BME100 f2017:Group14 W1030 L2

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BME 100 Fall 2017 Home
Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3
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Name: Lydia Gabric
Name: Anshul Krishnan
Name: Christopher Ward
Name: Sara Bacon
Name: Charmayne Seaton


Device Image and Description

The prototype consists of 3 different parts itself, the top the middle and the bottom sections. The top section is the area that the solution is added to and where the results are listed at. The middle section houses the "sheet" that the solution goes on to, and the bottom section acts as a point to hold the "sheet" in place so it does not come out, and it keeps the "sheet" clean until use.

Top View

Exploded Isometric

Side View

Technical and Clinical Feasibility

Technical Feasibility

a. What are the challenges? Some of the possible challenges we will face include the technological aspects that test the urine. The chemical reaction that the Gonorrhea and Chlamydia test is based off of uses a swab instead of urine. Our group instead wants to be able to detect the bacteria in the urine rather than a swab. The test has to have a high accuracy rating. Another challenge is making the product easy and straightforward to operate. The package also must include easy to read directions that any individual could understand without difficulty. b. What could go wrong? The test needs to have proper packaging to prevent spillage and contamination. It is possible during shipping and handling that the buffers and tests could be damaged. The individual who is being tested will need to mix buffers and apply them to the test. It is possible for someone to accidentally mix incorrect buffers or incorrectly apply the solution to the testing stick.

Clinical Feasibility

a. Will it work in the clinic?
Our product is designed to have accurate testing in the privacy and comfort of the individual's own home. Most urine STD testing occurs in a laboratory with the process called ligase chain reaction. Our testing product is trying to use immunoassay to detect the bacteria.
b. What are the clinical risks?
Our product deals with bacteria cultures and one needs to take precautions when completing the test. Also, if the test has a false negative result it would directly affect the consumer.
c. Have similar products been in a clinical trial? How long was the trial?
There are not a lot of at home testing products that are in clinical trials, but there are trials on at home STD testing effects on the individual lives and how the home test results compare to clinical testing. There is one study based off of Self-Obtained Vaginal Swabs for Chlamydia and Gonorrhea Testing (SOVS-CTG). This tested the results of the SOVS vs. when the sample is collected in a clinical setting where the individual was there for 24 hours. This study was conducted from April 2013 to June 2016. Another study examined the individuals feelings towards at home testing. This study was of random Men in the St. Louis area that completed an at home or clinical STD test. The at home samples were sent through the mail, while the clinical STD test occurred at a local clinic. This was a 12-week study.
d. Using the fundability worksheet chart, determine the scores (0-3) for technical feasibility and clinical feasibility and provide support for scores.
Technical Feasibility is a 2 because there are certain challenges left to have an accurate test. There is still research that must be done to be able to detect bacterial infections in urine using a simple kit. Clinical Feasibility is a 1 because tests like the one we are conducting have not been achieved yet. It will be difficult and may take some time to achieve success.

Market Analysis

Value Creation

1) The prototype is cheap to manufacture, user-friendly in terms of size and operation. - Its small size helps it fit in almost any bag, purse etc.

2) The total cost to make the Chlamydia and Gonorrhea test is $30. The cost breakdown is demonstrated below in part b.

-0. 05 N Sodium hydroxide solution Buffer A: 65 Cents per kit

-Tris-HCI buffer pH 9.0 with 0.02 % sodium azide Buffer B: 80 cents per kit

3) A detailed instruction manual will be included with the product, so as long as the customer follows the instructions, they should have accurate results within 15 to 20 minutes. Since there are two tests in one box, the customer just has to pay attention to make sure that they keep the two tests separate. Additionally, the kit can be set up and used in any private space that you can occupy for roughly 15 minutes that has a flat surface that can be used to mix solutions. Since the test requires a few pieces (such as multiple test tubes, an eye dropper, and the test itself) we estimate the box to contain all of the merchandise to be about 7”x5.5”x5.2”. This packaging will be small enough to fit in a purse or medium sized bag.

Manufacturing Cost

Assuming we choose to use a cheap packaging, the box for the product will cost roughly 40 cents. The immunoassay strip and plastic housing will cost approximately $1.20. The buffers for the Chlamydia test will cost $1.55. The small plastic containers for the buffers will each cost 20 cents per container, giving a total cost of 80 cents. The pipettes will each cost 10 cents, and the mixing tubes will each be 20 cents.

Sales Price

Since the anticipated sale price should roughly be five times the cost to create the product, we estimate the sale price to be $30. ($5.00 additional as safety)

Market Size


Fundability Discussion

Using the fundability worksheet, I do not believe that our prototype would be funded. This is because we only received a score of 4. The majority of the rows received a rating of 1 or 2 because there is a similar product, but our product is fairly complicated and therefore would take a lot of testing to ensure that the product is accurate and produces the desired results.