BME100 f2016:Group12 W1030AM L1

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Contents

OUR TEAM

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

LAB 1 WRITE-UP

Health Care Issue

Type 2 diabetes is a health issue that effects about 27.84 million people in the United States,1 or about 9.3% of the population.11 Type 2 diabetes develops either when the body is unable to produce the necessary insulin to lower blood glucose levels or when the body has developed resistance to insulin. The main causes of type 2 diabetes are thought to be lack of exercise, unhealthy eating habits, and obesity.2 Diabetes is a severe medical problem because it can lead to blindness, nerve and kidney disorders, and an increased risk for heart disease.11 Another side effect of diabetes is hypoglycemia, which can lead to seizures, unconsciousness, and death.11 The CDC reports that the total cost of diabetes in the United States in 2012 was $245 billion.11 This included costs directly related to the treatment of the disease, as well as indirect costs (those associated with disability, work loss, and premature death). Obviously, this is a huge market size, and a health issue in which we can make a big difference in people's lives.

Competitors

There are several different types of systems available for people with diabetes to monitor their blood glucose levels. The first is the most common and the traditional method of pricking the finger and placing a small drop of blood on a test strip. The second method involves placing a patch on the body that would be in contact with the blood stream at all times. The third method of testing blood glucose levels is using devices that are noninvasive. The advantages and disadvantages of each will be evaluated below:

Advantages

  1. Blood Glucose Test Meters3
    • Simple to use
    • Meters are not very expensive
    • Quick results
    • Common way to test blood glucose level
  2. Patches or Chips that Monitor Blood Glucose Levels
    • Easy to set up
    • Continuous monitoring
    • High accuracy
    • No additional costs after initial procedure
    • Wireless system links to your phone
    • An example of a patch is FreeStyle Libre.7
  3. Noninvasive Glucose Level Testing
    • Painless
    • No finger pricks
    • No blood
    • No risk of infection
    • Sometimes continuous monitoring
    • Potentially lower costs
    • No waste from blood testing strips

Some of the noninvasive competitors currently under development are the following products (listed with their respective advantages):

  1. GlucoWise4
    • Uses high frequency radio waves to determine blood glucose levels
    • Used by placing the sensor between thumb and forefinger or on earlobe
    • Data is uploaded through cloud server to app on phone
    • High accuracy
  2. GlucoSense5
    • Uses laser sensors to monitor blood glucose level
  3. Smart Contact Lenses6
    • Continuous monitoring system
    • Uses tears to determine blood glucose level
    • Small and unnoticeable


Disadvantages

  1. Blood Glucose Test Meters3
    • Must prick finger in order to use
    • Buying additional test strips can be expensive
    • Invasive
  2. Patches and Chips
    • Can only be monitored on a separate device
    • Patches could cause risk for damage if they are elevated above skin level
    • Invasive procedure
  3. Noninvasive Devices
    • Noninvasive products are not yet available. They are still in development phases and not yet ready for testing.
    • Cloud storage of user's data may have privacy issues
    • App/phone is sometimes necessary to check blood glucose level
    • Laser testing is slow (30 seconds to process data)


Customer Validation

Patient
The patient will be able to check blood glucose level very easily and manage a treatment plan to avoid complications with the disease.8

Payer
Devices that monitor blood glucose level may lower premiums which will reduce costs for insurance companies.

Physician
These devices will allow them to give their patients an expanse of treatment options and allow the patients to closely monitor their own blood glucose levels and possibly reduce office visits. They can also use the device to see how the patients are reacting to the treatment plan and adjust it accordingly.9

Provider
If a patient comes in with an emergency related to blood glucose level, the device will have a record of their levels and they will be able to asses the situation much faster.9

Purchaser
Companies will want to acquire this technology because the patient base is very large and many people will be wanting to use a non-invasive, convenient product.10

IP Position

Glucose-Sensing Contacts:14 Google secured a patent for glucose-sensing contact lenses which would allow the patient to record their glucose levels without having to prick for blood. The patent was filed November 10, 2014, Application number 14/536,856. The product was designed by Frank Honore, Brian Otis, and Andrew Nelson. The product that they have designed communicates with radio waves from the eye to an app that would allow the patient to view blood glucose levels at any time. The patients are also able to request information from the contact lens through the app.

Patent for the Whole Blood Glucose Test Strip12 The filing date for the blood glucose test strip was March 21, 1995 and the test strip was patented October 8, 1996. The publication number is US5563042 A. The inventors were Roger Phillips, Geoffery McGarraugh, Franklin A. Jurik, and Raymond D. Underwood. This patent deals with the development of the whole blood glucose test strip, which allows the patient to place a drop of blood on the strip and determine their blood glucose level. This product is primarily used for diabetic patients.

Noninvasive Blood Glucose Meter:13
US20110263954 A1
Filed April 1, 2010
The inventor of this device was Tzu-Yi Lin.
The basic premise of the patent is that it is a “wristwatch” type device that measure glucose levels and conveys them to the user on the display.

The abstract of this patent is fairly lengthy: “A noninvasive blood glucose meter for testing a blood glucose level of a living organism includes a casing, a printed circuit board and a display device. The casing includes a containing space, and the printed circuit board is installed in the containing space and includes a control unit and a memory unit, and the printed circuit board is electrically coupled to a light emitting device and a light receiving device, and the light emitting device is capable of emitting a light beam, and the light receiving device is provided for receiving a reflected light beam. After the light beam emitted from the light emitting device is entered into the testing living organism, reflected from the testing living organism, and received by the light receiving device, the light beam is passed through and processed by the control unit, and then displayed on a display device and stored in the memory unit.”


Method of selectively determining glycated hemoglobin: 15
Arkay Inc. filed a patent for a certain method of selecting the ratio of glucose within the blood. The inventor was Satoshi Yonehara. The patent was filed August 30, 2016. The application number is 14/329,019, and the publication number of WO02/06519. This patent takes the ratio of glucose in blood by dissolving the blood sample in protease that causes a redox reaction that can be used to determine the ratio of glucose in blood. With this type of selection, glycated hemoglobin can be accurately tested.


Fundability Worksheet Scores

Competitors
This area is a two because there are quite a few competitors but the products are still in the testing phase. There are improvements being made to the products and new technologies developing in this field.

Customer Validation
This area is a three because type 2 diabetes is a common disease that affects many people, and is predicted to continue being an issue in the future. A blood glucose test will allow them to monitor their own levels and control their treatment plan.

IP Position
This area is a two because there are patents that have been filed and issued. However, patents for new technologies are still pending and the products are still in development phases.

References

1Statistics About Diabetes. (2016, April 1). Retrieved August 31, 2016, from http://http://www.diabetes.org/diabetes-basics/statistics/

2Mandal, A. (2013, November 17). Diabetes Mellitus Type 2 Pathophysiology. Retrieved August 31, 2016, from http://www.news-medical.net/health/Diabetes-Mellitus-Type-2-Pathophysiology.aspx

3Tsai, A. (2015, March). Meters: Does Your Device Measure Up? Retrieved September 01, 2016, from http://www.diabetesforecast.org/2015/mar-apr/meters-does-your-device-measure-up.html

4GlucoWise™. (n.d.). Retrieved September 01, 2016, from http://www.gluco-wise.com/

5Partners, I. (n.d.). GlucoSense: Non-invasive, continuous glucose monitoring. Retrieved September 01, 2016, from http://www.glucosense.net/

6Google Secures Patent for Glucose-Sensing Contact Lens. (2015, April 18). Retrieved September 01, 2016, from http://diatribe.org/google-secures-patent-glucose-sensing-contact-lens

7Brown, A. (2015, January 09). Abbott’s FreeStyle Libre – Transforming Glucose Monitoring Through Utter Simplicity, Fingersticks Aside! Retrieved September 01, 2016, from http://diatribe.org/abbott-freestyle-libre-transforming-glucose-monitoring-through-utter-simplicity-fingersticks

8Staff, B. M. (2014, December 20). Diabetes. Retrieved September 01, 2016, from http://www.mayoclinic.org/diseases-conditions/diabetes/in-depth/blood-sugar/art-20046628

9Checking Your Blood Glucose. (2016, August 4). Retrieved September 01, 2016, from http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/checking-your-blood-glucose.html

10Kirk, B. P. (2014, October 17). Companies Developing Non-invasive and Wearable Glucose Monitoring Devices That Can Report Test Data in Real Time to Physicians and Clinical Laboratories. Retrieved September 01, 2016, from http://www.darkdaily.com/companies-developing-non-invasive-and-wearable-glucose-monitoring-devices-that-can-report-test-data-in-real-time-to-physicians-and-clinical-laboratories-1015#axzz4J2zJRuD0

11Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Retrieved September 2, 2016, from https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf

12Phillips, R., McGarraugh, G., Jurik, F. A., & Underwood, R. D. (1996). U.S. Patent No. US5563042 A. Washington, DC: U.S. Patent and Trademark Office.

13Lin, Tzu-Yi. (2010). U.S. Patent No. US20110263954 A1. Washington, DC: U.S. Patent and Trademark Office.

14H, F., O, B., & N, A. (2015). U.S. Patent No. 20150061837A1. Washington, DC: U.S. Patent and Trademark Office.

15Yanehara, S. (2016). U.S. Patent No. US RE46,130E. Washington, DC: U.S. Patent and Trademark Office.

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