# BME100 f2017:Group1 W0800 L2

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# OUR TEAM

 Name: Alexandra Richey Name: Matthew Tam Name: Erin Lockwood Name: Caiden Gledhill Name: Maryah Alalwan Name: Aymard Irakoze

# LAB 2 WRITE-UP

Our prototype is a small, portable saliva vitamin tester. At 2 in by 3 in by 5/8 in, this device is convenient and can be handheld for easy use. An attached tube of litmus papers serve to provide all of the materials necessary for the test. The litmus paper is inserted into a small slot on the bottom edge of the device after the paper is swabbed with saliva. The machine then tests the saliva to see which vitamins the individual being tested is lacking. Using a binary code, the machine will display either a plus or minus next to each vitamin type to indicate whether the vitamin is present or lacking based on a predetermined level of "normality" for each vitamin. This device will address our health issue as it will properly identify which vitamins are below standard levels in a fast, discrete manner to help our customers spend their money more effectively and to feel better without expensive doctors visits for such a minuscule detail of their health.

## Technical and Clinical Feasibility

Technical Feasibility

A chip installed in our device will check if you are sufficient or deficient in the most important vitamins our bodies need.The chip will be in binary code, so it will displays either a "+" or "-" sign in front of all the vitamins. A "+" sign by the vitamin, will mean you currently have enough of that vitamin, and a "-" sign will mean you have a deficiency. In addition, there will be a guide notebook which shows how to use the device and give you recommendation how to increase vitamins if your body has an insufficient amount. Our device is easy to use, has relatively few technologies, and gives straightforward results. No potential challenge or obstacle should impede the technical feasibility of our machine.

Clinical Feasibility

Our product will be used in the clinic to test for deficiencies in common vitamins that could have an impact on overall health. There are relatively few clinical risks as well as there is a minor risk of fraud and fabrication(VITASTIQ). In trials related to testing of vitamin D deficiency, there is a lack of evidence regarding the feasibility related to healthy populations. In high risk and at risk populations, the feasibility of adoption is high. However, there appears to be low benefit for testing in a healthy population. As such, the clinical benefit and overall value of money is unknown. In trials related to saliva testing, this form of testing is usually reliable. However, the concern arises that if the patient is sick with some other ailment, it has the potential to be contagious and if this is the case it would be problematic to have saliva samples around, increasing the chances of the sickness spreading, especially if the patient is self diagnosing at home around their family. At the same time, saliva testing is clinically feasible as it is non- invasive and easy to do. In trials related to the blood glucose meter, which has a similar overall design as our prototype, it was found that a great deal of the reliability is in relation to the user. The accuracy would be dependent on factors of the meter such as proper handling and storage of the litmus strips, cleanliness of the meter, and size and placement of the saliva sample on the strip. In an effort to troubleshoot these errors, a small manual will be provided with the machine to educate the user on proper use of the machine as well as suggested steps to take if the user tests negatively in a certain vitamin.

## Market Analysis

Value Creation

Our device is more likely to be in first world countries where the emphasis on personal health and dieting are commonplace. Unlike other methods of vitamin level detection which exclusively involve a blood sample, our device would provide a more pediatric approach since saliva is a much easier interface when dealing with children, as well as people with needle phobia. In addition, such technologies are uncommon in the Americas; providing more people with means of testing themselves for vitamin deficiencies. Though it's price of 84 dollars may deter some customers who would rather avoid the cost, consumers will ultimately be attracted to a "blood-less" means of gathering the information. Furthermore, future development may allow our device detect other information, such as hormonal imbalances, allowing our device to reach a wider consumer base.

(Production and) Manufacturing Cost

Display screen: ~$4.00 http://www.mouser.com/Optoelectronics/Displays/LCD-Displays/ Test Paper Strips: ~$4.08 for 12 (the amount that will accompany the product.) http://www.chemworld.com/pH-Testing-Strips-p/pHTS-14.htm?gclid=EAIaIQobChMI3fD2iMSi1gIVgod-Ch0E7w6xEAQYASABEgJEmPD_BwE

AAA Batteries used to power the device: ~$0.63 (for 2) https://www.costco.com/batteries.html Biosensor inside: ~$5.22 We divided the price of a glucose meter from Walgreens by 2 to account for profit, and then subtracted the cost of the other parts of the device to estimate the cost of the biosensor. https://www.walgreens.com/store/c/walgreens-at-home-a1c-test-kit/ID=prod6248361-product

Plastic Shell: ~$2.06 http://www.custompartnet.com/estimate/injection-molding/ Labor: ~$5.00 for assembly of parts (this is just a rough estimate)

Total Cost: $20.99 Sales Price the sales price will be$83.96 because of the employees and the manufacturer, it's a custom manufacturing , it will take time to make it. also the marketing for the product takes place and the delivery.

Market Size

Studies performed by the National Institutes of Health suggest that approximately 33% of Americans over the age of 1 take some form of a multivitamin/mineral supplement at least once a month (Source 1). This data in conjunction with the estimated average sales price denotes a market size well over $500 million, resulting in a fundability worksheet market size score of 3. ## Fundability Discussion Customer Validation Score: 2 - Our device provides a convenient service that allows people to diagnose themselves for a vitamin deficiencies without reliance on blood samples. However, our device is not an essential or lifesaving one, which may devalue the device's worth. Market Size Score: 3 - Studies performed by the National Institutes of Health suggest that approximately 33% of Americans over the age of 1 take some form of a multivitamin/mineral supplement at least once a month. This data in conjunction with the estimated average sales price denotes a market size well over$500 million.

Competitors Score:

3 - Current methods for measuring the presence of vitamins in the body are almost exclusively performed via a blood sample, not a saliva test. Saliva tests do exist, but are primarily employed to detect hormone levels, and not vitamin deficiencies. The combination of these two technologies would expand the customer pool to include a more pediatric application, saliva being a much more compatible interface when working to improve child health. Competitors exist but could be easily displaced by the proposed device.

IP Position Score:

3 - Patents claiming to detect vitamin levels via a saliva sample are non-existent. Known patents do claim the ability to measure certain levels of bio-chemicals, though none claim to be able to do so via a saliva sample. The proposed product is patent-able and infringement on existing patents is unlikely.

Technical Feasibility Score:

3 - As mentioned above, the device is easy to use, requires less technologies, and uses only a binary coded chip to display straightforward results for our tests. Furthermore, saliva-based detection technologies already exist, though they do not appear in the Americas, nor do they target the deficiencies that our device does.

Clinical Feasibility Score:

2 - Our device has a higher chance to get used only by sick or at risk population since healthy population might be reluctant to use the device, considering there might be no need to. In addition, proper use of our device will be emphasized as saliva test is used in our prototype which might constitute as a hazard after usage. Saliva is a means of contamination of some contagious diseases.

Determination of Overall Fundability:

Total Fundability Score: 324

Our product is greatly worth the investment in, providing a safe and convenient alternative to test one's vitamin deficiencies, while having no apparent disadvantages. This is especially apparent with the large interest in personal health and dieting.

## Sources

1. Multivitamin/mineral Supplements, Office of Dietary Supplements, National Institutes of Health, US Department of Health and Human Services. https://ods.od.nih.gov/factsheets/MVMS-HealthProfessional/