BME100 f2016:Group2 W8AM L2

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BME 100 Fall 2016 Home
Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3
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Mariam El Sheikha
Yesenia Barrera Millan
Vishvak Rangarajan
Tori Johnson
Reese Morehouse


Device Image and Description

This device is remarkably similar to a cholesterol test in that a blood sample is collected and tested for high levels of oxysterol. High levels of oxysterol have been noted to be a sign of Multiple Sclerosis. The device shown above has two buttons: one button to turn it on and one to run the test. Once the test is done, the screen will display the oxysterol levels and a message that indicates a possible chance of having Multiple Sclerosis. Our product would come with a few extra strips to repeat the test if needed, although, it is more of a one time test.

Technical and Clinical Feasibility

Technical Feasibility
The technology needed for our product is a device that can detect the possibility of having Multiple Sclerosis. The way in which we would try to detect this possibility is by gathering a blood sample and testing for high levels of oxysterol.
Some challenges with our device include being able to pick up oxysterol from the blood sample, as well as creating the device in a manner as to where it can test the blood sample instantly and give accurate results.
Testing oxysterol levels is a relatively new method, thus it may turn out to be more time consuming or expensive that the current methods already existing. A possible problem we could run into while trying to implement this in clinics are already existing patents since our device is relatively similar to other cholesterol tests.

Clinical Feasibility
We think that our method will work in the clinic. There are no clinical risks in terms of harming the patients. Our device is a bit similar to other cholesterol tests in terms of how it works, but it doesn't relate in terms of what it's testing and what it could indicate.

Technical Feasibility (2): We gave our product a 2 in technical feasibility because there may be some challenges that include inaccurate results the first couple of times.
Clinical Feasibility (1): The bio-marker that we are using to test for Multiple Sclerosis was recently studied and published so we can not be sure if this method will work for certain.

Market Analysis

Value Creation
This Multiple Sclerosis test would help patients who do not have a reliable test for by testing for high levels of oxysterol, which is an oxidized form of cholesterol. The consumer value of home cholesterol tests range from $30 to $300, and a reliable Multiple Sclerosis test will be valued similarly, if not, higher. Manufacturing Cost
The Manufacturing cost would be based off of cholesterol test strips and devices. The cost of producing the device would be $96.10 and the cost of the test strips would be $92.25 for a box of 30 strips.

Sales Price
Cost will be around $130.00 for a device and $125.00 for a box of strips capable of lasting one month.

Market Size
There are approximately 240 mil. adults in the United States who have Multiple Sclerosis. Although, it is also important to keep in mind that anyone could be affected. Symptoms vary between people, so some people may not even know that they have this. About 200 cases are diagnosed each week. 1 in 750 people are at risk for Multiple Sclerosis. The cost of 30 test strips and one device costs $255. This number multiplied by the population that is at risk for MS is $115,600,000. This is the annual market size.,,20862965,00.html

Using the Fundability Worksheet:
Customer validation (3): The customer would like this product because it is a cheaper and faster test to determine whether being diagnosed with Multiple Sclerosis is a possibility. Most other tests, such as MRI's and spinal taps, range from months to years to determine whether it is really a possibility.
Market size (1): We would be appealing to physicians as opposed to any patient.
Competition (3): No other company is currently making this product.
IP Position (3): There are no current patents on this technique or device since it is relatively new.
Technical Feasibility (2): Our device is very similar to a cholesterol test but no one is using our method to test for an indication of Multiple Sclerosis.
Clinical Feasibility (1): Our device would be successful during a clinical trial because, if we compare it to the method being used by cholesterol tests, we can see that those tests have had success. Thus, if we set up our device in a similar manner, it would most likely work as well. Although, because the bio-marker we are testing is an upcoming study, we are not quite sure if this method will truly work.

Fundability Discussion

Using the information and scores from the Fundability Worksheet, we believe that this test could be funded at a future time. If we were to actually create this product and try to get it on the market, we would need to do a vast amount of research to determine how exactly it would work and go over any gaps within our process. Because of this, at the moment it would not produce enough revenue to be funded.