BME100 f2017:Group15 W0800 L2

OUR TEAM

Name: Megan Koehler

Name: Cade Montplaisir

Name: John Navas

Name: Samuel Ramirez

Name: Julia Raub

LAB 2 WRITE-UP

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[[Image:BME100WG15_PCRsetup.JPG‎|200px|Description of image]]

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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.

Technical Feasibility

What are the technologies needed?
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.

What are the challenges?
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.

What could go wrong?
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.

Clinical Feasibility

Will it work in the clinic?
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.

What are the clinical risks?
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.

Have similar products been in a clinical trial? How long was the trial?
1)Focused Ultrasound Thalamotomy-13 months
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)
3)ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders- September 26, 2014-December 2017

Fundability Worksheet Scores

Technical Feasibility
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.

Clinical Feasibility
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.

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.

Cost to Manufacture

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.

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.

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)

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.

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

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