Team:CSMU Taiwan/Entrepreneurship

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Problem definition

Currently, oral cancer is detected by visual examinations administered by dentists, ENTs, and other healthcare professionals. According to our interviews with dental professionals in CSMU and several clinics, they mentioned that the detection bias in visual examinations may lead to problems such as delayed treatment. After consulting with several stakeholders and related professionals, we presented a new detection device, miRNA.DOC, which is non-invasive, quantitative, and accessible.

Our solution

3D Modelling

We made a 3D simulation to visualize miRNA.DOC. The exterior of the product has our team logo on it, as shown on the home page. Users can also examine the interior of it to see all the items in this kit, including PCR tubes with freeze dry, bottles of ddH2O and sucrose, a can of test strips, some microcapillary tubes, a timer, a dry bath incubator, and a glucometer.

Instruction Manual

We also made an instruction manual for users. Users can carefully follow the detailed description of the whole procedure so that they can correctly use miRNA.DOC.

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Commercialization

Putting Ideas into Action

Inspiration

While we were reaching out for advice on biomarker selection, professor Yu also shared his experience of commercializing his research project and how his team collaborated with NARLabs Medical Device Alliance. That interview inspired us to discover more about entrepreneurship and started planning our business plan.

See more at Human Practices




Visit to NARLabs

During our visit to NARLabs Taiwan Instrument Research Institute, they introduced their Medical Device Alliance and services they can provide.They also suggested some common cooperation patterns to us. This gave us some insights on building our business model.

See more at Human Practices



miRNA.DOC Product Launch

We visited the consultant of the glucose meter leading brand, Bionime, and demonstrated our product.Consultant Tsai gave us positive feedback on our creativity and product potential, he also said he could assist us in finding resources for our future research.

See more at Human Practices

Blue Print



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We would like to collaborate with Bionime and Medical Device Alliance of NARLabs in order to commercialize our product. We chose the glucometer leading brand Bionime as our miRNA.DOC glucose meter supporter, and the Medical Device Alliance to assist in our commercialization progress.1

The Medical Device Alliance of NARLabs was established in 2014, gathering the industrial, government, academic and research entities to accelerate the production of biomedical equipment in Taiwan. The Alliance is in line with the development characteristics of the Northern, Central and Southern Taiwan Science Parks and connects the three major medical technologies, including medical electronics, polymer medical materials and metallic medical materials. By professionally dividing responsibilities and integrating platforms across 20 members, this Alliance has come together to create a “one-stop service” to streamline Taiwan’s medical device industry.

Their services include:

  1. Trial Production of Prototype, Verification of Specs and Functions
  2. Pre-clinicals and Clinical trials assistance
  3. Listing Counseling and Financial Planning

Market Analysis

Target Customers


The current target customers for miRNA.DOC are health care settings where visual examinations take place and institutions where our data will be in use. In the near future, we expect the public to be our customers and use miRNA.DOC as a home-style health care gadget. Ultimately, we hope the government involves miRNA.DOC in the National Health Insurance System as an official certification for being beneficial to oral cancer detection.

Competitor Analysis

There are some other AI-related assisting methods, but they are too expensive to be widely used in many countries.2 Some assisting staining methods are cheap, but they are neither quantitative nor accurate.2 Therefore, there is no assisting method for oral cancer detection that satisfies all factors at present. Launching a new assisting diagnosis that overcomes many obstacles put by the existing solutions would presumably meet the market’s need for more effective and appropriate oral cancer detection.


PEST Analysis


Political

Oral cancer problem in Taiwan still needs to be solved:
The Health Promotion Administration provides free oral cancer screening once every two years for the people who chew betel nuts or smoke. Under this policy, 900000 people were screened each year, and about 1300 patients with oral cancer were found. However, it’s estimated that 7000 people in Taiwan get oral cancer every year.3 The executing policy is useful but not good enough to change the fact that the prevalence of oral cancer in Taiwan is higher than the global average.4 Therefore, from the government's point of view, current screening method needs to be improved.

Advantages:
Our products can potentially increase the rate of the people participating in the screening process because the testing process is flexible enough (please refer to the social analysis for explanation). At the same time, miRNA.DOC has the potential to possess a higher accuracy in comparison to the commonly used visual examinations due to the incorporation of 3 selected miRNA biomarkers. These two factors together can reduce the amount of undetected patients which is a favourable investment for the government.




Economic

Excessive medical expenditure:
In today's low-paying situation in Taiwan, many people work overtime, including doctors.5 Therefore, the way to reduce excessive medical spending is a big problem. However, people who have to do the biopsy after visual examinations are mostly negative, which means that a lot of resources are wasted on biopsy.6 This scenario increases the unnecessary workload as well as the costing time of the doctors and the entire process. In the end, precious medical resources are wasted.

Advantages:
This product allows the first-line doctors to use an accessible glucometer to evaluate the risk through a simple process, reducing the money and labour costs.




Social

The public is not willing to do the screening:
The external reasons for the low screening rate are that the opportunity cost is too high for the general public and that the subsequent economic burdens might be heavy.7 For example, people have to sacrifice work-time to go see a doctor, especially for high-risk groups whose type of work acquires long working hours. Internally, people are afraid of biopsy because it is invasive and people are also scared to be diagnosed with oral cancer.8

Advantages:
In the future, miRNA.DOC will be improved to allow people to take samples at home, send them back to clinics, and even conduct self-examination at any time. The method of using it is so simple that there is no need for a professional doctor to be at present. What's more, this product only requires a saliva test, which is non-invasive for sure.




Technological

The current detection method lacks scientific backup:
Inspections highly rely on the doctor's experience and the results are not quantitative8. Also, small symptoms may not be observed by merely a peek at the oral cavity, especially when high-risk groups are not able to open their mouths wide enough (Human Practices: Sunshine Welfare Fundation). All of these may result in imprecise judgment.

Advantages:
Our products are quantitative and objective. It enables doctors to obtain the risk of oral cancer from the database with the use of glucometers, a product that has been standardized for a long time. Therefore, miRNA.DOC has the advantages of unified specification, low price, and wide use. It is for sure the best choice for easy quantification.


SWOT Analysis

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STP Analysis

We conducted this STP Analysis mainly upon our interview with Health Promotion Administraion. They provided us valuable insights into the social-demographic segmentation of high-risk group on OSCC.

  • S (Segmentation) :

    • Geographic segmentation
      1. Country side.
      2. Agricultural county.
      3. Aboriginal tribes.

    • Demographic segmentation
      1. Gender: male.
      2. Occupation: driver, worker, fisher
      3. Aged: middle aged (the average age is declining ).

    • Psychographic segmentation
      1. Social class: blue collar.
      2. Lifestyle: chewing betel nuts, smoking.

  • T (Targeting):

    • The government: Health Promotion Administration can use our product to implement the National Cancer Screening Program.
    • Hospitals and clinic.

  • P (Positioning):

    • The product which is non-invasive, quantitative and accessible for oral cancer detection.

Business Model

Key Partners:


1. Research& development：

A. National Applied Research Laboratories

B. National Health Research Institute

C. Medical centers



2.Manufacture：

Glucose meter companies

Key activities：


1. Conduct fundamental research to further improve our product's diagnostic accuracy, portability, and screening period.



2. Assist in promoting HPA's oral cancer screening.

Value Proposition：


1. Assist in current detection method with its non-invasive, quantitative and accessible trait.




2. Provide academic evidence for OSCC or other oral lesion research.

Relationships：



1. Long-term relationship with healthcare institutes.

2. Specialized product for different customers.

Customer Segments:



1.Current：

A. Dental Clinics

B. ENT clinics

C. Hospitals

D. Public Health Centers

E. Clinical laboratories




2. Future：

Public

Key Resources:


1. Intellectual properties

2. Knowledge and expertise

3. Laboratory

Channels:


1. B2B(business-to-business)

2. B2C(business-to-customer)

Cost Structure:

1. Manufacturing cost

2. Research & development

3. Distribution costs

4. Marketing and sales

Revenue Streams:

1. miRNA.DOC revenue

2. Research funds

Timeline

Figure. Proposed timeline of our product.

Reference

  1. National Research Central of Medical Meterial. About the alliance. Available online: http://mda.tiri.narl.org.tw/en/introduction-to-the-alliance (accessed on 27 October 2020).
  2. Sharma, G. (2015). Diagnostic aids in detection of oral cancer: An update. World Journal of Stomatology, 4(3), 115-120.
  3. Cancer Registry Annual Report, 2017 (Taiwan). Available online: https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=12235 (accessed on 18 October 2020).
  4. Hung, L. C., Kung, P. T., Lung, C. H., Tsai, M. H., Liu, S. A., Chiu, L. T., ... & Tsai, W. C. (2020). Assessment of the risk of oral cancer incidence in a high-risk population and establishment of a predictive model for oral cancer incidence using a population-based cohort in Taiwan. International Journal of Environmental Research and Public Health, 17(2), 665.
  5. Sharma, G. (2015). Diagnostic aids in detection of oral cancer: An update. World Journal of Stomatology, 4(3), 115-120.
  6. Ho, J. C., Lee, M. B., Chen, R. Y., Chen, C. J., Chang, W. P., Yeh, C. Y., & Lyu, S. Y. (2013). Work-related fatigue among medical personnel in Taiwan. Journal of the Formosan Medical Association, 112(10), 608-615.
  7. Huang, C. C., Lin, C. N., Chung, C. H., Hwang, J. S., Tsai, S. T., & Wang, J. D. (2019). Cost-effectiveness analysis of the oral cancer screening program in Taiwan. Oral oncology, 89, 59-65.
  8. Lee, J. J., Hung, H. C., Cheng, S. J., Chiang, C. P., Liu, B. Y., Yu, C. H., ... & Kok, S. H. (2007). Factors associated with underdiagnosis from incisional biopsy of oral leukoplakic lesions. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology, 104(2), 217-225.