Team:CSMU Taiwan/Implementation

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Proposed Implementation

Proposed End users

Current problems for the diagnosis of oral cancer

Currently, the process of diagnosing oral cancer lacks an objective evaluation. Experts believed that a quantitative screening method is desired and thought this screening method was a great proposal after we consulted them. Thus, miRNA.DOC may have the potential to tackle the current problem.

The end-users of miRNA.DOC

Doctors in hospitals and clinics and OPMD (Oral Potentially Malignant Disorder) patients would be the proposed end-users of miRNA.DOC. Doctors can use miRNA.DOC to see whether patients are at high risk of oral cancer after conducting visual examinations on OPMD patients and thinking it necessary to do the biopsy for further diagnosis.

Anticipated benefit of miRNA.DOC

Users can use the glucometer to measure the concentration of glucose in the reaction tube and further deduce the concentration of our selected miRNA biomarkers. The quantitative data presented by the glucometer helps doctors evaluate patients' health conditions more objectively.


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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Implement miRNA.DOC in the real world

Product Analysis

Safety is sure to be the first priority to consider when it comes to developing a product. Our project adopted a cell-free system, suggesting that no creatures would enter human bodies and hazard humans' health. Also, no creatures would be discharged into the environment and disrupt the ecosystem. As for the sample we targeted, saliva can be collected without any invasive procedure such as blood drawing. Users only need to split some saliva out of the mouth and then they may start to use miRNA.DOC.

For more safety information, check the Safety.

To keep reagents functional and active in the lab, we had to preserve these reagents in different temperatures, ranging from room temperature to -80 degrees Celsius. It will be a big obstacle for users to appropriately restore these reagents in the real world. According to research1 2, we would freeze-dry the reagents and our designed toehold switches onto the wall of the reaction tube. Reagents will not be activated until users drop some water to rehydrate.

Laws and regulations are important issues for implementing the product in the real world. Since miRNA.DOC is a medical product, it has to comply with regulations for Governing the Management of Medical Device in Taiwan before allowed to hit the market. Moreover, we consulted the staff in Taiwan Instrument Research Institute and realized the whole process of product development. These laws and regulations also need to be taken into consideration.

A project from engineering in the lab to launching in the market requires passing a series of trials and challenges to prove it useful, beneficial and harmless to humans. Since miRNA.DOC aimed to be applied in the realm of medicine, some trials related to humans are required. One of the most famous examples is the clinical trial. Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes, according to WHO.3 miRNA.DOC needs to pass the clinical trial to ensure its impact on human health before hitting the market.

Market Analysis

Users do care about the duration of the reaction. If the entire reaction time can be shortened as much as possible, doctors and patients can get the results sooner and further go on to the next process of diagnosis.

The whole reaction of miRNA.DOC briefly consists of two processes, protein synthesis for two hours and enzyme reaction for an hour. To reduce the duration of the enzyme reaction, we chose the DNA encoding invertase from Thermotoga maritima for its high fidelity according to research4 as well as conducted both wetlab and drylab experiment to characterize and validate this enzyme. On the other hand, we modified the duration of enzyme reaction from an hour to thirty minutes by means of trial and error.

As for the process of protein synthesis, we followed the manual of PURExpress Protein Synthesis kit5 and incubate for two hours. In the future, we hoped to conduct more experiments on shortening the time for the incubation to less than two hours. These modifications would help users take less time to get the test result from miRNA.DOC.

The lower price of the product is, the greater acceptance the product will gain in the market. To reduce the price of miRNA.DOC, we modified the total volume from 25uL to 5uL in our experiment and proved it feasible. With this adjustment, we successfully reduce the price to one-fifth of the original one.

Users especially focus on quality when it comes to medical products. It will be ideal for medical products to show great accuracy in screening. To enhance the functionality of miRNA.DOC, we consulted the expert, Dr. Alexander Green , after doing paper research into the toehold switch technique. Next, we started our design following his suggestion and guidance to minimize the leakage . Besides, we modified the proportion of each solution and successfully showed wider differences between the treatment group and the control group . These experiments bettered the quality of our toehold switch design.

Users may be more willing to buy the product if the operation is simple. In the lab, several kinds of reagents and materials were needed for the reaction. If the process of using miRNA.DOC is as complicated as that of performing experiments in the lab, users would be troubled to deal with these chemical substances and operate correctly. Thus, we planned to freeze-dry the cell-free system into the test tube. Users only need to add a little water to rehydrate and they can start to test.

On the other hand, the volume of reagents is so little that it requires using pipettes to deliver reagents. Though pipettes in labs are readily accessible, they aren’t commonly seen in hospitals or clinics. Thus, to make it easier to use miRNA.DOC, we would replace pipettes with the microcapillary tubes in our final product. Microcapillary tubes are precisely-molded tubes and have excellent sample retention. They're able to deliver solutions in a tiny amount, just as pipettes in the lab. Also, they can deliver samples in a calibrated and fixed capacity. Moreover, the process of using microcapillary tubes is so straightforward that users may have little difficulty operating them. These advantages suggest that micro capillary may be a better choice than pipettes for users to operate more easily.

When it comes to some medical practices such as screenings, surgeries, therapies, and so on, patients usually feel uncomfortable or hurt. These bad experiences may discourage patients to receive medical practices. However, miRNA.DOC provides a non-invasive screening method for patients. Patients only have to collect their saliva and then doctors can start to use miRNA.DOC. Patients don't need to have an injection or other invasive processes to get the sample. Besides, after consulting with the manager in Sunshine Welfare Foundation, we realized that it wouldn't be easy for some oral cancer patients to open their mouths, so doctors might have difficulty doing visual examinations on patients. Thus, the non-invasiveness of miRNA.DOC may help doctors screen for seriously injured patients. Also, these patients needn't suffer from additional pain during the process of screening.

The current method for screening oral cancer is mainly dependent on visual examinations conducted by doctors. However, there is only one OSCC case confirmed out of nine biopsies , suggesting that there is room for improvement in it. If miRNA.DOC may help doctors have better performances on doing biopsies than current visual examinations, it will prove that miRNA.DOC is more accurate and than the current screening method, making our product more competitive in the market.