Team:XMU-China/Applied Design

Team:XMU-China/Applied Design - 2018.igem.org

Applied Design
Overview

This year, XMU-China designed a device named Fang that could applied in real-time cancer screening field by detecting biomarkers. The overwhelming advantage of Fang is that it can overcome the drawback that some cancer detections could only be achieved in the big clinical lab by large and expensive equipment. That is, it could be more widely used in the community hospitals,especially in remote areas that are short of necessary medical resources.

We wondered if it would have a bright future in the IVD market, so we launched many associated Human Practices, including visiting specialists. Those specialists gave us some beneficial advice about the product sale strategies, which was beneficial for our project's further development. What's more, we also visited the Community Health Service Center where our distributed devices could play an important role in testing lab. This business plan accurately analyzed and identified the target customers, and then identified the core competitiveness and competitive advantages based on the needs of the target customers. At the same time, combined with the market background, we reasonably applied the model into determining the marketing plan, and further designed an appropriate business model to show products' characteristics.

Project Background

With the acceleration of urbanization in China, many factors, such as aged population, unhealthy living habits, environmental pollution and so on, make malignant tumors a major threat to human health. Screening and early diagnoses of cancer of high incidence will help patients to treat and reduce mortality. Our product, as an in vitro testing instrument, is committed to providing users with faster and more convenient early detection of cancer, so that cancer testing can really enter people's lives, so that fewer people will miss the best treatment period for missing the detection.

Data show that the current global POCT market has exceeded $40 billion. In the early 1980s and 1990s, the POCT market in Europe and the United States achieved an average compound annual growth rate of nearly 30%. China has a large population and large differences in medical resources, which is a huge potential market for POCT. It is estimated that the annual growth rate of China's POCT market is more than 30%. However, China's POCT market is still in the early stage of development, the overall market is still equal to the level of the European and American countries in 1980s and 1990s. Not only the penetration rate of hospitals and other terminals are extremely low, but the products are basically monopolized by foreign enterprises. In terms of domestic enterprises, they emphasize more on domestic blood glucose meter market, therefore only very few of them, like Shanghai Opel and Guangzhou Wanfu, could be the leading POCT enterprises. Not until 2010 did Li Bang equipment usher in talented people, and gradually established POCT product line.

Core Concepts

Fang Tumor Markers Rapid Tester is a disease-detecting product specializing in detecting tumor markers. It is based on IoT model (namely a network of medical devices and other items embedded with electronics, software, sensors, actuators and connectivity which could be connected and exchange data), and a Point of Care (POCT) model (a model which patients receive the testing by or near the site where they obtain the medical care). Our company, as a development and sale company of rapid tumor marker detecting machines, and a result - identifying platform, is based on grass-roots clinics and community hospitals. We also combine the online and offline diagnoses so that regional disease detection services could be provided.

By using the Fang Rapid Tumor Marker Detector, the users upload the offline test results to the APP detection system by taking photos with devices. After that, the company's platform will identify the probability of catching certain disease according to what is displayed in the testing photos; the users can also learn related information about disease-diagnosing on the app of Fang Rapid Tumor Marker Detector and realize self-treatment. In addition, users can consult professional doctors online through that app, and obtain more professional and specific treating suggestions. In this way, they can treat diseases scientifically, precisely, and conveniently.

Product Position

The target consumers of the "Fang tumor markers rapid detection system" are mainly divided into two categories. The first group is the government and the grass-roots community hospitals, and the second group are those whose families are of a history of high disease risks. The focus of the government's work is to supply citizens with better service and to increase people's happiness index. However, a very important issue encountered now is that it is difficult and expensive to see a doctor. An important task for the government is to solve this problem. Because for many people, seeing a doctor is a necessity, and it is indispensable. If this demand cannot be met, people's happiness cannot be guarantee generally. "Hard to see a doctor, expensive to see a doctor" means that it is not only difficult to obtain medical resources (because resources are limited but the people's demands of seeing a doctor are enormous), but also the cost of seeing a doctor is too high for most people.

The value of this product lies in that it can solve the problem of "difficult and expensive to see a doctor". The cost of this product is much lower than that of precision instruments in large hospitals, amounting to only 1050 yuan. Therefore, it is extremely suitable for the government to purchase and distribute it to the grass-root clinics and small hospitals.Firstly, because most of the grass-root clinics are very close to the residential areas, and some are even near the door of the communities, therefore, the residents do not have to spend a lot of time to go to a distant third-class hospital to see a doctor. Secondly, the number of people who go to community hospitals is comparatively small. In this case, patients' waiting time on register, together with other cumbersome procedures could be greatly reduced. Thirdly, because the price of this instrument and the reagents used for testing are much cheaper than those of the third-class hospitals, the average cost of a medical diagnosis is only 100 yuan. The disparity in price can largely reduce the economic burden of the patients.

Fang Tumor Marker Rapid Detector is operated online and offline.

The online part is running the Fang Rapid Tumor Marker Tester APP, which is still under the development and will be launched when the number of fans reaches a certain level. The App will invite qualified and experienced doctors to provide services for consumers. Consumers can upload photos of diagnostic results from APP, obtain test results, and contact online doctors appointed by the platform to ask questions about the disease.

The offline part will mainly be responsible for contacting the relevant government departments which take charge of medical care and other divisions, as well as contacting community hospitals as initial trials for users’ experience. What's more, the offline part will be responsible for contacting professional doctors and discussing issues like cooperation and signing contracts.

Product characteristics

1. Easy to detect

In our survey, we found that the current cancer testing is mostly carried out in large hospitals in urban areas. The detections, such as screening tests, are often complicated and expensive. Besides, testing equipment are also deficient remote mountainous areas. In this situation, people rarely take the initiative to go to the hospital for cancer testing. More often than not, they go to the hospital for testing only when severe symptoms emerge, and therefore miss the best treating period. Our products make cancer detection faster and easier to sample and detect, so that patients can still guarantee regular cancer screening even they are busy. People living in remote mountainous areas can also receive remote detection and diagnoses.

2. Low cost

It is undeniable that most hospital cancer testing programs are very expensive. Doing a regular check-up will undoubtedly be a great burden on consumers. Our products are committed to developing small, inexpensive analytical techniques. If customers choose our products, the cost of per check-up will reduces a lot. That is to say, they can conduct regular inspections with less the economic burden.

3. Coverage is wider

Cancer testing in hospitals targets more on specific cancers, which is unsuitable in terms of the preliminary screening in health checkups. Our instruments, although not as accurate as the special examination, can detect a variety of cancers at the same time, which is very suitable for cancer screening.

4. Sampling is simple, and it is harmful to patients

Current cancer testing methods have strong side effects on patients, or are as complicated as gastroscopy, which exert great pain on patients. But in vitro testing targeting on tumor markers can greatly alleviate the damage suffered by patients during testing.

Core competitiveness

1. Core patent technology and core R & D personnel

The company's ABCD System and microfluidic chip are developed by our technical department and the tutor team in Xiamen University. The patents have now been applied. Authorized R & D personnel can improve products continuously to provide better and perfect service.

2. Innovative application of IoT mode

IoT model refers to a network embedded with electronics, software, sensors, actuators, and connective items. These items serve to connect and exchange data. IoT breaks out of the traditional Internet service mode, set the base on the mobile Internet of Things (IoT) mode, and develop these transaction business models of the mobile end.

3. Nursing point test (POCT) mode

Nursing Point Test (POCT) refers to a medical diagnostic testing by or near a patient's care-receiving positions, which greatly saves the distance to hospital and the registration and queuing time. Besides, it considerably reduces the cost of patients' access to medical diagnostic services. In general, it is "saving money and saving worry".

4. China's POCT market is far from being met

China's POCT market is a huge, with the demands scarcely met. What’s more, the research and development of substitutes imported by domestic enterprises has just begun. China has a large population and a great division in medical resource distributions. Therefore, it is a huge potential market for POCT. It is estimated that the annual growth rate of China's POCT market is more than 30%. However, China's POCT market is still in the early stage of development, the overall market's situation is only equal to the level of the European and American countries in 1980s and 1990s. Not only the penetration rate of hospitals and other terminals are extremely low, but the products are basically monopolized by foreign enterprises. In terms of domestic enterprises, they emphasize more on domestic blood glucose meter market, therefore only very few of them, like Shanghai Opel and Guangzhou Wanfu, could be the leading POCT enterprises. Not until 2010 did Li Bang equipment usher in talented people, and gradually established POCT product line.

5. The advantage of forerunner

The aim of Fang Tumor Markers Rapid Detector is miniaturizing detection instruments and simplifying detection procedures. Other competitive products or similar models of it have not yet seen in the market and other related research institutes. Moreover, we plan to quickly occupy grass-root hospitals and community clinics in major cities. In the blank period before strong competitors' involvement, we will improve our business procedures, improve the performances. That is to say, we will continue to develop new technologies, increase user-stickiness, and provide barriers to new entrants. After the completion of establishing user-stickiness, the amount of personnel on the platform will have taken shape. At the same time, some users with high frequency of use would become dependent on using our software, which will impose more challenges on potential competitors.

6. The introduction of new models and multiple user experience

Fang Rapid Tumor Marker Detector (ATM-TM Rapid Detector) introduces the concept of "online treatment" into the traditional offline medical diagnostic system. Fang Tumor Markers Rapid Tester is a new model of "Offline Testing + Online Diagnosis + Online Consulting", which attracts people with similar needs as product users to use the product by providing more completed and well-done medical services for those who use it. More benefits can therefore be brought through focusing on overall benefits of users and the potential consumers. In addition, various disease counseling, patient mutual assistance can also be achieved on the platform of " Fang tumor marker rapid detection device" App, and therefore greatly enrich the users’ experience.

7. Service on demand

At present, the number of large hospitals is not enough to solve all the medical and diagnostic problems. The development of the medical industry facilitates more and more convenient medical services to enter into the community hospitals and other grassroots medical systems. One-to-one professional consultation services are also supplied, which, to a certain extent, alleviates the "difficulty and high expenditure" of the current medical treatment.

8. Matching recommendation algorithm in consultation physician matching

Algorithms in matching consultant tend to match experienced physicians with more related diseases’ diagnosing experience to users with or likely to have the corresponding diseases, so that the patients can match the right physicians immediately. What's more, the more related diseases a doctor treat and diagnose, the more experienced he or she will be in treating and diagnosing these kinds of diseases. That can provide convenience to patients to a large extent, and allow users to enjoy the most scientific and accurate medical diagnoses and treatments.

Market Analysis

1. Background

Currently, it's common that "seeing a doctor would be a great expenditure of money, time and spirit". Taking disease detection as an example, the methods of diagnosing diseases in large hospitals are mostly confined to expensive, time-consuming and low sensitivity precision testing equipment. People often spend a lot of time queuing, and the price is often expensive. It is not a very suitable method or choice for the general public. As a result, many people would be inclined to share the medical problems which could not be solved with their friends through instant messaging software or telephone communication, with no helpful response sometimes, only to lead to a worse relationship amongst friends. Of course, some people want to ask strangers for help, so they try to post help on the website. However, in doing so, on the one hand, the feedback information could not be instantly communicated, that is to say, the remote help is inefficient, on the other hand, it is difficult to identify those who give help to those who have solid and scientific knowledge, the risk of misdiagnosis greatly increased. In this context, people increasingly need a suitable price, convenient and fast for medical testing products.

2. Market demand

The development trend of the medical industry is to combine the Internet of Things (IoT) with the Nursing Point Test (POCT), greatly improving the efficiency and reliability of diagnosis.

The Internet of Things (IoT) is a network of physical devices, vehicles, household appliances, and other items embedded with electronics, software, sensors, actuators, and connectivity, enabling them to connect and exchange data. The Internet of Things (IOT) combines offline medical testing services with the Internet, making the Internet "the front desk" for preliminary offline disease detection. Based on the online and offline characteristics of the Internet of Things, on the one hand, offline services could be used to solicit customers online and update data in real time, on the other hand, consumers could screen the required diagnostic services online, and professional doctors could consult online to achieve near-by (or even at home) rapid initial diagnosis. The most important feature of the model is that the effect of product promotion could be checked, and every diagnosis result and feedback could be tracked. With the development of Internet localized e-commerce, the relationship between online and offline one has become more and more closely related.

Nursing Point Test (POCT) is a medical diagnostic test at or near the place where patients receive care. It greatly saves patients' time to large hospitals and that spent on registration and queuing for medical services. It also greatly reduces patients' expenditure on medical diagnostic services. POCT is becoming very popular because of its convenience, simplicity and efficiency.

The characteristics of the Internet of things (IoT) combined with POCT (Nursing) test include: (1) sharing the economy. All the best platforms now must be good enough and simple enough; (2) customized on demand services. At present, the number of large hospitals is not enough to solve all the medical and diagnostic problems. The development of the medical industry, more and more convenient medical services into community hospitals and other grass-roots medical systems, to a certain extent, would alleviate the "difficult and expensive" phenomenon.

And what we're doing is an innovation that fits the trend of the medical industry. In the future, we'll only need users to buy this product or provide testing services in nearby community hospitals using App and follow instructions. We'll be responsible for letters sent by users. Interest content would examine whether there is a disease risk and what it is, providing users with preliminary identification results and corresponding recommendations. At the same time, provide users with online contact with medical staff, and promote the realization of offline tasks, and then through the user for the test experience scoring or evaluation. As a "off-line detection, on-line diagnosis" of disease preliminary detection products, Fang uses the Internet thinking to build a unique business model, to achieve on-demand customization, on-demand service effect.

Our product combines the design idea of ABCD system, which is the result of our research, with the above concepts of POCT and IoT, and proposes a small and convenient design idea of microfluidic tumor real-time detection system.

3. Competitive product analysis

At present, based on the relevant literatures and the list of applied patents, we have not found any similar product, which means that our product pioneered a similar field of preliminary medical diagnosis. Since it is unique, it has more power to occupy the micro-medical field. Taking the first affiliated hospital of Xiamen university as an example, the detection platform for tumor markers commonly used in first-line clinical work, including ABBOTT I2000 automatic particles chemiluminescence immunoassay system, BECKMAN COULTER IMMAGE automatic specific protein analyzer, BIORAD MODEL680 enzyme-labeled instrument, BIO-RAD1575 microplate, JETLIA-962 type charging luminescence immunity analyzer, OLYMPUS fluorescence microscope, DML2000 gene hybridization signal detection system and other large and advanced detection equipment. According to the price list, it would cost above 900 Yuan for patients doing some specific clinical test items. But there is no denying that the test results are quantitative, which gives precise numerical values.

However, our product is of high quality and reasonable price. It just costs less than 1,000 yuan and can be reused by changing a new Chips after one test. For consumers with early screening needs, qualitative analysis of specific markers is sufficient to initially determine whether there is a possibility of cancer, which also could save money and time to complete the initial diagnosis, it is a perfect fit for community hospitals, small clinics and families with high risk of hereditary diseases.

4. SWOT Analysis

Business Plan

1. Place

Considering the high cost of opening stores offline, our main sales channels are completed online. Thanks to advanced and developed express delivery industry, intentional consumers can learn about our products through the official website where they could directly order instruments, chips and reagents needed. And then we would deliver them to customers by express delivery. At the same time, our APP will also launch mall services, users can choose to purchase products on APP. We will actively communicate and collaborate with the government to distribute the products to basic community hospitals and remote medical points.

2. Promotion

As a medical product, the most important thing is that we need to win the trust of consumers, so our marketing campaign focuses on how to let consumers trust and our products. Through a variety of publicity channels, we hope to achieve ideal that after-sale service chain that consumers can easily contact our customer service, and any questions can be timely feedback.

● Establish official website.

Official website is an important way for consumers to know our products. On official website, they can know the principle of our products, application methods, the obtained approval, the obtained certificate and so on. If the official website can provide enough information to make consumers trust, it will greatly promote the promotion of products.

● Put up posters or brochure in the hospital.

After a partnership with the hospital, we can design advertisements to be distributed in the hospital so that patients will have a great chance to notice our posters, understand our products and accept them.

● Use famous journals, magazines and newspapers to promote.

Regularly write articles on research progress and results, and contribute to well-known medical and innovative journals, magazines, newspapers and other publicity, thereby expanding the popularity of projects and earning consumer trust for products.

● Apply micro-blog account for publicity.

Through micro-blog information platform, we could communicate with our consumers. It can not only answer the public's doubts about product, but also upload some experimental videos to make consumers know more about how to use the product and to expand publicity through forwarding activities.

Above we use 4P model as a benchmark, combined with the characteristics of the product and expected business plan, the follow-up practice will be centered on this, But certainly with the changing market environment, our program will also be changed and adjusted accordingly in view of the actual situation encountered in various problems.

Risk Management

1. Market risk

At present, there are relatively mature cancer detection methods on the market. As a new research and development technology, ABCD System and Fang may be less accepted by users when entering the market, which would be a disadvantage in competition with those original products.

Countermeasures: When entering market in the early pstage, the company should increase publicity and win the trust of consumers. It may be subject to competition from later products and large medical companies.

2. Financial risk

In initial stage of the project, there are many investments like R&D investment, production investment, fixed equipment investment and so on, which require a lot of money. However, the existing funds of entire group in initial stage are not sufficient.

Countermeasures: Carrying out more contacts with investors to attract investors' investment, and paying attention to the government and school preferential policies for this project.

3. Technology risk

(1) Our project only runs for the span of a year. To realize its full potential, the project would have to be developed into a further project. (Time-limited)

Countermeasures:There is potential for the project to be continued as a further project. We need to keep with those academics and researchers who would like to continue this.

(2) The barriers to getting IP rights on our product/technology is unclear. (IP Application)

Countermeasures:We have to seek further guidance regarding the IP rights to our project. The writing of the patent application happened in close correspondence with an assigned patent attorney, who was responsible for taking our scientific input and write it in the format of a strong patent application.

(3) We have been told that this portion of the project is not IP protected. (IP Projection)

Countermeasures:We should strengthen our core competitiveness like higher-level technology which keeps pace to current medical needs. Also it makes difficult for competitors to kick off. And we plan to extend and survive in the international market.

(4) Companies may be unwilling to invest in these ideas to a commercial level as a result of this technology being novel and the public's reactions not being known. (Marketing)

Countermeasures:Seeking to collaborate with companies while in the development stage will ensure the final seeds produced have the best chance of success in the marketplace.

(5) The chip breaks, which cause the biological agent to leak. Or the hardware is not well controlled. (Biosecurity)

Countermeasures:Replacing the chip or hardware are free within the warranty period.

(6) Lacking of sensitivity leads to the unnecessary missing detection. (Quality)

Countermeasures:Do a good job in the pre-experiment, and strictly control the influence of irrelevant variables. Based on the possible independent variables included, we try our best to draw a standard working curve.

4. Industry standard risk

The government has stricter control over medical products. When entering the market, it may be subject to relevant policies and control so that it cannot enter and develop smoothly.

Countermeasures: Actively improving products, participating in various tests to win the trust of the government especially through clinical experimental data, and strictly controlling the production process to ensure the quality of products.

5. Management risk

Due to its simple organizational structure, lax hierarchy and relatively few personnel, the company has smooth flow of information and communication. But at the same time, due to its strong organizational flexibility, the central leader-group is weak and vulnerable.

Countermeasures: Companies should give full play to their inherent advantages in organizational efficiency and flexibility, but as the company develops, the energy invested in management needs to increase to reduce the inefficiency caused by management loopholes.