BME100 f2017:Group8 W0800 L1

· Introduce the Fundability Worksheet from Medicoventures. · Identify an existing health care issue. · Report on the impact of the issue on society (why it’s important) · Identify your customers for validation. · Review current solutions to the chosen health care issue. o Available resources: Google Scholar, Patent Searches, News Searches (Lexis Nexis), Journal Searches · Describe advantages/disadvantages to each current solution. o Identify the unmet needs (financial, technological, etc.) · Score relevant portions of the fundability worksheet o Customer validation. o Competitors o Intellectual Property (IP)

Assignment:

• Cite appropriately all resources used in completing this analysis.*

1. Describe the health care issue you will develop a solution for. Include a description of the pathology your device or technology that will treat/prevent/diagnose. -The health care issue our group is developing a solution for healthcare concerns such as dry mouth and cavities.Tooth decay is also a major issue for all ages. “Tooth decay is caused by bacteria and sugars that react to create acids” (Tooth Decay Process, 2013). These acids then break down enamel or if no enamel is present it will actually eat away at the hard outer coating of the tooth. This process is what causes holes in a tooth which is also known as a cavity. For children, the main cause of cavities is the amount of sugars they eat and the lack of toothbrushing. Another major cause of tooth decay is as people age, their mouths are more prone to dry mouth caused by a lack in saliva. Saliva helps protect against tooth decay because saliva has minerals such as calcium and phosphate which help in repairing enamel. With all of these factors causing tooth decay, our group decided we could develop a gum that people could chew that would prevent the acids from attacking teeth. -The first development with our gum is to attempt to help people that have low pH levels in their saliva. Low pH levels cause them to be more susceptible to tooth decay. “While having a mouth that is too low on the pH scale can put one at a higher risk for cavities” (Townsend, 2015). “Tooth decay can occur when the pH level in the mouth is 5.5. For reference, the neutral level is 7.0” (Dental, 2016). Low pH levels are most commonly caused by a person being deficient in certain minerals. “In the mouth to prevent tooth decay the most useful minerals are calcium (Ca+2), potassium (K+), magnesium (Mg+2), and sodium (Na+)” (Saliva, 2000). In the gum we would add these minerals so as the gum is chewed the body absorbs these minerals and in turn the pH level of the saliva should neutralize. The gum is a much easier way to obtain these minerals instead of changing a person’s way of eating to obtain these minerals by eating a lot of vegetables and fruits. -Our product is being designed to help combat tooth decay in an easy and efficient manner that is also suitable for children of young age.In order to effectively treat the disbalanced pH, various types of chemicals may be used to alkalize the saliva. For our product to be able to neutralize saliva we are using xylitol, a common chemical already used in regular gum that allows gum to be sugar free. The primary use of the product was to create an alternative for young children who do not take the proper precaution of cleaning their teeth after a meal or a snack. Xylitol has been seen to diminish mutans streptococci, which is what causes the formation of plaque buildup on teeth(Janakiram, 2017). Other benefits that xylitol provides for our product is to target another key issue our product can treat, which is dry mouth. Dry mouth is another leading cause of tooth decay but xylitol stimulates salivation (Alanen, 2000). To help combat dry mouth, and tooth decay, amylase will be also added. Amylase is natural found within saliva but often people cannot produce saliva, or the pH levels are too high, amylase cannot function properly. By adding amylase, starches left by food will be broken down in an efficient and timely manner(Function of Amylase). Because of the added solutions into our product there are many benefits that can be provided to a large range of people with different health concerns.

2. Customer Validation: Create a list of 20 specific customers that you would contact to validate your device/technology (physicians, individuals, organizations etc).

3. Competitors: List current solutions for this healthcare issue. Create a column for each of the following: a. Advantages (with reference to other solutions) b. Disadvantages (with reference to other solutions and the ideal solution) i. Include unmet needs and categorize them (financial, technological, etc.). c. Given the above (a and b) describe why your device/technology is more marketable.

4. IP Position: Perform a patent search and describe existing patents related to your device/technology.

5. Using the information you have compiled, score the portions of the fundability worksheet listed below.

a. Customer Validation (use a value of 1). We will use a value of 1 for customer validation.

b. Competitors. We will use a value of 2 for competitors. After reading many clinical trials about different types of gums on the market that are trying to do what we are attempting, but all the results show no difference between traditional methods and the gum method due to poor testing, however our product is "better" because we are implementing new techniques that target more than simply reducing cavities. Thus we have competitors who were unsuccessful because their faulty clinical trials and their product only targets one issue meanwhile our product has many benefits.

c. IP Position. We will use a value of 2 for IP Position. This idea of a gum that could help both those with sensitive teeth and those with diabetes is not relatively common. The idea of creating an enzyme full of amylase is not new, but the ideas have not developed much and the idea to use the gum as a way to help diabetics with dry mouth is a relatively new idea. There exists some patents to items such as an amylase gum used to reduce bad odor originating from the mouth and amylase used in gum for industrial usage. These patents were issued, but they are only slightly similar to our product and they have already expired.

- “How-to” Videos: o How to cite different resources o How to use Boolean Operators to improve searches on Google and Google Scholar o How to search for News Articles on Lexis Nexis o Understanding and searching for Patents o How to find peer-reviewed journal articles

HW: Lab Report 1 (due 09/05/17 by 11:59PM on OpenWetWare) Grading Scheme: 50 points – See Rubric

50 points – Peer Assessment (through CATME)

References

A&N Dental. (2014). About A&N Dental. Retrieved September 05, 2017, from http://aandndentalcenter.com/about Aubrey, A. (2009, July 20). Gum: A Stick A Day May Keep The Dentist Away. Retrieved September 05, 2017, from http://www.npr.org/templates/story/story.php?storyId=106347234 Alanen, P., Isokangas, P., & Gutmann, K. (2000). Xylitol candies in caries prevention: results of a field study in Estonian children. Community Dentistry & Oral Epidemiology, 28(3), 218-224. AXIM Biotechnologies. (2015). Home. Retrieved September 05, 2017, from http://aximbiotech.com/ Chiu, C. (02/09/1993). U.S. Patent No. 5185176. Washington, DC: U.S. Patent and Trademark Office. Retrieved September 05, 2017, from https://patentimages.storage.googleapis.com/50/b5/94/471c53100746f8/US5185176.pdf Chiu, C. (12/11/1990). U.S. Patent No. 4977252. Washington, DC: U.S. Patent and Trademark Office. Retrieved Septermber 05, 2017, from https://patentimages.storage.googleapis.com/3c/1e/d7/6da778231e9187/US4977252.pdf Dental, C. (2016, March 28). The Importance of pH Balance in the Mouth. Retrieved September 05, 2017, from https://www.carefreedental.com/resources/17-nutrition/152-the-importance-of-ph -balance-in-the-mouth Dr. Jason H. Nordean. (n.d.). Retrieved September 05, 2017, from http: www.drjdental.com/ EHealth Insurance, Inc. (2017). Arizona Health Insurance Companies - AZ Medical Insurance Providers. Retrieved September 05, 2017, from https://www.ehealthinsurance.com/health-insurance-companies/arizona-carriers Improve Oral Health. (n.d.). Retrieved September 05, 2017, from http://www.wrigley.com/global/benefits-of-chewing/improve-oral-health.aspx Janakiram, C., Kumar, C. D., & Joseph, J. (2017). Xylitol in preventing dental caries: A systematic review and meta-analyses. Journal Of Natural Science, Biology & Medicine, 8(1), 16-21. doi:10.4103/0976-9668.198344 K. (n.d.). About Us. Retrieved September 05, 2017, from https: www.kidsdentalcenter.com/about-us/ Plevy, D. J. (04/26/1988). U.S. Patent No. 4740368. Washington, DC: U.S. Patent and Trademark Office. Retrieved September 05, 2017, from https://patentimages.storage.googleapis.com/a8/a9/ba/7e105fd683b272/US4740368.pdf Saliva pH Test. (2000-2017). Retrieved September 05, 2017, from http: www.alkalizeforhealth.net/salivaphtest.htm Statistics & Data Corporation . (2017). Statistics & Data Corporation Specialized Data Services CRO. Retrieved September 05, 2017, from https://www.sdcclinical.com/ SunWest Dental. (2017). Our Doctors - SunWest Dental. Retrieved September 05, 2017, from http://sunwestdental.net/about-us/our-doctors/ The Tooth Decay Process: How to Reverse It and Avoid a Cavity. (2013, May). Retrieved September 05, 2017, from https://www.nidcr.nih.gov/OralHealth/OralHealthInformation/Childre nsOralHealth/ToothDecayProcess.htm Townsend, L., DDS. (2015, September 16). Understanding pH Balance in the Mouth. Retrieved September 05, 2017, from https://www.jeffersondentalclinics.com/blog/underst anding-ph-balance-in-the-mouth What Are the Functions of Amylase, Protease and Lipase Digestive Enzymes (n.d.). Retrieved September 05, 2017, from http://healthyeating.sfgate.com/functions-amylase-protease-lipase-digestive-enzymes-3325.html Xlear FAQ's | Xlear Products with Xylitol. (n.d.). Retrieved September 05, 2017, from http://www.xlear.com/resources/faqs/