BME100 f2016:Group10 W1030AM L2

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OUR TEAM

Name: Amy Polanecki
Name: Tariq Madni
Name: Kyle Hull
Name: Andrea Hnatievych
Name: Neaco Fox

LAB 2 WRITE-UP

Device Image and Description

This product is a universal tip replacement and attachment for crutches, canes and walkers. Its purpose is to deform under pressure with the application of body weight to increase the surface area during ground contact, reducing pressure experienced by the user. The rigidity of the material during deformation will also allow for the force of the impact with ground to be spread over a longer period of time, decreasing the overall impulse. Some material options for this product are polyurethane and clay/rubber mixtures to optimize elasticity and deformability.

Prototype Design with Lines Prototype Design

Technical and Clinical Feasibility

Technical Feasibility
The technologies needed for this product are a spherical elastic/rubber material with a high coefficient of friction. The deformability of the material needs to be such that it deforms completely with the application of a user’s full body weight, yet not lose all its rigidity during this process.

Due to the diverse body shapes and sizes in our world, there may be a need to sell different materials of the product in order to accommodate weight differences. For example, in order to support someone who is obese, it may be beneficial to use a polyurethane rubber due to its rigidness. Another challenge that may be faced is the breakage of certain rubbers in our products. Rubber has been seen to break, lose its bounce, and be affected by extremely cold and hot temperatures. We must find a durable material that will maintain its condition while supporting the user. In addition, we will be challenged to find a material mix that is not patented by some of our competitors like Fetterman and Ingrid.

During the clinical trials and testing, this product could potentially lose function with an obese or large user. The material may not last as long if exposed to high and low temperatures as well as rugged environments. If not used properly, a user could fall or lose balance during crutch/cane/walker motion, further injuring themselves.


Clinical Feasibility
The product will work in the clinic because clinics provide everything that can help patients and reduces the anxiety that people feel. The improvements we added on the walking aids (i.e. crutches, canes, walkers) can make them work better for people with less endangerment.

There are studies highlighting the downside of people who are using walking aids without training, like falling down for example that can cause other health issues, injuries, and sometimes it cause a death especially old people. Another study indicates that between the years 2001 and 2005, there are about 3,932 nonfatal falls for people who are 65 and older because of using walkers and canes. Researchers estimates that there are 47,312 falls a year.

There were several studies conducted on impact of mobility within varied specific circumstances however none were specific to trials using and adjusting crutch tips. One such feasibility study that was applicable to our product was commenced September 13, 2005 and last verified on May 5, 2014. The purpose of this study was specifically addressing obesity and osteoarthritis using a single point cane to assist in weight distribution and pressure on limbs. Although this study is evaluating the effects on osteoarthritis there was pertinent information pressure relocated from walking aid use. A second trial was started on June 28, 2012 and last updated on April 4, 2016.This research is being conducted concurrently evaluating motor impairments, orthopaedic injuries and neurological and gait characteristics. This research is applicable as it evaluated different walking aids with differing combinations of medical issues. Noting that there was quite a change in needs and stability support mechanisms for each, possible proving that one device with better adaptability is needed.
A Final trial was initiated on October 28, 2014 last verified on October 2014, this trail was short in length never concluding. It reviewed a four-point mobility tool that aided in stroke patients. This study evaluated and adjusted its hardware based on individual patient needs.


Work Cited
Henry, D. (2009). Study Warns of Hazards for Elderly Using Walking Aids.
Retrieved September 07, 2016, from website:
http://www.nytimes.com/2009/06/30/health/30fall.html?_r=

U.S. Institutes of Health (2014, May)
Gait Characteristics Following a Fall
Retrieved from website:
https://clinicaltrials.gov/ct2/show/NCT01631604

U.S. Institutes of Health (2012, June)
Walking Aids in the Management of Knee Osteoarthritis
Retrieved from website:
https://clinicaltrials.gov/ct2/show/NCT00223795

U.S. Institutes of Health (2014, October)
4-Point vs 4-roll Canne as Walking Aids after Stroke
Retrieved from website:
https://clinicaltrials.gov/ct2/show/NCT02279069

Walkers and Canes: You Can Fall Using a Mobility Aid | Everyday Health. (n.d.).
Retrieved September 07, 2016, from website:
http://www.everydayhealth.com/columns/lynda-shrager-the-organized-caregiver/wait-you-can-fall-with-a-walker-or-cane/

Market Analysis

Value Creation
The product that we have decided to design will allow the customer to theoretically have a reduction of pressure experienced at the contact points between the device and user. This will provide an ease of discomfort during the use of crutches, canes and walkers on hard surfaces. A claim of pain and discomfort relief is a huge seller for most medical devices, and this is the reason for developing our product.

Manufacturing Cost
The Cost per item will be a variable and based on a product estimated size of 40 grams. This product will also range in colors offered. Two considerations were found and evaluated.

The first consideration is to purchase bulk EPDM Rubber. This will require costs for equipment, employees, overhead for warehouse costs in the U.S.
Consideration 1: Cost per EPDM bulk rubber manufacturing in U.S. Rubber per 55 lb bag at 40 gram item will produce 623.6 items per 55 lb bag.

Color Price per 55 lb bag
Blue $56.10
Red $51.15
Green $56.10
Black $19.25

Manufacturing cost estimates are based on similar products in the United States; direct labor, production, distribution and production overhead were all considered. The prefered manufacturing process is based on the liquid injection molding currently used by rubber manufacturing companies throughout the country. Manufacturing cost: $1.20 per unit cost for manufacturing, this price does not include marketing, and Distribution. Total price of product produced in U.S.
$1.20 Manufacturing + $11.12 cost of bulk rubber product (Blue) + plastic base .56=$12.88 per unit

The second option is based on similar products that are currently manufactured in China and shipped to the U.S. The product that was evaluated was Floor Rubber endpin tips for table and chair bottoms. Full manufacturing price is a completed product from Qinghango Rainbow Rubber manufacturing per units costs:
$0.10-$2.50 + $0.56 plastic base per unit cost is determined based on quantity requested and location of distribution and does not include marketing or shipping.

Sales Price
The end cost of our production and manufacturing in China would equate to less than $4. We will be packaging two tip prototypes and would equate to ~ $8. Due to competitors in the industry, our anticipated average sale price would be $12 to compete against Ingrid and Fetterman’s product.

Market Size
In the United States, more than 6.8 million people are using walking aids in different situations. Our market size involves people with polio (the average of children who have Polio each year is more than 35,000), injured students (it is estimated 10 to 25 percent of students at the ages 10 to 14 got injured each year), injured athletes(it is estimated more than 775,000 children ages 14 and younger are treated in emergency rooms because of sports), veterans, etc..

Should we be funded?
Although our product scores an 8 on the fundability worksheet, our medical device should be funded. Our device will benefit a large market of injured patients, athletes, and veterans, the elderly, paraplegics, polio patients, etc..

The reason our product scored so low was due to the competitor and customer validation section. Using the fundability worksheet, we noticed our product scored low on competition due to the crowded market space. Even though the market is crowded, there are plenty of products in the medical industry that have broken through a crowded market space. Also, there was not enough customer feedback in order to score highly on customer validation. Our product can benefit a large number of injured people, such as injured athletes, polio patients, veterans, and paraplegics. Furthermore, we believe that our product will be more aesthetically pleasing than our competitors due to the production and manufacturing of multiple colors. The variety of colors in our product will allow people to style up their walking-aid device(s).

With this being said, there is a possibility that our product will do very well in the market industry. Therefore, our prototype should be funded by the investors.

Work Cited
A Polio-Free U.S. Thanks to Vaccine Efforts. (2016).
Retrieved September 14, 2016, from website:
http://www.cdc.gov/features/poliofacts/

By far, the most common injuries are sprains and strains. (n.d.). Default - Stanford Children's Health.
Retrieved September 14, 2016, from website:
http://www.stanfordchildrens.org/en/topic/default?id=sports-injury-statistics-90-P02787

Enterprises, I. S. (n.d.). Sparton Enterprises | Recycled Rubber Products.
Retrieved September 14, 2016, from website:
http://spartonenterprises.com/

Rainbow Rubber Extrusions - Custom Viton Extrusions. (n.d.).
Retrieved September 14, 2016, from website:
http://rainbowrubber.com/

Wolff, J. L., & And, E. M. (2005). Jennifer L. Wolff.
Retrieved September 14, 2016, from website:
http://content.healthaffairs.org/content/24/4/1140.full

Fundability Discussion

Technical Feasibility
2-Although there is known materials and methods to creating our product, or something similar to our product, we will still need to do trials in order to test our material mix and make sure it is durable. Due to our product not being ready for production we have decided to rate it a 2 rather than a 3. Although there may be some challenges faced in our trials, it should not be too costly and should be overcome in a short period of time.
Clinical Feasibility
2- Clinical success is likely as there are several very similar products that already exist. However, it will require some specific research and trials due to it being a support tip that is malleable as opposed to the already stiffer solutions. The product will appear structurally the same as the previously designed competing tips; however, they will conform differently in use and therefore stability trials will need to be conducted to ensure safety.