The prototype is a transdermal patch. The bottom outer edge of the patch possess an adhesive to latch to the skin. The supplement exists through the bottom center of the patch. Within the patch contains a microprocessor, battery, and cartridge holder. The supplement are handled through cartridge and loaded into the patch. The microprocessor is preprogrammed to be able to control the flow of the supplement into the body. The transdermal patch method of delivery is iontophoresis. This uses local electrical currents to move the supplement into the system (Prausnitz). The microprocessor is used to control this flow and to counteract for Ohm’s Law. This law states that the decrease of resistance increases the flow of current (Chandrashekar).
Technical and Clinical Feasibility
Technical Feasibility
The use of a microprocessor in a transdermal patch with a power source is shown feasible due to tests with a similar patch for anti-cancer drugs. This type of patch, according to the experiment, shows potential yet it needs improvement (Chandrashekar). Iontophoresis is a method of delivery that is also feasible due to existing patches that use this method (IontoPatch). The technical challenge will be pre programming the microprocessor to control flow, account for Ohm’s Law, and skin permeability. This will require a lot of research, testing, and analysis.
Clinical Feasibility
The transdermal patch can be used very simply in clinics. The patients will be diagnosed for signs of Alzheimer's and assessed to see if the transdermal patch will be effective. Additionally, patients already using the supplement in another form can be assessed for potentially switching to the the transdermal patch. The patch will be self administered by the patients by placing on the skin. The potential clinical risk is the possible negative reaction on the skin to the patch material.
An example of clinical trials of a similar transdermal delivery system is the Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD. This patch has been FDA approved for childhood ADHD and these were the first adult trials (University of Utah). The trial first used a eligibility/exclusion criteria to determine potential patients. The subjects went through two screening visits and a baseline visit. Once the eligible patients were identified it moved onto the double-blind phase. The experiment was broken up into A and B. Experiment A went on for four weeks and used the MTS patch on patients, continuous contact was made with the patients, the dose was increased during the first two weeks based on treatment response and side effects. It was held constant during the last two weeks. Experiment B processed in the same way but a placebo patch was used instead. The results were then compared.
Market Analysis
Value Creation
This prototype creates a more effective way to treat the advances of Alzheimer's by providing a mechanism that directly measures the levels of choline in the body through the use of a microprocessor located in a transdermal patch. The microprocessor utilizes the collected information on choline levels to determine the amount of choline supplement that will be released into skin. The supplement will then travel through the bloodstream and into the brain in order to stop the limiting factor of choline from inhibiting the production of acetylcholine. This device provides a more convenient and practical method for treating Alzheimer's compared to pre existing methods such as cognitive therapy, change of diet, or traditional supplements taken by mouth, which can prove to be unreliable and impractical.
Manufacturing Cost
The estimated cost to produce this device would be $23. This total cost is comprised of the price of each individual part of the device. The parts include the microprocessor($15), the supplement cartridge($1), the battery power source($3), the outer patch material($1), the wiring to connect the microprocessor to the release of supplement($2), and the adhesive($1).
Sales Price
The estimated sales price for this device would be $115. This was determined by multiplying the cost to create the design by 5 to account for additional required marketing, and other necessary costs.
Market Size
Considering that over 5,000,000 people are living with Alzheimer's in the United States, the expected portion of the population that would purchase the device would be about 200,000 people (Alzheimer's Disease & Dementia). Therefore, the market size would be $21,850,000 after subtracting the 5% penetrance from $23,000,000.
Fundability Discussion
Market size (US only)
1 - The market size of the device is under the recommended amount; however, the device is still feasible because it will still reach a large population.
Technical Feasibility
2 - The technical feasibility has potential but requires more research and testing.
Regulatory Pathway
2 - This device is simple and similar to two other methods that have already been implemented in different medical treatments.
Clinical feasibility
1 - Since this disease is time sensitive and recovery varies among patients, large patient volumes and and long time-frame trials are required.
Reimbursement.
3 - This device is more convenient and effective than existing methods of treatment and, therefore, customers are more likely to purchase the product.
Due to these scores, the device should be funded as it meets most criteria and will make a positive impact in treating Alzheimer's Disease.
Chandrashekar, N. S., and R. H. Shobha Rani. “Microprocessor in controlled transdermal drug delivery of anti-Cancer drugs.” SpringerLink, Springer US, 1 July 2008, link.springer.com/article/10.1007%2Fs10856-008-3510-6. Accessed 19 Sept. 2017.
“Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD.” Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD - Full Text View - ClinicalTrials.Gov, University of Utah, clinicaltrials.gov/ct2/show/NCT00506285. Accessed 19 Sept. 2017.
Prausnitz, Mark R., and Robert Langer. “Transdermal drug delivery.” Nature biotechnology, U.S. National Library of Medicine, Nov. 2008, www.ncbi.nlm.nih.gov/pmc/articles/PMC2700785/. Accessed 5 Sept. 2017.
BME 100 Fall 2017
