Purpose

Cerebral spinal fluid is a colourless, transparent fluid found in the ventricles and subarachnoid region of the brain, which is crucial to maintaining brain health. The cerebrospinal fluid removes metabolites and inflammatory exudates, supplying nutrients to brain cells and transporting metabolites from brain tissue. It also provides a protective and supporting function for the brain and spinal cord since it envelops and supports the whole structure. Therefore, a person's health may suffer greatly as a result of a cerebrospinal fluid rhinorrhoea, which can also result in ascending infections and a deficit of cerebrospinal fluid.

However, CSF rhinorrhoea is often neglected in diagnosis and currently there is no method that quickly detects CSF rhinorrhoea. The commercialisation of a new CSF rhinorrhoea test kits also remained in a mystery. In order to have a more fulfilled understanding for the product development and the business planing, we interviewed professionals and experts from various areas, and the stakeholders from different perspectives. They gave us many valuable suggestions and inspired our insight for the designing, application and marketing of our product.

In the course of of these research, we also discovered that public perceptions of synthetic biology and genetic engineering can influence the purchase and use of our products. As a result, we conducted a number of surveys to learn what the general public thinks about these fields as well as to identify the target market for our products.

Meanwhile, from the result of the questionnaires, we also discovered that the attention of public for the Brain Health and CSF rhinorrhoea is still insufficient. Thus, based on the expertises and the statistic we collected from questionnaires, we carried out a number of activities to arouse public awareness of brain health, particularly cerebrospinal fluid health, and the prevention of cerebrospinal fluid rhinorrhoea in PearlDelta region.

Figure 1

Survey

Questionnaire 1

The first questionnaire, or Public Opinion Questionnaire, explores general public opinion on two subjects: Synthetic Biology and Brain Health.

We divided our parts into a list of demographic variables, including:

· Age

· Gender

· Literacy level

· Regional Economic Condition

The second part of the questionnaire includes the respondents’ level of understanding and acceptance to genetic engineering and synthetic biology. An example question would be:

· Do you use, or support you family to use genetically modified products?

We assumed that

1. an individual's age exhibits a negative correlation

2. an individual’s year of education exhibits a positive relationship with their acceptance and understanding towards genetic engineering.

After collecting 2066 valid data, we found the first hypothesis to be true.

e.g. Do you accept genetically modified products (e.g. Genetically modified Food)?

Pulling out data selectively from under 18 aged respondents, from a scale of 1 (totally do not accept) to 10 (totally accept), the distribution tends to approach to ‘totally accept side’, showing a general acceptance towards synthetic biology.

Figure 2. IHP-Questionnaire-1-AgeUnd18

Figure 3. IHP-Questionnaire-2-Age51-60

However, those respondents from age 51-60 presented a completely different trend. More tend to deny the use of genetically modified products.

For the second hypothesis, we see those who received maximum of high school education (N.B. 90% of them are still students) to the question “what is your understanding towards genetic engineering”, the response shows a trend of:

Figure 4. IHP-Questionnaire-1-HighSchool

(From left to right: Completely understand, relatively understand, basic understanding, relatively do not understand, completely do not understand. Same for Fig. IHP-Questionnaire-1-Post/Mast)

However, people who received longer education period has a better understanding of synthetic biology, namely those who have a Master’s degree or above.

Figure 5. IHP-Questionnaire-1-Post/Mast

Although as they are under 18, having confidence in synthetic biology products, we found that they are not confident about their understanding towards it. We may consider promoting our programme (as an example of synthetic biology) to high-school-level students, strengthening their understanding towards synthetic biology more than strengthening their confidence. as they also lack some understanding in synthetic biology.

Thus, it is considered the most important to raise youngsters’ attention and give them knowledge regarding to synthetic biology. They should be to a confident level in knowing about the synthetic biology.

The third part of the questionnaire is a series of questions about brain health. It included the interviewee's awareness of their own brain health, the frequency of brain examination, and their cognition of the cerebrospinal fluid itself. Moreover, a series of knowledge questions that determine whether it is right or wrong can verify that the answers of the fillers (about their knowledge of cerebrospinal fluid) are true and valid, making the collected data more credible.

Hypotheses:

· People don’t know CSF rhinorrhoea at all

· People are more concerned about brain itself than CSF

We took the response from the question: Do you know what is CSF rhinorrhoea?

Pulling out datas, it is true that over a half have no idea about CSF rhinorrhoea, however the number of people who heard this term before surprised us:

Figure 6. IHP-Questionnaire-1-KnowCSFR

(Left to right: knows, only heard about it, do not know at all)

This again proved the danger of CSF rhinorrhoea, although it can cause neurological complications and fatal consequences, people and even doctors may increasingly tend to wrongly identify it as a runny nose in a cold or sinusitis.

However, as some heard the term before but doesn’t know what “CSF rhinorrhoea” is, education programmes aiming towards enhancing their further understanding towards this concept is feasible and necessary.

We asked, in the questionnaire, We also concluded that people are more concerned about the brain itself than its peripheral structures, like CSF:

Figure 7. IHP-Questionnaire-1-Brain&CSFetc.

(L-R: Cerebral blood vessels, brainstem, cranial nerves, CSF, meninges)

Questionnaire 2

We collected more than 200 responses for this questionnaire.

As the test kit product have the potential to be pursued into market, understanding people’s views and opinions may mean better amendments towards our business plan, hence promoting our product in a wiser strategy.

Firstly, we proved that Point-of-Care (POC) style testing, which people can do tests themselves completely at home, is much more popular amongst consumers. A half of consumers particularly favors doing the test at home only as it is stunningly convenient compared to laboratory analysis which requires long waiting time and expensive hidden service (technician) cost.

Figure 8

Now, due to the COVID-19 pandemic, Point-of-Care (POC) test kits have been known by the public as Fast Antigen test for SARS-CoV-2 is distributed extensively around the world. We expected that a majority of the population have seen and accepted POC test at home.

This can be again justified by their evaluation to test kits they have used, which the majority commented them being ‘more convenient’.

Figure 9

From the results we collected, consumer predilections are listen below. The images below visually prove our conclusions here.

· Price consumers accept is best at maximum of 50RMB, and price should not exceed 100RMB.

· People would like to get products from community healthcare institutions such as pharmacies.

· People may prefer to purchase test kits only in case of presence of possible symptoms (thus there might be not that much sales if sold to individuals directly)

1st

· The majority could accept up to 15 minutes of test time which our product may not achieve at this stage. (COVID-19 Fast Antigen Test is so fast that it decreases people’s time expectation in general test kits) This might be a weakness of our product.

Figure 10-13

Expert Interviews

interview - Professor Li Wei

Interviews are one of our integral information gathering methods. Due to the fact that research papers were unable to provide us with all the information we need as well as first-hand experience about CSF rhinorrhoea, we scheduled two separate interviews with Professor Li and Doctor Ren respectively. We aim to round out our knowledge and theory base by supplementing our data with information gained through interviews with them. Specifically, we had to make sure of the stability as well as medical safety of the test technology, as well as an estimate of the cost needed for such a test system. In addition, a comparison between current methods commonly used for CSF rhinorrhoea detection was needed, as well as their efficiency and cost effectiveness. Finally, we had to make sure of the overall feasibility of the use of reagent test kits for detection of nasal CSF leakage.

Figure 14

Key learnings outcomes from the interview with Professor Li Wei:

1. We gained information about methods of clinical diagnosis of cerebrospinal fluid leakage, including looking at the properties of rhinorrhea fluid, the patient’s position at the time when the rhinorrhea occurs, and the concentration of glucose in the leakage.

2. We learned about the current treatments for cerebrospinal fluid leakage and the current main means of detection of cerebrospinal fluid leakage. Here, we were corrected that with the special treatment of magnetic resonance, we can use cerebrospinal fluid film to see the flow of cerebrospinal fluid, which is one of the ways to detect the leakage of the fluid.

3. We realised that the public awareness of brain health and neurosurgery is far below the required average. To raise public awareness of brain health, we will launch activities to promote the importance of brain health so that many brain health symptoms can be diagnosed at an early stage.

4. From the conversation, the idea that we are designing a kit for the reminder that the user might have cerebrospinal fluid leakage if the result is positive was affirmed by the professor, which makes us more confident about our project.

* Prof. Li even mentioned that a few otolaryngologists even wrongly identify CSF rhinorrhoea as sinusitis!

Interview - Doctor Ren Yanli

Interview purpose

After discussing the clinical situation of CSF rhinorrhoea with Professor Li, we recognize the need for more theoretical information to assess the viability of our project. To address this, we have scheduled an interview with Doctor Ren. Our primary objective is to ensure that the method we use to indicate beta-2-transferring is both feasible and economical. We will discuss the proposed method with Doctor Ren, considering factors such as accuracy, cost-effectiveness, and practical implementation. This interview will provide valuable insights for optimizing our approach and ensuring its success while being economically sustainable.

Figure 15

Interview report

Doctor Ren has made an adequate preparation before the interview that she made a PowerPoint for this interview. Which had surprised us for her attentiveness.

She first shown us a video about a patient of CSF rhinorrhoea who ignored his symptom of CSF leakage for three years talks with his doctor. Using this video, Doctor Ren informed us that CSF leakage has degree varies in different body positions. This can be indicated as a unique feature of CSF rhinorrhoea compared to discharge of nasal secretions.

We have mentioned about testing at home using the test packages. Doctor Ren stated that when most test packages involves a TMB reaction which need a special equipment called microplate reader which has a high price. This results as there's no effective test package which supports customers to test at home.

Before the interview, we already known some doctors tests the concentration of glucose in the fluid from nose to indicate the possibility of having CSF leakage. We had asked Doctor Ren about its criteria. She suggests that this method has a low specificity and sensitivity which the concentration of glucose in CSF varies with the glucose concentration in blood.

Doctor Ren stated us the common testing method of beta-2-transferring up to now. Most of the test packages existing in the market uses ELISA method which has four main detailed method, direct ELISA, indirect ELISA, sandwich ELISA and competitive ELIAS. Almost all test packages with ELISA method is using sandwich ELISA. Then, Doctor Ren described the detail of this method.

About the availability of this method economically, Doctor Ren says that if these research is connected to finance,it will become difficult. The researches we have done in laboratory is far away from being clinical and make economical profits. But she also suggested that researches we are doing is possible to promote the development of this area.

After this interview, we had gained a lot about this technology. With interviewing Doctor Ren, we are also encouraged to move further on our topic, which gave us great confidences about our research.

Interview - Entrepreneurship expert Mr. Ye Zhongtian

In our pursuit of a robust business plan, we recognised the need to leverage the expertise of a professional financial analyst. Their valuable insights were sought as we conducted a comprehensive presentation, which offered a detailed overview of our project's objectives, potential benefits, design principles, and budget allocation.

Throughout the presentation, we emphasised the significance of our solution in addressing the challenges faced by our target market. We showcased the unique features and competitive advantages of our product, illustrating its potential to revolutionise the industry. Additionally, we outlined our marketing strategies, distribution channels, and financial projections, providing a comprehensive understanding of the market landscape.

Figure 16&17

Following the presentation, the financial analyst meticulously reviewed our business plan, offering specific and targeted suggestions to enhance our pitch. Their expertise and insights proved invaluable as they pointed out areas for improvement and refinement. They provided recommendations on optimizing financial projections, reducing costs, and mitigating risks, all with the aim of maximizing our project's potential for success.

(We went to see Shanghai EMEH 2023 to gain a better understanding of our potential competitors, learning how test kits have been designed, presented to the public, and sold.)

The impact of the analyst's suggestions on our business plan and presentation was highly positive. Their inputs allowed us to refine our messaging, making it more compelling and attractive to potential investors. They identified potential errors or omissions, enabling us to rectify them and present a more accurate and comprehensive business plan.

In conclusion, the interview session with the financial analyst proved to be an invaluable opportunity for us. It enabled us to present our project to a seasoned professional in the financial field and receive targeted and constructive suggestions tailored to our business plan. The analyst's recommendations not only enhanced our pitch but also provided us with a deeper understanding of the financial aspects of our project, making our business plan more practical and robust. We are grateful for the insights provided by the financial analyst, and we are confident that incorporating their suggestions will significantly strengthen our business plan's potential for success.

Field Trip & Stakeholder interviews

Visit to Zhongshan Hospital affiliated to Fudan University

Interview - Dr. Zhao Yajun

On July 6, a number of members of the team paid a visit to Dr. Zhao at Fudan ZHONGSHAN HOSPITAL and conducted an interview and study session with him in order to learn more.

Dr. Zhao gave us a guided tour of the facility so we could observe how departments like respiratory medicine, ENT, neurosurgery, and brain surgery are organized. We discovered through the neurosurgery outpatient clinic that many patients with lateral cerebrospinal fluid leaks overestimate their symptoms and schedule appointments with the respiratory and ENT departments. This can result in misinterpretations by medical professionals in these unrelated departments, which can cause delays in treatment and other issues.

Figure 18&19

Dr. Zhao served as our tour guide as we then went to Shanghai Medical College of Fudan University. He gave us an overview of the strategies Zhongshan Hospital use to raise awareness of brain health. He described the methods and their emphasis on spreading information among the general population, which helped us develop more effective educational dissemination programs.

Also, we observed how the neurology department displayed information in form of posters. When the patients are waiting for the doctor’s consult, they can see the posters to gain a variety of information about many other neurologically based health issues and ways to prevent them.

The clinical diagnosis of cerebrospinal fluid nasal lateral leakage was also presented to us by Dr. Zhao at the same time. The example demonstrated how to respond to a nasal leak that develops suddenly as well as how to treat and control it afterwards.

Dr. Zhao was given our portable medical diagnostic instrument, the Cerebrospinal Fluid Test Kit, as a gift in an effort to assist. Regarding the fundamentals of the condition and its management, Dr. Zhao provided us with helpful guidance.

Visit to Shanghai International Medical Equipment Exhibition2023

To find the answer of the question from financial analysts Mr. Ye, 5 of our our dry team members attended the Shanghai International Medical Equipment Exhibition 2023 (EMEH 2023). Since our team’s goal is to design a fast test kit for cerebrospinal fluid leakage, the main purpose of our visit is to gain more knowledge on the emerging techniques and methods for in vitro diagnosis, to gain inspirations for the appearance and function of our test kit. Meanwhile, through these communications, we gained a brief idea about business practice and further access information of our potential competitor. We also began considering principles such as target users, demand for products, cost of production, and the direction of future development.

Figure 20-22

The exhibition mainly includes machine producing consumable equipments, equipments for clinical detection, and recovery equipments. We mainly focuses on researching diagnosis reagent and test kits for blood, immune system, tumor, and microbiome. During the exhibition, our team members watched exhibition booths on medical equipments and consumable equipments, especially test kits and diagnosis reagent. Our team members worked in pairs to explore the exhibition and communicated with representatives from various medical companies about the principles and designs of their diagnosing equipments. For example, from one company that specialized in producing swabs and test kits, we learned about the different designed shapes of swabs, how they are related to the function of the test kit, and how the customers react to these shapes. These informations helps with our design of the test kit.

We read and collected leaflets introducing the products from different companies, which provided us knowledge about what should be included in our advertising and roadshow, such as explanation of product importance and instructions for usage. We also learn about how these products are introduced through presentations and leaflets, to help with our advertising design. (Check the Education by clicking here)

Huangpu District Synbiogen Field Trip

Although we had accessed enough the theoretical knowledge from current interview and exhibition, the new questions also arise. Is our modelling corresponding to the reality? How does a biological technology company applicate their on-market permission? How these company actually estimate they potential customer, and expand the market? To examine our planing, a field trip would be necessary.

On June 14th, 4 of our team member visited HeyGear, a 3D printing company that serves the medical equipment production, and Synbiogen, a bio-engineering on market company that has the largest GMP(Good Manufacturing Practice of Medical Products) cell production base in South China.

We took a tour for the overall process for the production and application of these synthetic biology products, and the routine for a medical product that takes in to practice.

We then interviewed with Dr. Huang, who provided valuable insights for the following business plan of our project.

Stakeholder Interview - Doctor Huang

After the journey to the company, we then had a meeting with Doctor Huang, a members of the research and develop group in Synbiogen.

Figure 23

As an experienced member of the Synbiogen company, Doctor Huang gave comments for our project from the supplier stakeholder perspective. He told us that the potential consumers do play an important role and should be taken in to consideration in the selling of the products, especially for a synthetic biology test kit that detects a potential disease from the head injury.

He also suggested that we may need to pay more attention on some specific potential consumers that frequently to have head trauma, such as bicycles riders, because they have a higher possibility to have CSF rhinorrhoea.

Inspired by these suggestions, we had a more accurate and effective method for our modeling, to accurately quantify the number of consumers in China.

Stakeholder interview: Important potential consumers

nterview with Mr Simon Howells

Rugby is famous for being a vigorous contact sport, which sport injuries, including head traumas, occurs frequently. Mr Simon Howells is an invaluable member of SCIE faculty and his 20+ years of experience in rugby on both coaching and playing, meaning he is not only an expert in this sport, but also an organiser and educator.

Figure 24&25

In our interview with Mr Howells we focused on the frequency of head injuries in rugby, the most common types of head injury, the main consequences as well as long term effects of said injuries, current rules and measures in place to limit head injuries, and the degree of awareness players possess of CSF rhinorrhoea. Through discussion with Mr Howell we learned that rugby players do see a much higher rate of head injuries with the accompanying long term injury effects such as CTE and concussions. However, most of the players currently playing are not aware of CSF rhinorrhoea, implying further education is needed.

He assures that he would 100% buy our product. As the rugby coach in UK who had his team with secondary school students playing around the country, he said he had the responsibility to ensure maximum safety to the children in the team. This still applies when it comes to professional, adult games, as games tend to be more vigorous and risk & sport injury assessments are important when regulating a competition. It is almost a default for teams to pay for maximum insurance on member’s safety, including suspected CSF rhinorrhoea.

Many professional teams do not have doctors, thus for them, test kits with no need for professional medical staff are feasible for them to run trauma assessments, which means a greater possibility for our product to be sold to sport clubs, amateurs or professional.

Interview with Ms. Rebecca Heddrick, Mr Graeme Wrightson and Mr. Justin Halls

Ms. Heddrick is the Edinburgh International Award (a widely known outdoor programme dedicated in physical education) manager qualified for hiking, rock climbing, caving, absenting and cannoning, and she is also qualified for professional First Aid.

Although in First Aid, CSF leakage is a mentioned issue, but not specifically its treatment. The patient should lie on a certain body position in order to prevent more serious rhinorrhoea and further complications (from interview with Prof. Li).

She mentioned that in outdoor programmes, it is vital for risk evacuation assessments to be carried out when incidents happen, otherwise one must cease the programme for maximum safety.

CSF rhinorrhoea test kit, for her, thus becomes very important, as it is hard to identify it. She said 100% she would buy the product.

We also communicated with Mr. Graeme Wringston, an enthusiast organising running programmes in remote areas, and Mr. Justin Halls, operations manager of Husaak Adventure company, organising outdoor activities in UAE, Saudi Arabia and Oman. They agreed that the product is feasible, however there are some important concerns.

Firstly the test kit should be compact. It should fit in a portable First Aid kit

Secondly the test kit should be in a‘reasonable budget’, i.e. not very expensive for companies to buy them.

Group Meeting in 7.17 introducing the project

On July 17, John had the honour of being invited to a significant group meeting at Guangzhou Medical College. After he presented the team's WetLab design, Professor Zhao offered invaluable insights and feedback. She emphasised the importance of clearly identifying the scientific question that the project aims to address. Furthermore, she provided guidance on how to present the project in a scientific manner. It's essential, she noted, to include a thorough background of the research, encapsulating summaries of previous work in the field and the underlying scientific question. The presentation should also highlight the team's achievements and contributions to the study and conclude with an outline of the intended future direction.

Proposed Implementation Summary

Our Project Impact

Our project introduces a test package for cerebrospinal fluid rhinorrhoea that offers superior accuracy and efficiency compared to current market options. By leveraging the specificity of beta-2-Transferrin (bTF) for diagnosing CSF rhinorrhoea, our product addresses a niche that currently lacks effective competition. The design, based on recent research findings and advancements in our laboratory, promises significant market penetration, potentially revolutionizing the diagnosis of CSF rhinorrhoea. Moreover, our product is environmentally conscious, with components made of biodegradable materials, aiming to reduce our environmental footprint.

Proposed End Users

Our proposed end users span a wide range of sectors: Schools and Sport Organizations: Given the risks associated with head trauma in sports, our product is particularly relevant for schools and sports clubs. Construction Companies: Workers in this sector are exposed to risks of head trauma due to the dynamic nature of construction sites. Nursing Homes: The elderly are at an increased risk of falls, making them a potential user group.

Small Clinics in Rural/Marginal Areas: These areas often lack advanced medical facilities and specialized equipment, making our product a valuable diagnostic tool.

Spine Surgeons: Post-operative decisions regarding potential CSF leaks are critical, and our product can aid in quick diagnosis.

General Public: Given the potential risks of head injuries in daily life, our product can serve as a preventive measure for the broader population.

Envisioned Product Usage

We envision our product being used as a primary diagnostic tool for CSF rhinorrhoea across various settings. Schools and sports organizations can incorporate it into their health and safety protocols, ensuring quick diagnosis after head injuries. Construction companies can have it on-site, providing immediate testing for workers who suffer head traumas. In nursing homes, it can be a part of the regular health check-up, especially after falls. Rural clinics can use it as a primary diagnostic tool, given the lack of specialized equipment in such areas. Spine surgeons can utilize it post-operatively to make quick decisions regarding patient care.

Proposed End Users

Our proposed end users span a wide range of sectors:

Schools and Sport Organizations: Given the risks associated with head trauma in sports, our product is particularly relevant for schools and sports clubs.

Construction Companies: Workers in this sector are exposed to risks of head trauma due to the dynamic nature of construction sites.

Nursing Homes: The elderly are at an increased risk of falls, making them a potential user group.

Small Clinics in Rural/Marginal Areas: These areas often lack advanced medical facilities and specialized equipment, making our product a valuable diagnostic tool. Spine Surgeons: Post-operative decisions regarding potential CSF leaks are critical, and our product can aid in quick diagnosis.

General Public: Given the potential risks of head injuries in daily life, our product can serve as a preventive measure for the broader population.

Envisioned Product Usage

Construction companies can have it on-site, providing immediate testing for workers who suffer head traumas. In nursing homes, it can be a part of the regular health check-up, especially after falls. Rural clinics can use it as a primary diagnostic tool, given the lack of specialized equipment in such areas. Spine surgeons can utilize it post-operatively to make quick decisions regarding patient care.

Real-world Implementation

To implement our project in the real world, we would:

Engage in Promotional Activities: Using both online (social media, videos) and offline (school medical office promotions, roadshows) channels to raise awareness about our product.

Collaborate with Potential End Users: Establish partnerships with schools, sports organizations, construction companies, and medical facilities to introduce our product.

Ensure Legal and Ethical Compliance: Navigate the regulatory landscape to ensure our product meets all legal requirements and addresses any ethical concerns. Adopt a Competitive Pricing Strategy: With an estimated cost of 10 RMB for the test kit, we aim to offer a cost-effective solution, making it accessible to a wide range of users.

Continuous Research and Development: To stay ahead of competitors and address any emerging needs or challenges in the diagnosis of CSF rhinorrhoea.

We also drafted a comprehensive entrepreneurship plan to discuss our project implementation. Please kindly refer to our entrepreneurship page for further information.