Empowering Early Detection: Revolutionizing Cardiovascular Disease Management
Addressing the Critical Need for Accessible, Efficient Biomarker Testing
Early screening for cancer, cardiovascular disease, infections, and other major illnesses constitutes a critical component of safeguarding human life and well-being. Precise medical diagnosis, grounded in the identification of biomarkers, stands as the most direct, expedient, and effective diagnostic tool, playing a pivotal role in disease detection, progression monitoring, treatment, and assessment of treatment efficacy.
In the context of cardiovascular disease, the leading global cause of mortality, the early detection of heart disease biomarkers holds paramount importance in reducing fatalities. Given the covert and sudden nature of heart conditions, there is a growing desire for community hospitals and even households to be equipped for early problem detection. Serum and plasma samples have long been considered the optimal sources of biomarkers due to their ready availability. However, as biomarker levels in blood samples tend to be exceedingly low, there arises a need for the development of highly sensitive and efficient detection techniques and tools. Moreover, for household or portable applications, such tools must be cost-effective and user-friendly. To enable the detection of various diseases, modularity and scalability are essential attributes. The current testing method, ELISA&ECLIA, falls short of meeting these requirements, prompting our decision to address and rectify this situation.
Stakeholder-Centric Approach: Ensuring Practical Solutions
Following the identification of our project, it is crucial to ascertain the key stakeholders involved. Through extensive deliberations, we have categorized our stakeholders into four distinct groups: healthcare, the general public, experts, and manufacturing. While the perspectives of stakeholders in each category are invaluable, prioritizing stakeholders based on their importance will help us make informed choices, especially when faced with conflicting views.
Our analysis, utilizing the Analytic Hierarchy Process (AHP), indicates that healthcare and the general public hold the highest importance as stakeholders in our project. These groups are closely tied to the real societal needs, and their opinions directly and practically address the fundamental issues of our project. Expert opinions primarily serve as constructive guidance, while the viewpoints of the manufacturing sector are of significant importance to our hardware design and eventual industrialization.
Fostering Efficient Team Collaboration
We have gained experience in how to closely connect each team, achieve real-time information sharing, and improve project efficiency. By establishing an exclusive shared literature library, a “Wet Lab Daily” for progress tracking, a resource sharing repository, and a standard method repository, we have significantly enhanced our ability to collaborate effectively. Additionally, our weekly team meetings foster a clear understanding of the overall project progress, facilitating better project management.
Entrepreneurship and Implementation: Addressing Real-World Needs
After engaging with various stakeholders, we started to explore entrepreneurship opportunities. We built a business plan centered around integrated cardiovascular disease testing reagents and point-of-care testing (POCT) services, analyzing market conditions, business models, human resource management, and financial planning. In terms of implementation, we delved into CVD issues, existing problems, medical device registration, target users, user manuals, and market risks, ensuring our solutions are practical and responsive to societal needs.
Prioritizing Safety: A Commitment to Responsible Innovation
Ensuring the safety of every aspect during the project promotion process is a fundamental consideration in our development. From laboratory safety and experimental operation safety to experimental strain safety, the development process of social practice, and the privacy protection of disadvantaged groups, we approach our project with a strong sense of responsibility and a rigorous attitude to prevent harm to the environment, society, and people.
Collaborative Ecosystem: Building Connections, Gaining Insights
During the project, we had the opportunity to attend the 10th Conference of the China iGEMer Community (CCiC), where we fostered productive and collaborative relationships with various teams. Through effective communication and cooperation, we not only gained a wealth of information on project promotion but also motivated ourselves to think critically about our established strategy and to select the best underlying technology and model for our teamwork.
Reflective Journey: Identifying Challenges, Refining Solutions
Although we have received substantial support from stakeholders, we have also encountered numerous concerns or flaws with our initial project approach. For instance, we initially planned to use saliva as the test sample, but after discussing with doctors in community hospitals, we discovered several disadvantages and ultimately chose blood testing instead.
Furthermore, when we focused the project on using NT-proBNP for heart failure detection, we made significant efforts in this direction. However, after discussing with Dr. Wang, we learned that due to heart failure being a condition rather than a distinct disease, early detection of heart failure is not deemed highly necessary. Therefore, we realized the necessity of developing a “plug-and-play” modular, portable, and sensitive detection tool that can facilitate low-cost, rapid, and efficient multi-molecule parallel testing, aiming to take full responsibility for the well-being and health of the patients.
Comprehensive Evaluation System: Prioritizing Stakeholder Needs
In order to further assess the aspects of the product that stakeholders value throughout the product development, production, sales, and usage processes and determine the order of optimization for our project, we established an evaluation system of indicators using the Analytic Hierarchy Process (AHP).
At the systemic level, various factors that could potentially influence stakeholders’ perceptions of the product were identified as criteria, including quality, safety, ethics, respect, public health, innovation, efficiency, and cost. At the indicator level, specific measurable aspects were defined for each criterion, and pairwise comparisons were made to determine the weighted importance of each indicator.
According to the system-level analysis results, quality is the most critical factor, accounting for 29.21% of the total weight and should be given the highest priority. Ethics, safety, public health, and efficiency follow in descending order of importance. Respect and innovation have lower weights, each below 10%. Therefore, in the future development and sales processes, special attention should be paid to the quality of the product to ensure the accuracy and precision of the testing results, providing consumers with reliable outcomes.
Expanding Project Boundaries: Future Aspirations
In the future, we hope to more fully incorporate the guidance and suggestions of Professor Wang, designing multiple chromatographic test paper flow channels to achieve more distinct detection lines, facilitating the parallel detection of various molecules. This will enhance the product’s comprehensive assessment capability. Moving forward, we also plan to optimize and design adaptive adjustable devices compatible with all phone models, and explore the integration of AI in the feedback result analysis software to provide more personalized and direct guidance.
Responsible Innovation: Positive and Negative Impacts
Our project team aims to develop a biomarker detection tool that can be conveniently used in community hospitals and homes. Due to its “plug and play” nature, it enables low-cost, efficient, and precise detection across various scenarios. Moreover, as it employs a non-pathogenic strain of E. coli as the chassis cell and operates outside a cellular system, the product is non-infectious, ensuring maximum biosafety for users.
As a portable detection tool, it can significantly assist individuals in impoverished areas or places with limited medical resources in their daily health monitoring, promoting equal distribution of medical resources and enhancing overall well-being. However, as our test kit uses blood samples for detection, it will come equipped with disposable blood collection needles and other one-time-use blood collection and processing accessories, which poses the risk of puncture wounds or infections due to mishandling or packaging breach. Moving forward, we will continuously monitor and maintain a responsible attitude to rigorously address potential hazards.
Conclusion: Towards Responsible and Impactful Solutions
As a project team closely linked to human health and well-being, the actual needs and ideas of stakeholders are crucial to us. Our ultimate goal is to use the protein cage as a vehicle to develop a practical and responsible portable detection tool for disease biomarkers that benefits the world. This requires us to fully understand the values and needs of stakeholders, consider the positive and negative effects of our proposed solutions from environmental, social, ethical, safety, and various perspectives, and make reasonable adjustments at different stages of the project.
Through our collaborative efforts and continuous engagement with diverse stakeholders, we aim to create a comprehensive and impactful solution that advances synthetic biology applications for global health, empowering early detection and effective management of cardiovascular diseases. By prioritizing quality, safety, and ethical considerations, we are committed to delivering a responsible innovation that can truly make a difference in people’s lives.
