BME100 s2017:Group9 W8AM L1: Difference between revisions

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==Health Care Issue==
==Health Care Issue==


<br><br> Nasogastric tubes are used universally to both give food to patients and to drain the stomach. These tubes are effective but can pose a problem when they are used with children. Children do not typically respond well to tubes protruding from their face and so doctors are faced with the dilemma of forcing the children to not mess with their tubes. Pulling the tubes out of their nose can cause issues if the tubes were to scrape the throat or worse. In order to combat the children's ability to compromise their medical treatment an alteration must be made.
<br><br> Cancer is a treatable disease, if it is caught in its early stages. Many women develop no symptoms of their cancer until it has spread and it can be classified as a higher stage of cancer. Once cancer reaches stage 4 it is extremely difficult to remove the cancerous cells from the body and thereby it is likely that doctors will only be able to give the patient a small amount of time to live. In order to lower the mortality rates it is important to get tested early and often. The common way of testing for breast cancer is by use of a mammogram at a doctors office. Women are made to get tested The idea of this device is that women can take home a bra like device that measures the density of their breast tissue and changes over time. This device should be able to track changes in order to convince women to seek further tests.


==Customer Validation==
==Customer Validation==


<br><br>
<br><br> On average, one in every eight women will develop breast cancer, and is also the second most deadly cancer for women in the United States. Currently, women are encouraged to perform self examinations in order to catch breast cancer early, however, there is a stigma attached to these examinations and many women do not complete them. Additionally, women usually only get mammograms once a year because of the expense and hassle, leaving a long period of time for breast cancer to develop before being discovered. Women, especially those who are high risk for developing breast cancer, want, and need a way to test their breasts for cancer in a comfortable and reliable way that does not require them to go to the doctor. Mammograms also have a high percentage of false positives, therefore, having a device that can track the changes in a women's breast density would be both convenient and more personal, taking data on much more frequent intervals, allowing for the women to track the changes in their breasts. This could also have implications for pregnancy as well as determining the onset of menstrual cycles through analysis of the data collected from the home density tests. Physicians would support the device as well, since the more frequent data would make an early diagnosis more likely. The providers would also support the device, since more consistent testing and early diagnosis, which would save the insurance company a lot of money. The purchasers would be big biomedical engineering companies such as medtronic, since breast cancer is one of the leading causes of death for women, meaning that there is a large impact area for the device.


==Competitors==
==Competitors==
1.) Early breast cancer detection device (iTBra)
2.) Mammogram


3.) iBE (intelligent breast exam)


'''Advantages'''<br>  
'''Advantages'''<br>  
1.) Usage of heat-conductive web that measures breast temperature. It is portable, goes into the breast-receiving cups of a bra. It would display change in color when detected any abnormalities in the breast tissue. Self-examinations with the device can be made without any assistance from a medical professional.
2.) Detects breast cancer, doctor present to analyze information
3.) Detects breast cancer at home through sensory technology. The company claims that the test has an 85% accuracy rate and takes only 5 minutes. The device also utilizes an app on mobile devices.




'''Disadvantages'''<br>
'''Disadvantages'''<br>
1.) Temperature measurement may not be the best in detecting breast cancer. As it may not be the best in cancer deduction, medical professionals may not approve of it. Additionally, this device only detects breast cancer.
2.) This method requires the patient to go to a clinic, and it is expensive. Additionally, this process is painful, has a 60% false positivity rate, and 15-20% false negativity rate.


3.) Measuring with a handheld device could lead to user error and only breast cancer is detected.


<br><br>
<br><br>
Line 56: Line 69:
<br><br>
<br><br>


The patent landscape is fairly open for our product. There are some patents that are filed on bras that sense health parameters and gives feedback to the consumer. The status of these patents is pending. There are several active patents that are filed for devices that measure breast temperature and relate that to the probability of developing breast cancer. There aren’t any direct patents related to a bra that tests for breast cancer susceptibility. 
There is a potential risk for infringement with the bra that is used for cooling breasts after a thermography procedure. This bra is used after a woman has undergone a thermography used for breast cancer diagnosis. Since this bra is involved with a breast cancer procedure, there could be an infringement possibility. 
US15144691
Stress test bra
This bra is configured to cover a woman’s breasts while deploying a health sensor to monitor critical health information to inform the patient on stress levels. The signals can be sent to a device through a wire or wirelessly.
2016-05-02/
Pending
DE201210010355 Single-use breast holder for cooling breast for thermography recording to diagnose breast cancer of woman in e.g. hospital, has two plastic layers, where cooling liquid is made to flow between layers and passed from storage container
This bra employs a cooling liquid that is applied to a woman’s breasts after she has undergone a thermography, used for breast cancer diagnosis. The breasts are heated during this procedure and the woman puts on this bra to cool the breasts, after the procedure.
2012-05-25/ Pending
US09018765
Differential temperature sensor device for use in the detection of breast cancer and breast disease
This sensor device detects differential temperatures in a human breast. The pad is covered in an adhesive layer that allows it to remain in contact with the breast and the temperature sensor.
1998-02-05/ Active - Reinstated
US11405497
Therapeutic bra
This bra is used for reducing breast inflammation for a woman who recently underwent breast surgery. This bra is made up of a sports bra and has a hook and loop fastener.
2006-04-18/ Active
US09908294
Ultrasonic diagnostic imaging transducer with hexagonal patches
Ultrasonic imaging method that views the coronary arteries of the heart. A 3-D image is produced from the ultrasonic scanning and projected onto a screen, producing a picture of the coronary arteries.
2001-07-17/ Expires - 2020-11-21


==Fundability Worksheet Scores==
==Fundability Worksheet Scores==
Line 62: Line 107:


'''Competitors'''<br>  
'''Competitors'''<br>  
'''2''' Competitors exist but clinical improvements are still being sought




'''Customer Validation'''<br>
'''Customer Validation'''<br>


'''1''' Not enough customer feedback to-date


'''IP Position'''<br><br>


'''IP Position'''<br><br>'''2''' Issued patents, but weak





Latest revision as of 14:07, 31 January 2017

BME 100 Spring 2017 Home
People
Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3
Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6
Course Logistics For Instructors
Photos
Wiki Editing Help

OUR TEAM

Name: Jocelyn Alvar
Name: Emma Spencer
Name: Aswathy Lawrence
Name: Will Anderson
Name: Brett Nasch
Name: Anna Seminara

LAB 1 WRITE-UP

Health Care Issue



Cancer is a treatable disease, if it is caught in its early stages. Many women develop no symptoms of their cancer until it has spread and it can be classified as a higher stage of cancer. Once cancer reaches stage 4 it is extremely difficult to remove the cancerous cells from the body and thereby it is likely that doctors will only be able to give the patient a small amount of time to live. In order to lower the mortality rates it is important to get tested early and often. The common way of testing for breast cancer is by use of a mammogram at a doctors office. Women are made to get tested The idea of this device is that women can take home a bra like device that measures the density of their breast tissue and changes over time. This device should be able to track changes in order to convince women to seek further tests.

Customer Validation



On average, one in every eight women will develop breast cancer, and is also the second most deadly cancer for women in the United States. Currently, women are encouraged to perform self examinations in order to catch breast cancer early, however, there is a stigma attached to these examinations and many women do not complete them. Additionally, women usually only get mammograms once a year because of the expense and hassle, leaving a long period of time for breast cancer to develop before being discovered. Women, especially those who are high risk for developing breast cancer, want, and need a way to test their breasts for cancer in a comfortable and reliable way that does not require them to go to the doctor. Mammograms also have a high percentage of false positives, therefore, having a device that can track the changes in a women's breast density would be both convenient and more personal, taking data on much more frequent intervals, allowing for the women to track the changes in their breasts. This could also have implications for pregnancy as well as determining the onset of menstrual cycles through analysis of the data collected from the home density tests. Physicians would support the device as well, since the more frequent data would make an early diagnosis more likely. The providers would also support the device, since more consistent testing and early diagnosis, which would save the insurance company a lot of money. The purchasers would be big biomedical engineering companies such as medtronic, since breast cancer is one of the leading causes of death for women, meaning that there is a large impact area for the device.

Competitors

1.) Early breast cancer detection device (iTBra)

2.) Mammogram

3.) iBE (intelligent breast exam)

Advantages
1.) Usage of heat-conductive web that measures breast temperature. It is portable, goes into the breast-receiving cups of a bra. It would display change in color when detected any abnormalities in the breast tissue. Self-examinations with the device can be made without any assistance from a medical professional.

2.) Detects breast cancer, doctor present to analyze information

3.) Detects breast cancer at home through sensory technology. The company claims that the test has an 85% accuracy rate and takes only 5 minutes. The device also utilizes an app on mobile devices.


Disadvantages
1.) Temperature measurement may not be the best in detecting breast cancer. As it may not be the best in cancer deduction, medical professionals may not approve of it. Additionally, this device only detects breast cancer.

2.) This method requires the patient to go to a clinic, and it is expensive. Additionally, this process is painful, has a 60% false positivity rate, and 15-20% false negativity rate.

3.) Measuring with a handheld device could lead to user error and only breast cancer is detected.



IP Position



The patent landscape is fairly open for our product. There are some patents that are filed on bras that sense health parameters and gives feedback to the consumer. The status of these patents is pending. There are several active patents that are filed for devices that measure breast temperature and relate that to the probability of developing breast cancer. There aren’t any direct patents related to a bra that tests for breast cancer susceptibility. There is a potential risk for infringement with the bra that is used for cooling breasts after a thermography procedure. This bra is used after a woman has undergone a thermography used for breast cancer diagnosis. Since this bra is involved with a breast cancer procedure, there could be an infringement possibility.


US15144691 Stress test bra This bra is configured to cover a woman’s breasts while deploying a health sensor to monitor critical health information to inform the patient on stress levels. The signals can be sent to a device through a wire or wirelessly. 2016-05-02/ Pending


DE201210010355 Single-use breast holder for cooling breast for thermography recording to diagnose breast cancer of woman in e.g. hospital, has two plastic layers, where cooling liquid is made to flow between layers and passed from storage container This bra employs a cooling liquid that is applied to a woman’s breasts after she has undergone a thermography, used for breast cancer diagnosis. The breasts are heated during this procedure and the woman puts on this bra to cool the breasts, after the procedure. 2012-05-25/ Pending


US09018765 Differential temperature sensor device for use in the detection of breast cancer and breast disease This sensor device detects differential temperatures in a human breast. The pad is covered in an adhesive layer that allows it to remain in contact with the breast and the temperature sensor. 1998-02-05/ Active - Reinstated


US11405497 Therapeutic bra This bra is used for reducing breast inflammation for a woman who recently underwent breast surgery. This bra is made up of a sports bra and has a hook and loop fastener. 2006-04-18/ Active


US09908294 Ultrasonic diagnostic imaging transducer with hexagonal patches Ultrasonic imaging method that views the coronary arteries of the heart. A 3-D image is produced from the ultrasonic scanning and projected onto a screen, producing a picture of the coronary arteries. 2001-07-17/ Expires - 2020-11-21

Fundability Worksheet Scores

Competitors

2 Competitors exist but clinical improvements are still being sought


Customer Validation

1 Not enough customer feedback to-date


IP Position

2 Issued patents, but weak