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
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
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
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)
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
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.
BME 100 Spring 2017
