BME100 f2017:Group4 W0800 L1

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OUR TEAM

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

LAB 1 WRITE-UP

Health Care Issue



A prevalent health issue in the diabetes community is the pain and inconvenience of monitoring the level of glucose in the bloodstream consistently throughout a daily routine. The current methods require multiple skin invasive procedures. Our goal is to eliminate the need to consistently puncture the skin, but still have a 24/7 accurate reading of the glucose level in the blood through a skin patch, which will connect to your smart phone via Bluetooth for constant live updates. You will be able to receive alerts when your glucose level drops below a certain point and to what extent so you are aware of the exact amount of insulin you are required to take at any given moment.

Customer Validation



Physicians


1. Sonoran Desert Medical Specialists: Krishna M. Pinnamaneni, MD

• Address: 2034 East Southern Ave., Suite T Tempe, AZ 85282-7519

• (480) 838-2277


2. Arizona Integrative Medical Solutions: Mona Morstein, ND

• Address: 4657 S Lakeshore Dr #1, Tempe, AZ 85282

• (480) 284-8155


3. Weight Loss Institute Arizona: John J De Barros, MD

• Address: 1855 E Southern Ave Ste 1, Tempe, AZ 85282

• (480) 829-6100


4. Katherine Droste Emershad, MD

• Address: 451 E. University, Tempe, AZ 85281

• (480) 965-9603


5. Denise I. Beighe, MD

• Address: 451 E. University, Tempe, AZ 85281

• (480) 965-3346


Providers


6. Mayo Clinic - Phoenix

• Address: 5777 E Mayo Blvd, Phoenix, AZ 85054

• (480) 342-2000


7. Arizona Integrate Medical Solutions

• Address: 4657 S Lakeshore Dr #1, Tempe AZ 85282

• (480) 284-8155


8. Mountain Park Health Center

• Address: 6111 S All America Way, Tempe, AZ 85283

• (480) 964-3013


9. Diabevita

• Address: 5111 N Scottsdale Rd, Scottsdale, AZ 85250

• (480) 315-9757


10. Juvenile Diabetes Research

• Address: 4343 E Camelback Rd # 230, Phoenix, AZ 85018

• (602) 224-1800


11. Tempe St. Luke’s Hospital

• Address: 1500 S Mill Ave, Tempe, AZ 85281

• (877) 351-9355


12. Endocrinology, Diabetes & Longevity Center of Arizona

• Address: 7344 E Deer Valley Rd #100, Scottsdale, AZ 85255

• (480) 513-1042


13. Amnah Clinic

• Address: 524 W Broadway Rd, Tempe, AZ 85282

• (623) 362-8679


Purchasers


14. Medtronic Inc

• Address: 1002 S 52nd St, Tempe, AZ 85281

• (480) 921- 6457


15. McKesson Medical-Surgical

• Address: 7343 S Hardy Dr #101, Tempe, AZ 85283

• (602) 707-0820


16. 21st Century Healthcare Inc

• Address: 455 W 21st St Suite 101, Tempe, AZ 85282

• (480) 966-8201


17. Juvenile Diabetes Research

• Address: 4343 E Camelback Rd #230, Phoenix, AZ 85018

• (602) 224-1800


Payers


18. Arizona Health Insurance Experts

• Address: 3800 N Central Ave, Phoenix, AZ 85012

• (480) 725-7484


19. Aetna

• 7228-7252 E Indian School Rd, Scottsdale, AZ 85251

• (480) 445-8500


20. SCAN Health Plan Arizona

• 1400 E Southern Ave #735, Tempe, AZ 85282

• (855) 901-7226


Patients

Patients with Diabetes that would like a simpler and faster way to treat their illness would like this new technology. It would mean less pain for them, and a hassle-free way of treating themselves.

Competitors

Description and Image - Accu-Chek is a blood sugar test, and can also act as a Glucose meter Advantages - It is the leading provider of insulin pumps and blood sugar monitoring systems. Disadvantages - There is no “All-In-One” device that will incorporate all of the important aspects of diabetes. Traction to Date - The market size for diabetes is estimated to reach 35.5 billion dollars by 2024. ASP and Sales Model - There are options to purchase combo sets that lower the price per unit and ways to free meters. Marketing, Branding, Positioning - It is based out of India, which is where 20% of the world’s diabetes patients are. FDA Indications - Patient uses the device to measure glucose at home.


Contour Next is a trade brand owned by Ascensia Diabetes and strives to make products for people with diabetes. Ascensia Diabetes Care announced it has entered into a strategic alliance by signing a development agreement with Insulet Corporation. Under the terms of this agreement, the Ascesia ContourNext One blood glucose monitoring system will connect to Insulet's next generation Omnipod System, which is currently in development. Easily connecting the ContourNext and the Omnipod Dash system will provide people living with diabetes with an innovative continuous insulin delivery system to manage their diabetes. The ContourNext One Personal Diabetes Manager will pair with the Omnipod via bluetooth to automatically transmit a person's blood glucose readings directly into the system. These readings will be used by the Omnipod Dash to calculate insulin dosing and support highly accurate delivery of insulin. Under the terms of this worldwide agreement, Insulete will develop and seek marketing clearance for their Omnipod Dash, with the collaboration from Ascesia Diabetes Care who will provide the ContourNext One meter and ContourNext test strips. The ContourNext One received 510(k) clearance from the FDA in November 2016 and has been shown to meet the stricter accuracy requirements of the FDA over-the-counter BGMS guidance that was recently issued in 2016.

IP Position



We were unable to find any patents for a device that could painlessly monitor glucose levels without the use of needles.This shows that a device like this does not yet exist. Below are publications that announce the research of a potential option.

1)Bloodless Glucose Measurements Date: 1998 Summary: Research for new technologies in monitoring the levels of glucose in Blood is already underway. The goal to created a bloodless and painless way to measure blood sugar for patients with diabetes.

2)Can interstitial glucose assessment replace blood glucose measurements? Date: 2000 Summary: The current form of measuring glucose is through inserting needles in the fingertips. In order to create a method that is less invasive method, is to switch from blood glucose measurement to the measurement of subcutaneous interstitial fluid (ISF) glucose. Research for this continues, but the relationship between the subcutaneous interstitial fluid glucose levels and blood glucose levels still needs to be established.

Fundability Worksheet Scores

Competitors: 2

There are not many competitors in regards to this new diabetes technology. The commonly used glucose monitors do not have the technology that would be set uo in this new device. They all have different disadvantages that may be able to be solved with this new device.

Customer Validation: 1

Fabricating the new technology would be very expensive compared to the already existing technology. If the price of this could be reduced using already existing technology, the medical providers and the purchasers could lower the prices of the device drastically, increasing the accessibility of the device to the needing patients.

IP Position: 1

There aren't many patents in regards to the device. There are different ways of developing this device to make it easier to use and to acquire. This is a competitive health care area, and there must be patents in order to secure success.


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