The device we have decided to create is a sock for people with diabetic neuropathy. Since people with this condition lose feeling in their extremities, and diabetics are usually at a greater risk for infections, we thought there must be a way for these people to become notified of any skin breaks or blisters early on in order for the chance of infection to lessen. To solve this problem in the feet, we have come up with an idea for a heated sock with the ability to detect plasma in blood. It will look like a normal sock on the outside, and possibly feel like one along the top and sides. On the inside of the sock, the bottom base will be coated in a polymer as a foundation for the technology to rest in and on top of. There are 7 microfluidic biosensors placed strategically on the ball, heel, and outer side of the bottom of the foot. Connecting these sensors will be almost imperceptible microwires, which will lay within the polymer base as to not get damaged by the day to day motions of the persons wearing the sock. Finally, the sensors will be encased in a gel like substance made of breathable material through which the plasma will travel.
Technical and Clinical Feasibility
Technical Feasibility
The materials needed for the diabetic neuropathy sock are a flexible microfluidic sensors, gel with which to protect and encase the sensors, microwires, wool sock, and a heating device. The flexible microfluidic sensors have already been made in a lab, however they detect sweat. Our group’s device will detect plasma released from blisters and blood. The gel is simple to create for this device, and the microwires are very cheap and are abundantly on the market. The sock is basic wool sock that can be made for under two dollars USD, and the heating device is also rather inexpensive and easy to make.The challenges involved in making this device are simply making it cheap and effective. The microfluidic sensors also must be changed to detect plasma instead of detecting sweat. Also, creating a way to detect plasma even when the sensor has been broken by an outside object will be a challenge. The gel must be breathable allowing sweat and blood to pass through; if the gel is not breathable, cuts are more susceptible to infection due to the moist conditions. Placing the sensors strategically is a challenge, because the sensors must detect a cut anywhere on the foot. The heating sock must be made thin and a good size so the sock fits comfortably inside any type of shoe. This device must be comfortable, however the patients lacking feeling in their feet helps us out in this aspect a bit.The sensors could lose connection with the phone when broken and become dysfunctional, instead of alerting the user that the gel has been cut. Also, the heating pads could mess with the microfluidic sensors and make them dysfunctional. It is also possible the blood could leak out of the breathable material before it is ever scanned by the sensor.
Clinical Feasibility
The technical feasibility is pretty high. The technology already out there leads us right to the product that we are trying to build. If we put the time and effort into making sure the product is highly reliable and effective, then we should have no problem with clinical trials. The product should work just fine, and if there are some failures in material it should not be very hard to make corrections until perfected.There is a risk of electrocution, however the research labs developing the sensors reported no issues with breaks. Also, the charge running through the sensors is very minimal and is not the least bit worrisome. The only other risk possible, is an influx in heat that is too much for the body to handle. However, while designing this product we will pay special attention to keeping heat to a minimum will also making it effective. No similar products have gone through a clinical trial. Our products most similar product is the sweat sensing microfluidic sensor patch. However, this product has only been done in a research lab and has only undergone initial clinical trials. There is one product that is a microfluidic device rather than a sensor that has gone under a clinical trial, but the use for this device is very different. This device studies the development of embryos in what is known as a Smart System. The clinical trial lasted one year.
Market Analysis
Value Creation
The prototype has a very large value to the customer, and can prevent many complications. The payoff for this product is huge, and is definitely a product that improves the quality of life (every biomedical engineer’s dream). This product prevents the need for antibiotics due to infections, and eliminates the option of amputation. This is a huge benefit to the lives of diabetic neuropathy patients; also, this product improves circulation through the application of heat, and limits the likelihood of infections even further by improved circulation. The gel is also tough to break through, so the sock provides as a protective material from outside objects.
Manufacturing Cost
The self heating sock is already on the market, and costs 9 dollars for a pair that covers the ankles. The microwires in the sock that detect the breakage are going to be made cheaply using a conductive film. This film is going to be in small symmetrical lines on the bottom of the foot, which virtually covers the whole foot. The cost of the roll of conductive film is 195 dollars per 64,800 square inches. The film cost per sock is calculated by the film price divided by the average foot size which is 31.5 square inches. This price comes out to 10 cents per sock, or 20 cents for the pair. As far as the sensor and gel go, the product has not hit the market. However, the creator of the flexible microfluidic device hopes to hit the market with four dollar sensors. To cover the foot effectively our device will have 7 sensors on the bottom of the foot. If we buy in bulk directly from the seller we can cut the cost of all of these single items by at least 10 percent. This places the cost of our device hover around 58 dollars.
Sales Price
To put a price on the device that both optimizes the amount of buyers, and the greatest profit by the creator of this product, the price should be five times the cost of production. That price settles at around 275 dollars. Obviously that price seems ridiculously high. However, with the correct medical insurance codes, the price could become very affordable.
Market Size
Market Size = (275 X 0.05 X 30 million) = 412,000,000
Fundability Discussion
Fundability Chart Scores:
Costumer Validation: 1
Market Size: 2
Competition: 3
IP Position: 2
Technical Feasibility: 2
Regulatory Pathway: 1
Clinical Feasibility: 2
Reimbursement: 1
Should It Be Funded
Using the fundability worksheet, the product does not seem to be appealing. Because of this, the product probably should not be funded. However, the payoff for this product is beyond astronomical, especially in the near future. Diabetes is on the rise, and the price of these sensors will become increasingly cheaper. The market size will increase dramatically, and the price will fall making the likelihood of buyers purchasing multiple pairs increase. The future of this product should be taken under consideration, and funded a great amount.
purchase and/or are willing to invest
BME 100 Fall 2017
