BME100 f2017:Group8 W1030 L2

BME 100 Fall 2017	Home People Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3 Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6 Course Logistics For Instructors Photos Wiki Editing Help
OUR TEAM Name: John Carey Name: Jennifer Brodsky Name: Jacob Hayes Name: Kristin De Jesus Name: Elizabeth White Name: Your name LAB 2 WRITE-UP Device Image and Description Technical and Clinical Feasibility Technical Feasibility A transdermal patch includes several layers: the adhesive, the microneedles, the medication, the membrane, and the overlaminate tape. The adhesive ensures the patch will stick to the skin. A waterproof adhesive is required to prevent the patch from peeling off. The microneedles will transmit the drug into the body. Because insulin in a macromolecule, microneedles are required to administer the hormone. The type of microneedle used will be a 3 mm to reach the subcutaneous tissue. The medication used is insulin. Insulin is a hormone naturally produced by the pancreas that allows the body to break down and store sugar in the form of glucose for energy use. Because diabetics are unable to either produce insulin or respond to insulin production, this insulin infused transdermal patch will administer the hormone, thus allowing the body to break down and store sugar. The membrane controls the rate of hormone release into the body from the patch. The overlaminate tape is a protective covering on top of the membrane. This layer protects the hormone and patch from invasive external sources. A portion of the microneedles used will be used as a glucometer to measure the concentration of glucose in the blood. A glucometer is required to measure the concentration of the glucose from the blood. If the glucose levels are not within normal range, a signal will be sent to the remaining microneedles to disperse the hormone into the bloodstream. Because insulin is a large molecule, the passage from the patch, through the needles, and through the skin could be an issue. Making the needles larger would compromise the durability of the patch; however, using smaller needles would compromise the administration of the hormone. The efficacy of hormone diffusion into the body is dependent on the structural composition of the needle used. The needles would be required to penetrate deep enough to reach the capillaries in the subcutaneous tissue under the skin. Deciding the length and size of the needle without compromising the infusion of insulin into the skin is an issue. Needles that are too long become invasive while needles that are too short compromise the administration efficacy of insulin. A drop of blood (1/480 fl oz) is all that is required for the glucometer to measure and determine the glucose concentration. A cotton pad will be present above the microneedles to absorb the blood taken. Clinical Feasibility a. Given the technical feasibility it work in the clinic? Given the technical feasibility of the insulin patch, it is likely that the technology will work. Seeing that there are already transdermal patches used for other practices, it is known that the basic structure of our product is reliable. Our patch is designed to be easily used by patients who must simply place the patch on their upper arms for application. Since it can be applied directly by the patient there is not much reliance on professional healthcare assistance, though it will require a prescription to obtain. The patch itself is in five layers including the adhesive, microneedles, medication, membrane, and overlaminate tape and the membrane would prevent the patient from receiving too much of the insulin they are prescribed while keeping them up to date with their dosage. A glucose meter would also be provided to the patient is able to monitor how much glucose is in their blood at any given time. b. What are the clinical risks? Since the patch is an invasive device, there could be issues with sterilization upon application of the patch since it must be clean upon entry of the skin. An unsterile patch could cause bacteria to enter the skin and lead to infection. There is always the risk of injecting too much insulin which could cause serious health complications, but the membrane in the patch should effectively combat this issue. c. Have similar products been in clinical trial? How long was the trial? There is no record of insulin patches being in clinical trial. Such products have only been tested in murine models of Type 1 diabetes by North Carolina University who is working on developing a similar product. It is believed that it could be a few more years before such a product could be used in clinical trial. Sources: 1. Hackethal, Veronica. “‘Smart Insulin Patch’ for Diabetes Is Years Away from Human Trial” June 26, 2015. http://www.medscape.com/viewarticle/847059. Market Analysis Value Creation Our prototype values customers in the sense that it is more convenient and will not have to be used as frequently as current insulin treatments. For example, people will not have to take multiple shots a day or carry around an insulin pump. The patch would be a simple way to provide patients with the medication they need to treat both Type 1 and Type 2 diabetes. Customers would only need to place the patch on their upper arm (easily accessible location and discrete in appearance) every 12 hours as necessary. During those 12 hours, the patch would slowly release the needed medication through microneedles on its surface into the patient's body. The patch would be significantly less painful than shots and would only require attention from the customers once a week in comparison to many times per day. Even when compared to insulin pumps, the patch would require much less material since insulin pumps need tubing, a cannula, and plastic connector to join the two while the patch is one item with a glucose meter to measure how much glucose is in the blood at any given time. Therefore, the insulin patch would be an overall more convenient option of insulin treatment for customers than other options on the market. Manufacturing Cost Sales Price Market Size Fundability Discussion Technical Feasibility Score: 2 Justification: Clinical Feasibility Score: 2 Justification: Cost to Create Average Sale Price Market Size Fundability Based off of our fundability worksheet, our product should...