BME100 s2017:Group6 W1030AM L2

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Name: Jasmine Garcia
Name: Maryl Harris
Name: Marcos Delgado
Name: Brandon Mallory
Name: Christian Quintana
Name: Francesca Hoskyns


Device Image and Description


Our prototype is a silicone-hydrogel contact lens. These contact lenses contain a color changing indicator (dye) located on the rims of the contact lens. These indicators are a timed- oxidation reaction designed to fully react in one month’s time. By indicating when it is time to replace the contacts, the indicator serves as a helpful reminder for the user to remove and change their contact lens. This prevents the user from overusing their contacts and developing eye infections or eye damage.

Technical and Clinical Feasibility

Technical Feasibility
The product is based around the already existing silicone hydrogel contact lens, with the addition of a color-changing indicator that degrades or changes colors over the course of a month. It has proved challenging to find an appropriate indicator for the task, as the majority of materials that could be used are toxic and/or irritating to the mucous membranes of the eye. A vat dye holds the most potential, but choosing the correct dye and dye concentration to allow a appreciable color change after precisely one month (30 days) may prove difficult. The problem with dye is the potential hazard that having the dye so close to such a sensitive area

The indicator is a type of dye that changes color based on Oxygen exposure, as other choices were too risky to be in close contact with the surface of the eye. This is the only place where this device could fail and potentially cause permanent damage.

We give our product a 2 for technical feasibility. There are many methods and materials that could be used to change color over time, but finding one that changes over the correct period of time may be difficult. Additionally, we have yet to address in detail the process of injecting or inserting dye into the contact lens.

Clinical Feasibility
The clinical feasibility lead to the notion that this product would work. Even if we were to use an irritating product, it would be suspended in the hydrogel, and would never be in direct contact with the eye. The clinical risks include, dryness, irritation, and a potential risk of blindness due to exposure to a toxic indicator. The closest product to ours would be a standard silicone hydrogel contact lens, which made it through a one year clinical run. There is one patent with a medical dye that uses oxidation in order to cause a color change. This dye is intended to be used on various disposable medical devices.

We also gave our product a 2 for clinical feasibility. Research on certain dyes and indicators are necessary, in order to determine the safety of these substances when inserted into the eye. Additionally, the dyes may prove inaccurate when changing in the correct time period, which could make the lenses less reliable in predicting replacement time.

Market Analysis

Value Creation
The added value that the customer receives from our product is the benefit of knowing more precisely when to change their contact lens. This is important due to the fact that contacts can potentially create a vast amount of harm to the eye if left in for too long.

Manufacturing Cost
Parts: The cost of our product consists of 2 main materials. The first is our silicone hydrogel contact lense. This on average is about $6.36 to manufacture per contact lense. The cost of the Vat dye that we are using to indicate the time to change lenses retails at a price of $40 per pound. This translates into $40 per 160 L. Labor: The average salary of a assembly line/factory worker is $28,580 per year. A definite number of workers can not be stated because we do not know how much the company could grow. However, a small factory would be needed around the price of $1.5 million and the wages of the workers would need to be paid. Estimating at a total of $2 million for the factory and paying wages.

Sales Price
The anticipated price would be marked up at about 47% to allow for profit. This number was determined based on the average markup on eyewear and contact lenses in America. This would put our product at a price of around approximately $12 per pair of lenses.

Market Size

 About 13.2 million people use monthly contacts in the U.S. per year. The average cost of monthly contacts is around $12.00 per pair.  Therefore, the market size is approximately $1.6 billion. On the fundability worksheet, the market size has a score of 3.

Fundability Discussion

According to the fundability worksheet, our project should be funded. The majority of our scores are 2 or 3, and the score of 3 in market size is a promising aspect of our design. The only component of our Fundability Worksheet that received a score below 2 was the Customer Validation section with a score of 1. This is due to the fact that our product has not been widely advertised and is new to the consumer market. Additionally, this is a technically simple device with relatively high chance of clinical success, which gives clinical and technical feasibility scores of 2.