further reducing misconceptions and increasing public literacy about allergies and synthetic biology, proactively responding to emerging market needs such as food allergies and underserved populations, and implementing a global expansion roadmap that prioritizes domestic approval before strategically entering markets like the U.S. and Japan while adhering to international regulatory standards. At the same time, we are committed to fostering a sustainable and adaptable platform that ensures long-term scalability and societal benefit.