This is a self-releasing blood sugar regulator that releases appropriate amounts of insulin as the body sees differences in blood sugar. This is a bar that will be around 4 inches long and 2 millimeters wide. The shape is of a long oval. Inside, there is a compartment that will hold the insulin and it fits the entire length of the bar. There is a thin separation of the outside and inside compartment to keep the insulin completely separated from the blood. Lastly, there is a short tube that goes from the inside compartment to the outside compartment to allow for the release of insulin. On the outside compartment, there is small sensor of 2 cm length that will monitor the blood sugar.
Technical and Clinical Feasibility
Technical Feasibility
A. What are the Technologies needed?
1. Sensor
2.Mechanism to release the insulin
3.Hyper-concentration of the insulin
B.What are the challenges?
1.Finding a good sensor
2.Finding the mechanism to release the insulin
3.Hyper-concentrating the insulin
C.What could go wrong?
1. The diabetes bar could break
2. The diabetes bar could not release insulin
3. Communication form the sensor to the phone does not work
Clinical Feasibility
A.Will it work in the clinic?
Yes; we believe the bar will work for diabetes patients in clinic.
B. What are the clinical risks?
If the bar breaks, or if the bar does not release enough or if it releases too much insulin.
C. Have Similar products been in trial? How long was the trial
Yes; "Implanon- A bar that functions as a self-releasing hormone regulator. The study went on for about 3 years and was done on females age 18 to 40 who were in good physical and mental health" (A Bioequivalence Study (2008).
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (345280(P05720).(2008). ClinicalTrials.gov. Retrieved from CLinicalTrials.gov website https://clinicaltrials.gov/ct2/show/NCT00620464
Market Analysis
Value Creation
This new medical device offers added convenience and reliability to diabetes patients that is otherwise not found using traditional methods of maintaining a balanced blood sugar level (Finger prick blood glucose test,insulin pumps,insulin pens,jet injectors,medical syringes). The main value of the creation of this device is the level of convenience it provides for the customers. Some factors of convenience provided through the use of this device includes: a more stress-free lifestyle,increased level of comfort, and the removal of the time and pain involved with daily blood glucose tests. Through the creation of this self-regulating device, patients with diabetes will be able to maintain their blood glucose levels without the need to test for blood sugar levels on a regular basis. Unlike blood glucose tests or insulin pumps which require patients to consistently test for level of blood sugar, through this device, patients will be able to avoid the pain and time involved through a simple medical implantation of the device into the inner arm which can last for approximately one year. Additionally, despite the process of implantation, the flexible material of the device as compared to constant finger pricking and the inconvenience of an insulin pump provides patients with an increased level of comfort and a more stress-free lifestyle. Beyond the benefits of added convenience, the creation of the device will additionally increase the reliability of monitoring and releasing insulin to maintain a balanced blood glucose level. Through integrating a blood glucose monitoring sensor, a patient's blood sugar levels will automatically be monitored and regulated accordingly, providing greater accuracy and reliability.
Manufacturing Cost
Electrical Engineer to manufacture sensors, they have an average hourly wage of $27.00 (Electrical Engineer Salary United States).
Manufacturing Engineer to produce the plastic tube for inserstion, they have an average hourly wage of $24.00 (Manufacturing Engineer Salary United States).
The material used will be Ethylene Vinyl Acetate Copolymer, this is because the similar product used in contraception (implanon) is made up of the same material. We also know the material is safe because implanon has passed all FDA regulations and is rated to be implanted for up to 3 years. It also has a cost of $1,200 a ton, making it extremely cheap (EVA/Ethylene Vinyl Acetane Copolymer).
Sales Price
Costs between $0 and $800 up front,this number is based off of a similar product that is a contraceptive.
Birth Control Implant (Implanon and Nexplanon). (2008). Planned Parenthood. Retrieved from Planned Parenthood website https://www.plannedparenthood.org/learn/birth-control/birth-control-implant-implanon Market Size
Diagnosed and undiagnosed diabetes in the United States
"Total:29.1 million people or 9.3% of the population have diabetes" (2014 National Diabetes (2014)).
"Diagnosed: 21.0 million people" (2014 National Diabetes).
"Undiagnosed:8.1 million people (27.8% of people with diabetes are undiagnosed)"(2014 National Diabetes (2014).
Technical Feasibility-
A score of 2 due to having to find a good sensor and mechanism for release of the insulin. In addition, hyper-concentration may be needed to increase the number of dosages. However, the design is very straight-forward and simple and should be able to to be produced with cheap materials and in a timely manner.
Clinical Feasibility-
A score of 2 because of having similar designs, like the Implanon device for birth control, that has had clinical success and is already in market. However, our device will require additional research in application of diabetes and new sensory material.
BME 100 Fall 2016
