BME100 f2016:Group13 W1030AM L2

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Contents

OUR TEAM

Name: Corey Miles
Name: Corey Miles
Name: Ricardo Dominguez
Name: Ricardo Dominguez
Name: Your name
Name: Your name
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LAB 2 WRITE-UP

Device Image and Description



The device is going to be a circular wristband that is covered with flexible rubber material for the comfort of the user. The reason that the design is so simple is so that it is appealing but not in the way of the user. Our design looks like a FitBit, which is an extremely popular and aesthetically pleasing design. The device will be lightweight and designed so that the user soon forgets that he or she has the device on his or her wrist. In order for the device to work most efficiently, the device will have to be elastic and will firmly fit on the wrist of the user. The reason for that is so that the device is tight enough to detected tremor changes and enforce actions in order to counteract it. This will also give the user less temptation to take his or her device on and off, or to constantly change the tightness of it. Due to the the band being elastic, we will ensure that the device is not too tight by making the device available in multiple sizes including: extra small, small, medium, large, and extra large. The hump in the middle will be elastic and will form to the wrist of the user. This is the sensor that will both detect and counteract the tremor.


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Technical and Clinical Feasibility

Technical Feasibility - 1
a. What are the technologies needed?

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
a. Will it work in the clinic?

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 Analysis

Value Creation
There are several factors that would contribute to the cost of making a prototype. First, and most costly, proper programming for the device is a necessity. A special sensor would have to be created to distinguish regular hand movements from a tremor. Luckily, the advanced motion detectors in iPhones could be a starting point for programmers, decreasing costs. There also needs to be programming that would transform tremor detection into vibrations that would stabilize the patient's hand. This can cost anywhere from 150,000 to 1,000,000 dollars. The actual design and aesthetics would be relatively inexpensive to create since it would be a simple, sleek design that would resemble a sort of fitbit. Since similar technology that the product is based off already exists, no research is needed; programming would be the largest cost of value creation. The value of this product is that it would be suitable for living; other options such as the stabilizing spoon and glove are not wearable at all times and not suitable for all tasks. The light bracelet design, on the contrary, would be easy to wear and utilize for various daily activities. The technological value of this product is that it can determine what kind of vibration is needed to stabilize the hand based off of movement detection, which means it can work for all types of hand movement not just tremors. This would be the first stabilizing product targeted for not only those who have Parkinson's or very intense tremors, which widens the market greatly.


Manufacturing Cost
We predict that the cost of this device would be similar to the Fitbit ($17.95), but with a more advanced motion sensor and processor, similar to what an iPhone($242) has, which would increase the manufacturing cost to more than a Fitbit. The cost of an apple processor is $37 according to an i-phone 6 cost breakdown. The materials would cost no more than a few dollars, same with the battery. The next highest costs would be the sensor and the mechanism which sends the vibrations. The combined costs of these technologies and materials that make up the device could range from 50 to 75 dollars approximately. Teardown.com. "Apple IPhone 6 Teardown." Apple IPhone 6 / 6 Plus Teardown. N.p., n.d. Web. 07 Sept. 2016

Sales Price
Since the product is considered to be a medical treatment and targeted for high end professionals, we can increase the price than that of a Fitbit($99). The manufacturing cost is higher as well, which attributes to the sale price of 200$. This would give the company a margin between 62.5 and 75%.

Market Size - 1
One million people are affected by Parkinson's disease and doctors diagnose sixty thousand new cases each year. This alone is a two hundred million dollar market. One in five people over the age of sixty five according to Medtronic have some degree of tremors, whether it's mild or as intense as Parkinson's. In the United States, there are 41,600 surgeons, 100,000 dentists, and many other professions that would consider using this device. Overall, we can estimate that the market size is two hundred thirty million. "29-1067 Surgeons." U.S. Bureau of Labor Statistics. U.S. Bureau of Labor Statistics, n.d. Web. 07 Sept. 2016 "29-1021 Dentists, General." U.S. Bureau of Labor Statistics. U.S. Bureau of Labor Statistics, n.d. Web. 07 Sept. 2016.




Fundability Discussion

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.

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