Diabetes is the common name for different metabolic disorders that pertain to an overabundance of high blood sugar levels and a deficiency of the hormone insulin. In healthy individuals, beta cells in the pancreas regulate the amount of blood glucose by releasing insulin. The most common type of diabetes are grouped into two categories. Type 1 diabetes refers to people who cannot make insulin where type 2 diabetes refers to people who don't respond well to the insulin their bodies make. There isn't a clear cure for diabetes; however, some people can recover with proper nutrition and exercise and diabetes--for most people--is a livable disease. Insulin must be injected under the subcutaneous layer of fat in order to reach the blood.
The use of transdermal patches is a recent addition to the medical field most commonly used for delivering small, lipophilic, low-dose drugs through the skin and into the bloodstream. While current transdermic patches can only diffuse molecules the size of of a few hundred daltons, insulin has a molecular mass of close to six-thousand daltons. However, newer technology and innovation of the transdermic patch progressing through clinical trials can deliver drugs that have larger macromolecules. Some transdermal delivery systems use systems of microneedles, thermal ablations and other methods to increase the permeability of the skin in order to absorb larger molecules.
Rekha K. Agarwal MD: Diabetes, Endocrinology: (623) 876-6960
Dr. Devendra G. Wadwekar, MD: (480) 782-9531
Patients
Diabetes
Type 1: +200,000 patients
Type 2: +29 million patients
Blood sugar issues
Providers
Diabevita (diabetes center): (480) 315-9757
American Diabetes Association: (602) 861-4731
Arizona Endocrinology Center: (602) 439-9000
Juvenile Diabetes Research: (602) 224-1800
Arizona State Hospital: (602) 244-1331
Payers
Blue Cross
State medicaid (ACA)
Children’s Health Insurance Program (CHIP) (ACA)
UnitedHealth Group
Humana
Purchasers
Noven Pharmaceuticals, Inc. (world’s largest manufacturer of transdermal patches)
Tapemark (contract developer and manufacturer specializing in transdermal patches)
Novo Nordisk (insulin manufacturer)
Nexcare (waterproof skin adhesive)
ProSolus, Inc. (specializing in transdermal patch development)
Competitors
IP Position
An existing patent related to our model insulin patch is that of the transdermal patch. The patent is for a patch consisting of four layers including a protective, adhesive, matrix and cover layer. The inventors of the patch, John LeDonne of New Jersey and Claudia Meyer of Delaware, filed the patent on January 8, 2015 and it was later published on July 14, 2016. The main claim of the patent states, “The cover layer is at least partially bi-elastic, and the adhesive layer comprises an acrylic copolymer having hydroxyl functional groups. The matrix layer comprises a physiologically effective amount of buprenorphine or pharmaceutically acceptable salts thereof.”1
Another related patent was created for a transdermal patch made with microneedles that can deliver a specific amount of medicine to the skin provided. The patch consists of a drug reservoir where the drug is held and gradually released by a membrane controlled by a release trigger positioned between the release control membrane the support system of the patch. The patent was filed by Russell F Ross from Atlanta, GA on February 28, 2011 and was published on August 30, 2012.2
A patent combining both the distribution of insulin and the use of a transdermal patch was filed by Kwang Kyun Jang and Young Sig Oh on May 23, 2005 before being published on October 28, 1997. The patch claims to be a “device for iontophoretic transdermal medication of insulin of one-piece form having a container for holding gel-like insulin and a power supply for furnishing insulin with electricity.” Unlike the previously mentioned patent, this patch does not require the use of microneedles but does need a circuit board in order to power the patch placed on the receiver portion of the patch.3
Fundability Worksheet Scores
Competitors-1
Our product was evaluated as a 1 because there are so many different insulin products and devices ranging from pumps, to kits, needles and made from multiple companies.
Customer Validation-1
IP Position-3
There already exist multiple strong patents for insulin products and transdermal patches that administer medicine through the skin, including the usage of microdermic needles.
BME 100 Fall 2017
