BME100 f2016:Group11 W8AM L2
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LAB 2 WRITE-UP
Device Image and Description
Technical and Clinical Feasibility
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.
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.
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.
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.