BME100 f2016:Group11 W1030AM L2

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OUR TEAM Andrea Grio Sonya Baran Jake Perrine Saul Vidrios Joshua Hsu LAB 2 WRITE-UP Device Image and Description This device is a portable dialysis machine. It contains three compartments where the blood is sent through to be cleaned and filtered. The cleaning process of the compartments occurs at all times constantly cleaning the blood. The belt and straps help support the patient making the machine easy to carry. Dialysis today is usually performed in a clinic where the patients have to sit next to a huge machine for hours while their blood is cleaned. This portable dialysis machine removes the inconvenience of having most of a persons's day be spent with dialysis. This will make dialysis much easier for patients and eliminates any hassle involved with the current dialysis machines. Technical and Clinical Feasibility Technical Feasibility a. What are the technologies needed? The main technology for our device is a filtration system with separate compartments. All of the compartments will be connected by tubes and wires, which filter waste out of the kidneys. These compartments, tubes, and wires are supported by a fabric belt that the patient wears around the waist. The patient will also wear fabric straps around their shoulders to support the belt around their waist. In order to power our device,rechargeable batteries and a plug-in charger with be required. b. What are the challenges? Some challenges include hiring people build our device and the training involved. The costs our technologies will also be a challenge, particularly the filtration components. We have to figure out a way to reduce the cost of our product to make it affordable for the masses. Creating a battery that can go hours before needing to recharge is also problematic. All of these problems take long periods of time and money to address, which is another challenge we face. c. What could go wrong? A malfunction of any particular part of our device is potentially lethal. Especially in regards to the filtration components. Rupture or straining of the tubes is also an ever present problem. Another potential problem is battery power running low when dialysis is needed. Clinical Feasibility Determine the clinical feasibility. a.Will it work in the clinic? The main point for the potable dialysis machine is to get out of the stuffy clinics and move into a more homely and comfortable environment. All around the world, there are clinics with dialysis machines that work. With using a portable kidney dialysis machine, the patient would get an equal amount of positive treatment as they would in a clinic. b.What are the clinical risks? Clinical risks that can possibly come from the product is that the needed training of how to use a kidney dialysis machine. If done improperly, some malfunctions of the machines or the process during dialysis can come upon and affect the machine and the patient's health. Clinical risks involve harm to the subjects from possible problems in our device. Another risk is the device failing completely and having to start from scratch. c. Have similar products been in a clinical trial? How long was the trial? In 2014, FDA approved University of Washington's Jonathan Himmelfarb's, Director of the Kidney Institute at UW, clinical trial on a portable artificial kidney. In early June 2016 the trial has ended in a successful result. His portable belt for his kidney dialysis machine is a similar model of what we are trying to build. Market Analysis Value Creation Our portable dialysis device would be used to treat people who suffer from Kidney Failure and stage four kidney disease. Our dialysis device would help treat kidney disease which according to the National Kidney Association, “is most commonly caused by type 2 diabetes and high blood pressure”. When a person’s kidneys begin to fail and are not able to filter their own blood, our device would provide the value of this blood filtrations process. Furthermore, our device would be performing peritoneal dialysis which is less invasive form of dialysis compared to hemodialysis. As Melinda Ratini, DO from WebMD explains, “hemodialysis requires the patient to be hooked up to a dialysis machine and have their blood filtered through the dialyzer in the machine”. The dialysis machine is very large and requires the patient to travel to clinics to receive treatment. Hemodialysis takes a long time and is considered very tedious for the patient. Our devious would eliminate this long time of tediousness and allow the patient to go about their days. Manufacturing Cost The per unit manufacturing cost is a follows: The raw materials for the actual dialysis machine is unknown as we do not have a set amount of material chosen for our design. However, the price range for the manufacturing will range from $550 ~ $2495.00 based on one of our closest competitor, Inogen, as well as a young teen’s invention of a dialysis machine. We are assuming 25% of the estimated cost is raw material cost. The total time to assembly of a single dialysis machine by a single person for a science fair project was 300 or so hours. Given that information, if we took a Biomedical Engineers average salary of $41.45 per hour and assume that a Biomedical Engineer would take a tenth of the total to build the machine due to the biomedical engineers training, resources, as well as the company he/she works for, the labor cost comes around $1,243.50. SInce the $550 dialysis machine is primarily comprised of raw material cost, we can say the raw material for a functioning dialysis machine is about $500. Therefore our total estimated manufacturing cost is around, $500 + $1243.50 = $1743.50 http://www.bls.gov/ooh/architecture-and-engineering/biomedical-engineers.htm http://montreal.ctvnews.ca/teen-invents-portable-low-cost-dialysis-machine-1.2522672 http://www.directhomemedical.com/inogen-one-g3-portable-oxygen-concentrator-IS300.html?fe_feedid=119&fe_code=inogen-one-g3-portable-oxygen-concentrator-IS300&utm_source=googlebase&utm_medium=CSE&utm_campaign=feedexact&gclid=Cj0KEQjwvIO_BRDt27qG3YX0w4wBEiQAsGu3eVee3IjP1fope5dX6Id6FSBH97gPTVc9BGstmxp-d0MaAn8J8P8HAQ#.V-IIdPArKM8 Sales Price Sales price will be 133% of the total manufacturing cost estimated to be around $2318.85. This price allows us to generate 33% in profit from our device to fund future R&D efforts in our company. Market Size The Market for this product is fairly large with over 468,000 individuals in the U.S. alone being dialysis patients. Furthermore, the market for kidney failure in just Medicare spending in the U.S. is approximately $31 billion dollars. This market is well suited for our introduction to help patients in the U.S. https://www.kidney.org/news/newsroom/factsheets/End-Stage-Renal-Disease-in-the-US Fundability Discussion The device would allow for dialysis to take place while on the go in a safe and effective manner. It is small and compact and it has a reasonable market size of $31 billion. The device itself would not be overly expensive, which, in turn, would not make for a costly machine. This means that the machine would be more affordable to both insurance companies, big and small, and to the individual patient. A prototype would not be too expensive to produce and would also allow for the producers to view problems with the machine that otherwise would have gone unnoticed. The closest competitors still do not have a small, portable dialysis device, and all others are still in theory. Customers love the idea of a portable dialysis machine since it enables them to go about ordinary tasks and not have to spend three four hour days a week, on average, in a clinic.