BME100 s2017:Group7 W8AM L2

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BME 100 Spring 2017 Home
Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3
Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6
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Rafael Aguilar
Raneem Asiri
Brandon Boyle
Joseph Dimodica
Margaret Miller
Nicole Robinson


Device Image and Description

xSolid Works design
xSolid Works design

This is the design from the outside. The concept is that this will be a shell casing with all the technology inside.

Solid Works design
Solid Works design

This picture is of where some of the sensors will go, such as ultrasound sensors that will measure the blood velocity, and blood pressure.

Solid Works design
Solid Works design

This picture is of where the flexible circuit board will go. These images are just basic designs of where some of the components of our device will be implemented.

Technical and Clinical Feasibility

Determine the technical feasibility
What are the technologies needed?

  • Doppler ultrasound sensor
  • Bluetooth communication
  • Reusable adhesive
  • Application that is automatically activated when triggered by biomarkers
  • Software on app for phone to receive signal from patch and do analysis with data

What are the challenges?

  • Accurately measuring all these biomarkers through the neck
    • Blood flow, Blood pressure, Pulse
  • Connections via bluetooth
  • A way to make sure that the doppler sensor is working

What could go wrong?

  • Incorrect measurements
  • False positive
  • Doppler Malfunction
  • Connection with phone issue

Determine the clinical feasibility
Will it work in the clinic?
Yes, the doppler ultrasound detects other carotid artery abnormalities that may disrupt blood flow
What are the clinical risks?
Little to no clinical risks because this process is non-invasive. The main risk comes from choosing correct biomaterials to interact with the skin
Have similar products been in a clinical trial? How long was the trial?
Transcranial Doppler is used in clinics by doctors to diagnose acute ischemic stroke.

Doppler Patch
Doppler Patch

Market Analysis

Value Creation
What value does your prototype create for the customer?

  • The prototype shows the customer what are goal is, which is to detect strokes faster, and get the person to the hospital as soon as possible
  • It also shows that the device is simple, and only has key components that are necessary in determining stroke/stroke risk
  • Prototype is non-invasive
  • Size, shape, shell design with reusable patch

Manufacturing Cost
Determine the cost to create your design. Justify.

  • $30.00/bluetooth wireless communication device to talk to cellular device
  • $1.00/battery energizer 317 Low drain 1.55V Button cell silver oxide (assuming we aren’t buying in bulk).
  • $2.00/ shell with adhesive much like tens unit (approximate)
  • $599/ sensor Ultrasonic transducer Micron Miniature

So overall, the estimated manufacturing cost for one unit (2 sensors, 2 batteries, 2 shells) is $1264

Sales Price
$1500 - $2000 dollars per unit. This cost is due to the manufacturing cost of $1200. With this price range, we are still able to massively undercut the price of existing competitors. This is our current sales price, but we are flexible with the amount of profit.

Market Size
One hundred percent of people: 795,000 (because that is how many people have strokes per year in the U.S.)
Five percent of people: 39,750
Sales Price: $1,500
Market Size 100%: $1,192,500,000
Market Size 5%: $59,625,000

Fundability Discussion

Fundability Worksheet Scores
Fundability Worksheet Scores

Technical Feasibility
Is scored as a 2 because the technology is proven regarding the doppler ultrasound, we just need to modify it to be a wearable size.
Clinical Feasibility
Is scored as a 2 because clinical success has been done with the doppler ultrasound detecting blood flow for diagnosis of a stroke (i.e. transcranial doppler), but it still needs to be modified to be a size small enough to fit in a patch. But this is also shown through a found patent regarding an already existing ultrasound patch (US 20120065479 A1)
Market Size
Is scored as a 2 because the 25% of the amount of people who have strokes every year multiplied by the cost of the device is in the 2 range in the fundability worksheet.