BME100 s2017:Group9 W8AM L2

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


Device Image and Description

Front panel of Pectoris Sani This image shows the front panel of the Pectoris Sani including where the ultrasound patch will be.

Front panel of Pectoris Sani This image shows the back panel of the Pectoris Sani including the sensor portion of the ultrasound.

Front panel of Pectoris Sani Illustrated copy of front of device, including dimensions.

Front panel of Pectoris Sani Illustrated back panel with ultrasound sensor and dimensions.

The idea behind the design of this device is to have two parts to the band. The front piece will include the ultrasound patch embedded in rip stop nylon fabric which is sturdy and hardy enough to withstand the weight. The front piece will also be fitted with both soft and rough velcro to attack to the back piece. The back piece of the device will also have the rough and soft velcro as well as the matching sensor to the ultrasound patch. This sensor will be combined with the bluetooth technology to take the readings of the person's density and send them to either a doctor's office or the patient's own device. The purpose of the device is to allow a woman/man at high risk for breast cancer to measure the density of their breast tissue from the comfort of their own homes. These readings can be taken monthly so as to monitor changes in the density which may be a sign to get medical attention and further testing. The design incorporates long strips of soft velcro to allow a range of sizes to fit with minimal changes to the design. Dimensions of the ultrasound patch and sensor are 18"x7"x1.5" the soft velcro is 26"x10.5" the rough velcro is 4"x10.5" and the rip stop nylon fabric that creates the entire device is 76"x12"

Technical and Clinical Feasibility

Technical Feasibility

The technologies that are needed for this device to function properly are an ultrasound patch and bluetooth technology. The patch is incorporated into a band made with a strong material made of nylon, neoprene and lycra. The device will also use velcro to attach and stay snuggly attached around the body. The challenges that come out of this device are mostly to do with the ultrasound patch.The first and most important function of the device is the readings that the ultrasound patches provides. Women will be reliant on these devices to warn them of changes in their breast density so that they can seek medical attention in time to increase their survival rate. The reliance on the device means the readings must be valid and precise. Ultrasound devices provide false negatives at a rate of 1/2500 readings. (1) This rate is fairly low but with a less established device as the ultrasound patch it is possible that this rate will be higher. The purpose of our device is not to monitor breast density once every year but more often. Hopefully, having women take readings once a month the diagnosis will be based on changed in the women's unique body type and thereby will be more reliable. Handheld ultrasound readings can be more effective but continual readings over time can trigger women to seek further scanning and medical testing before their scheduled annual check ups if a severe change is detected. In order to determine if the readings are showing change in density the ultrasound readings must be monitored by a professional radiologist to determine what the results mean in terms of possible cancerous tissue. A registered technician is able to determine what changes are representative of cancer and which ones are natural changes in the body. (2) This area of the device must be able to send the results to a handheld device and then can be relayed to a doctor's office. The challenge here is ensuring the information is relayed correctly. The handheld device will have to be built with wifi technology to send the results to a radiologist. There are several things that can go wrong in this device.

(1) "Breast Screening." False Negative Results | Topics, Breast Screening, Cancer, People's Experiences. DIPEx, n.d. Web. 08 Feb. 2017. <>

(2) Halls, Steven. "Ultrasound Scan for Breast Cancer Screening - Moose and Doc." Breast Cancer - Moose and Doc. N.p., 06 Feb. 2017. Web. 08 Feb. 2017. <>.

Clinical Feasibility

The process for the device is noninvasive and inexpensive. Especially for people who are predisposed to breast cancer, the device will be very helpful for early diagnosis. The creators are foreseeing a high chance in the increase in clinical feasibility. Unfortunately, false positives are to be looked out for. The way that this device will be tested in a clinical setting will be very simple. Very much like the testing t=for the Automated Breast Ultrasound (1) the patients will be chosen from a range of ages (18-90) and will be monitored for six months to a year or more, if necessary. Similar technologies have taken much longer to complete clinical trials when new technologies are being introduced. For example, one study has taken closer to 3 years to complete trials and have not yet completed their research on a new ultrasound device to detect kidney or liver lesions. (3) The people will be tested once a month by both the current ultrasound technologies and then again by our device. The readings will be taken by different doctors so that they will be blind to what the other test has shown. The device should work in a clinical setting as it is just a new application for existing technology. The issue being tested at the clinical level will test more of if this new application is reasonable and efficient. A similar technology of non hand held ultrasound breast cancer screening was tested in 2016 and proved that their technology was effective at determining breast caner.(2) The trials took two years to be completed and approved. They tested 501 women between the ages of 18 and 90 with both a handheld ultrasound and the ABVS technology to see if both devices produced the same results. There were no risks associated with this device as it does not permit radiation that could be harmful to patients. (1)

(1) Mendelson, Ellen. "Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound." Lesion Detection of Automated Breast Ultrasound Compared With Handheld Physician-performed Breast Ultrasound - Study Results - Northwestern University, n.d. Web. 08 Feb. 2017. <>.

(2) Boyd. "ACUSON S2000 ABVS Ultrasound System, HELX Evolution with Touch Control." Siemens Healthneers. N.p., 2016. Web. <>.

(3) Stanford University. "Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions." Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions - Full Text View - National Cancer Institute, 26 Jan. 2017. Web. 08 Feb. 2017. <>.

Market Analysis

Value Creation
Our prototype's value to the customer includes an ultrasound patch that is built into a bra that has the ability to measure breast density. The customer is intended to wear the bra once a month for five to ten minutes to measure changes in breast density on a month-to-month basis. If the density is fluctuating between months the bra will alert the customer that breast cancer could possibly be developing. The purpose of this device is to function as an at-home supplement to a clinical mammogram. The customer will not need to visit a physician to check for warning signs for breast cancer. The convenience of this device will also make it easier for the customer to have more frequent and periodical check-ups on the density, to try to catch the onset of cancer as soon as possible.

Manufacturing Cost
The cost to manufacture one device is approximately $821.80. This accounts for the price of nylon bra fabric at $5.59/yard [1]. The mobile ultrasound patch is produced exclusively by Nanovibronix, which retails at $795 [2]. There will also be a bluetooth adapter which allows for the density measurements to be sent to a mobile phone or a computer for easy access for the consumer. This adapter retails at $15 [3]. The last piece of our device is the velcro strap that the women will wrap around themselves, costing $6.21 but the price of the straps decreases as the quantity increases [4]. The manufacturing cost varies on location and how many employees, but a source in Italy references the price to produce one bra at $53.53 [5].

Works Cited "[1]. Rip Stop Nylon Fabric." N.p., n.d. Web. 08 Feb. 2017. "[2]. NanoVibronix." PainShield® Kit | Products | NanoVibronix. N.p., n.d. Web. 08 Feb. 2017. "[3]. Insignia™ - Bluetooth 4.0 USB Adapter - Black." Best Buy. N.p., 07 Dec. 2016. Web. 08 Feb. 2017. "[4]. 24 X 1 Inch Cinch Straps - 5 Pack." Secure™ Cable Ties. N.p., n.d. Web. 08 Feb. 2017. "[5]. The Italian Model of Management." Google Books. N.p., n.d. Web. 08 Feb. 2017.

Sales Price
The average sale price for the product should be at least $950. This is based on data that encourages women over 40 to go through the mammogram screening process once a year [1]. While some women develop breast cancer earlier than 40, a number around 5% of breast cancer cases, reported by the Cleveland Clinic [2]. The price of mammograms varies based on insurance providers and on cash versus credit card payments. The range of cost for an uninsured mammogram is between $80-$212, while the general copay prices for an insured mammogram cost from $10 to $35 [3]. Annual health insurance costs are also pricey, with the average cost in 2016 of premiums being $18,142 for family health plans [4]. Premiums for individual plans were $321 per month on average [5]. These costs accumulate quickly as customers get annual mammograms. Our device would not require insurance and it would not require women to frequently visit their physician to have them perform breast cancer analysis. Our device would instead off a one-time payment, while also providing the same healthcare benefits. Our company would be making $80 per device sold if the manufacturing cost did not vary.

Works Cited "[1]. Mammogram Guidelines: What's Changed?" Mayo Clinic. N.p., n.d. Web. 08 Feb. 2017. "[2]. Breast Cancer Under 40: Early Detection." Cleveland Clinic. N.p., n.d. Web. 08 Feb. 2017. "[3]. How Much Does a Mammogram Cost? -" CostHelper. N.p., n.d. Web. 08 Feb. 2017. [4]. Legislatures, National Conference of State. "Health Insurance: Premiums and Increases." Health Insurance: Premiums and Increases. N.p., n.d. Web. 08 Feb. 2017. "[5]. How Much Does Health Insurance Cost Without A Subsidy?" EHealth Insurance Resource Center. N.p., 30 Jan. 2017. Web. 08 Feb. 2017.

Market Size
In the United States, the American Cancer Society estimates that there are 252,710 cases of breast cancer that are diagnosed each year [1]. Of the 318.9 million people living in the United States, 50.8% are women and 54.3% of those women are 35 and older [2]. The American Cancer Society recommends that women over the age of 40 begin to have regular mammograms [3]. Estimating that the amount of cases each year represents the amount of women who would be potential customers of our product the market size is then calculated by multiplying the cost of the bra by 252,710 cases per year, which nets $240,074,500 per year, for 100% of the market. The 5% market size is $12,003,725 per year. The 100% market size gave our fundability score of two because it's between the range of $200M-4500M, while the 5% size gave us a zero because it is less than $80M per year. The market size could end up being much larger since the number of women over the age of 40 in the US is 88 million.

Works cited [1]. "How Common Is Breast Cancer?" American Cancer Society. N.p., n.d. Web. 10 Feb. 2017. [2]. "U.S. Population." US Population, Women's Health USA 2012. N.p., n.d. Web. 10 Feb. 2017. [3]. "American Cancer Society Guidelines for the Early Detection of Cancer." American Cancer Society. N.p., n.d. Web. 10 Feb. 2017.

Fundability Discussion

Technical feasibility: 2- Some challenges but will be overcome with time and within a reasonable cost. This rating was determined for this device because the technology is taking a new device and altering it. While ultrasound patches do exist they are most commonly used to treat pain and will likely need to be altered to act as effectively as a handheld ultrasound device. Should the research show that the current technology cannot be transformed to this function a new piece of technology will need to be developed and that will cost a considerable amount of money and would most likely extend the process by quite a long amount of time.

Clinical feasibility: 2- Clinical success is likely but will require special expertise and/or research This device claims to be able to treat all women and men and in order to prove that this is possible many different ages and body sizes will need to be tested. It does not necessarily need to be tested for an exorbitant amount of time but the device should be able to last for several years at promised function which will require some form of test to ensure the quality of readings does not go down over time.

Overall fundability: Score: 16 Customer Validation: 1 No customers feedback to determine interest or validation. Market size: 2 If current market is saturated the market size will be large. Competition: 1 There are many different companies working on ways to find breast cancer early. IP Position:1 No patents have been issued at this point. Technical Feasibility: 2 Some research will be necessary but it is not exorbitant. Regulatory Pathway: 2 Clinical data will be needed but not a completely new device. Clinical Feasibility: 2 There will need to be tests to determine function and ability to diagnose. Reimbursement: 1 New application to device.