BME100 f2016:Group14 W8AM L2

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Contents

OUR TEAM

Name: Diego Barra
Name: Diego Barra
Name: Savanna Bracale
Name: Savanna Bracale
Name: Casin Corallo
Name: Casin Corallo
Name: Imelda Fragoza
Name: Imelda Fragoza
Name: Andrew Samanta
Name: Andrew Samanta

LAB 2 WRITE-UP

Device Image and Description


The product is a 30mm x 30mm x 2mm patch that administers ADHD medication topically. This patch includes a slot in which a microchip fits into. This microchip distributes electrodes to release additional dosage of medication. The currents are controlled by an app, which monitors the overdose amount. The app also creates a profile for the user. Helping doctors with future prescriptions.

Technical and Clinical Feasibility

Technical Feasibility
The technology needed for the device is a patch, a device inside it to transfer electrodes, manufacturing chip, and creating an app. The challenges would be creating a chip that correlates with the amount of current that controls the amount of medication administered. Also creating and designing an app. The app is intended to collect data to share with doctors, so they can interpret the information for future prescriptions. In addition, the app would control the current that is released through the chip. The cost of manufacturing our device and creating an app could be less cost effective compared to other medications out on the market. Some things that could go wrong would be the patient administering all of the medication at once. Another would be if their method of access to the app failed or if the patient did not have access to the app. The app could crash, in order to avoid this, there would be an adequate server to be capable to handle the demand.
The products technical feasibility score is 2 on the fundability worksheet. This score was given because the technology is there but finding it within a reasonable price range might be challenging.

Clinical Feasibility
The device will work in the clinic the same as the current pill works the clinician will prescribe the patch the same as the pill, but after evaluating the patient's lifestyle the patch may be more convenient to use if they are extremely active or forgetful. The clinical risks that may occur deal with the device not functioning correctly and allowing the drug to be administered too quickly or too slowly. The patients who are using this new device may suffer more from side effects if the drug is administered in non-prescribed amounts. The device being made now is similar to the Daytrana patch which has been available to people with ADHD, but it has been since been recalled. The Daytrana patch was recalled because it no longer met their release liner removal specification. The Daytrana patch did have two clinical trials in order to be approved by the FDA. The drug did have some side effects on the children who were part of the trials. The first clinical trial was two weeks long and the second trials was one week long, each with a different age group of children.
The clinical feasibility is very promising because there is already a patch on the market, that has done well, so the score it was given was a 3 for these reasons.

Market Analysis

Value Creation
The value of the new patch comes from drugs being administered will be monitored through an app by the patient’s physician. But these drugs treating ADHD will also have dose ranges from which the patient themselves can monitor how much more of the drug they might need if they don’t feel like they are getting the right dosage. But these dose range will be specific to the patients since they will be reacting to the drugs differently and it will make it so that patients won’t overdose on the drugs. This will be lessen the amount of people who might overdose from the drugs that treat ADHD.

Manufacturing Cost
The cost to create the device would come from three individual factors. First is the the cost of a prescription of Adderall $23 for 30 or one month of 20mg pills. The second factor is the the cost of the device that changes the permeability of the patch, and therefore release of the drug into the body, through the app. The cost of the device itself would likely be between $50-75. The third and final main factor is the cost to create the app that is integrated with the chip. The cost to create the app is around $450,000.

Sales Price
With all these factors combined along with the cost to manufacture, this is how the price came to $100-200 for the Device. With the cost of a prescription of Adderall ($23 for 30 20mg pills) and the cost of a prescription of Daytrana, the average sale price for the month supply of patches would be in a range of $200-300 for thirty 20mg patches. The app that is needed for the patch would be free to the customers (they would simply need the product code, provided when they purchase the Device.

Market Size
ADHD medication is a $13billion industry, and if the company is able to take advantage of even 5% of that market it could easily see profits exceeding $650 million per year.

3.8 Million Patients∗12 One‐Month Prescriptions per Year∗$300 per Month=13.7 Billion Dollars per Year



Fundability Discussion

Based on the review of the fundability worksheet, the product receives a two in customer validation, because it would be more convenient than the pills or other patches. A score of three in market size, because the demand for ADHD medication is high. Since competition does exist, but improvements to the patches are still being made, the product receives a two in competition. Since the idea is built upon from an existing device, patents already exist but are weak. This makes the score for IP position a two. Since the technology already exists and has little room for error or malfunction, the score for technical feasibility is a 3. The clinical feasibility would also be a three because clinical studies have already been conducted effectively. Therefore our product should be funded.

Works Cited

Giovangrandi, Laurent, Kristin Gilchrist H., R. Whittington Hollis, and Gregory Kovacs T.a. "Low-cost Microelectrode Array with Integrated Heater for Extracellular Recording of Cardiomyocyte Cultures Using Commercial Flexible Printed Circuit Technology." Sensors and Actuators B: Chemical 113.1 (2006): 545-54. Web. 20 Sept. 2016.

Holland, Kimberly. "Reduce ADHD Costs with Patient Assistant Programs." Healthline. N.p., 23 June 2014. Web. 20 Sept. 2016.

Kanellos, Michael. "Intel's Manufacturing Cost: $40 per Chip." CNET. N.p., 13 Sept. 2005. Web. 20 Sept. 2016.

Kovacs, Gregory T. A., and Laurent Giovangrandi. "Patent US7501301 - Low Cost Fabrication of Microelectrode Arrays for Cell-based Biosensors and Drug Discovery Methods." Google Books. N.p., n.d. Web. 20 Sept. 2016.

Liu, Zi-Yu, Lin -Tsung Chiou, Chia-Hsien Yeh, and Yu-Cheng Ling. "Using Developed Transdermal Delivery Chip to Transfer Drug for Skin Permeation." IEEE Explore Digital Library. N.p., n.d. Web. 20 Sept. 2016.

"PAC1710." - Current And Power Measurement ICs. N.p., n.d. Web. 20 Sept. 2016.

"Prices and Coupons for Adderall." Adderall Prices and Adderall Coupons. N.p., n.d. Web. 20 Sept.

"Prices and Coupons for Daytrana." Daytrana Prices and Daytrana Coupons. N.p., n.d. Web. 20 Sept. 2016.



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