BME100 f2016:Group10 W8AM L1

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BME 100 Fall 2016 Home
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Name: Eli Ozaki
Name: Mauro Udave
Name: Nicholas Guzek
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Health Care Issue

Type 1 Diabetes, a disease in which the body does not produce insulin, has as of now only one primary method of treatment, which is dependent upon a frequent and invasive delivery of insulin. This problem affects millions of Americans very day. This inconvenient method of treatment can sometimes lead to improper insulin delivery, in turn causing minor to extreme hyperglycemia, which can lead to severe health problems later in life, from amputated limbs to failing vital organs to loss of vision.

Staff, B. M. (n.d.). Type 1 diabetes. Retrieved September 06, 2016, from

"Insulin Injection: MedlinePlus Drug Information." Insulin Injection: MedlinePlus Drug Information. N.p., n.d. Web. 06 Sept. 2016.


There are two current primary solutions to treatment.

Method 1
One is direct insulin injections after each time the patient eats and whenever the blood glucose levels are too high.

Rarely has delivery blocked Delivers insulin immediately

Inconvenient Invasive A pen or multiple syringes must be carried at all times Insulin injections take hours to take full effect once in the blood stream

Method 2
The other method is an insulin pump, where a plastic needle is injected and fixed on the patient's body, leaving the needle in indefinitely, feeding insulin through the needle as needed by entering carbohydrates consumed or blood glucose levels into the insulin pump.

Delivers insulin immediately Insulin bolus is just the press of a button away, slightly more convenient

Still must be carried at all times Invasive Can cause severe bleeding Can have insulin delivery blocked fairly easily

Unmet Needs
Both methods are incredibly expensive, particularly the insulin pump Both methods are fairly inconvenient and invasive Both methods can fail and have delivery blocked

Customer Validation

People with type one diabetes This method would be less invasive than others, as well as more reliable

Insurance companies This method would be cheaper than others RN, By David Spero BSN. "Paying for Diabetes." Diabetes SelfManagement. N.p., n.d. Web. 06 Sept. 2016.

Endocrinologists (specifically for juvenile diabetics) More convenient and more reliable than other methods, resulting in healthier patients "Medtronic Probes Software Flaws in Insulin Pumps." Medtronic Probes Software Flaws in Insulin Pumps. N.p., n.d. Web. 06 Sept. 2016. Provider
Pharmacies, Hospitals. Easier to deliver, as well as less storage space

Medtronic Medtronic has a large vested interest in the industry of diabetes treatment, so if this product is successful, it could be seen as a potentially strong competitor, as well as a quick way to boost their company's growth

By Your Side Is a Service Mark of Medtronic, MiniMed Inc. "4 Ways to Get Started." MiniMed Insulin Pump Therapy. Medtronic, n.d. Web. 06 Sept. 2016.

IP Position

IP Position
0- No patentability or freedom to operate

1- No or weak patent applications or provisionals only

2- Non-provisional(s) filed and pending or issued patents, but weak

3- Strong, issued patents

Our Product
3- Strong, issued patents

There is one patent similar to our product, though notably different, and that patent is expired

Jang, Kwang Kyun, Young Sig Oh, and Samsung Electro Mech. "Patent DE19518733A1 - Pad for Transdermal Insulin Delivery." Google Books. N.p., n.d. Web. 06 Sept. 2016 Filing date May 23, 1995 Dec 15, 2009 Expired due to failure to pay maintenance fee Used an electrical system to release the insulin. It is a layered patch consisting of multiple parts.

MUSABAYANE, Cephas, Heerden Fanie Retief Van, Samson MUKARATIRWA, Mark Andrew TUFTS, and University Of Kwazulu-Natal. "Patent WO2013136234A1 - Transdermal Delivery Devices." Google Books. N.p., n.d. Web. 06 Sept. 2016. Filing date Mar 7, 2013 A patch releasing insulin is a slow controlled manner.

陈绚丽, 王兵, 吴晶, and 湖北医药学院. "Patent CN103705494A - Insulin Nano Transdermal Patch and Preparation Method Thereof." Google Books. N.p., n.d. Web. 07 Sept. 2016. Filing date Dec 26, 2013 Nano transdermal patch, insulin drug is mixed in water based solution to promote absorbsion.

Fishman, Robert, and Inc. All Natural Fmg. "Patent US7033998 - Alcohol-free Transdermal Insulin Composition and Processes for Manufacture and Use Thereof." Google Books. N.p., n.d. Web. 07 Sept. 2016 Filing date Apr 11, 2003 Active An alcohol-free delivery system. Using both human insulin and fabricated insulin. Must add sterile water and mix for five minutes.

Fundability Worksheet Scores

2, We give ourselves a 2 under competitors because there is competition out there, but there are still improvements that are being sought out by many people.

Customer Validation
3, We give ourselves a 3 under customer validation, because many people would be interested in having a non-invasive way of getting insulin rather than using needles as many people are known to experience discomfort.

IP Position
3, We give ourselves a 3 under IP Position, since all of the related patents we found were all expired, therefore we could have a strong patent.