BME100 f2016:Group12 W1030AM L2

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Contents

OUR TEAM

Name: Aly Carlson
Name: Aly Carlson
Name: Adin Roemer
Name: Adin Roemer
Name: Ryan Faust
Name: Ryan Faust
Name: Ryan Shannon
Name: Ryan Shannon
Name: Kyle Tappendorf
Name: Kyle Tappendorf

LAB 2 WRITE-UP

Device Image and Description

This product is a watch based design with laser glucose monitoring. The main band portion is made up of a silicon rubber material with an adjustable band. The red button on the side of the watch turns the watch on and off. The blue button is pressed when the wearer wants to test blood glucose level. The laser is on the underside of the watch with a glass surface in constant contact with the skin. The glucose reading will be taken through this glass and the information about the blood glucose level will be displayed on the face of the watch. All blood glucose readings are stored on the watch and can be transferred to storage on a computer through a charging/connection port on the opposite side of the watch from the buttons. This transfer of data protects patient confidentiality instead of transferring data over the cloud like some noninvasive glucose monitors. When blood glucose levels are not being tested, the band also functions as a watch.This is a convenient noninvasive way for the wearer to test their blood glucose level, store it on the device, and track the progress of the disease over time. The following diagrams were adapted in SolidWorks using template designs from GrabCad.10


Technical and Clinical Feasibility

Technical Feasibility
The patent for Glucosense, a glucose monitoring technology, is a British patent and we were unable to find the patent. A description of the technology is provided on the website: "nano-engineered silica glass with ions that fluoresce in the infrared region when stimulated by a low power laser. When the glass is in contact with the user’s skin, the reflected fluorescence signal varies based on the concentration of glucose in their blood. The process takes less than 30 seconds."1 Our wearable glucose monitoring system will take a reading from the wrist instead of the finger. Modifications will need to be made in order to take the reading from a different part of the body. Also, since one of our goals is to decrease the time it takes to determine glucose levels, technological advancements will be needed in order to decrease that time.
Technical Feasibility Score
Our product would have a technical feasibility score of a 2 because there are some challenges surrounding the product but the main technologies have been developed. The existing technology of laser blood glucose monitoring will need to be modified in order to measure the glucose level through the wrist. This will require some time and cost for development.

Clinical Feasibility
The clinical trial results for Glucosense have been kept silent for now as the research team is still working on the product. So we cannot use those as a basis for our clinical feasibility. However, there are a few clinical trials that have been completed under American studies, including a non-invasive type 1 diabetes glucose monitor that shines infrared light on the skin to see how the light bounces back or gets absorbed. This study took a year and a half from "February 2013 to June 2014 and had subjects tested every 20 minutes for 12 hours a day and up to 6 visits per patient up to 4 months. The sample size included individuals age 12-75 previously diagnosed with type 1 diabetes metals, and are using insulin to treat their condition. Pregnant women and nursing mothers were not allowed to participate and neither were people with skin conditions that would have prevented being able to wear the device on their person."2 Given this information, the clinical trials for our product will take around the same time to test, based on the technology that was used. We will perform tests on a wide range of subjects to see how the accurate the device is compared to blood test samples. To ensure accuracy, the clinical trails will include an age range of 12-75 and people from different ethnicities and demographics. Once the product goes to the public, the product will be used in public and private by the customer to monitor glucose and then upload the information online.

Clinical Feasibility Score
Our product would have a clinical feasibility score of a 2 because the study will likely succeed as other similar studies have, but the usage of laser technology will require some research to determine whether or not it is actually possible to measure the glucose level through the wrist. We may need an expert opinion on whether or not the product can actually work.

Market Analysis

Value Creation
This blood glucose monitoring band would be very valuable to the customer. It allows them to test their blood glucose level non-invasively and quickly. The device is slim and very wearable. The device will allow the customer to test their blood glucose level at anytime because the band can be worn all day. The information is also stored on the device and be downloaded to a computer to analysis and track the progression of the disease. The device also has the practical application of being a watch for telling time.

Manufacturing Cost
The cost to manufacture a similar product, the FitBit, is $17.36 with materials and manufacturing costs.8 We expect that the production of our product will be very similar due to substitutions between products that are included in the FitBit but not in our device and vice versa. The Bluetooth chip which costs about $2.005 and the GPS chip with cost $2-$36 will be removed and silica glass which cost $2.16 for 5x7 mm of 35.84 feet/lbs7 and low power laser diode: $19 will be added. The rest of the cost from the product come from the rubber band, watch interface, circuits, and the cost of labor. This will keep the cost around $17-$18.

Sales Price
We will sell the product for $75.00. This will give us enough profits, yet still be appealing to the customer since the competition is generally more expensive.

Market Size
"The International Diabetes Federation reports that there were about 350 million people living with type 2 diabetes."3 The global growth rate of type 2 diabetes is 6.5% according to research done by GlobalData4 our market size will continue to grow over the years and there will be new customers who can buy the product. With the sale price being $75 and assuming 100% participation, the potential market size is about $26 billion. This gives the market size a score of 3 on the fundability worksheet.

Fundability Discussion

Based on the categories of competitors (2), customer validation (3), IP position (2), technical feasibility (2), clinical feasibility (2), and market size (3), our fundability worksheet score is 144. We believe that our product should be funded because it has practical use and convenience for the consumer. This product will also generate a large amount of revenue. It is also a growing market because of more people developing type 2 diabetes. Noninvasive glucose monitoring is on the rise and will benefit people across the globe.

References

1NetScientific. (2016). Non-invasive, continuous glucose monitoring. Retrieved September 07, 2016, from http://www.glucosense.net/

2Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2. (n.d.). Retrieved September 12, 2016, from https://clinicaltrials.gov/ct2/show/NCT01831752?term=noninvasive glucose monitor

3Santos-Longhurst, A. (2016, September 8). Type 2 Diabetes Statistics and Facts. Retrieved September 14, 2016, from http://www.healthline.com/health/type-2-diabetes/statistics#2

4Global Type 2 Diabetes Market Set to Almost Double to $58.7 Billion by 2025, says GlobalData. (2016, June 8). Retrieved September 14, 2016, from https://healthcare.globaldata.com/media-center/press-releases/pharmaceuticals/global-type-2-diabetes-market-set-to-almost-double-to-587-billion-by-2025-says-globaldata

5Electronic Components. (n.d.). Retrieved September 14, 2016, from http://www.mouser.com/search/refine.aspx?Ntk=P_MarCom

6Gps chips wholesale. (n.d.). Retrieved September 14, 2016, from https://www.alibaba.com/showroom/gps-chips-wholesale.html

7National Scientific Company. (n.d.). Retrieved September 14, 2016, from http://www.quartz.com/quartz.html

8Media, I. E. (2013, October 17). Teardown: Fitbit Flex. Retrieved September 14, 2016, from http://electronics360.globalspec.com/article/3128/teardown-fitbit-flex

9Alibaba Manufacturer Directory - Suppliers, Manufacturers, Exporters & Importers . (n.d.). Retrieved September 14, 2016, from https://www.alibaba.com/product-detail/635nm-low-power-laser-diode-5mw_60260918384.html?spm=a2700.7724857.0.0.9PGKbU

10John Rodrigues. Retrieved September 7, 2016, from https://grabcad.com/library/watch-125


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