BME100 f2016:Group5 W1030AM L2

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Contents

OUR TEAM

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LAB 2 WRITE-UP

Device Image and Description



Image:BME100WG5_Stroke1.JPG This device would wrap around the top part of the ear and the circular extruded part was be placed on the vein to measure blood pressure. the extruded part would also have adhesive applied so that it can stick to the skin easily. When the patient has a stroke, or showing symptoms of a stroke monitored by the device, then it would release a dose of warfarin to clear any blood clots that the user may have. Because of that, it solves our overall issue of preventing strokes.

Technical and Clinical Feasibility

Technical Feasibility

Two wave sensors to determine blood pressure coming in and out of the brain. Also an alarm and a GPS system is needed to alert the authorities when there is a stroke so that they will be able to get there quickly. It would also have to be waterproof to withstand the elements. Also a battery would be needed. Solar battery could also be an option so that the battery would not have to be replaced. Warfarin injection to stall the effects of a stroke until authorities arrive.

Challenges

Not very appealing to wear and may be an annoyance to wear. Getting accurate readings and battery life. Also, it way have some difficulty getting past the FDA.There could be a malfunction and alert the authorities mistakenly. External damage to the device might cause device failure or bodily harm. If someone is exercising it could cause false reading of information. If placed in the wrong spot it could cause complications such as false readings. Also, you may get injected with the Warfarin without actually needing it and could cause some major problems.

Clinical Feasibility

It would be simplistic to install onto someone in a clinic because it wraps around the ear and you install it externally.

Clinical Risks

If someone is allergic to any of the material of the sensor. The sensor could also malfunction and may cause harm because of inaccurate readings. Also, it could potentially give false readings and lead to problems such as alerting the authorities of danger when the is none or if it does not alert the authorities of when a stroke does happen. Accidental injections could also happen due to false readings. Any side effects from warfarin could cause harm.

Similar devices

There is a watch(Mesh Network Stroke Monitoring Appliance) that asks several questions to the client if there are having a stroke. For example, it may ask if you are feeling dizzy or it may ask you to squeeze something and it will determine if you have a stroke or not. Another similar product

Market Analysis

Value Creation

The value we would be creating for the consumer would be that they would be receiving medical attention faster and decrease the damage of the stroke. According to Lenora M. Maze's article called Factors Associated with Hospital Arrival Time for Stoke Patients, she stated that only 28.9% of patients arrive at a hospital within 3 hours of having the first warning signs and and average arrival time of 5.5 hours. http://www.medscape.com/viewarticle/481393

Manufacturing Cost

Carbon fiber costs around $10-$12 per pound according to plasticnews.com. For the sensor, we could use the Omron BP652N Automatic Wrist Blood Pressure Monitor which costs $70 unit. For the GPS, we could use something similar to the GPS kid Tracker Smart Wristwatch which costs around $60. For batteries, we could use Energizer Battery - CR2016 - Li 90 mAh which costs about $5 for 2. According to healthline network a single dosage of warfarin would cost around $4. For waterproofing we could use a spray from yachtingworld.com that costs $30. To manufacture the product, we can manufacture it in China because of the reduced cost of labor, however there may be some shipping costs associated with it. In total it would cost approximately $130 to develop.

Sales Price

Since this is still a relatively new product, we could sell it for around $299.99 because we have the manufacturing cost at around $130. The product cannot be too pricey because of other possible competitors. Then we would be able to make a profit of $169.99 from each unit. From then on, the sales price of the device could increase as profits are made and cost of development and parts will decrease thus decreasing the price of the device.

Competition

Our primary competitor for our product would be Life Alert. With life Alert you simply press a button where you are in danger and it alerts the authorities immediately. However with the cost of Life Alert, it costs around $95-$115 to install and a monthly cost of $29.95 a month. Also with Life alert you are required to gave a 3 year contract with them. http://medicalalertsystemshq.com/reviews/life-alert-review.html

Market Size
According to the cdc.gov, more than 795,000 people in the United States have a stroke so we would be catering to that population. Out of the 795,000 people, 600,000 of them are first time stroke patients while 195,000 people have already had a stroke before. Those people who have had a stroke before increase their chances of having another stroke by 40% within in the next five years. If another stroke occurs, there is a higher rate of damage to the brain or even death because there is already damage to the brain from the first stroke.

Fundability Discussion

Technical Feasibility

2 because the technology is there with the sensors, the GPS, batteries, and the injection with the Warfarin. There will be some challenges to overcome, such as getting accurate measurements at all times and not having any malfunctions with the injection or the alerting of the authorities.

Clinical Feasibility

1 because there will need to be extensive trials and research with using the Warfarin drug to stall the effects of a stroke when the patient is waiting for the authorities to arrive. A clinical trial similar to our medical device is endovascular ischemic stroke intervention. In that trial, it is still at its early stages in development, as it ran into a few problems. Such problems include: limited time for treatment, safety, and "complex technology in a delicate end organ" according to the U.S. National Library of Medicine National Institutes of Health.

Market Size

2 because with the number of annual stroke victims at approximately 795,000 people a year according to cdc.gov and our selling price for our product at $299.99 we would be making a revenue stream of $224,992,500.

Fundability

When the numbers were scored for the fundability worksheet, our product received a 72. It should funded because competition is fairly low and people with strokes are susceptible to having strokes again which makes it pertinent to have preventative measures as some reoccurring strokes could lead to disabilities or even death. Also, the materials used to create this product are fairly simplistic which include, but not limited to: carbon fiber, blood pressure monitors, and energizer batteries.


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