BME100 f2016:Group8 W8AM L1

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OUR TEAM

Name: Dhantin Kumar
Name: Andre Bordeleau
Name: Blake Sentyrz
Name: Jasmine Davis
Name: Juan Pablo Robayo


LAB 1 WRITE-UP

Health Care Issue

Allergic rhinitis-- commonly referred to as nasal allergies-- is an “inflammatory process affecting the lining of the nose” when an individual comes into contact with an allergy-triggering substance (1). It is the most common chronic disease of childhood and is a major health problem for individuals of all ages. These substances are known as allergens, and when these allergens come into contact with the nasal passage or are inhaled by an individual, the immune cells lining the inside of the nose and lungs react, prompting a change in the individual’s immune system, leading to allergic symptoms. Allergies are simply defined as a malfunction in the human immune system where the body perceives these harmless substances (allergens) as a threat, and acts accordingly. When the allergen is first introduced to the body (a process known as sensitization), the white blood cells in an individual's blood stream become activated once coming into contact with the allergen fragments. Once these white blood cells (called type 2 helper cells) are activated, they interact with the immune cells in an individual’s body (known as B cells) and cause these cells to transform into antibody-producing plasma cells. These antibody-producing cells create large amounts of immunoglobulin E (IgE), an antibody molecule that is different for each type of allergen. For example, the IgE molecule for a dust allergen would not cause a allergic reaction for another allergen, such as a grass allergen. This antibody IgE then binds to the mast cells in the lining of the tissue. Once an individual has been sensitized to an allergen and is exposed to the same allergen again, the allergen binds to the IgE on the surface of these mast cells that have already been created and is circulating in the bloodstream, which then causes histamines to be released from inside the mast cells, which then travel around the body and attack anything it detects as harmful. This then cause an allergic reaction to occur (1).

Allergy symptoms, specifically in the nasal area of the face, are caused by the histamine released from the mast cells. The histamine, which is released when the body detects a harmful substance, causes inflammation near the site where the allergen and histamine is present. This inflammation is what we view as an allergic reaction, causing symptoms like runny nose, itchy nose, sneezing, and nasal blockage. Over 50 million are affected by nasal allergies per year, and over 11.1 million people visit a physician and are diagnosed with allergic rhinitis per year. Being the 6th leading cause in chronic illness in the United States, the loss of productivity from allergies costs $18 billion per year, according to the CDC (2). It is a chronic illness that affects "one in four school children (6–7 year olds) and one in two teenagers (13–14 year olds)" (1).

The current medication in the market for fighting allergies are antihistamines. Antihistamines work by binding to the cite of the mast cell where the allergen is supposed to bind to, thus not allowing the allergen to bind to the mast cell, which then does not allow the mast cell to release more histamines (3). These antihistamines are found in allergy pills like Claritin, and can also be bought generically over the counter in a near-by pharmacy. Over a 4-month period, these allergy pills (with daily use) can cost an individual anywhere from $60-$150. Some individuals can also be allergic to such drugs and therefore cannot consume these allergy pills.

Our product provides a more long-term solution to combat allergy symptoms as opposed to the daily consumption of allergy medicine. The device is installed 1 time under the skin, near the neck so that when histamines are created the antihistamines can be released to the site of inflammation. Refills occur every 4 months in order to replace the old "cartridges" and is capable of holding multiples of these "cartridges" of allergy medicine (antihistamines). An app or standalone device would also be provided in order to administer the dosage of medicine needed whenever needed. Our device will eliminate the need to go buy allergy medication very often, thus reducing costs and time in the long run, thus allowing the life of the patient to be more productive.


(1) Rotiroti, Giuseppina et al. Paediatrics and Child Health , Volume 26 , Issue 7 , 298 - 303. DOI: http://dx.doi.org/10.1016/j.paed.2016.03.006

(2) "National Hospital Ambulatory Medical Care Survey, 2002." ICPSR Data Holdings (n.d.): 30-31. National Ambulatory Medical Care Survey. Center for Disease Control, 2010. Web. 6 Sept. 2016.

(3) Church, Martin K, and Diana S Church. “Pharmacology of Antihistamines.” Indian Journal of Dermatology 58.3 (2013): 219–224. PMC. Web. 7 Sept. 2016.



Competitors

Our main competitor is any company that sells antihistamine pills.

Advantages:                                                        Disadvantages: 
  - Allergy pills are easily accessible, as they can be found        - Pills must be taken everyday for effectiveness. Individuals may forget to take pills.
    off the counter.                                                 - May cost up to $150 in a 4-month period in allergy pills.
  - Almost anyone is able to take allergy pills.                     - Effect only lasts a short amount of time.
  - Relatively cheap method of fighting histamines and reducing      - An inconvenience to some to keep buying and using. 
    allergies.
  - Pills are widely used.

Customer Validation

Patient
On top of other solutions to nasal allergies, such as pills, shots, or nasal spray, which could take too long to come into effect, patients will have the option of not having to take time out of their day to take their medications. Instead they simply use an app on their phone or a hand-held device and simply press a button to get instant relief from their allergies.

Payer
Because each patient comes in 3 times a year and there are 50 million patients coming in, there would be at minimum 150 million appointments, which means insurance companies would get paid at least 150 million times.

Physician
Many physicians are currently paid using a 'fee-for-service' model through medicare or medicaid. This model pays doctors 'for each service [they preform](like an office visit, test, or procedure).' (Medicaid.gov) The implantation fits in nicely with this model of payment, since the the patient will need to come in to get the initial implantation and then get a refill every four months. A physician will get three automatic procedures for every single patient that chooses to use the implant, with around 50 million patients coming in.

Provider
Hospital pharmacies would see a boon in customers around the time of their medicine refills. The device would also cut down on time by eliminating the patient's need to go to the pharmacy themselves, as the allergy medication would be delivered directly into their implant. Since the procedure is minimally invasive and requires only a re-injection of the medication after the insertion of the implant, the procedure can be said to be safe and reliable

Purchaser
The implant integrates personal technology with a common healthcare issue. It is anticipated that purchasers will find the convenience of this, and the potential of having a popular app, very attractive.


Sources
American College of Allergy, Asthma, and Immunology et al. "AAFA." Allergy Facts. Asthma and Allergy Foundation of America, n.d. Web. 06 Sept. 2016.
Medicaid.gov. Fee-for-Service. [1], (accessed Sept 6, 2016)

IP Position

Patents for parts of implanted chemical distribution devices created from few companies with no direct patent on an allergy medication distributor

Method for controlling insulin pump through internet

Publication number US7231263 B2

Publication type Grant

Application number US 11/546,110

Publication date Jun 12, 2007

Filing date Oct 10, 2006

Priority date May 23, 2003

Fee status Paid

Also published as US20070032891

Inventors Soo Bong Choi

Original Assignee Soo Bong Choi

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Expert system for insulin pump therapy

Publication number US7751907 B2

Publication type Grant

Application number US 11/753,420

Publication date Jul 6, 2010

Filing date May 24, 2007

Priority date May 24, 2007

Fee status Paid

Also published as EP2160694A1, 9 More »

Inventors Michael Blomquist

Original Assignee Smiths Medical Asd, Inc.

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Fixation device chemical dispensing system


Publication number US5895375 A

Publication type Grant

Application number US 08/890,834

Publication date Apr 20, 1999

Filing date Jul 10, 1997

Priority date Aug 14, 1995

Fee status Paid

Also published as US5681289, US5891101

Inventors Todd Wilcox, E. Marlowe Goble, Alan Chervitz

Original Assignee Medicinelodge, Inc.

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Apparatus and method for implanted self-powered medication dispensing having timing and evaluator means


Publication number US3923060 A

Publication type Grant

Publication date Dec 2, 1975

Filing date Apr 23, 1974

Priority date Apr 23, 1974

Also published as CA1038044A, CA1038044A1, DE2544884A1

Inventors Jr Everett H Ellinwood

Original Assignee Jr Everett H Ellinwood

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Drug dispensing irrigatable electrode

Publication number US4360031 A

Publication type Grant

Application number US 06/186,106

Publication date Nov 23, 1982

Filing date Sep 11, 1980

Priority date Sep 11, 1980

Inventors David L. White

Original Assignee Medtronic, Inc.

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Fundability Worksheet Scores

Customer Validation

2- People have expressed interest to purchase this product and would be willing to buy such a product, since there is no other product on the market like ours; however some have expressed an opinion against the sub-dermal procedure, and some do not think the product to be effective.

Market Size

3- There is a potential market size of around 2.5 billion due to the price of the product to be $50, and a customer base of around 50 million people affected by seasonal, nasal allergies.

Competition

2- There are some competitors in the allergy medication field, but none in the exact sub-dermal implant field. Our competitors are allergy medication companies like Claritin, but there are no competitors in this field allergy medication.

IP Position

2- Weak patents designed for chemical dispensers, but none for allergy relief, like ours.