BME100 f2016:Group4 W1030AM L2

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OUR TEAM

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LAB 2 WRITE-UP

Image:Screen Final.jpgImage: Watch.jpg


The blood glucose meter watch gives victims of high blood pressure an easier and more convenient way to monitor their blood glucose levels more frequently. This device fits comfortably on the patient's wrist (50mm x 50mm x 18mm, l,w,h) and features characteristics of a watch and a blood glucose meter. Within the watch, there is a spring loaded lancet and test strips, giving patients the ability to test their blood anywhere with ease. The watch also contains a glucose meter which displays on the touchscreen LED display along with the time. All information gathered form the watch can be monitored by the patients phone via Bluetooth if they find that they prefer the information to be displayed on their phone rather than their watch.

  • Image screen-captured and edited from Grab CAD user: Rinkeh Patel, then edited by us*

Technical and Clinical Feasibility

Technical Feasibility
a) What are the technologies needed?

The blood glucose meter watch integrates existing technologies into a new, more efficient device. These technologies include a digital LED display, digital watch, blood glucose reader, spring loaded micro lancet, and Bluetooth capabilities.

b) What are the challenges?

While all these technologies already exist, integrating them into one device may raise difficulties. We may experience challenges making a glucose meter small enough to fit on a wrist. The device must also fit a lancet and test strips which will add bulkiness. The micro lancet must be hidden in the device, but also be opened to easily replace the micro lancet. Another challenge will be creating an easy way to reload test strips into the watch.

c) What could go wrong?

If we are unsuccessful in addressing these challenges, the blood glucose meter watch will become very bulky and cumbersome. Reloading the watch would be very difficult for consumers, deterring them from using the device. The micro lancet and test strips could fall out or pop out from the device.

Technical Feasibility, Fundability Worksheet Score:
The score for our device is a 2, this is based on a plethora of factors that contribute to our product being feasible to create with troubles in only integrating the technology in such a small area. All technology we would like to integrate in our device (micro-lancet, watch, LED display, small glucose meter,etc) all exist and have been used in several ways. As an example the type of glucose meter that we plan to use in our device is commonly use as a phone attachment but it is small enough and takes minimal coding for the same information that the meter reads to the LED display of any device. All of the smaller components we are integrating into our watch also are also very cost effective and all cost under 15 dollars market price.(the next cheapest component is 5 dollars) It may be a challenge to integrate some of the technology but our device is not expensive to make.


Clinical Feasibility
a) Will it work in a clinic?

The blood glucose meter watch will work in a clinic. All the technologies featured in this device have already been through clinical trials and determined to be safe. This includes any blood glucose meter, test strips, or lancet we decide to incorporate.

b) What are the clinical risks?

Clinical risks for the blood glucose meter watch include the lancet needle popping out, incorrect blood glucose level readings, lancet applying too much pressure causing pain, and the device being bulky causing pain on the patient's wrist. the blood glucose meter watch would also incur all clinical risks associated with a blood glucose meter, test strip, lancet and watch.

c) Have similar products been in a clinical trial? How long was the trial?

A similar device, the Accu-chek Compact Plus glucose meter was in clinical trial for 3 years.

References

Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG (September 14, 2016). Retrieved from https://clinicaltrials.gov/ct2/show/NCT01820169?term=Accu-chek+Compact+Plus&rank=1

Clinical Feasibility, Fundability Worksheet Score:
The score of our device for this category is a 3. There are many micro/wearable diabetes and blood glucose monitoring devices that have been in market for quite a while. Not many of them are terminated or discontinued by the FDA, an example of this is the Accu-check compact plus which was able to pass trials and be approved by the FDA in 3 years compared to the device average of 4-7 years that medical devices are usually approved within so it is feasible that our device could take a short amount of time for our device to pass clinical trials and be approved quickly.



Market Analysis

Value Creation

The biggest value to the customer is the fact that all of the devices needed to measure their blood glucose are integrated in one device, that can interact with their smartphone, as well as perform many other capabilities such as HR sensors, pedometers, watch functions, etc. Not only this, but since the device can be initially created with relatively inexpensive materials, the watch-monitoring device could be purchased for not much more than the typical all-in-one devices (such as the Accu-Check Compact Plus), while integrating many more functions at the same time. Finally, because the device is highly portable, and very in-conspicuous to use, there is a significant convenience value to the customer, especially for people who live more active life styles.

Manufacturing Cost

Watch body and strap: The cost of the watch body and strap with basic LED touchscreen components like you would find in a typical watch should be less than $3.50 at the most. The cheapest LED smart watches can be bought in bulk from China for about this cost, so this should be readily feasible as long as we can manufacture significant amounts of our device at once. If we wanted to use higher quality materials like stainless steel and crack-resistant screens, the cost could go up significantly though. This is something that might be considered down the line, but not right away.

Blood glucose reader: The Bluetooth readers on the market right now, such as the MyDario and iHealth Align, that are small enough for our device can be purchased for about $15. Therefore they can most likely be manufactured for a cost around $8 or less.

Blood glucose strips: Strips for a device of comparable size, the MyDario, can be purchased for $0.25 per strip. Thus, the blood glucose strip cost is negligible.

Strip storage device: Since strips are able to be inserted into the device for storage, this cost is essentially just the cost of the plastic built into the watch is included in the cost of the watch body and strap.

Lancing Device: Micro lancing devices can be purchased for around $4-$10 dollars. Manufacturing is likely to be about half this, but since our device must be slightly more complicated to fit inside the watch, its feasible to argue $5 is a very safe estimate for adding this component to the watch.

Lancets: Micro lancets of correct dimensions can be purchased for about $0.10 a piece ($11.00 for 110 lancets), therefore manufacturing cost of micro lancets is negligible.

Electronics for smart watch capabilities: It is nearly impossible to find accurate estimates for this value, however since middle tier smart watches cost about $80-$120 in total. The electronic components are relatively cheap, and probably only cost about a quarter of this amount or less. Thus the electronic components are almost sure to be under $13.

Total: The total cost comes to about $38 in material costs. Labor can vary dramatically depending on where the device is manufactured, but if we assume that our product is manufactured in china then that would make the price to be at the cheapest. The average manufacturing job in china in 2012 made 55,532 yen per year which equates to $553.34 USD and after calculating an hourly wage is about $0.31. Then also taking an educated guess on the time that it takes to manufacture one watch being 2 hours, then assembly would be a less than $1 (We determined the assembly time by taking a watch apart and putting it back together). Shipping from China to San Francisco(for simplicity sake) via a large shipping container by boat would cost hardly $0.01 per unit and then from San Francisco to ship out to pharmacies stores across the US would cost at most $0.09 per unit. Then the packaging of a watch that includes a hard plastic frame and soft Styrofoam is completely negligible. Thus the total cost after shipping/distribution, packaging and labor costs are taken into account comes to somewhere around $32.10 dollars.

References:

Ahn, D. (2015, April 14). [Review of product: iHealth Align]. iMedicalApps. Retrieved from: http://www.imedicalapps.com/2015/04/review-ihealth-align-glucose-meter/

Ascensia Microlet Lancets, Single Use, 110 Lancets (2016). Amazon. Retrieved from: http://www.amazon.com/Ascensia-Microlet-Lancets-Single-Use/dp/B00X69NPOU

Chinese wages (2016). Retrieved from: http://www.tradingeconomics.com/china/wages-in-manufacturing/forecast

LED Watch Search (2016). Alibaba. Retrieved from: https://www.alibaba.com/showroom/led-watch.html

MyDario (2016). Retrieved from: http://into.mydario.com/DarioGlucoseMeter/D/

Microlet 2 Lancing Device (2016). Retrieved from: https://diabetessupplies4less.com/shop/microlet-2-lancing-device?gclid=CLWs4PGUjc8CFZBcfgodw6kNVw



Sales Price

Often times companies choose to sell their products at a 100% profit rate. For our device, with safe estimates following the 100% profit margin, this would come out to about $75. Because we are in the market of blood glucose measuring, this cost may be supported by insurance, so that the cost to the consumer may be actually less than this. The closest product on the market currently is the ACCU-CHEK Compact Plus which currently sells for around $60, our device not only has all the benefits of this all in one but it is also much more portable and convenient for a diabetes patients and includes features of a smart watch making our device not only extremely affordable and desirable making it the best option out there.

Market Size

According to the american Diabetes Association, 21 million Americans are diagnosed with Diabetes in 2012. We will use this number as a basis for the market size for our product, assuming each patient will wish to monitor their blood glucose levels. We plan to sell our product for $75 which makes our market size come out to be 1.575 billion. At this number our market size is well over the qualifying factor of 500 million meaning that we qualify for a 3 on the fund-ability assessment.

References Statistics About Diabetes (April 1, 2016). Retrieved from http://www.diabetes.org/diabetes-basics/statistics/



Fundability Discussion

So far, the blood glucose monitor watch has received scores in Competition, Customer Validation, IP Position, Technical Feasibility, Clinical feasibility, and Market Size. The scores are as follows:

Competition- 2

Customer Validation- 1

IP Position- 2

Technical Feasibility- 2

Clinical Feasibility- 3

Market Size- 3

Multiplying these scores, the blood glucose meter watch has a total fundability score of 72. Considering this score is still high despite not having two categories factored in, we believe our prototype should be funded. Also, the customer validation score is subject to change. We were forced to assign a one due to lack of research and resources because we are unable to present our device to patients or physicians to get input for this catagory. The blood glucose meter watch provides a cheap, innovative way for a large percent of the American population to check their blood glucose levels. The technology used is simple and based off common smart watches. This is why the blood glucose meter watch can easily be bought out by other smart watch companies such as Samsung or Apple. After being bought out, the watch can be enhanced with more features and sold to more countries. Therefore, the fundability score can only increase form this point on. The blood glucose meter watch is the first step to a massively lucrative and life changing device and, as such, should be funded.



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