The device is aimed to be as easy to use as possible, consisting mainly of a single screen which will show the results of the test. The device will fit easily even into a child's hand, but is sturdy enough to take a few drops without suffering major damage.
Through the port in the bottom, the test strips used to collect the saliva are inserted into the device, which the analyzes the test sample. After use, the test strip is disposed.
An internal battery with micro-USB charging capability keeps everything sleek and easy to use.
Technical and Clinical Feasibility
Technical Feasibility Different technologies we will need for our product to work are saliva collecting test strips that the device will read, a bluetooth component that will connect with a database held by the physician, a micro-USB cable to charge the device, and of course the device itself. Since there is already a similar product in making, we may have trouble getting the patent, however our product will be unique with different features than the other. We may also have problems in creating strips that collect enough saliva to acquire and accurate reading, however even that is a challenge that can be overcome. Ultimately what could go wrong is we could discover in the end that saliva is not in fact a feasible method of monitoring blood glucose levels with accuracy, however, there is much research to support our claim that it will in fact be accurate.
Clinical Feasibility In clinical testing, our product will prove to be more accurate than current options for blood glucose monitors, and will be less painful and invasive. There are little to no clinical risks of this product, because it simply involves inserting a strip into the patient's mouth for a swab of saliva, then inserting the test strip into the device. The strip will then be discarded and not used again. Since there is no requirement to break the skin, there is no risk of infection. A similar product is going through clinical trials right now. Their product is the first to use saliva to monitor blood glucose levels, but ours adds an additional features to it. Ours uses bluetooth to send the results to the physician, and has a color coded chart which helps children in particular learn how to respond to their results. The "iQuickIt" saliva monitor has been in development since mid-2012, and is still in clinical trials.
Market Analysis
Value Creation The unfortunate struggle of childhood diabetes is the scary reality that this is a condition that one will spend the rest of their life dealing with. To a child, this is terrifying and devastating, and as a parent, this reality is even more scary. There is now a responsibility on the parent to walk their child through daily life to make sure his or her diet is balanced and that insulin is delivered on time and food is eaten whenever necessary. While that is important and should still continue, our device offers the unique value of teaching children how to take care of themselves and be independent again in their new reality. Our device is a less invasive and more informative way of monitoring blood glucose levels. The child need only take a swab of saliva for the test, instead of the traditional finger prick method currently required. After the sample is tested by the device, the results will appear on the screen with not only the number result, but suggestions on how to respond to that result. This teaches the child how to take care of his or her-self which is a skill that he or she will need for the rest of his or her life. Our device also has Bluetooth capability, so every time the child runs a test, the results are sent to not only the doctor, but also to the parent. Simply being able to see the results and what the child needs to do will help put ease to the mind of the parent and also help them learn how to help their child. The doctor will use this information to track and monitor the child’s diabetes and know more about how to treat him or her. While it is specifically helpful to children, it is also a good device for anyone with diabetes to use; whether diabetes is new, or familiar, and regardless of age, our product is less invasive than current solutions and offers suggestions that will be helpful to all users whether the user has been dealing with this for years, or encountering it for the first time.
Manufacturing Cost
The approximate total cost of developing one prototype is 219.42 USD before tax. This is the maximum possible cost. There are price breaks when buy the chips in bulk.
One prototype is comprised of:
• Ultra low-power operation
Price .33 per unit (“LMV324: Ultra Low,” n.d.)
• Two operational amplifiers (OPAMP)
Price per unit .77 (“TL072CP Texas Instruments,” n.d.)
• Two transimpedance amplifiers (TRIAMP)
Price per unit 4.87 (“Electronic Components,” n.d.)
• 16-bit SAR analog-to-digital converter (ADC), 4 differential channels and up to 12 external single-ended channels.
Price per unit 41.01(“AD976AANZ - Analog,” n.d.)
• 12-bit digital-to-analog converter (DAC)
1.89 price per unit (“Microchip Technology,” n.d.)
• Inter-integrated circuit (I2C)
4.95 price per unit (“935,” n.d.)
• Universal serial bus (USB) connectivity
1.33 price per unit (“Molex Incorporated,” n.d.)
• Multiply-accumulate unit (MAC only in MCF51MM)
149.00 possibly price breaks if bought in bulk (“Freescale,” n.d.)
• ColdFire V1 and HCS08 cores, respectively
Cold fire V1 price per unit 4.21 (“FXLC95000CLR1 NXP,” n.d.)
HCS08 price per unit 11.87 (“MC9S08GT60ACFBER NXP,” n.d.)
• On-chip electrochemical sensing device
There is no pricing information on salvia since it is still in clinical we estimate that that it will cost approximately .72 per unit
A deal would need to be reached with bluetooth to allow use for device price is currently unknown.
(Garcia Yanez, 2013)
Sales Price
Considering that the manufacturing cost for one prototype is 219.42 USD, the anticipated average sale price for one device would be 349 USD, in order to make a profit and remain competitive.
Market Size
We would sell our device at 349.00 USD and with the "29.1 million Americans" that have diabetes, our market value would be over 500 million ("Statistics about Diabetes," n.d.).
Fundability Discussion
Customer Validation: 1 - We have not had a lot of time or opportunity to get customer feed back on our product or to generate interest in our product. Some people have stated an interest in our product, but the number of interested customers is small.
Market Size: 3 - 29.1 million Americans ("Statistics about Diabetes"n.d.) are effected by diabetes, the price of our device is $349.00 making the market size over 500 million.
Competition: 2 - There are several options for blood glucose monitoring available currently, however, our product improves upon these standards, making it stand apart form the competition.
IP Position: 2 - There is only one other device out there that measures blood glucose levels through saliva, they currently have a patent pending, however our device is different from theirs in design and certain function abilities that getting a patent would have a clear pathway.
Technical Feasibility: 1 - We would have to do a lot of research to develop this, because not a lot of research has been done yet on using saliva to measure blood glucose levels.
Clinical Feasibility: 3 - The results are more accurate and pain free than current solutions. The device is helpful to those learning to live with diabetes and to those who have had it for years. There are no real risks as to why this wouldn’t work.
BME 100 Fall 2016
