BME100 s2017:Group2 W1030AM L2

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Anh Nguyen
Sheridan Hill
Skye Russell
Thomas Andrews
Derall Riley
Kiryl Sheleg


Device Image and Description

2D Drawing
See-Through View
View When Closed
Exploded View

Description: The prototype is similar to a double-sided chapstick tube. One end contains a photochromic dye that will be applied under a layer of sunscreen. This dye will change colors to indicate when a person has to reapply sunscreen, which deals with the health issue of skin cancer because people are overestimating the powers of sunscreen. The other end of the tube will contain a dehydration monitor, which will deal with the dehydration that usually occurs when people are in the sun and have to use sunscreen.

Technical and Clinical Feasibility

Technical Feasibility
-Removal of carcinogens from the photochromic dye
-Manufacturing plastic tubes for the container
-Lab with materials to mix and make chemicals
-Dye for the dehydration sensor
-Material for making sunscreen

Potential challenges:
Some potential challenges will be getting the photochromic dye to change color at the right time and not when initially exposed to the sun. The idea is the sunscreen will shield the photochromic dye and when it wears off, it will allow the sun to change the color of the photochromic dye. There are also challenges of getting the photochromic dye skin safe, however there is a process to remove all of the carcinogens. As for the hydration monitor, there will be challenges with getting good readings. This has to do with outside conditions, whether the person is swimming, and whether or not they rub up against something and cause the readings to shift.

Potential Obstacles:
Some potential obstacles will include the IP position. There are already a patent with the photochromic dye and sunscreen, but there is not a patent with both photochromic dye and the hydration monitor. Also, there will be challenges making the sunscreen and getting it to work as a prototype. It could go wrong if all these criteria are not met, but it should not be dangerous to the user.

Technical Feasibility Score: 2
The idea behind the product is very simple, but there might be some problems with getting the photochromic dye and dehydration monitor to work the way we want it to. The process for getting the dye to work and be skin safe has already been tested and proven. The difference is that we are using it in a different context. We have to do some work in order for the dye to work for as long as we want it to with the sunscreen. The dehydration monitor is also simple but needs work. The monitor already works, but we need to make it so that there is some indicator along with the monitor to tell people they are dehydrated. These problems can be overcome with not too much time or money since the basic concept has already been established. But not all of the methods have been done before.

Clinical Feasibility
There are some guidelines by the FDA for what is considered safe for sunscreen:
-Low incidence of adverse events under directions for use and warnings
-Low potential for harm if abused under conditions of widespread availability
-Significant human marketing experience
-Adequate tests to show proof of safety
-Data publically available
-Applies to all potential formulations of an ingredient

The product meets all of these descriptions. After the photochromic dye is free of carcinogens, it becomes skin safe. There is low harm in sunscreen and accidents that come along with use of it. There is plenty of data available from other products and tests can show proof of safety. But clinical risks could still occur if something unexpected happens to make the product not skin safe.

Similar Clinical Trials:
This clinical test was to see if an electronic device reminding people to re-apply sunscreen would work or not. The experiment was set into two groups, a control and experimental. The goal was to see if a reminder to reapply sunscreen would actually work. The results showed that the amount of people who would re-apply and use sunscreen increased when there was a reminder. This relates to our product because ours is a built in reminder with the photochromic dye. If the results hold up, this means there is a good possibility that users will actually re-apply sunscreen if they have a reminder.
This clinical test was to see if sunscreen would irritate eyes. This test was to test the safety of sunscreen and know if it is safe and will not damage the eyes. The results were not posted, but this directly relates to our product because the main concern will be if it is skin safe.

Because of all of this information, the product should be safe for clinical trials. Our clinical trials will follow a similar structure to clinical trials of sunscreen.

Clinical Feasibility Score: 3
The score for clinical feasibility would be at a 3 due to the previous innovations that allowed the carcinogen-free photochromic dye and the indicator within a sunscreen kit. Various clinical tests have been done with a variety of sunscreens in addition to various patents filed for numerous FDA UV ray indicators. The most recent patent filed, US Patent #9550897, provided a new processing mechanism for the photochromic dye that allowed the potentially harmful dye perfectly suitable for skin.

Market Analysis

Value Creation
Most other products on the market are just regular sunscreen. Some have moisturizers, more SPF, less greasy, but none of them have an indicator to tell the consumer when to reapply. The other competitors just state in the direction to do so every hour or two. The problem is most people lose track of time or over estimate the power of sunscreen. This product has photochromic dyes to change color, which none of the other competitors have. This adds tremendous value. Also, it adds an extra safety precaution for the consumers. It also adds a dehydration monitor, which no other sunscreens have. People need to also know when they are dehydrated because that happens easily in the sun, when they will be using sunscreen.

Manufacturing Cost
Tube: $.10-$.20
Label: $.36
Zinc Oxide (10% of 0.07oz.): $0.00294 per tube
Titanium Dioxide (10% of 0.07oz.): $4.96*10^(-4) per tube
Avobenzone (3% of 0.07oz.): $8.93*10^(-4) per tube
Solar Color Dust (5% of 0.07oz): $0.069 per tube
Oil (most expensive) (30%): $0.0595 per tube
Oil (least expensive) (30%): $0.00179 per tube
Butter (most expensive) (20%): $0.0397 per tube
Butter (least expensive) (20%): $3.97*10^(-4) per tube
Labor: $0.05 per tube

Total: $0.58-$0.78

Sales Price
Sales Price: $2.99
Even at the most expensive the product would be, the product’s sale price would be almost three times the price of manufacture. It is affordable, especially for what it would provide, a dual dehydration-and-UV-monitor; with inexpensive sunscreen being around $6, and higher-end stuff anywhere from $8-$15, an added $3 to tell when sunscreen is worn off would be minor. At the cheaper end, the price is closer to six times manufacture cost. This is a reasonable price, and around the same price as lip balm, an arguably less essential item.

Market Size
Sun care market, 2016: 1.8B. 5% of the market is 90M
No figure for dehydration paste detectors. Added the “sun protection” market to compensate. Sun care + sun protection = 3.37B. 5% of the market is 17M
Total: $107,000,000

Market Size Score: 1
The market size score is 1 because after the calculations, the market size is over $80 million, but under $200M. The justifications of why the price falls in this range is given above.

Fundability Discussion

Customer Validation: 1
Market Size: 1
Competition: 2
IP Position: 1
Technical Feasibility: 2
Clinical Feasibility: 3

Due to the weak customer validation and the nearly nonexistent IP position, this product should not be funded. Patents exist that are much too similar to the proposed idea. In addition, simple competitors exist that can defeat the purpose of this innovation. The people do not seem to want this innovation and the market size is small enough as it is so presenting this idea is not a very good solution to the prevalent issue of skin cancer. Despite the innovation being cost effective, not enough people seem to want to spend money and use this additional product. Even though this idea is feasible to create and will require very little clinical footwork, the lack of a want and the resonating issue with too similar of patents is a severe issue. Just because this idea can be helpful and easily made does not mean that this is the best solution.