BME100 f2016:Group1 W8AM L1

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Contents

OUR TEAM

Name: Audriana Sedmak
Name: Audriana Sedmak
Name: Benjamin Robles
Name: Benjamin Robles
Name: Emma Rodriguez
Name: Emma Rodriguez
Name: Mitchell Miranda
Name: Mitchell Miranda
Name: Your name
Name: Your name


LAB 1 WRITE-UP

Health Care Issue

Diabetes is a disease that affects millions of people worldwide. "Insulin Dependent Diabetes Mellitus (IDDM) is a type of organ specific autoimmune disorder characterized by the destruction of pancreatic beta cells by cytotoxic T cells. About 1,000 insulin secreting beta cells are located in a spherical cluster called an islet of Langerhans. These islets make up 1-2% of pancreatic mass, are scattered throughout the pancreas, and contain other secreting cells. The autoimmune attack on the beta-cells, compromises the production of insulin and thereby the functions associated with insulin.The attack on beta-cells is initiated by activated cytotoxic T-lymphocytes (CTLs) that target specific islets for lysis (destruction). The CTL activity triggers the release of cytokines (immune hormonal messengers) which in turn stimulate the proliferation of activated macrophages and autoantibodies that are attracted to the site of inflammation (immune activation). The autoantibodies, together with complement-mediated lysis as well as macrophage and CTL activity, are responsible for the overall destruction of pancreatic tissue" ("The Pathology of Diabetes," n.d.).
Currently, the treatment for diabetes is very painful for patients as they have to draw a sample of blood, by pricking their finger, in order to measure their glucose levels. Considering that this treatment is very problematic to most, if not all, patients, a pain-free device to measure glucose is necessary in order to improve the lives of millions of people.


The Pathology of Diabetes. (n.d.). Retrieved September 06, 2016, from http://biomed.brown.edu/Courses/BI108/BI108_2003_Groups/Diabetes_Technology/type1.htm



Competitors

Blood Glucose Monitoring Devices

Advantages
Devices that measure glucose through a sample of blood are generally more accurate and require only a small sample of bodily fluid to achieve accurate results. These results of these devices are also easy to read - for most consumers.

Disadvantages
Although these devices are accurate, the method of pricking a finger in order to obtain a sample of blood is not ideal as it is painful.

Saliva Glucose Monitoring Device (Patent Pending)

Advantages
A device that measures glucose through a sample of saliva is painless and produces results that are easy to read - for most consumers.

Disadvantages
Although the method used for this device is painless, it requires a larger sample of bodily fluid to achieve results; and those results are not as accurate as those of a device that measures glucose through a sample of blood. The results can be harder for children and adolescents to understand.

Tear Glucose Monitoring Device

Advantages
A device that measures glucose through a sample of tears is painless and produces results that are easy to read - for most consumers.

Disadvantages
Although the method used for this device is also painless, it too requires a larger sample of bodily fluid to achieve results; and those results are neither as accurate as those of a device that measures glucose through a sample of blood. These results can also be harder for children and adolescents to understand.



Customer Validation

Patient
Patients will like our product because it is more user friendly than current options. The product test blood glucose levels based on saliva, so all that is required is to insert the sensor into your mouth instead of pricking your finger as how it is traditionally done. Also, the color coded chart will be more child friendly and help them learn better how to live with diabetes.

Payer
Insurance companies will have interest in our product because the patient would require less hospital visits and medical care since this product is easier to use and understand. Therefore, payers would be spending less money in the care of the patients using this product.

Physician
Physician’s jobs will be made easier by our product; our product teaches the user how to respond to the results of the blood glucose tests, therefore the physician won’t have to do as much work in teaching the patient what to do. The patient will also require fewer visits with the physician.

Provider
Our device will interest providers, because it will be less likely to error, more accurate, and require less maintenance than the traditional devices available for monitoring blood glucose levels.

Purchaser
Purchases will want to purchase our product because it will require less maintenance and will last longer than current treatment options, which will save money in the long run.














IP Position

1) Number/Assignee: Application number: EP20110156507

                               Publication number: EP2494920 A1

Title: Medical device capable of measuring a blood glucose level containing a data projector.

Summary: According to the invention, the display device (3) comprises a projector unit (3.2) with a light source and an array of optical elements (3.2.11). The projector unit (3.2) is capable of optically projecting and displaying an image (I) on a suitable surface (6) like, for example, a wall or a ceiling(GmbH,2011) Filing date/Status:March 2, 2011.

2) Number/ Assignee: Application number: US 14/494,517

                               Publication number: US20150141871 A1
                               Original assignee: Kaveh Khast 

Title: Pain minimizing injection system

Summary: The invention incorporates a lancet and a glucose test strip into a disposable cartridge. The user inserts the cartridge into the port of the device to turn it on. The base vibrates to quench or reduce pain from a lancet puncture. The test strip is exposed to the blood sample at the site of the lancet puncture which is analyzed by the device(Khast & Julian,2014). Filing date/ Status: September 23, 2014

3) Number/ Assignee: Application number: US 12/588,733

                               Publication number: US8385998 B2
                               Original assignee: Jin Zhang , William Gerald Hodge 

Title: Contact lens integrated with a biosensor for the detection of glucose and other components in tears.

Summary:These contact lenses can be worn by diabetics who can colorimetrically see changes in their contact lens color or other fluorescence-based properties, giving an indication of tear and blood glucose levels(Zhang and Hodge, 2009). Filing date/ Status: October 26, 2009

4) Number/ Assignee: Application number: US 12/153,647

                               Publication number: US9244035 B2
                               Assignee: Northeastern University

Title: Saliva Glucose monitoring system

Summary:Fabrication of the sensor involves depositing single-walled carbon nanotubes onto the surface of a working electrode in a 3 electrode electrochemical detector and functionalizing the nanotubes by depositing layers of polymers, metallic nanoparticles, and glucose oxidase enzyme onto the nanotubes. The sensor can be used as a disposable, single-use device or as part of an analytical system, such as a microfluidics system, for the analysis of multiple analytes. The sensor enables the diagnosis and monitoring of diabetes to be performed without pain or the need for finger pricks in a home or clinical setting(Zhang, Wang, and Northeastern, 2014) Filing date/ Status: January 13, 2014


Bibliography:

1)Bibliographic data (2012) Available at: https://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2494920A1&KC=A1&FT=D (Accessed: 7 September 2016).

2)Patent images (2015) Available at: http://pdfaiw.uspto.gov/.aiw?docid=20150141871&SectionNum=2&IDKey=CEF68CCD1D12&HomeUrl=http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1%2526Sect2=HITOFF%2526d=PG01%2526p=1%2526u=/netahtml/PTO/srchnum.html%2526r=1%2526f=G%2526l=50%2526s1=20150141871.PGNR.%2526OS=%2526RS= (Accessed: 7 September 2016).

3)Bibliographic data (2012) Available at: https://worldwide.espacenet.com/publicationDetails/biblio?CC=EP&NR=2494920A1&KC=A1&FT=D (Accessed: 7 September 2016).

4)Zhang, W., Wang, M.L. and Northeastern (2014) Patent US9244035 - saliva glucose monitoring system. Available at: https://www.google.com/patents/US9244035?dq=US+14/153,647&hl=en&sa=X&ved=0ahUKEwjA7ZiUz_zOAhUIz2MKHTAQBwsQ6AEIHjAA (Accessed: 7 September 2016).



1. IP Position List and describe the patent landscape and patent status. Will you own the space? Are there blocking patents you may end up infringing on? 4.1 Patent Landscape:

       The desired place would be at local hospitals or clinics to be supplied there.


4.2 IP Risks:

       Some of the patented products are very similar in concept, but are subject to change.

Fundability Worksheet Scores

Competitors
A 2 was given for a few reasons. There is no real training device widely used already for diabetes in children or newly diagnosed patients. It will eliminate the pain of the monitors that the finger pricking ones cause so that also moves it up. However there are multiple programs dedicated to educating people about diabetes including some by some major medical companies like Johnson and Johnson. The perk with this device is that it all done at home and by yourself as opposed to having to attend classes or making multiple doctor visits a year. That would have to be advertised in order to overcome the education classes.

Citations
Institute, J. D. (2016). Johnson & Johnson Diabetes institute. Retrieved September 7, 2016, from jjdi, https://www.jjdi.com/education-and-training


Customer Validation
A 1 is given right now for one simple reason there has not been enough time to acquire customer feedback. However there is a demand for diabetes treatment tools it is just to early to tell if the if this training device will work.


IP Position

A 1 is given on the IP position because there are no patents on the device yet. The device is still in the idea phase and could be changed depending on group consensus.



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