BME100 f2016:Group13 W1030AM L2
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LAB 2 WRITE-UP
Device Image and Description
Technical and Clinical Feasibility
Technical Feasibility - 1
Current technologies on the market should prove to be sufficient for the composition of the prototype. Necessary technologies would include a battery, accelerometer, gyroscope, storage component, flexible material, and a central processing unit. There are various options for compact, long lasting, and powerful batteries such as: Li-Ion, NiMH, and solar. There are also comparable devices used for electrical pulse therapy; Our device is distinctive from other products because of the use of accelerators and automation to counterbalance tremors. For the convenience and observation of the patient, and SD device will also be inputted to the device to record data. Comfortability is also a component when creating a device that the customer will constantly be wearing. The final production model may need slightly smaller components in order to make it more aesthetically appealing to the patient.
b. What are the challenges?
The device's biggest challenge will be generating an energy pulse big enough to affect and treat the tremors without causing harm to the individual. Another obstacle will be programing the accelerometer to detect the difference between tremors and the patient's normal movements. Since the device is specific for everyday use, it must be able to submerge fully under water as well as have an efficient battery life, bringing up questions such as: how the device will charge, how long will it remain charged, what temperatures can it withstand, etc.
c. What could go wrong?
The device could be uncomfortable for patient use because of the constant electrical shocks. It’s performance needs to remain optimal despite everyday “wear and tear.” The battery may not last long enough to be competent. Additionally, the device may be too big or too cumbersome, getting in the way as more of a nuisance, rather than being helpful. Electrical shocks could be administered too intensely, resulting in more involuntary movements, discomfort, or pain.
d. What would this device receive for technical feasibility?
Our product would receive a one for technical feasibility. While the there are pre-existing components on the market that would enable us to make the device, the ultimate goal of having a light weight and non burdensome product could be hindered by the size and weight of these preexisting technologies. The device might also be held back by the accuracy of the accelerometer, battery life, and ability to counteract the tremors.
Clinical Feasibility - 2
The device will work in the clinic for many different reasons. First, when patients come in with tremors of any sort, the device will be able to detect and counteract the tremor. This will help the patients perform tasks that they may not have been able to complete previously. This will be a great advantage to the clinical setting because all the patient has to do is put on the device and the tremor will be eased. Instead of taking medication as the clinical setting does now, the patients will be able to easily put on a wristband. The way that it will be used in the clinic is that the patients will come in and tell the physician they need their tremor to be fixed. Once the physician knows that the patient has the tremor, all they have to do is put the wristband on the patient(s) and the tremor will be minimized.
b. What are the clinical risks?
Due to the device being non-invasive, there should be no clinical risks in regards to causing internal harm to the user/patient over time. The only clinical risk the device could pose would be if the user is allergic to any of the material that the device is made of. In comparison to medication, this device will have significantly less side effects during its use. Most medications intended to help with tremors tend to cause instability, dizziness, and even nausea, whereas this device aims to be as risk-free as possible.
c. Have similar products been in a clinical trial? How long was the trial?
There is a device that contains sensors which attach to the patients’ skin and detects the motor skills in Parkinson’s patients. The way that they performed their trials included containing the patients in a room while videotaping them. For this trial, they used twenty-four individuals and did two, four hour recordings each day. One recording was in the morning, while the other was at night. They did this for five consecutive days. This clinical trial was of twenty- four patients. This seems to be a rather quick clinical trial lasting only one year. US National Library of Medicine Nation Institutes of Health. "" A System for Monitoring, Assessment and Management of Patients with Parkinson's Disease", np, nd, 15 Sept. 2016. This is dealing with the same clinical group as ours, but our device will be going a step beyond theirs. Not only will ours detect the motor skills in the patients, but it will also try to counteract it. Therefore, I expect our clinical trial to be a bit more extensive. Another trial that is similar to ours is a study that examines and calculates the safety and feasibility of electrical muscle stimulation in order to help tremors. This trial just started in February of 2015 and goes until May of 2017. The way that they will be determining this is by giving the 60 patients electrical muscle stimulation in their most tremulous hand for ten seconds. After this is performed, data will detect if the tremor was eased. I am assuming that the reason the clinical testing will take so long is not just because of the testing itself, but also getting sixty individuals to take part in the clinical trial. We will not be doing muscle stimulation, but instead vibrations. I do not foresee the clinical testing being as extensive as this one, but will be similar since we are using vibrations to counteract the tremor. clinicaltrials.gov. "Development of Parkinson's Glove for Detection and Suppression of Hand Tremor", np. nd. Web. 14 Sept. 2016. Our biggest issue will be the clinical testing of the accuracy and efficiency of our device.
d. Clinical Feasibility on Fundability Worksheet:
As far as the clinical feasibility goes, our product would be scored a 2. First, our device does not have many risks in the clinical setting. The only risks are very minimal so that would be an advantage for clinical feasibility. Additionally, our clinical trials would take a while in order to get the accuracy and efficiency down but overall would not require as much regulations as other devices that are inserted into the body. Our device would also require special expertise and research in order to make the device work effectively. Our score would not be a 3 because there are not too many similar devices out there that would make an easy path for clinical testing. Therefore, our clinical feasibility would be scored as a 2.
Market Size - 1
Our team believes that the product would be hard to pitch when it comes to fundability. While in theory the device would help a lot of people, it has received an overall score of 16, not including scores for regulatory pathway or reimbursement. Although there is a fair number of comparable products, none are as wearable and as versatile as ours. However, the competition of devices using similar technologies targeted towards Parkinson's patients is one of the reasons for our low fundability score. Customer Validation is an important factor for comparability to current market products. Because our product is new, but not in the sense of new technologies, we have to give it a fundability score of 2. Our device works in a very different way from the others that are on the market, however, there are similar patents pending. For this reason we gave our IP Position a score of 2. As far as technical feasibility, our product faces many challenges despite the pre-existing components that the market has to offer. Our device could potentially be vetoed because it could lack the accuracy that is necessary for its internal hard-drive to perform optimally- making the technical feasibility a 1 according to the fundability worksheet. This device would be a great alternative for medications because it is a non-invasive device, but it would require a lot of expertise in making the function of the device perform to par. This brings our Clinical Feasibility score to a 2. The vast market size for our product makes it more feasible because it is a newer evolving technology.