BME100 f2017:Group16 W1030 L2

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Part 1 of Lab:

1. Design and draw your prototype in SolidWorks. Upload as an image and provide a brief description (including how addresses health issue) on Open Wet Ware.
   The skin patch shown above has sensors that can detect blood pressure changes and clotting. This information collected by the sensors can be used to determine whether a person is going to have a stroke. 

2. Determine the technical feasibility of your design. Include answers to the following questions:

a. What are the technologies needed?

-A skin patch made out of (tegaderm-similar material) on the outside of each carotid artery

-Sensors to measure the extreme change in pressure

-Sensors to let the person know when their pressure is very high (letting them know through their smart phone/watch.

b. What are the challenges?

-Getting it to stay on the skin without affecting the function of it.

-Creating something that small in size

-Making sure the sensors are accurately measuring the change in pressure

c. What could go wrong?

-The skin patch could not attach

-The patient could have an allergic reaction

-Inaccurate measurement of pressure

-Affect the function of the artery

-Sensors could not work

3. Determine the clinical feasibility.

a. Given the technical feasibility will it work in the clinic?

-It is a very feasible product because people can test this in a clinic and it is all external. If the patient does not want it, they can take it off. However, they will need to have it put on by a physician in order for them to get the correct placement and ensure all functions are working properly.

-There will be extra steps we would have to take because we want this device to be wireless. However, there has been a device made that is a patch and Bluetooth this was the one measuring the blood/alcohol level. We want to make our device Bluetooth as well, we know it is possible however we will need to do more research.

b. What are the clinical risks?

- It could not function properly

-The patient could have an allergic reaction to the patch (materials)

-False alarms/warnings of oncoming stroke

-The patch could fall off of the person or move to where its readings are inaccurate

c. Have similar products been in a clinical trial? How long was the trial?

-A device was created in which the blood alcohol content of a person was measured through their sweat.

-9 subjects were taken in and given alcoholic beverages, then the device was tested.

4. Using the fundability worksheet chart, determine the scores (0-3) for technical feasibility and clinical feasibility and provide support for scores.

Technical Feasibility: 3, the purpose of the device is straightforward, measuring changes in blood pressure in the carotid arteries. The way the device functions, which is externally through the placement of the device on the neck, is also simple and practical.

Clinical Feasibility: 2, a similar device has been made before to measure alcohol content in the body through sweat. We want this device to be Bluetooth so it won’t have any wires connected to it. This is what we will need to research because there has only been one patch that is wireless and successful.

---Part 2 of Lab:

1. What value does your prototype create for the customer? By creating this specific device, customers with a history of strokes or family history of strokes will be able to detect oncoming strokes. For physicians, family members and friends, this device will also be able to alert the device holder in time to contact emergency medical personnel as well as a family member/friend in the event that the device holder is unable to contact others for help. Increased pressure in the blood flow coming into the neck will alert the device holder of a possible blood clot in the body.

2. Determine the cost to create your design. Justify. The device will include sensors, a permeable film that will be placed on the skin, and a Bluetooth chip. The estimated total cost to make the device is $80.

3. What would be the anticipated average sale price (ASP)? Justify. $80*5= $400 The estimated total cost of production for one device is roughly $80, and assuming that the cost of production varies up to 5 times the anticipated cost, the price of the device would be close to $400 in order to obtain a profit.

4. Using initial market size analysis in Lab 1, determine the market size in dollars per year. Assume 5% penetrance of the market (Sales price X 0.05 X total market size). 400*.05*200 million= $4 billion The anticipated price of the device is $400 which is then multiplied by the assumed/possible market penetrance, 5%. That number is then multiplied by the market size, with the number being over 200 million people, including those who are genetically prone to strokes, those who have already suffered from one and the 800,000 who wi;; suffer from one in just a year.

5. Using the fundability worksheet, determine if your prototype should be funded. Justify why or why not.

-Market size: 2, the market size for this device is in the 200 million range. On average, 800,000 people in the United States suffer from a stroke per year, however, the market also includes people who are genetically inclined to suffer from a stroke and those who are susceptible to recurrent strokes.

-Competition: 2, because there are other devices similar to the design of this device, however, none of these devices measure changes in blood pressure about the left and right carotid arteries. In other words, the functionality of the device is what sets this device apart from its competitors as opposed to design.

-IP Position: 2, similar patents exist but none specifically to monitor blood pressure changes near carotid arteries.

-Technical feasibility: 3, the design of the device is simply a patch, which is easy to produce as well as place onto patients. There are no major or required procedures the patient must undergo in order to utilize the device.

-Clinical feasibility: 2, while the purpose of the device itself is easy to test, patients are also more likely to have to seek consults if the device is damaged or malfunctions.

-Regulatory Pathway: 1 (Scored for us), we will not actually be going through FDA approval for this device.

-Customer Validation: 1 (Scored for us ), we will not actually go out and present this device to customers (hypothetical device).

-Reimbursement: 1 (scored for us), we will not actually produce this device (hypothetical device).

*Total Score : 14 (out of 24 ). This device should be funded because there is potential for its success among consumers (~60% success rate, 14/24=58). In terms of the worksheet, the device scored fairly positive scores in all categories, however, in regards to consumer benefit, the value of this device is immeasurable. It provides the patient/consumer with a certain peace of mind and reasonable health security in any case involving a stroke.