# BME100 f2017:Group4 W0800 L2

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# OUR TEAM

 Name: Ally Coen Name: Monica De La Cruz Name: Christian Cuciniello Name: Brock Connolly Name: Jose Loya

# LAB 2 WRITE-UP

## Device Image and Description

Proposed design of the device itself and the technology being used in it. (lack of SolidWorks software)

This new form of glucose monitoring device would be able to measure levels of glucose in patients, without the the painful burden of having to pinch their finger throughout the day. This lowers the discomfort in patients and allows them to easily see their critical numbers fast when it comes to diabetes and glucose. Glucose found in sweat will be measured. Sweat will be collected and will be produced with the help of heat inducers. All recorded information will be sent to the patient's mobile device through Bluetooth.

## Technical and Clinical Feasibility

Technical Feasibility
This new form of glucose monitoring would require a new technology, as well as many already existing components. A long living battery, like one in a pacemaker, would be used in order to prolong the battery life and to ensure patients do not have to worry about it. This could then power the electrochemical sensors that would specifically detect the glucose levels in the sweat of the patient. Sweat would be induced using a small electrical heat inducing patch that would help create a detectable amount of sweat. A Bluetooth RF Transceiver would be places in the sleeve in order to be able to send the collected information to the patient's mobile device. This, all together, will be able to receive sweat samples, analyze glucose levels, and report the results in back to the patient in one simple and comfortable device.

Some challenges that could come from our device are how well a battery could work. It may be hard to find a good, long lasting battery. Another challenge could be that the heating technology will not work correctly, and will basically make our whole device dysfunctional. A main challenge could be that someone could develop something extremely similar but get it approved and processed first.

Things that could go wrong are that the battery could run out quicker than projected and it not being able to record the levels of glucose. Another possibility could be that the heat inducer will not heat enough to produce the amount of heat needed for the patient's body to produce sweat. This could limit the accuracy of the sweat reading and glucose levels provided. Another possible disadvantage is that the device will not pair properly with the patient's mobile device and they will not receive the information that is being obtained.

Clinical Feasibility
Due to the wide variety of blood glucose monitors on the market, we know the success rate of designing a glucose monitor. Although other companies have had major success with their products, the success of our product specifically will require some expertise and research to determine accuracy of the procedure we are using to calculate the body's glucose levels. Many clinical trials will be needed by volunteers from all around the world that have diabetes. Most of our research will be focused on glucose sensors,pH sensors, temperature sensors, bluetooth, and thermo-responsive drug delivery. Since glucose meters are already on the market, it will be easy to interpret the devices technology into our own. The way our device will be used is we will have a heat inducing patch that will go on a person arm that will detect sweat and be able to determine the person's glucose levels without a needle and blood, and send the results to a mobile device via bluetooth. Clinical risks, or risks in general, may include a less accurate reading of glucose levels due to the readings coming from sweat and not straight from the person's blood. another risk may be the person not sweating enough for an accurate reading or needing to check glucose levels and not having a mobile device with them. A leading competitor of glucose meters Accu-Chek, has done clinical trials on all genders of people ranging from 18-75 years of age with type 1 and 2 diabetes that were using insulin as therapy for the diabetes. The study was done to assess the change in treatment satisfaction of participants who utilize the ACCU-CHEK Connect Diabetes Management System over a period of 6 months.

## Market Analysis

Value Creation
The value of our potential product comes from its ability to measure blood sugar with sweat instead of blood. This means that our product does not require the users to have to insert any needles into the skin and still be able to monitor their blood glucose levels. This has not yet been achieved so it would have great value.

Manufacturing Cost
- $200 per device The market price of electrochemical sensors seems to range from about$150 to $500. We think that the sensors inside of our product with be on the more expensive side of the spectrum because of the advanced technology it takes to get accurate glucose readings. We estimate the cost of production of the expensive sensors by dividing the market price(500) by five(5), to get a cost of$100. The Bluetooth technology that our device requires is a relatively low cost technology. The most significant cost of this is the license that the manufacturers are required to get. For this part of our device, we added $50 into our unit cost of production. The last significant part to our device is the heaters to induce sweat. This will be a relatively low cost and will contribute$25 to the unit price of production. The estimation of the cost it will take to manufacture one device will be about $200 dollars with the fees of manufacturing and extra materials. Sales Price -$1000 per device

We believe that the market value of our device is five times the quantity of the cost of production. People with diabetes, who have experienced the current invasive methods of measuring glucose will definitely be willing to pay \$1000 for this device.

Market Size
- almost 450 million

## Fundability Discussion

Customer Validation - 2 The current methods of treating diabetes is so painful and invasive, that a significant amount of interest has been expressed for the creation of something better. This product is highly sought after by a large group of people.

Market Size - 2 Our market size score is two because almost 450 million people in the world have diabetes. This is a very strong market size.

Competition - 2 There is currently a few competitors for this product, but they have yet to accomplish the goal of an accurate technology that is ready to put on the market. If this product were successfully executed, it would stand a very good chance in the market.

IP Position - 1 Currently it is very hard to find patents for this kind of device. This might be a possible setback for the production of this device.

Technical Feasibility - 2 The technologies within device are advanced, but they are reasonable. There are challenges created by the accuracy of measuring glucose in sweat, but we can overcome these with a reasonable amount of cost and research.

Regulatory Pathway - 1 It is likely that it would need a PMA(Pre-market approval) before this device could be put on the market.

Clinical Feasibility - 2 The likelihood of having clinical success with the technology in this device is very high. Getting successful clinical results would take stong expertise for the problem of the measurement accuracy, but it is highly probable.

Reimbursement - 3 Diabetes is a very serious problem, so the people who are affected by it are definitely willing to pay cash for a device like this. This makes the situation of reimbursement to investors a very positive one.

Discussion With the scores that this potential device received for fundability, we believe that this device would be worth the research and cost of successfully achieving it. Developing the technology to make this device is possible and would benefit the lives of people living with diabetes.

## Resources

How does Bluetooth work? https://www.scientificamerican.com/article/experts-how-does-bluetooth-work/ (accessed Sep 20, 2017).

Where To Find It | Bluetooth Technology Website https://www.bluetooth.com/what-is-bluetooth-technology/where-to-find-it (accessed Sep 20, 2017).

Electrochemical Sensors & Biosensors | CTI http://www.conductivetech.com/products/electrochemical-sensors/ (accessed Sep 20, 2017).

Macroduct® Sweat Collection System https://www.elitechgroup.com/product/macroduct-sweat-collection-system/ (accessed Sep 20, 2017).