LAB 2 WRITE-UP
Device Image and Description
The health issue we are mainly dealing with is disability resulting from stroke(though this could also logically work with any kind of brachial injury or impairment)
We are creating an affordable myoelectric brace that slides on over the affected limb and helps both move the arm and provide rehabilitation therapy. The way the brace differs from it's competition is in the way it works and the way its made.
The way it works is by having stick on, non-invasive surface electrodes pick up the weakened electric activity in the muscles and then having an amplifier magnify the signal it picks up and sends it to the motor (which is acting as the brain). The motor then provides assistance in moving the arm for the patient, and by repeatedly doing this helps form new connections in the neurons which has been shown to improve and help regain function. Eventually the arm could may be be able to move on it's own.
The electrode-amplifier combination takes the place of the high-price sensors our competitors are using.
The "brain" of the robotic arm sits on the bicep, the motor is by the elbow, and the electrode pads are on the forearm.The easy to open box that sits on the bicep area will hold the power source(a chargeable battery), amplifiers, and sensor board. There is a hole where the surface electrode wires can run up the arm and connect to the amplifiers. The cord that connects the motor to the sensor board will also run through the hole.
The way its made will be by 3-D printing out panels made of the same plastic used in Lego bricks(ABS plastic), and having those panels connected by strips of Velcro, so that the user can adjust it to fit their size, therefore eliminating the cost of multiple doctors, fittings, and consultations that are required with the super customized nature of competing devices
Technical and Clinical Feasibility
Our main challenge of our project is making it cheaper than other neuro-prosthetics in the market. We will make a design that is based on the generic size scale: small, medium, large. In doing so, the product needs to still be thin , comfortable, and strong. The materials we will need include ABS plastic, neuron sensors, and Velcro. Furthermore, we will need to find a motor circuit that is compatible for both the left and right arm. One major obstacle we want to avoid is breakage in the prosthetic arm, as well as any pain to the patient caused by the brace.
This product will be able to work in the clinic because it has already been seen in the market, we are just making it more affordable, more generic, and easy to size (we are doing this by making the basic S, M, L, and XL sizes). However, there are clinical risks that can happen with this product. These can include the brace not fitting the patient correctly or in fact hurting them in some sort of way. There also is a possibility that this brace can break over time due to the quality of the materials being used and the environment the patient will be wearing it in. In the past there has been similar products that have gone through a clinical trial, an example of one of these products is Myomo. Myomo has been running clinical trials for their myoelectric elbow/wrist/arm powered to help support patients since 1940. Another similar product that is on the market right now is the Dextrus Open Hand Project. Because this product is so new and the company has not totally started up yet, they are currently running clinical trials on their Open Hand Project through the company, Open Bionics.
The value created in our new product is that it is cost friendly. Our prototype will cost much less than the other similar products that are on the market right now. We have constructed a design with different types of materials and electrodes that allows this brace to be much affordable for patients who suffer from strokes. Another value for our product is that it is easy to replace as the patient grows up. The individual will keep getting bigger sizes as they grow up, or depending on when the stroke occurred. This again goes back to it being affordable for patients because the products already out on the market are only customizable, which means once a patient grows out of it or needs sizing redone, they would have to construct a whole new brace, which could get very costly. With our small, medium, large, and extra-large design sizes this allows for the generic sizing which means that the brace can easily be replaced with growth.
-$22.00 Arduino Uno Rev3
-$140 for 4 Muscle Sensor Surface EMG electrodes
-$2 for 6 ft. Velcro Straps
-$37.95 MyoWare Muscle Sensor
-$19.61/kg ABS plastic
-$47.85 CMRR Instrumentation Amplifier by Texas Instruments
Adding all of the items added up should amount to $282.41, not taking into account shipping and handling.
When looking at the prices of the competing devices on the market, whose prices start at $4,000(not including consultations and fittings), our device sits at an affordable price of $1,499.99. Since this item isn’t as customizeable as its competition, this item should be cheaper than the other devices, but still cost enough that we’re making a profit.
Market size in dollars per year would be $417,375,000.00. The way that was calculated was by taking the average amount of people that get a stroke per year (795,000) and then taking 70% of that number, which is the approximate percentage of victims who have impaired function after a stroke. Then we multiplied that by the price of our product and divided it in half(because realistically, not every single person will buy our product)
Using the fundability worksheet, determine if your prototype should be funded. Justify why or why not.
According to the fundability worksheet, I think our prototype should be funded. We have scored high enough in most of the categories that ensure our product to be different than those already on the market. Our product offers the same main function but in a more affordable, generic, and comfortable way. The market size for our product is high and with our new design it will be available in a timely manner.
We scored a
2 in Customer Validation
2 in Market size
2 in Competition
1 in IP Position
3 in Technical Feasibility
3 in Regulatory Pathway
2 in Clinical Feasibility
2 in Reimbursement