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 of miRNA.DOC to present the exterior of the product. Users can also see the interior of miRNA.DOC to see all the items in this kit.

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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Commercialzation

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.

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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.

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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.

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

Competitor Analysis

VELscope

TBlue

Oral Cytology

Oral CDx Brush Test

Equipment requirement

VELscope: a handheld device that emit blue light(400~460nm)

TBlue Marking System: chemiluminescence, blue-white LED, and autofluorescence.

Syringes, sponges, forceps, scalpels, a specimen cup or microscope slide, and the department of pathology.

The specialized brush, glass slides, still need to send to labs for analysis.

Detection mechanism

The ability to distinguish between normal and abnormal fluorescence patterns grows with the user’s experience.

TB is a metachromatic vital dye that may bind preferentially to tissues undergoing rapid cell division (such as inflammatory, regenerative and neoplastic tissue), to sites of DNA change associated with OPML or both.

The gold-standard diagnostic test for oral mucosal lesions

uses a specialized brush that collects transepithelial cellular samples composed of free cells and clusters. These samples are fixed onto a glass slide and sent to a laboratory where they are stained (via a modified Papanicolaou test), scanned and analyzed microscopically by means of a computer-based imaging system that can rank cells on the basis of degree of abnormal morphology.

Sentivity

ranging from 84 to 100%

median 85%

golden standard

varied from 71 to 100 %

Specificity

almost 100%

median 67%

golden standard

varied from 27 to 94 %

price

$1.96 per screening

$0.30 per person

$185~$231

$120 Average fee


PEST Analysis

Political
Oral Cancer in Taiwan still needs to be improved: 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. 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. Therefore, from the government's point of view, screening needs to evolve.

Advantages: Our products can increase the rate of the people to do the screening process because the testing process is flexible enough (go and read the social analysis for explanation). At the same time, miRNA.DOC has higher accuracy in comparison to the commonly used visual examinations, and the these two factors added 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. Therefore, the way to reduce excess medical spending is a big problem. However, people who have to do the biopsy after inspections are mostly negative, which means that a lot of resources are wasted on biopsy. 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 lets the first-line doctors use an accessible glucometer to evaluate the risk through a simple process, reducing the money and labour costs at the beginning.

Social
The public is not willing to do the screening: The reason for the low screening rate is that the opportunity cost of screening is too high for the general public. For example, people have to sacrifice work-time to go to see a doctor. Especially for high-risk groups, because mostly their type of work has a large amount of work in a short time.

Advantages: This product only requires a saliva test. The method of using it is simple, so there is no need to have a particular doctor to deal with it. People can choose any time to deal with, and the willingness of the people will be higher. In the future, it will be improved to allow people to take samples at home, sending them back to clinics and even test them themselves, which will further increase the screening rate.

Technological
The current diagnosis method lacks scientificity: inspections rely more on the doctor's experience, and the results are not quantitative. And also the small symptoms cannot be observed, which affects judgment.

Advantages: Our products are quantitative and objective so that doctors can obtain the risk of each value after statistics in the database. The glucometer we chose is a product that has been standardized for a long time. Therefore, it has the advantages of unified specification, low price, and wide use. It is the best choice for easy quantification.

SWOT Analysis

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STP Analysis

  • 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. Umscheid, C. A., Margolis, D. J., & Grossman, C. E. (2011). Key concepts of clinical trials: a narrative review. Postgraduate medicine, 123(5), 194–204. https://doi.org/10.3810/pgm.2011.09.2475
  3. Taiwan, Food and Drug Administration. Guidance, Law & Regulations. Medical Devices. Available online:https://www.fda.gov.tw/ENG/law.aspx?cid=5063(accessed on 26 October 2020).