BME100 f2016:Group4 W1030AM L1

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Contents

OUR TEAM

Jaeger Moore
Jaeger Moore
Matt Morton
Matt Morton
Mahinalani Wing
Mahinalani Wing
Trevor Wood
Trevor Wood
Name: Your name
Name: Your name
Name: Your name
Name: Your name

LAB 1 WRITE-UP

Health Care Issue

Type II diabetes is a genetic/acquired disease in which the body's cells become resistant to the hormone insulin. Insulin causes cells to uptake blood sugar, and when this process is faulty, blood sugar concentrations rise to potentially dangerous levels after eating (Barrier, 2005). Hyperglycemia occurs when the body's blood sugar rises too high making the patient susceptible to a coma (Hyperglycemia, 2014). Hypoglycemia occurs when the body's blood sugar drops too low and when sever can lead to death (Hypoglycemia, 2012). Type II diabetics monitor their blood glucose through pricking their finger and placing blood on disposable test strips. The strips contain glucose oxidase, which reacts with the glucose in the blood creating ferrocyanide (Jensen, 2011). An electric charge resulting from this reaction flows down the test strip to a calibrated meter, which can then determine the blood sugar content (Jensen, 2011). When their blood sugar drops too low, they can eat a sugary snack. When it is too high, they can self-administer insulin into subcutaneous tissue. This higher concentration of insulin is more effective than natural levels in the blood.

Current glucose monitors and tools which monitor bloods/glucose are cumbersome and embarrassing for type II diabetics to monitor their blood glucose levels consistently in public. What we wish to develop is a more efficient and convenient way to measure/monitor blood glucose levels so patients are able to avoid hyperglycemia, hypoglycemia or other serious complications associated with type II diabetics.


References:

Barrier, P. (2005). Type 2 diabetes for beginners. Alexandria, VA: American Diabetes Association.

Hyperglycemia (High Blood Glucose). (2014, September 16). Retrieved from http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html

Hypoglycemia (Low Blood Glucose). (2012, July 1). Retrieved from http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html

Jensen, S. (2011, October 18). How do Glucometers Work? Retrieved from http://engineering.mit.edu/ask/how-do-glucometers-work

Competitors

Competitor Advantages Disadvantages
Accu-Chek Compact Plus "All in one" monitoring device that includes attached lancet, a role of dispensable test strips, and screen for viewing results. Relatively inexpensive for the unit ($40 on Amazon). Requires 1.5mL of blood for testing, whereas many other competitors require only 0.3 to 0.6mL. Dispenser for test strips is very loud and conspicuous. Test strips are more expensive than competitors.
Continuous Glucose Monitoring Devices (CGM) Incremental updates (usually about 5-10 minutes) of blood glucose sent wirelessly to a phone/insulin pump for constant maintenance. Easy to record glucose readings throughout the day, and allows you to modify diet/exercise based on readings. Still requires you to prick fingers up to twice a day for calibration of the device. Monitoring device and insulin pump must be inserted into the body, usually through minor surgery. Much more expensive than other types of glucose meters. Bluetooth can cut out at times for certain devices.
Standard Inexpensive Blood Glucose Testers Cheap, and the device that measures the blood itself is usually very small. Easy to read and use. Generally keeps readings for up to a month. Easy and quick to manufacture in mass. Must carry around a pack with lancet, test strips, etc. Conspicuous and cumbersome to use in public places. Usually not Bluetooth compatible.
Our Device Can be worn and used discretely. Combines all the different aspects of glucose-monitoring devices into a small wrist-watch type device. Able to integrate other fitness watch components such as a pedometer, HR monitor, and time. Could even be made waterproof to a certain degree so device can be worn at all times (from doing dishes to being in the rain). Great for people who work jobs that make it difficult to carry around other monitoring devices and do not want the intrusive nature of CGM's. Price would be more than other monitoring devices due to the increased integration of electronics and smart watch components. Watch would be more bulky than traditional watches or smart-watches which might result in less demand. Strips would have to be stored in an alternate method (roll) in order to store an adequate amount. If insulin was included, that would further increase the size.


References:

Hanselman, S. (2015, October 13). [Review of product: Dexcom G5 CGM]. Hanselman.com. Retrieved from http://www.hanselman.com/blog/DiabetesTechnologyDexcomG5CGMReviewSoMuchWastedPotential.aspx

P., Sandy (2011, December 10). [Review of product: ACCU-CHEK Compact Plus Meter Kit]. Amazon. Retrieved from: https://www.amazon.com/gp/customer-reviews/R3MKC0S6W515N0/ref=cm_cr_arp_d_viewpnt?ie=UTF8&ASIN=B00005V3D9#R3MKC0S6W515N0


Customer Validation

Patient
Type II Diabetes patients will want this product because of the convenience of not having to carry around a diabetes "kit". As quite a few diabetes dislike the idea of having to carry around multiple objects in order to be able to check their blood glucose levels.(Alexys Cearlock-Harrison, personal communication, 9/3/2016) our device allows for patients to be able to check their blood glucose levels with ease and without the clutter of having to carry around multiple objects. Also type II diabetics who work jobs that make carrying around other glucose monitors impossible would test their blood more frequently with a product such as ours (Skylar Crudup, personal communication, 9/5/2016).

Payer
Reduces risk of having to go to the hospital or having a significant episode that would be much more expensive to insurance companies. This would be due to people testing their blood glucose more often because of the convenience and ease of using our device.

Physician
Less worry of patients dealing with more severe issues that can be brought on by poor management of diabetes due to people monitoring their levels at a more consistent rate. Should lessen the rates of severe illness, hyper-and hypoglycemia, and even peripheral nerve damage (an epidemic right now according to a local Nurse Practitioner (Susan LaSala, personal communication, 9/4/2016).

Provider
With Patients having the ability to be able to check their blood glucose levels with ease insurance providers would not even hesitate to assist people purchasing our product. Providers much rather pay for a device that will keep people from having some sort of episode and having to go to the ER just because of not monitoring their blood glucose levels due to embarrassment. With an average cost of having somebody in the ER at approximately $2,168, any provider much rather help pay for a $40-$80 device.

Purchaser
The smartwatch and wearable health market is such a large and innovative one (Kosir, 2015), so there should be at least some interest from companies such as Samsung, Apple, Google, Fitbit, etc. Companies such as these are always looking to get an upper hand in the market, and because the market for diabetes management devices is such a huge one. Each diabetic is expected to pay $174 per year for smart monitoring devices by 2020. Also, in 2016, $265 million was spent on connected medical devices (such as glucose meters), self-management apps, and tele-medicine for diabetics (Statista, 2016). These statistics show there is a lot of money to be made if a product such as ours can be successful.


References:

Lindsay Abrhams (2013, February 8). How Much Does It Cost to go to The ER. Retrieved from http://www.theatlantic.com/health/archive/2013/02/how-much-does-it-cost-to-go-to-the-er/273599/

Alexys Cearlock-Harrison, 9/3/2016, Personal Interview

Kosir, S. (2015, April 15). Wearables in Healthcare. Retrieved from https://www.wearable-technologies.com/2015/04/wearables-in-healthcare/

Skylar Crudup, 9/5/2016, Personal Interview

Statista, The Statistics Portal (2016). Diabetes. Retrieved from https://www.statista.com/outlook/314/109/diabetes/united-states#

Susan LaSala, 9/543/2016, Personal Interview

IP Position

Number Assigned Title Summary Image Filing Date
Application #: 14/289362 Needle-Free Blood Draw A system for needle-free drawing of blood is disclosed. A device can include an evacuated negative-pressure barrel with a membrane sealing an aperture at a distal end, and a housing affixed to a proximal end. An accelerator barrel can be positioned within the negative-pressure barrel and fixed to the housing, with an open proximal end in a chamber in the housing, and an open distal end aligned with the aperture. The chamber can be filled with pressurized gas, and a trigger valve can hydrostatically separate the chamber from the open proximal end of the accelerator barrel. A micro-particle positioned within the accelerator barrel can be accelerated to high speed by an abrupt surge of gas by releasing the trigger valve. The micro-particle can attain enough momentum to pierce the aperture membrane and penetrate adjacent dermal tissue. A resulting micro-emergence of blood can be drawn into the negative pressure barrel. 05/28/14
US20100004522 A1 Continuously Wearable Compact Blood Glucose Measuring Device A wearable blood glucose measuring device based device and kit that incorporates non-continuous, invasive, electrochemical glucose test strip technologies for measuring blood glucose concentrations. The device can be inconspicuously worn due to its compact nature and integration into commonly worn articles such as watches, bracelets, armbands, wristbands, and the like. All-in-one embodiments include integrated test strip management including automatic test strip dispensing/ejection as well as incorporating spring loaded lancet apparatus capable of the dispensing, arming and activating functions enabling the user to provide a blood sample for glucose testing. Some embodiments do not integrate, nor contain any lancing devices/lancets. Other embodiments contain secure storage compartments integrated into the wearable blood glucose measuring device where the user can choose to store loose glucose test strips, calibration strips, lancets, cleaning wipes, and any combination thereof. 01/07/10
US6110522 A Blood glucose monitoring system A blood glucose monitoring system includes a broadband light source and a specially fabricated optical filter for modulating optical radiation to be transmitted through a fleshy medium. Optical radiation which passes through the fleshy medium is detected by an optical detector which generates an electrical signal indicative of the intensity of the detected light. Digital signal processing is performed on the electrical signal to extract those optical characteristics of the electrical signal due to the optical characteristics of the filter and constituents of the fleshy May 1, 1995 medium other than blood glucose concentration. The monitoring system employs a unique "double-log" transformation to minimize errors due to indeterminate path length variations of the optical radiation through the fleshy medium. The monitoring system further employs specialized signal processing to avoid inaccuracies due to the previously unidentified solvent effect which arises when glucose is dissolved into water. 04/16/98


References:

Lepper J. M., Diab M. K. (1998). Publication No. US6110522 A. Location: Google Patents (https://www.google.com/patents/US6110522)

Peeters E., Smith P. H. (2014). Application No: 20150342509. Location: US Patent & Trademark Office (http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20150342509.PGNR.)

Varela E. (2010). Publication No. US20100004522 A1. Location: Google Patents (https://www.google.com/patents/US20100004522?dq=glucose+meters+built+in+watch&hl=en&sa=X&ved=0ahUKEwi0zenT6e_OAhVLwiYKHbBVDssQ6AEIPDAE)

Fundability Worksheet Scores

Criteria Score Rationale
Customer Validation 1 While we have some interest from interviews we have done thus far, we do not have enough feedback so far to be statistically sound. Therefore a score of 1 is the most accurate for Customer Validation.
Competition 2 This is because there are not many wearable devices that aid the monitoring of blood glucose levels. But our device would also not displace many other blood glucose monitoring kits of its kind due to the low commercial value of these products. It is difficult to determine where our device would stand in such a new market because of the lack of hybrid monitors in the market right now.
IP Position 2 There are other similar devices that have patents however none of them are exactly like ours. The few devices that share the same background idea of an all inclusive device for diabetes patients. But many do not have the capabilities of our device, they are not a complete functional watch, not a smart watch(In the hopes of having our product be bought out), do not have Bluetooth capabilities, and do not have all the various parts built in; using this for a general storage space instead.


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