BME100 f2017:Group8 W0800 L2

Lab 2: “Prototype Design: Part 1” - Learn how to use SolidWorks. o Leverage “Help” in SolidWorks and Custom video on Blackboard. - Design a prototype to address the chosen health issue. - Draw prototype in SolidWorks. - Determine the technical feasibility. - Determine the clinical feasibility. Assignment: 1. Design and draw your prototype in SolidWorks. Upload as an image and provide a brief description (including how addresses health issue) on Open Wet Ware.

This prototype is a piece of gum that will aid in oral health. The gum is 1.00in x 0.50 in x 0.15 in. This piece of gum will be made a natural sweetener called xylitol but will also be a mint flavor. The purpose of the gum is to combat starch residues with the enzyme it releases after eating and when chewing the gum, the mouth will increase saliva production. Besides the enzyme, the gum will also contain contain traces of calcium, potassium, magnesium, and sodium which will decrease the acidity level of saliva the mouth. This would decrease the pH level present in the mouth and increase teeth health.

2. Determine the technical feasibility of your design. Include answers to the following questions: a. What are the technologies needed?

-The technologies needed to make our specialized gum include the original process of making a piece of gum with our added tooth decay prevention. Gum is made by starting with a gum base, which is made synthetic materials such as plastic or rubber, then add flavor (American Dental Association 2016). The flavor we are aiming for is mint. Next, add in sweetener by adding aspartame or mannitol, but our product will be using the sweetener xylitol, to make sure our gum is sugar free. With this step we would want to add in the powders of calcium, magnesium, potassium, and sodium. The gum is then mixed with a giant mixer and heated to around 116 degrees celsius (Wrigley 2016). Then, the amylase enzyme would be added and integrated into the gum mix and mixed with lower heat of about 70 degrees celsius for optimum functionality (Green 2008).

-Enzyme → Amylase (Saliva)

-Powdered minerals (pH Level)

b. What are the challenges?

-The problems faced with producing a medically based gum, that does not seem to be medically based, is producing a gum with a likeable flavor that may need to mask the flavors of certain ingredients. However another challenge would be to find the component of the gum that would actively prevent tooth decay, as well as ensuring the enzyme remains present in the gum after the making process due to the fact that amylase enzyme starts the process of denaturing at around 100 degrees celsius (AllSands). Another challenge is making sure we have the right amount of the enzyme present in the gum to combat starches as well as integrating the correct ratio of each mineral, which we will need to further research.

c. What could go wrong?

-Areas that could go wrong include our spearmint flavor not being favorable, and after the gum base is heated during the making process, there is a possibility that the enzyme will not survive. This could happen because when most enzymes are heated to a certain temperature, there is the chance that they will become denatured. There is also the possibility in which the amylase enzyme is not integrated with the gum very well.

3. Determine the clinical feasibility. a. Given the technical feasibility, will it work in the clinic?

-Our gum would definitely work within a clinical trial, because chewing gum is not anything new among users. Once we got past our technical challenges, the subjects would just need to physically chew the gum for the trials.

- Our product would be successful within a clinical trial because it is an easy product to mass produce, thus more test subjects can be acquired to produce conclusive results. There is no new level of learning involved with our gum so test subjects would be more inclined to use the gum. Results could be quickly and efficiently gathered because there is no constant need for the test subjects to record data, instead they simply go to dental clinics that can analyze the state and/or difference of the mouths condition.

b. What are the clinical risks?

-Our product has many clinical risks that include a dislike of the flavor of our products but the primary risk is the lack of control with individual test subject because there is no way to prove if the subjects are using the gum after every meal where they do not brush their teeth directly after eating. Nor can we see if they change their dental regime. Another risk is the possibility that the gum will have no effect in preventing dental decay.

c. Have similar products been in a clinical trial? How long was the trial?

-There is a clinical trial that is currently being recruited for Xylitol, which is another health gum. This trial is looking for adults 20-50 to test the gum by chewing the gum for about 5 minutes in the morning. This study is estimated to be completed on November 30, 2018. (Fouad, 2017).

-There is another clinical trial with gum produced with Xylitol that is completed. The study was to figure out if the gum can affect the salivary mutans streptococci (MS), dental caries, and dental plaque. This was a clinical trial for children ages 10-36 months. The study started February 2009 and ended September 2017. The conclusion was “Maternal xylitol consumption provided better preventive outcomes on salivary (MS) levels compared to fluoride varnish treatments” (Alamoudi, 2017).

4. Using the fundability worksheet chart, determine the scores (0-3) for technical feasibility and clinical feasibility and provide support for scores.

-For technical feasibility, we believe our gum would be a two out of three. This is because the technologies for making gum is a known and simple process among productions, but there are challenges that we would need to overcome that prevent it from being a three.

-For clinical feasibility, we believe our gum would be a two out of three. This is because if the technical challenges stated are overcome, then the clinical trials would just include subjects chewing the gum. The actual clinical trials would be more simple and easily executed compared to the technical making process of the gum.

Resources: - Video on the basics of SolidWorks - Video on how to search for clinical trial information. o See “Improving Searches with Boolean Operators” Video to learn about ClinicalTrials.gov HW: Lab Report 2 – both Parts 1 and 2 (due 09/19/17 by 11:59PM on OpenWetWare) Lab 2: “Prototype Design: Part 2” · Determine the market size. · Determine overall fundability.

Assignment: 1. What value does your prototype create for the customer?

-Our prototype is simple and a known technology among customers, which allows for them to be more inclined to buy our product, and trust it’s promised outcome. The prototype gives and idea of what the actual product would be and how it is made. This gives the customer a deeper understanding of the product making them more willing to invest/buy the product.

2. Determine the cost to create your design. Justify.

-Amylase enzyme’s price varies, but seems to lie around $10.00/ lb among the market, and our gum will weight around 3 g/ piece. So for one piece of gum will cost around 1 cent per piece assuming that a ⅔ of the gum is the base, and a ⅙ is the enzyme. For packaging, paper will cost $.002 per gram. The ball park estimate of producing a sugar free gum is around a quarter of a cent per piece due to the small size of individual pieces.

-The cost for each powdered mineral per one ounce is

-Calcium → $0.91=$ .032 per gram (Calcium Lactate Powder, 2017) 250 mg calcium (25% DV) = $ .008 per piece (NSP Web Team, 2017)

-Magnesium→ $3.30=$ .11 per gram (True Magnesium Berry flavored Powder Mix) 125 mg magnesium (30% DV) = $ .014 per piece (NSP Web Team, 2017)

-Potassium → $1.15=$ .04 per gram (BulkSupplements, 2017) 90mg Potassium (3% DV)= $ .0016 per piece (Nature Made, 2017)

-Sodium→ $1.90=$ .067 per gram (Abrams, 2017) 40mg (2% DV)= $ .002 per piece

So, the final price of the gum derived from the amylase, mineral additions and the estimate is about 2 cents/ piece.

3. What would be the anticipated average sale price (ASP)? Justify.

-The anticipated average sale price for the gum would be $1.99. Each pack would have 20 pieces of gum so each pack would cost roughly 40 cents to make, so we then are selling it for 5 times the price to make it.

4. Using initial market size analysis in Lab 1, determine the market size in dollars per year. Assume 5% penetrance of the market (Sales price X 0.05 X total market size).

-($1.99 x .05 x $2865.5 million) The projected market size in dollars per year is $285 million/year.

5. Using the fundability worksheet, determine if your prototype should be funded. Justify why or why not.

-Since our product is projected to earn around 5 times the production cost, we believe this prototype should be funded. Our product is also easily clinically tested, since there have been multiple similar clinical trials we know that our product should be successful in the long run. Our product has a high technical feasibility since the process of creating gum is already invented and used efficiently as well.

HW: Lab Report 2 – both Parts 1 and 2 (due 09/19/17 by 11:59PM on OpenWetWare) Grading Scheme: 50 points – See Rubric for Lab 2 50 points – Peer Assessment (through CATME)

Resources

A. (n.d.). Amylase Enzyme: The Effects Of Temperature. Retrieved September 13, 2017, from http://www.allsands.com/science/amylaseenzymeh_wpp_gn.htm

A. (2016, August 24). Chewing Gum. Retrieved September 13, 2017, from http://www.ada.org/en/member-center/oral-health-topics/chewing-gum

Abrams, E. (2017, August 19). Sodium Lauryl Sulfoacetate (SLSA). Retrieved September 13, 2017, from http://www.bulkapothecary.com/sodium-lauryl-sulfoacetate-slsa/?gclid=EAIaIQobChMItKTi98ai1gIVz42zCh3dCgoeEAkYASABEgK5CPD_BwE

Alamoudi, N. (2013, December 31). Impact of Maternal Xylitol Consumption on Mutans Sterptococci. Retrieved September 13, 2017, from https://clinicaltrials.gov/ct2/show/NCT02036151?term=gum&cond=tooth%2Bdecay&draw=1&rank=4

Alamoudi, N. M., Hanno, A. G., Sabbagh, H. J., Masoud, M. I., Almushayt, A. S., & El, D. A. (2012). Impact of maternal xylitol consumption on mutans streptococci, plaque and caries levels in children. Retrieved September 13, 2017, from https://www.ncbi.nlm.nih.gov/pubmed/23534323?dopt=Abstract

BulkSupplements Pure Potassium Citrate Powder (500 grams): Health & Personal Care. (n.d.). Retrieved September 13, 2017, from https://www.amazon.com/BulkSupplements-Potassium-Citrate-Powder-grams/dp/B01LMOIBDU?th=1

Calcium Lactate Powder. (n.d.). Retrieved September 13, 2017, from http://www.bulksupplements.com/calcium-lactate.html?gclid=EAIaIQobChMInsWb2Mii1gIVk0sNCh2oaw5oEAkYCyABEgLMrfD_BwE

Fouad, H. F. (2017, February). Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH. Retrieved September 13, 2017, from https://clinicaltrials.gov/ct2/show/NCT03061422?term=gum&cond=tooth%2Bdecay&draw=1&rank=2

Green, D. (2008, Jan. & feb.). The Science of Step Mashing. Retrieved September 13, 2017, from https://byo.com/mead/item/1497-the-science-of-step-mashing

Nature Made, Potassium Gluconate, 550 mg, 100 Tablets. (2017). Retrieved September 13, 2017, from https://www.iherb.com/pr/Nature-Made-Potassium-Gluconate-550-mg-100-Tablets/40429?ccode=us&currcode=USD&langcode=en-US&gclid=Cj0KCQjwruPNBRCKARIsAEYNXIj_RfQpASq1leQTaS7Ls2AHTIS2f_YUy5L8yRvVgegvYGkcV_avt_saAteMEALw_wcB

NSP Web Team (William J. Familia, Aaron Walker, Isaias Rojas, Robbie Williams). (2017). Calcium Plus Vitamin D (150 Tabs). Retrieved September 13, 2017, from https://www.naturessunshine.com/us/product/calcium-plus-vitamin-d-150-tabs/3243/

TrueMagnesium Berry Flavored Powder Mix. (n.d.). Retrieved September 13, 2017, from http://www.naturecity.com/product/mag060?gclid=EAIaIQobChMI7tiJoMai1gIVDGh-Ch0hmQSsEAQYAiABEgJ01PD_BwE

W. (2016). How Gum is Made. Retrieved September 13, 2017, from http://www.wrigley.com/global/about-us/how-gum-made.aspx