BME100 f2016:Group10 W8AM L2

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Contents

OUR TEAM

Name: Eli Ozaki
Name: Eli Ozaki
Name: Mauro Udave
Name: Mauro Udave
Name: Nicholas Guzek
Name: Nicholas Guzek
Name: Alexandra Dalbec
Name: Alexandra Dalbec
Name: Your name
Name: Your name
Name: Your name
Name: Your name

LAB 2 WRITE-UP

Device Image and Description

Transdermal Insulin Delivery Patch

This transdermal insulin delivery patch is approximately 2 mm thick composed of two thin mepitac layers with a central gap between them to store the heating agent (zeolite cream) to help absorption. The bottom layer has a coating of insulin solution to deliver the enzyme that is necessary for the treatment of Type One Diabetes.

Technical and Clinical Feasibility

Technical Feasibility
What are the technologies needed?

Our patch is a simple disposable model. In order to keep costs down, we will be using cheap materials. For the structure, a similar material to nicotine patches will be used (a thin mepitac material). In order for the insulin to be more easily absorbed, the contact zone will be layered with Zeolite, a solution that, when in contact, will heat up, easing pore access and allowing for sufficient insulin absorption.

What are the challenges?

A challenge we might face is the conservation of insulin. Our device must keep the insulin in, keeping it from any contamination or leaking to ensure full delivery.

Potential Obstacles?

An obstacle we might face is the under or over delivery of insulin. Since our patch does not have direct access to the blood stream, some of the insulin might be lost to some factors. Evaporation, or the skin not absorbing.


Clinical Feasibility
The patients will stop their normal form of injecting insulin and it will be replaced by our insulin patches. The patient will then use our insulin patches to get their insulin for 3 consecutive days to test if the patches work as a noninvasive way to get insulin into the body, rather than using needles and invading the body.

Possible Risks

-Skin Irritation

-Insulin not getting into the body

-Chronic Lung Disease (if inhaled)

-Respiratory Disease (if inhaled)

-Chance of Mesothelioma (if inhaled)

Similar Clinical Trials

In a clinical trial done by the Hadassah Hebrew University School of Medicine in Jerusalem, they tested their "InsuPatch" to see if heating up the site of injection would accelerate the rate at which the insulin is absorbed in the body. In the trial, they had 17 patients, ages 18-53 years. They had selected 9 random patients to use the device and 8 random patients to not use the device, and found that the patients that were using the device absorbed the insulin much faster than those who did not use the device.

In a different clinical trial, done at the Institut fuer Diabetes-Technologie GmbH, in Ulm, Germany, they tested to see if heating the site of insulin injection would affect the absorption rate of insulin. In the trial, they had 24 patients on continuous subcutaneous insulin infusion, and measured the impact of local skin heating. They found out that even just a slight increase in temperature, that had no affect on the patient, increased the absorption rate, without increasing the risk of hypoglycemia.

Works Cited

Freckmann, G., Pleus, S., Westhoff, A., Krinelke, L. G., Buhr, A., Jendrike, N., & Haug, C. (2012, March 6). Clinical Performance of a Device That Applies Local Heat to the Insulin Infusion Site: A Crossover Study. Retrieved September 14, 2016, from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3380773/

Raz, I., Weiss, R., Yegorchikov, Y., Bitton, G., Nagar, R., & Pesach, B. (2009, May 31). Result Filters. Retrieved September 14, 2016, from http://www.ncbi.nlm.nih.gov/pubmed/?term=

Market Analysis

Value Creation
Our product creates a relatively cheap and innovative non-invasive method for insulin delivery to properly handle the effects of type one diabetes in patients.

Manufacturing Cost
The labor cost is $2.50 per patch. The zeolite cream cost is $0.02 per patch. The insulin costs $1.39 per patch. Lastly, the mepitac tape cost $0.27 per patch. Therefore the total manufacturing cost is $4.18 per patch.

"First Option Medical." Shop. First Option Medical, n.d. Web. 20 Sept. 2016.

"Direct Labor." Direct Labor Definition - AccountingTools. Accounting Tools, n.d. Web. 21 Sept. 2016.


Sales Price
The price is tentatively set at $5.00 per patch.

This price is sufficient to make the product valid for profit while not being any more expensive for type one diabetics than current treatment.

Market Size
Market estimate at 540 million units sold at $5.00 per patch gives a market value estimate of approximately $2.7 billion, $442.8 million of which is profit.

The estimate of 540 million is only assuming 10% of type one diabetics use our product, so it is relatively conservative in nature.

Market Size Fundability Score: 3

2.7 billion well exceeds 500 million, and this 2.7 billion could be even higher if more than 10% of diabetics are interested in this noninvasive method of treatment.

Fundability Discussion

We should get funding for our product due to the fact that, according to our completed fundability worksheet, we have a score of three on: Customer Validation, Market Size, IP Score, Technical Feasibility, Regulatory Pathway, and Reimbursement. We have a score of two on both Clinical Feasibility and Competition, giving us a score of around 2916. Based off of the fundability worksheet and the other information we have gathered, our product could be very profitable and would definitely be of interest to investors. Since there is currently no non-invasive way to get insulin into the body for type 1 diabetics, there is significant interest in finding a more convenient way of getting insulin into the body and have the body absorb it faster, which is exactly what our product would do. With our massive market size, it should be very profitable, even if only 10% of type one diabetics are interested in our product.

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