BME100 f2016:Group11 W8AM L2

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Contents

OUR TEAM

Name: Erik Ireland
Name: Erik Ireland
Name: Elmer Correa
Name: Elmer Correa
Name: Maria Predtechenskaya
Name: Maria Predtechenskaya
Name: Isaac Alemu
Name: Isaac Alemu
Name: Your name
Name: Your name
Name: Your name
Name: Your name

LAB 2 WRITE-UP

Device Image and Description

Image:Capture78.PNG




The device, in position, will have isolating, filtering panels which are re-sizable based on the artery being treated on either end in order to block clot or plaque debris from leaving the treatment area. These panels will resemble nets in that way, still allowing for blood flow but preventing particles of a certain size from escaping into other parts of the body. A narrow wire runs through the area, itself having an ultrasound device built into it as well as a vacuum entrance for dissolved undesirable substances. This will also come attached with a temperature monitor to track for acoustic cavitation during the treatment process. The ultrasound source will appear as small slits along the length of the wire with a discreetly built in thermometer that will appear as no more than a different colored strip on the wire. The ultrasound device will dissolve detach cholesterol plaque and a variety of clots from artery walls to prepare to suction from the body via the built in vacuum.

Technical and Clinical Feasibility

Technical Feasibility
A. Essentially, we hope to create a comprehensive device that allows for a comprehensive method to treat thrombosis and dangerous concentrations of cholesterol plaque in arterial walls by emitting high-intensity ultrasound wave to dissolve the clot/plaque substances to be vacuumed up by the catheter tube in a controlled, dammed up area in the artery being cleaned. The technologies required for this device include a standard catheter wire with a built in ultrasound transducer of a sufficiently high power which is capable of HIFU (High-intensity focused ultrasound) along with a built in vacuum running through the whole length of the catheter wire to remove the dissolved blood clot/plaque (as done by effective use of HIFU). Similar filtration dams to those used by Capture Vascular will also be implemented in our device design. On top of this, a thermometer of sorts will have to be implemented into the wire in order to track for acoustic cavitation in the blood and prevent temperature from reaching unsafe levels during treatment.

B. It must be kept in mind that the wire needs to remain narrow and small enough to safely run through peripheral veins (as the device will be introduced in the groin area up through one such peripheral vein) and carry all the aforementioned accessories. Devices much as the Megavac as used by Capture Vascular's Thrombowire device show the feasibility of this feature. More issues might arise in fitting a suitably powerful ultrasound transducer into such a small device, though the compactness of current ultrasound probes (for use in targeting cancerous parts of the prostate via the rectum, for example) is promising.

C. Potential problems that might present themselves are vac components that are not correctly calibrated and cause unnecessary excess blood loss during the removal process of dissolved clot or plaque materials. The damming of the area being cleaned will prevent this from reaching dangerous levels but still should be considered. The ultrasound waves emitted might also not converge on the right point if not accurately aimed which could lead to tissue damage in the areas affected.

Clinical Feasibility
A. Will it work in the clinic? The device will work in the clinic because there have been similar devices that were tested and are currently used in clinics. Clinicians were evidently satisfied by the results of our competitors. Our device is of similar design but has slightly different internal contents; therefore, it should be able to work. There is a medical device patent US 20140188127 A1 which is composed of an outer and inner tube, and a tubular sleeve with a U-shaped area. That area allows for small particles to be sucked into the inner tube. This device is used for procedures in the blood vessels such as removing blood clots and other substances. The product was inspected and clinically tested for four months during the year of 2014. This device is similar to ours in the aspect of sucking out the cholesterol debris. Our product also has a tube inside another tube and there is a hole that through which the debris will be sucked out. Another device patent is US 20120022579 A1. This device has a tube and an inner expansile braid-like portion which puffs up and lets the fluids flow. This device operates as a clot shredder and puller. Similarly, we will have pads that also expand and isolate an area. After the cholesterol clots are shredded by the ultrasound waves, our device will suck out the debris.

B. What are the clinical risks? Precautions need to be made to ensure the safe removal of all debris to prevent possible blockage of other arteries and possible stroke, (blockage in the brain). Possible soft tissue damage due to exposure to high frequency of ultrasound waves though competent and deliberate use of HIFU should prevent this. Either the surgeon or a technician nearby will also have to track the temperature in the treatment area as the use of high frequency ultrasound through a fluid, in this case the blood, will create areas of low pressure (cavitations) which will violently pop and consequently heat up the blood. Left unchecked, this might risk vascular burn though as long as temperature is tracked throughout the procedure this will easily be avoided for prospective patients.

C. Have similar products been in a clinical trial? How long was the trial? Similar products have been in clinical trial for 2-3 years. One product poked at the cholesterol plaque before removing it. Another device sucks the cholesterol in once attached. Our product will isolate an area and vacuum the debris out, but the major difference is that instead of poking the cholesterol or attaching and sucking in cholesterol, it will incorporate a wiring that sends out ultrasonic waves in small waves to disassemble the cholesterol. In one such study, Capture Vascular tested the safety and efficacy of a similar device, the Megavac, as a proximal Embolic Protection Device for percutaneous coronary interventions. This was tested on 48 patients with either a single vein graft or native vessel and was assessed by physicians to be "successful" or "very successful" in 91% of cases.



Market Analysis

Value Creation
Our design is cheaper and does not cause as much damage to the arteries. Overall, our method of detatching clot material and cholesterol plaque of arterial walls proves to be much safer and more effective than alternative, more abrasive methods by our competitors that often lead to vascular damage and pain that lead to future expensive medical treatment to handle. Our product ends up saving providers and patient thousands of dollars in this way, as well in the prevention of the treatments that follow after the survival of heart attacks, strokes, embolisms, etc. with a value provided that cannot be understated.

Manufacturing Cost
The cost of the individual component materials required to produce are as follows: approximately 200 US dollars for a base catheter wire kit (source: https://www.esutures.com/product/0-in-date/103-angiodynamics/840-vascular-access/46241075-navilyst-bioflo-picc-with-endexo-ss-wire-mst-70-45-876/?gclid=CPLy5NCcj88CFQx9fgodIZwAYw), 3 dollars for each of five small ultrasound transducers attached to the device, determined by multiplying the cost of a 28mm transducer and increasing the price to account for the cost of making it smaller (source:https://www.alibaba.com/product-detail/Supply-High-Efficiency-Efficient-Micro-Ultrasonic_60411817496.html?spm=a2700.7724838.0.0.THtQ5p&s=p), the cost of a small thermistor is about 4 dollars, calculated from the cost of an already small thermistor at about a dollar (source:http://www.alliedelec.com/amphenol-advanced-sensors-cl-110/70181364/?mkwid=sabYU23qn&pcrid=30980760979&gclid=CIbaiaGfj88CFUGTfgod4WcODw), and a suction catheter costing 28 US cents (source:http://www.blowoutmedical.com/suction-catheter-14-fr-4814.html?utm_source=google&utm_medium=base&utm_campaign=products&feed_special=google). The filtration dams used in our device will cost negligible amounts with cheap stainless steel to be used and a simple circuit to control them with an estimated cost of a dollar. (source:https://www.metalprices.com/metal/stainless-steel/stainless-steel-flat-rolled-coil-304). Labor costs were estimated by estimating time spent per product per employee. 30 minutes of evaluation by an engineer (earning 50 dollars an hour) on average, along with another hour by a technician (25 dollars) along with administration labor costs covered by the average device (50 dollars) for a total labor cost of 100. This comes out to ~US$318.28.

Sales Price
Our manufacturing cost which includes the parts and the labor cost is: $318.28. We want a profit of $199.72 per item. This means a total of $518 for our product. We are asking a price that is about $250 lower than our biggest competitor (around $800) is for their product. This means that the product will at once be extremely marketable on top of profitable.

Market Size
According to American College of Cardiology, the most common of the heart diseases is Coronary heart disease (CAD). Also, "Every year about 785,000 Americans have a first coronary attack. Another 470,000 who have already had one or more coronary attacks have another attack" ("Heart Disease Statistics," 2016).

According to the NCBI, there are 8 million patients undergoing surgery with Coronary Heart Disease (CAD) per year. This is the audience we target because they need plaque removed from their heart veins ("Current Practice," 2014).

Furthermore, our product would target the population that has plaque in the leg veins, which is called Peripheral vascular disease. This affects 10 million people in the US; 600,000 people get an embolism per year ("Vascular Surgery," 2004).

Based on these numbers, we can estimate that the maximum market size is: (price of device) * (number of surgeries) = ($518) * (8,600,000 million) = $4,454,800,000

Sources: Heart Disease Statistics. (2016). Retrieved from https://www.cardiosmart.org/Heart-Basics/CVD-Stats

Padma, S., & Sundaram, P. S. (2014, April). Current Practice and Recommendation for Presurgical Cardiac Evaluation in Patients Undergoing Noncardiac Surgeries. Retrieved September 14, 2016, from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149772/

Kaczkowski, C. H., & Culvert, L. (2004). Vascular Surgery. Retrieved September 14, 2016, from http://www.encyclopedia.com/topic/Vascular_surgery.aspx

Yet, our biggest competitor specifies in his executive summary that the new products are used in 350,000 procedures per year (http://www.capturevascular.com/wp-content/uploads/2014/04/Capture-2-Pg-Executive-Summary-v2.pdf).

According to this number, we can estimate this market size as: (price of device) * (number of surgeries) = ($518) * (350,000 procedures) = $181,300,000 This number is more down-to-earth.

So, our market estimate is between $180 million and $4.5 billion (this number is over-inflated).

Fundability score: since it is best to underestimate and not fluff the numbers, our score for the market size would be a 2, because our lowest market size number is $180M which is between $80M and $200M category under score 2.




Fundability Discussion

Technical feasibility: 2 Will require effort in achieving a wire which is compact enough to enter necessary arteries and veins while also carrying built in vacuum and ultrasound transducer for clot and/or plaque removal. Still, sufficient precursor and similar devices exist that this will not require a significant investment in research and development and so a score of 2 seems accurate.

Clinical feasibility: 2 Needs specialist to do procedure. Needs to be carefully monitored to ensure that the heat generated does not exceed that of 1°C. Tests need to be run so that the device is tested, and we see that the blood vessels are not damaged as well as if stopping the blood flow for a short while will affect the results. Despite this, precursor devices such as those developed by Capture Vascular have shown that ours is more than promising and will provide a safer, more effective method to treat conditions such as thrombosis or common cholesterol plaque for futrue patients.

Competition:1 Capture vascular is a dominant competitor in intravenous devices for clot and plaque removal which could pose a problem for the future of our product, but ours is also significantly cheaper and less risky to use. This differentiation could be enough to push out even this major a competitor out of the market, or at the very least force them to share it.

Market Size:2 Justification given above.

Customer Validation: 2 Our product is cheaper than our largest competitor's and will provide potential patients with improved quality of life without the threat of potential future surgeries due to vascular damage.

IP Position:1 No patents have been issued, while similar ones currently exist for our competitors.

Our fundabiltiy score comes out to 32, reaching a maximum of 288 if the scores in the other two categories are 3's. This unfortunately falls short of the minimum required to be taken seriously by large investors and so at this stage is not wise to invest in. Still, it is very likely that our product's IP position will improve and subsequently allow us to break the threshold. In sum, while not fundable in the present, investors need only wait a short while for a device that could give impressive returns.



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