Overview

Our team, NATWORK is developing a new material for nucleic acid testing. Our final product is a type of enzyme that is a raw material used in nucleic acid tests. It s a new technology which can speed up the test a lot than the traditional ways. By applying for patents, we have the ability to establish technical barriers in our country's field of competence, while achieving an advantage in competing with local counterparts.

Since it is vital for our team to understand the social impact, commerce value and the actual meaning of the project, NATWORK has conducted several integrated human practices as we aim to develop the project responsibly. In summary , we have held two questionnaires, three interviews and one field trip. From these activities we know more about the market of our product, and they also provide much information and directions for our business plan.

Survey

Questionnaire 1

Due to the lack of understanding of our team members regarding the market and attitudes towards on-site testing, we designed this questionnaire with the main goal of finding direction for education and product landing for the team in the future. Based on this, the team divided the entire questionnaire into four sections to help us analyze the information collected and identify the target audience and stakeholders. Genetic engineering is an important technology we use in our research and development. To understand the level of awareness people have about genetic engineering, we designed the second part of the questionnaire to survey the public's knowledge about genetics. The third section focuses on microorganisms, mainly on the targets of our products: pathogens and bacteria, in order to determine public health awareness and identify different educational themes for different groups of people. We designed four demographic variable questions. The final seven questions are about in vitro detection technology. By answering these questions, NATWORK can understand people's acceptance and understanding levels, as well as know their concerns and needs for consumers. This will be useful for determining the form and direction of future product landing and sales.

After members of the team forwarded and promoted the questionnaire, NATWORK collected a total of 327 responses. Limited by the social circle of team members, the respondents were mainly middle-aged and young people with an educational background mostly at high school or undergraduate university. Based on our analysis of the questionnaire responses, we found that:

In the first part of the questionnaire, the first two questions were "How much do you know about genetic engineering and how do you learn about it?" The results showed that a large majority (87.47%) of people had limited knowledge about genetic engineering, with 62.39% of them learning about it primarily through the Internet. These data clearly show the importance of our education efforts, especially through online forms such as public account articles and popular science videos.

 

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According to the data from the second part of the questionnaire, a large majority of people have limited knowledge about pathogens and bacteria, with 74.62% choosing "occasionally concerned" or "completely unconcerned". One multiple-choice question asked about the harm caused by pathogens and bacteria on the human body, and the data showed that 73.11% believed it could lead to infectious diseases, 74.32% to immune system diseases, and 52.57% to chronic diseases. This suggests that the general public has basic awareness of pathogens and bacteria. When it comes to knowledge about pathogens and bacteria, most people know common sense, but some definitions are somewhat vague. Therefore, in education, it may be beneficial to provide more in-depth knowledge about them.

 

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According to the data from the third section of the questionnaire, a majority of people still have limited knowledge about in vitro instant testing technology, with only 7.85% of respondents selecting "very knowledgeable" or "relatively knowledgeable", but 84.29% believing that such tools are relatively convenient. When purchasing testing tools, consumers' top concerns include ease of use, price, and conditions required for use, which account for approximately 81.96%, 64.53%, and 46.79%, respectively. Our product has the characteristics of simple usage, affordable price, and being able to be used at constant temperature, indicating that our product is more in line with public demand. When asked if they would be willing to try a very convenient in-vitro testing kit if it were available, 70.65% of respondents selected "yes", while the remaining 28.13% chose "neutral", indicating that the public's acceptance of the kit is very high, making it relatively easier for us to promote our products in the future.

 

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At the end of the questionnaire, we asked participants if they would be willing to leave their contact information for further interviews. We received approximately 30 responses, indicating that people's enthusiasm for knowledge about microorganisms and in vitro instant testing technology is high, which will help us with future education and promotional activities.

Although this survey has some limitations, the overall results are generally consistent with those obtained from expert interviews conducted by our team. This provides us with many directions for selecting topics and forms for future education activities, as well as providing guidance for the landing of our products.

Questionnaire 2

To determine how the product will landing and be sold, NATWORK designed a questionnaire about public attitudes toward detection kits that are available on the market. The questionnaire was divided into two parts. The first part was the survey of demographic variables, and the other part was about the public's use experience and attitude towards the kit. The purpose is to understand the customer of the product, as well as the different needs of different age groups, to determine the advantages of our products and publicity direction.

Due to the short release time of the questionnaire, most of the questionnaires received came from friends and classmates of the team members. According to the results of demographic variables, most of the respondents were high school students. Therefore, we are going to continue expanding the scope of the questionnaire, and receive more data to support our research.

We first investigated the public whether suffering from respiratory tract, gastrointestinal tract, cardiovascular, endocrine and other diseases, the results showed that 43.48% of the people have a history of such diseases. This shows that in life, the frequency of detection is higher. The second question is about the channels for everyone to get the kit information. Almost half of the people knew about the kit through the Internet, such as WeChat official accounts and other forms. 26.09% of the people knew about the kit through community promotion or newspaper and television advertisement, while 28.26% of the people didn't understand it. It can be seen that there is still space for some education. The team can publicize the kit-related knowledge more in later activities to improve everyone's awareness of the instant detection technology.

 

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The information collected in the questionnaire mainly comes from the east China region, which is located in the coastal area of east China. The economic development is quite good and the consumption level is high. They mainly can accept for a test kit with a price range of mainly 21-50 yuan, the highest level for most people is 100 yuan, and few people can accept a higher price. This survey helps us to estimate the pricing range of the product.

 

 

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Regarding people's habit of purchasing kits, the information we collected was that 46.03% of people would choose to buy it right away and only buy it when there was a demand. The proportion is the largest among the four options, which confirms that the new product may have more price during the period of severe influenza or disease outbreak, and can also help our team to estimate the future revenue when writing the business plan.

 

 

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The team members also asked consumer’s attention to the storage conditions mentioned in the kit instructions. The answer showed that 12.5% of the people did not pay attention to them. Therefore, it is still necessary to raise people's awareness of this and more educational activities can be opened to raise people's attention. At the same time, it also increases our research and development direction and produces products that can be stored with simple storage conditions, such as at normal temperature.

For the commonly used COVID-19 antigen kits, more than half of the people thought it was very easy to use, but 51.79% thought the difficulty of reading the antigen results was not very simple, and 26.78% thought the steps of the detection kits were rather complicated. 61.90% of the people were "relatively satisfied" with the speed of the results produced by the kit. Overall, 32.14% thought they were very satisfied, and another 5.36% thought they were extremely dissatisfied. In summary, there is still room for further design and improvement of detection kits. Guiding the direction of our product application in the future.

The maximum time to a publicly acceptable kit outcome was 15 minutes or less for 41.27%, one hour or less for 25.4%, and two hours or less for 20.63%. The result of this investigation is very important for our research and development. The main feature of our product is that we hope it can be faster. Understanding the needs of customers can make our products more perfect.

 

 

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As for the test method, everyone also prefers to be able to do the test at home and get the results. It further proves that the demand and application rate in our market are still high. While almost everyone express very or relatively support for future kit digitization. By analyse it, NATWORK know that our future products can be linked to the internet, such as automatic upload data, AI analysis, health monitoring and other functions.

 

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In conclusion, the results of this survey have enabled NATWORK to have a better understanding of the customers' used experiences, concerns and needs of using the test box. For our products after landing to guide more direction, but also for our business plan to write a forecast to provide some reference.

 

Stakeholder interviews

Interview 1 - Dr. Zhou Xiangda

In order to solve problems related to pathogens, pathogenic bacteria, real-time detection and constant temperature detection technology, our team consulted Dr. Zhou Xiangda, a doctor of biophysics from the Humboldt School of Medicine of Saarland University in Germany.

After this interview, we gained a lot of knowledge from three aspects: real-time detection, constant temperature detection technology and IGEM competition experience. For example, we learned that if the sampling operability of constant temperature detection technology is improved, then constant temperature detection technology will be able to be carried out in various environments in the future, such as aerosol environment and water environment. If it is continuously improved and evolved, the application prospect of constant temperature detection technology will be very extensive in the future.

In addition, we also learned about the difference between qPCR and isothermal amplification techniques. The temperature requirement of qPCR is much higher than that of constant temperature amplification technology, and the high temperature may damage the DNA itself, resulting in errors in the results. In contrast, constant temperature detection technology is more stable than qPCR.

What‘s more, in terms of timely detection technology, "immediate" does not actually have an accurate time standard. It refers to a time that is relatively fast, does not delay the disease, and is within the patient's acceptance range. The application prospect of instant detection is also very large, especially after the new crown epidemic, this technology is very likely to be widely used in the future. According to data, since 2019, the Chinese market has experienced rapid growth in the development of instant detection technology, and it is expected that the compound annual growth rate will reach 28% by 2024, far exceeding the expected growth rate of molecular medicine and much higher than the growth rate of the medical market in developed countries. This is also related to the degree of economic and social development in China in recent years, as well as the medical insurance policy promoted by the Chinese government.

Moreover, real-time detection technology is also widely used in the current society. People usually use human tissue fluid and blood sampling to detect the presence of some viruses and pathogens in the human body. For instance, HPV virus, respiratory virus, tuberculosis virus, enterovirus... mainly focus on the detection of infectious diseases and pathogens that people are prone to. These diseases have a high cure rate, have a great impact on people's lives, and are even contagious.

Finally, we also learned that Dr. Zhou Xiangda was a member of the team that won the gold medal in the university group IGEM competition. Therefore, we also asked him how to promote genetic engineering, how to carry out Education, and how to attract people's interest through Promotion Video to better achieve the purpose of publicity. Through the conversation, we learned that teamwork is very important, and effective communication and communication between dry and wet teams is needed to better collaborate to complete these projects.

 

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Interview2 - Director Chen Jian

In order to understand the market development, customer coverage and future development trend of point-of-care in vitro detection tools, as well as the situation of QPCR and CRISPR detection methods, as well as the differences in policy environments between China and the United States, our team consulted Director Chen, R&D Director of Shanghai Berger Biotech.

After this interview, we obtained a lot of important information from three aspects: market development, real-time detection and technology development. Dr. Chen told us that pathogen detection is now more of molecular detection, and molecular detection is now in an era of high growth. The reason for the expansion of the molecular medical market is that during the epidemic, people have higher and higher requirements for the accuracy of molecular testing, so more and more hospitals now have molecular testing laboratories. It is worth noting that as the country pays more and more attention to education, the public is getting more and more educated, and they are becoming more and more interested in the real principles behind their own diseases.

Secondly, Dr. Chen also introduced the advantages of POCT. First of all, POCT is relatively fast and can be tested anytime, anywhere. Secondly, the detection speed of POCT is very fast, and some results can be obtained within a few minutes. In addition, POCT is a relatively small device that can be carried around, laying a solid foundation for home use. In the foreseeable future, the development prospects of POCT will become better and better, and the application scenarios will become more and more extensive. At present, due to the high cost of the experiment and the long experiment cycle, the number and types of qPCR and CRISPR on the market are relatively small. And for qPCR, its accuracy is still not satisfactory, and there are some missed detections and false positives. Finally, we asked some questions about the specific application scenarios of qPCR and CRISPR in the future. At present, qPCR has been fully applied in pathogen detection and pathological detection, including respiratory pathogens, bacterial pathogens, viral pathogens and so on. In the future, HPV testing, AIDS testing, and tumor testing may also be involved. For CRISPR, the future may involve immune detection and nucleic acid integration, as well as highly sensitive detection for qPCR. CRISPR technology is relatively convenient, low-cost, and highly specific. But a breakthrough in improving sensitivity is still needed.

 

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Interview 3 - Director Zhang Jiachen

To understand the main markets, environments, and national macro policies in the field of in-vitro diagnostics, how to improve the competitiveness of our product, how to break the monopoly of foreign technology, and the future development prospects of in-vitro diagnostics, we have invited Zhang Jiachen, Director of Public Relations of Dean Diagnostic Technology Group Co., Ltd. We interviewed Mr. Zhang based on three modules: in-vitro diagnostics market, project products, and the future of in-vitro diagnostics industry. 

Mr. Zhang's company is at the middle and lower reaches of the medical industry, mainly responsible for medical services and channel agent, selling medical products into hospitals, so he is very familiar with the medical industry market. Through the interview, we first learned that the market size of raw material production is 13.76 billion, with a profit margin of 80%-90%, and the market share of point-of-care testing is 11%, which translates to 1.514 billion market potential. And now China's aging problem is serious, and it is estimated that there will be more than 400 million people over the age of 60 by 2035, accounting for 30% of the total population, and medical demand will increase, resulting in an increase in demand for testing products. He also mentioned that because domestic core technology is less, and domestic products have low cost, stable supply chain characteristics, the government strongly supports the replacement of domestic products, so our products are likely to be able to win government subsidies and help, which is beneficial to the promotion of products. About the challenges facing the in-vitro diagnostics market currently, there are mainly high domestication rates, most producers do not have core technology, and need to predict future policies, etc. This helped us to better understand this market and provide content for the market analysis section of the business plan book.

Secondly, Mr. Zhang analyzed through understanding our team's project products, briefly analyzed measures that can be used to improve the competitiveness of other products. Based on his analysis, we learned that we need to first investigate the size of the market, find out if there are similar companies, find out the pain points of customer demand and then treat them accordingly. Improve the effectiveness and stability of our own products as prerequisites. For product publicity, Mr. Zhang pointed out that product advantages need to be distinguished by relevant institutions and whether they hold patents. Mr. Zhang shared that the company's profit margin accounts for 15% of its turnover, and the cost of R & D investment accounts for about 10%-20% of its profits, and the company's balance sheet took two years to achieve. It provides data assistance for team future business management. In terms of publicity, Mr. Zhang suggested that the team should invest more advertisements in hospitals, research institutes, reagent manufacturers. Mr. Zhang added that selecting raw materials requires considering costs, compliance, transportation conditions and other key points. Finally, regarding the future development of in-vitro diagnostics industry, Mr. Zhang pointed out that if we want to improve the limitations existing at this stage and gain recognition from midstream enterprises, in addition to the benefits our team's products have in terms of increased testing efficiency, reduced costs, and high accuracy, we also need to improve the accuracy of our product testing and gain market recognition. In addition, we also asked questions about the business plan for new biotech companies. Mr. Zhang said that if we want to gain greater recognition from product manufacturing companies on a larger scale, we need not only to display the company's strengths and values on the business plan but also to have professional articles and obtain national patents.

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Filed trip

Field trip1: Yulon Medical Testing

In order to gain a better understanding of the practical application of medical testing, NATWORK organized a visit to Yulon Medical Testing. Our team was contacted by one of their quality control staff members, Zhou Zhiwen. Led by her, our NATWORK members had a brief tour of the testing laboratory and conducted an interview with her.

In the first part of the tour, we visited their central laboratory and learned that the testing laboratory includes various clinical and health tests such as blood routine examinations, urine routine examinations, paternity tests, microbiological testing, and more. Ms. Zhou told us that strict control over temperature is required in the testing laboratory to ensure that precision machinery and reagents function better and are stored properly. Our members also had the opportunity to see many precision instruments that can process samples automatically even without staff. Their laboratory has high requirements for waste instruments and has a separate area for storage and disposal, which is then transported to specialized medical waste treatment institutions. She also introduced us to their PCR laboratory, which has strict personnel flow directions and is passed through special sample windows to ensure safety. They also regularly conduct safety drills to prevent accidents.

In the second part, we interviewed Ms. Zhou. She introduced their promotional methods, which include using the internet such as WeChat public accounts and official websites, as well as some self-media apps like Douyin and Xiaohongshu. Then combined with their own medical professional field to create an environment to allow people to quickly understand their testing background, products, and fields. We also asked what conditions are needed if we want to introduce a new technology or principle. She explained that first, the product needs to have universal validation to ensure its accuracy. They will investigate the companies and products produced, followed by market department docking, then provide small samples. The quality control department will compare the results, test time, and harm to human body of the raw materials used in previous laboratories before conducting an assessment. After considering cost factors, it is finally decided by the general manager. This information provided us with much help when writing a business plan book and how to attract customers and investment in the future.

 

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Field trip2: Aisheng Medicine

In order to understand the current status of the pharmaceutical field, the pain points and difficulties of the current development of pharmaceutical companies, how to win national support for domestic production, the corporate culture and sentiments (SDGs) of pharmaceutical companies, and how pharmaceutical companies choose reliable upstream suppliers and other details , our team went to Zhejiang Aisheng Pharmaceutical Co., Ltd. and consulted Mr. Deng Jinming, the general manager of Aisheng Pharmaceutical Co., Ltd.

After this interview, we got a lot of information on how to promote the pharmaceutical industry, the current scale and development prospects of the pharmaceutical industry, the formulation of corporate culture, and how to choose suppliers. Mr. Deng told us that currently the pharmaceutical industry invests less in publicity. Most pharmaceutical companies directly engage in activities with pharmacies for sales and communication, and most pharmaceutical companies mainly rely on brand culture, such as the brand of Aisheng Pharmaceutical. "New Synthesis" and "Yan Ji Tang". Publicity plays only a small part in sales, and relies more on the public's familiarity and trust in the brand.

Secondly, we also learned that in order to better promote exchanges between pharmaceutical companies, some new companies will publish product-related articles in medical magazines, and many large companies will also hold regular pharmaceutical exhibitions to exchange new technologies with each other. At the same time, new companies can also take this opportunity to attract their investment.

In addition, Mr. Deng also introduced the current scale of the pharmaceutical industry. First of all, the pharmaceutical industry is currently almost saturated, and only innovative and more effective medicines can compete in the market. In addition, product quality, price, timely supply, and compliance with regulations are also important considerations for pharmaceutical companies. What’s more, regarding the development prospects of the pharmaceutical industry, the current preference is for instant detection technology. This is due to the impact of the new crown epidemic. People need more convenient and rapid detection technology to ensure their health and safety.

Finally, we also asked questions about the status of pharmaceuticals and your company's corporate culture. During the conversation, we learned that most drugs exist in a solid state. This is because solid tablets are approximately equivalent to compacted powdered drugs. This makes it easier for people who need to take large amounts of medicine, as a small solid tablet can replace a large package of medicine, while powdered solid medicines are usually provided to patients who only need to take a small amount of medicine. And for the storage of medicines, solids are easier to preserve and less likely to deteriorate than liquids. In addition, Mr. Deng also mentioned that the core of their company's corporate culture is "the capable are teachers, and the teachers are wise."

 

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Conclusion

As an resulf of our integrated human pratices, we have gained much professional knowledge and a deeper understanding of our project. NATWORK is confident that our project and product is good and respondible for the world and able to contribute to our local community.  

 

Thoughts on Project Implementation

What impact will your project have?

Our project aims to revolutionize the Point of Care Testing (POCT) market, particularly in nucleic acid detection. By introducing a sulfur-modified dependent restriction enzyme, we hope to provide faster testing solutions compared to traditional methods. This will not only expedite diagnosis but also potentially save lives by enabling timely interventions. Furthermore, by emphasizing responsible research and innovation, we aim to ensure that our project is ethically sound and socially accepted.

Proposed end users

Our primary end users are medical institutions, diagnostic centers, and research facilities that require rapid nucleic acid testing solutions. Given the growing demand for POCT, especially in developed countries and the rapid growth in China's POCT market, we believe our product will cater to a broad audience seeking efficient and cost-effective testing methods.

How will end users utilize the products?

We envision medical institutions incorporating our enzyme into their diagnostic procedures, allowing for quicker and more accurate results. Research facilities might also utilize our product in various experiments and studies related to nucleic acid detection. Moreover, with the increasing emphasis on home-based testing solutions, there's potential for our enzyme to be integrated into home testing kits in the future.

Real-world Implementation of our Proejct

Our implementation strategy begins with rigorous testing and validation to ensure the enzyme's efficacy and safety. Once validated, we plan to collaborate with diagnostic companies and medical institutions for pilot testing. Our competitive pricing, combined with the enzyme's advantages, will be our selling points. We'll also engage in extensive marketing and awareness campaigns, emphasizing our product's unique selling propositions. Feedback from initial users will be crucial, allowing us to make necessary adjustments before a full-scale launch. Additionally, we'll continue our engagement with stakeholders, ensuring that our project remains ethically and socially aligned with community values.

(Additional Infomration: Here is our entrepreneurship page https://2023.igem.wiki/ulc/entrepreneurship for a comprehensive implemenation of our product)