BME100 f2017:Group15 W0800 L3: Difference between revisions

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(New page: =OUR TEAM= {| style="wikitable" width="700px" |- valign="top" | 100px|thumb|Name: Megan Koehler | [[Image:BME103student.jpg|100px|thumb|Name: Cade Montplaisir...)
 
 
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=LAB 2 WRITE-UP=
=LAB 3 WRITE-UP=




==SolidWorks Image==
==Descriptive Statistics==
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<nowiki>[[Image:BME100WG15_PCRsetup.JPG‎|200px|Description of image]]</nowiki>
'''Heart Rate (Ox vs Spree)'''<br>
{| class="wikitable"
|-
! Calculation
! Pulse Ox
! Spree
|-
| Mean
| 98.0897
| 98.9537
|-
| Standard Deviation
| 23.0305
| 24.8775
|}


http://www.openwetware.org/wiki/Image:BME100WG15_PCRsetup.JPG
Pearson's r Coefficient: 0.4772<br><br>


<br><br>
'''Temperature (Oral Thermometer vs Spree)'''<br>
 
{| class="wikitable"
==Description of Prototype==
|-
Our prototype is an ultrasound transducer probe with a detachable head. The remote itself is ergonomic and should contour the hand of the user to minimize discomfort for the administrator of the ultrasound.
! Calculation
! Oral Thermometer
! Spree
|-
| Mean
| 96.6472
| 95.53086
|-
| Standard Deviation
| 1.922602
| 0.87037
|}
Pearson's r Coefficient: 0.0372<br><br>


==Inferential Statistics==
The statistical analysis test that was used for both sets of data (heart rate and temperature) was a two-tailed t test. This test is the most effective test at determining if there is a difference between two sets of data which was the purpose of the experiment. The p-value for the heart rate t test was 0.4271 and the p-value for the temperature t test was 1.09676X10^-21


<br><br>
<br><br>


==Technical Feasibility==
==Graphing==


'''What are the technologies needed?''' <br>
[[Image:BME100WG15 sp1.0 PCRsetup.jpg|800px|Description of image]]<br>
The technology of ultrasound is already invented and exists so we do not need to create a new technology. However, we need to make sure that we up the frequency 50-200MHz to make sure that we are causing the stimulation required. The only piece of the ultrasound that we are trying to alter is to create a removable head instead of the existing option. The existing option requires the probe to be either thrown away after every use or to be sent away and cleaned. These would then be sent back to the hospital or clinic to be reused.<br><br>
<br>
'''What are the challenges?''' <br>
One challenge is being able to have the higher frequency working in the technology. Not all existing ultrasound machines are capable of the high frequency we are requiring. Another challenge would be ensuring that the removable head works just as well or even better than the existing non-removable heads.<br><br>
'''What could go wrong?''' <br>
The removable head could possibly cause the technology to be less effective and ultimately not work as well as just having the non-removable head-- causing it to be even more expensive than keeping the non-removable head. In addition, the removable heads could not be compatible with the technologies the clinics already have. Another thing that could go wrong is the removable heads not being more sanitary than what already exists.<br><br>


==Clinical Feasibility==
[[Image:BME100WG15 BG1.0 PCRsetup.jpg|800px|Description of image]]<br>
'''Will it work in the clinic?'''<br>
<br>
This ultrasound would most likely be used in a clinic specialized to neurological problems rather than a free clinic or a general clinic. This ultrasound would be highly specialized if placed in a free clinic as this is more for people who are already diagnosed with a brain condition rather than diagnosing a problem.<br><br>
'''What are the clinical risks?'''<br>
There is a risk that the heads can be too broad or too narrow which has the potential to target the wrong areas of the brain which might have an affect. In addition, the removable heads might end up delivering the wrong frequencies than what was desired. <br><br>
'''Have similar products been in a clinical trial? How long was the trial?'''<br>
1)Focused Ultrasound Thalamotomy-13 months<br>
2)Blood-Brain-Barrier Opening Using Focused Ultrasound With IV Contrast Agents in Patients With Early Alzheimer's Disease (BBB-Alzheimers)- December 6, 2016-present (ongoing)<br>
3)ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders- September 26, 2014-December 2017


<br><br>
[[Image:BME100WG15 sp2.0 PCRsetup.jpg|800px|Description of image]]<br>
<br>


==Fundability Worksheet Scores==


[[Image:BME100WG15 BG2.0 PCRsetup.jpg|800px|Description of image]]<br>
<br>


==Summary of Results==
'''Heart Rate'''-
There is not statistically significant evidence that the Spree device works any better than the Pulse Ox (they work about the same) because the paired t-test results in a p-value of 0.4271, which is much greater than the α-value (significance level) of 0.05. This is reinforced by the fact that the correlation coefficient is 0.4772, signifying that there is not a strong correlation. In conclusion, for heart rate,  the Spree device is not any better than using the Pulse Ox, they give relatively similar results. <br><br>


'''Technical Feasibility'''<br>
'''Temperature'''-
We gave technical feasibility a score of 2 because, while ultrasound technology exists, there is less available data when it comes to using the technology for high frequency. It is unclear how the crystals will work within the removable heads.<br><br>
There is statistically significant evidence that Spree does not work better than the Oral Thermometer because the paired t-test results in a p-value of 1.0967x10-21, which is much lower that the α-value (significance level) of .05. This is confirmed by the correlation coefficient being 0.0372, signifying that there is not a correlation. In conclusion, for temperature, the Spree device does not work better than the Oral Thermometer, in fact, the Spree values were very off.
     
'''Clinical Feasibility'''<br>
We gave clinical feasibility a score of three because there are already trials which have been mainly successful in the ones that have concluded. It is a new technology and therefore there are still trials occurring but so far the tests have been going well. <br><br>
 
==Value Creation==
The value in the transducer comes from the option to have removable heads. This allows for the customer to change delivery of the ultrasounds on the fly, in addition it allows for a much cheaper and easier way to clean. Our device also creates value to the customer by not being invasive. Deep brain stimulation surgery can cost patients upwards of thousands of dollars whereas a procedure using an ultrasound would be much cheaper.




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<br><br>
<br><br>


==Cost to Manufacture==
==Experimental Design of High Frequency Ultrasound Probe with Detachable Head==
Much like the Spree v. the Gold Standard experiment, we would need to test our device, removable heads for high frequency ultrasounds, against the non removable heads that are already being used. We would set up a paired t-test to make sure the frequency of our prototype matches the frequency given off by the gold standard. The parameters for this test would be testing our prototype, at each frequency between 50 to 200 MHz, against the gold standard 50 times (50 paired machines), repeating this exact set experiment 10 times to make sure the data is reliable and valid. This experiment should also have our prototype tested against multiple ‘gold standards’ because of the devices out there, there are multiple types of high frequency ultrasound machines. We would want to see a correlation coefficient of close to one with a p-value above the significance level, which is the α-value. We would want to see that our prototype works just as well as the gold standard, so that we have evidence that our prototype works just as well but is cheaper and more convenient for use, since having a removable head will make it easier and cheaper to use high frequency ultrasound devices rather than having a non-removable head that can only be used once (or be expensively cleaned). A second experimental design would be testing to make sure the removable head hits the exact same target area as the gold standard. <br><br>


The cost should be roughly around $500-750. This cost comes from the highly precise nature of transducer arrays and the need for the crystals found in the probes required to elevate the sound waves to frequencies required for deep brain stimulation and the sensors that detects the signals. Another added cost is making the head removable and able to still be effective.
The final experiment would have to be testing the device for deep brain stimulation. Rather than having a paired t test experiment, there would have to be two separate experimental groups to test for a placebo effect and therefore it would be an independent t test. Four groups of about 50 individuals with Parkinson’s Disease each will be used. Before the tests, a model for Parkinson’s needs to be developed. To accomplish this a test of hand control will be used on each individual. Each person will have a metal hoop around a wire that has curves in it. When both the hoop and wire touch an electrical current that can be detected (and not harmful) can be recorded. Each of the three groups’ scores will be averaged. One group will have deep brain stimulation, one group will have ultrasound stimulation, one group will have no stimulation, and one group will have a turned off ultrasound “give” them stimulation. The last group is to make sure there is no placebo effect. The test mentioned earlier will be performed by the individuals on a regular basis (probably every week) after stimulation. After so many weeks, the results will be graphed. In order for our probe to be “successful” an ANOVA test will determine whether the hypothesis is right or not.




<br><br>
==Sales Price==
The average sale price (ASP) should be roughly $2250 for a set of a single transducer and a few probes. The ASP for our product comes from the ASP of many ultrasound probes that are already on the market without much deviation. While our product does have its advantages, such as the various heads for use, it is not enough of a separate entity to warrant any noticeable fluctuations in price.


<br><br>
<br><br>


==Market Size==
The initial market size for the ultrasound brain stimulation is about 386,000,000. $625 x 0.05 x 386,000,000 = $12,062,500,000 (sale price x penetrance x number of customers)
<br><br>
==Overall Fundability==
Based on the fundability worksheet, our prototype should be funded. The deep brain stimulation market size is significantly large enough to keep the product active in the market. The price of the ultrasound probe is reasonable, especially when compared to other probes, while still maximizing its efficiency, portability, and disposability. Ultrasounds are not a new technology and have been proven to be successful and reliable devices. With that in mind, clinical feasibility should not be a problem for our probe. Any physician, doctor, or trained medical staff will know how to operate this device and there are no age requirements for the patients this probe will be used on.<br><br>
{| class="wikitable"
|-
! Score
! Criteria
|-
| 2
| Customer Validation
|-
| 2
| Market Size
|-
| 2
| Competition
|-
| 1
| IP Position
|-
| 2
| Technical Feasibility
|-
| 3
| Regulatory Pathway
|-
| 3
| Clinical Feasibility
|-
| 2
| Reimbursement
|-
| 288
| Total
|}





Latest revision as of 22:20, 27 September 2017

OUR TEAM

Name: Megan Koehler
Name: Cade Montplaisir
Name: John Navas
Name: Samuel Ramirez
Name: Julia Raub

LAB 3 WRITE-UP

Descriptive Statistics

Heart Rate (Ox vs Spree)

Calculation Pulse Ox Spree
Mean 98.0897 98.9537
Standard Deviation 23.0305 24.8775

Pearson's r Coefficient: 0.4772

Temperature (Oral Thermometer vs Spree)

Calculation Oral Thermometer Spree
Mean 96.6472 95.53086
Standard Deviation 1.922602 0.87037

Pearson's r Coefficient: 0.0372

Inferential Statistics

The statistical analysis test that was used for both sets of data (heart rate and temperature) was a two-tailed t test. This test is the most effective test at determining if there is a difference between two sets of data which was the purpose of the experiment. The p-value for the heart rate t test was 0.4271 and the p-value for the temperature t test was 1.09676X10^-21



Graphing

Description of image

Description of image

Description of image


Description of image

Summary of Results

Heart Rate- There is not statistically significant evidence that the Spree device works any better than the Pulse Ox (they work about the same) because the paired t-test results in a p-value of 0.4271, which is much greater than the α-value (significance level) of 0.05. This is reinforced by the fact that the correlation coefficient is 0.4772, signifying that there is not a strong correlation. In conclusion, for heart rate,  the Spree device is not any better than using the Pulse Ox, they give relatively similar results.

Temperature- There is statistically significant evidence that Spree does not work better than the Oral Thermometer because the paired t-test results in a p-value of 1.0967x10-21, which is much lower that the α-value (significance level) of .05. This is confirmed by the correlation coefficient being 0.0372, signifying that there is not a correlation. In conclusion, for temperature, the Spree device does not work better than the Oral Thermometer, in fact, the Spree values were very off.




Experimental Design of High Frequency Ultrasound Probe with Detachable Head

Much like the Spree v. the Gold Standard experiment, we would need to test our device, removable heads for high frequency ultrasounds, against the non removable heads that are already being used. We would set up a paired t-test to make sure the frequency of our prototype matches the frequency given off by the gold standard. The parameters for this test would be testing our prototype, at each frequency between 50 to 200 MHz, against the gold standard 50 times (50 paired machines), repeating this exact set experiment 10 times to make sure the data is reliable and valid. This experiment should also have our prototype tested against multiple ‘gold standards’ because of the devices out there, there are multiple types of high frequency ultrasound machines. We would want to see a correlation coefficient of close to one with a p-value above the significance level, which is the α-value. We would want to see that our prototype works just as well as the gold standard, so that we have evidence that our prototype works just as well but is cheaper and more convenient for use, since having a removable head will make it easier and cheaper to use high frequency ultrasound devices rather than having a non-removable head that can only be used once (or be expensively cleaned). A second experimental design would be testing to make sure the removable head hits the exact same target area as the gold standard.

The final experiment would have to be testing the device for deep brain stimulation. Rather than having a paired t test experiment, there would have to be two separate experimental groups to test for a placebo effect and therefore it would be an independent t test. Four groups of about 50 individuals with Parkinson’s Disease each will be used. Before the tests, a model for Parkinson’s needs to be developed. To accomplish this a test of hand control will be used on each individual. Each person will have a metal hoop around a wire that has curves in it. When both the hoop and wire touch an electrical current that can be detected (and not harmful) can be recorded. Each of the three groups’ scores will be averaged. One group will have deep brain stimulation, one group will have ultrasound stimulation, one group will have no stimulation, and one group will have a turned off ultrasound “give” them stimulation. The last group is to make sure there is no placebo effect. The test mentioned earlier will be performed by the individuals on a regular basis (probably every week) after stimulation. After so many weeks, the results will be graphed. In order for our probe to be “successful” an ANOVA test will determine whether the hypothesis is right or not.







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