BME100 f2016:Group16 W8AM L2

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Contents

OUR TEAM

Name: Christian Forbus
Name: Christian Forbus
Name: Nandini Sharma
Name: Nandini Sharma
Name: Todd Smith
Name: Todd Smith
Name: Jared Macanas
Name: Jared Macanas
Name: Brandon Gandolf
Name: Brandon Gandolf

LAB 2 WRITE-UP

Device Image and Description


Our design is a very simple and sleek design that has a similar look to many other sports watches. With the band being fully adjustable and made of an elastomer, it gives it a very flexible design that wont break or wear down easily with the regular day-to-day wear and tear. The clasp to hold the watch in place is made of a strong stainless steal. Our sensor placed in the bottom of the band senses a person's blood alcohol content along with their heart rate. The face of the watch is a 2 screen LCD with half of the screen showing a person's BAC and the other side showing heart rate and time. The bottom of the face of the watch fits flush with the skin to induce perspiration making it easier for the sensor to get a good reading.

Technical and Clinical Feasibility

Technical Feasibility
The technologies need for our product are available to use because they are either being used in already made products or have been tested and proven to work. To create the exterior of the watch we need a digital screen, a flexible material to create a watch band (such as rubber), and metal for the dials and outline of the watch. Inside the watch we need a BAC sweat monitor, a circuit board to transmit the data to the phone, an app that can process the data, blue tooth , display that can be turn off and off, brightness that is adjustable, a clock, and a hear rate monitor. There will be two separate displays. One for the clock and heart rate monitor. The second display is for the BAC sweat monitor. The challenges we will have included making sure the monitors fit within our design. We will also have to ensure that we are able to the sensors work. It will be a challenge to ensure that the we are able to find material that is inexpensive, but also fits the requirements that our consumers have. The material will have to be lightweight, durable, heat-resistant, waterproof, scratch proof, and shatter proof. Things that can go wrong include the BAC monitor not delivering accurate data, the circuits shorting, the bluetooth not working, the watch breaking, the display scratching or breaking, the clock not working, and the sensors not working.

Clinical Feasibility
Our product is non-invasive with very limited risk with the electrical components involved. In our clinical trials, we will get various patients with varying height, weight, and body fat indexes who are of legal age to wear our product to get baseline tests for how our product reads the transdermal alcohol concentration and displays it as an alcohol reading similar to that of a blood alcohol test and breathalyzer. We will only have our subjects consume a safe amount of alcohol to prevent risks of alcohol-related illnesses. There is currently a study that has just applied for a clinical trial in July 2016 to measure values of transdermal sweat alcohol concentrations by the Assistance Publique Hopitaux De Marseille. Their study will be using healthy Caucasian volunteers between the ages of 18 and 40 to measure blood alcohol levels in plasma, exhaling into a breathalyzer, and through insensible perspiration. All of their determinants have been deemed safe, with no parts of the tests designated as safety issues.

Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration (ALCOOCAPT). (2016, July 27). Retrieved September 07, 2016, from https://clinicaltrials.gov/ct2/show/NCT02860195?term=transdermal alcohol monitor

Market Analysis

Value Creation
The value our product will create for our customer is a way to monitor and prevent their blood alcohol level (BAC). This can be used as a preventative measure to stop people from drinking excess alcohol and making their body vulnerable to certain disease and damage. In addition, it will help prevent drunk driving accidents, as it will make drivers more aware of their BAC and warn them to not drive. When the wearer reaches a certain BAC, the device will flash warning signs of different colors. The warnings will vary from Furthermore, police officers and doctors can utilize it monitor the drinking of people on probation and patients. In some cases, people on probation are required to abstain form drinking alcohol or monitor their levels, this device would be a fast and simple way to do that. The officers could connect the device to their phone and monitor the BAC. Additionally, doctors, for example, could use it to monitor of their patients when they are in line for a liver transplant. Patients who are about to receive a liver transplant are required to abstain from drinking. Also, this device can be utilized in the treatment of alcoholism. Alcoholics who are looking to get better or are in a program that requires to monitor their alcohol level to get better can utilize to keep themselves on track with their treatment and ensure they do not drink in excess.

Manufacturing Cost
Our product will require the production of a watch exoskeleton, a circuit board with bluetooth capabilities, an electrochemical ethanol sensors that utilizes sweat, and a heart rate monitor. For the the watch we will use stainless steel and silicon. Titanium (1 Piece Titanium Sheet Ti 1mm x 100mm x 100 mm) costs about $10 and silicon costs about $0.50/gram. One sheet ($10) and about 20 grams of silicon ($10) will be needed for the exterior of the watch. A glass display will be used for the screen. This will cost about $30. The heart rate monitor costs about $4. For the monitor we will buy a pre-made heart rate monitor chip and insert it into our watch. Flex circuit boards cost about $0.60/ piece. For one watch about two- three circuit boards will be needed ($1.80). Currently, professors at UCSD have been the only ones to develop the electrochemical ethanol sensor that utilizes sweat. The price of the technology can not be determined as of yet. To account for the development of this technology we will factor in about $50. Manufacturing the product will involve labor which we will price at about $8.50 an hour. In total the watch will cost about $120 to make.

Sales Price
The sales price that we have decided on is $200 USD. Looking at similar products and looking at the cost to manufacture our product, $200 is a fair price with room to still make money. The market for a product of this sort is vast with a lot of potential for success.

Market Size
The size of this market is all dependent on who would be interested in purchasing this product and whether or not it's worth what it's being sold for. This market consists of anyone who wants to know their blood alcohol content for personal reasons or just someone trying to be cautious about their alcohol consumption. Another use for this product would be for someone recovering from alcoholism or in some cases, someone who has recently received a DUI and is not allowed to be drinking, and forced to wear it by law as a monitor. The market size will be about $600 million because our target market consists of about 3 million people and our average sales price is $200.

Fundability Discussion

Criteria:Score:Reasoning:
Customer Validation3By making a device that can be both inconspicuous and affordable, people sure to use it for safety and personal reasons.
US Market Size3Devices like ours don't yet exist so there currently isn't a market of devices like this. However in a population where approximately 70% of adults are reported to consume alcohol at least once per year, this could possibly result in a market size of well over $500 M.
Competition2There are a very small number of competitors in this field and none of them have sold any products
IP Position2Measuring blood alcohol content can be done in a way that doesn't interfere with other patents that already exist.
Technical Feasibility3Technologies required for our device have already been proven to work
Clinical Feasibility3Success of clinical trials seem likely with little to no risk to the users of our device.

Overall, we would support the funding of this device because, even without a rating in the Regulatory Pathway a Reimbursement criteria, our device receives a fundability score of 324.

Work cited:
Alcohol facts and Statistics, National Institute on Alcohol Abuse and Alcoholism. Retrieved September 20, 2016, from https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-facts-and-statistics

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