# BME100 f2017:Group8 W1030 L2

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# 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

The Glucogage is a new transdermal delivery system that will be introduced in the diabetes treatment market. The new device is capable of gaging the blood-glucose level of people with diabetes and can automatically administer insulin using microchip technology. This allows for comfortable, reliable delivery of insulin and gives time and peace of mind back to people with diabetes. No longer would people with diabetes have to continually prick their fingers in order to read blood-glucose levels as the glucogage perpetually monitors blood levels and automatically calculates the proper amount of insulin into the body. The delivery system allows people with diabetes a reliable alternative that will deliver a supply of insulin into the cusotmer. The insulin supply that will be injected into the customer is found within the body of the device and lasts for up to a week.

The primary interface of the device displays blood-glucose readings and tracks the amount of medication being pumped into the body. While the device will continually medicate the customer, they can also check their blood-levels by tapping on the screen in order to wake up the device and read the screen. Not only does it inform the patient of blood levels, but also tracks medication delivery over the course of 24 hours. The battery within the device lasts for a week and audibly beeps when medication patches need to be changed or after the battery dies.


Two elastic straps secures the device onto the body to make sure that the device doesn't move. Ventilating mesh technology allows the wearer comfort throughout the entire day in even the most humid of weather and sturdy, waterproof casing allows the wearer to confidently go into the water without fear of damaging the device.

Micro-needle technology allows for noninvasive, continual delivery of medication throughout the day to combat insulin spikes and allows for a constant stream of energy. About the width of a hair, but deep enough to penetrate into the subcutaneous fat, the tiny needles are a relatively painless alternative to the constant pricking and poking of outdated insulin delivery needles.

## Technical and Clinical Feasibility

Technical Feasibility
A transdermal patch includes several layers: the arm band, the microneedles, the medication, the membrane, and the overlaminate tape.

• The arm band will be used to provide support between the device and the body. A strong adhesive would not be enough to reinforce the weight of the device (the glucometer along with the microneedles and several protective layers). An arm band would not only support the insulin patch, but
• 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. Because only a minimal sample of blood is required to measure the concentration of glucose in the blood, a cotton pad will be a sufficient source of absorption throughout the day.

Sources: D. (2016, December 05). Transdermal Patches: How to Choose the Right Materials. Retrieved September 20, 2017, from https://www.deltamodtech.com/blog/transdermal-patches-how-to-choose-the-right-materials/, Bhattacharjee, Y. (2002, July 01). More Than the Patch: New Ways to Take Medicine Via Skin. Retrieved September 20, 2017, from http://www.nytimes.com/2002/07/02/health/more-than-the-patch-new-ways-to-take-medicine-via-skin.html?mcubz=0

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.

Link title==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

The manufacturing cost of our medical device would average around $150.00: • One small glucometer cost=$50.00
• ACE elastic wrap bandage= $6.00 • A section of microneedles=$30.00
• A microchip that dispenses insulin= $64.00 To provided insulin refills for the devices (10 mL vial)=$85.00

Sales Price

The average sales price would come out to $750.00 (manufacturing price times 5). ($150.00 X 5= $750.00) Market Size Our market size comes out to$1,087,500,000.00. The U.S. market size is only 29 million people including both type 1 and type 2 diabetes. The our equation came out to (750) X (0.05) X (29,000,000), equaling \$1,087,500,000.00.

Sources: 1. http://microchipsbiotech.com/ 2. http://www.diabetes.co.uk/blood-glucose-meters/smallest-blood-glucose-meters.html 3.https://www.acebrand.com/3M/en_US/ace-brand/products/~/ACE-Brand-Elastic-Bandages?N=4304+3294605848&rt=rud 4. https://www.acebrand.com/3M/en_US/ace-brand/products/~/ACE-Brand-Elastic-Bandages?N=4304+3294605848&rt=rud 5. http://www.sciencedirect.com/science/article/pii/S0169409X12001251

## Fundability Discussion

Technical Feasibility

Score: 2

Justification: While there is some small discomfort with the patch due to the small needles, the patch measures the patients glucose levels throughout the day, which administers the correct amount of insulin.

Clinical Feasibility

Score: 2

Justification: The product is very easy to apply and needs little to no maintenance, so testing in the clinic should be fairly simple. However there is a small amount of risk, therefore the patients should be observed frequently.

Should Our Product Be Funded? Based off of the fund-ability chart, our device should not be funded. Our product received scores of 1 for customer validation, market size, regulatory pathway and reimbursement. When the individual scores were multiplied together it only had a total of 12 points, and most investors would like to see a score in the hundreds.