(60mm): height of antihistamine storage. The antihistamines compartment is where the actual medicine that is delivered to the allergic site is stored.
(20mm): height of battery, motherboard and Bluetooth device storage. This battery, motherboard (CPU) and Bluetooth device storage is where the wireless components of the product is stored. The wireless components facilitate the effective drug delivery system of the product form a smartphone or other wireless device, thus ensuring easy accessibility to an individual's health.
(6mm): diameter of penetrable antihistamine storage. This is where the sysringe used to refill the antihistamine storage compartment is. The compartment will hold enough medicine to last 6 months, and after that specific time period, an individual will need to get their compartments filled up, so this penetrable area allows for that to happen.
(8mm): diameter of device.
(1mm): diameter of antihistamine dispenser. This is where the actual antihistamine is dispensed into the bloodstream without leakage or mishaps.
(2.4mm): cross length of Bluetooth device.
(20mm): cross length of motherboard.
(2.6mm): diameter of battery (15mm height)
Technical and Clinical Feasibility
Technical Feasibility
The technology needed for the device are a Bluetooth/ wireless component (which is used for the wireless connectivity of the device so that the user of our porduct can interact with the drug delivery system wireless), circuits and hardware for the wireless connectivity (parts that control the dispensing and other information that will make the drug delivery system work), medicine cartridges (which will hold the antihistamines that are being delivered to the bloodstream), and CPUs, and batteries (which power the overall device). Some of the challenges that we will face are figuring out the dosage for each individual, making the device physically convenient, computer programming the device so that it is able to dispense the medicine wireless and without any complications such as leakage, and making sure that the technology needed is available. Some things that could go wrong is there could be an infection from the initial procedure, the injectors in the device could get jammed, the signal between the CPU in the device and the Bluetooth could get lost, and the device could get dislodged or cause physical irritation.
Score: 3 - The parts to build such a product are simple and straightforward. The design for the product, the implementation of the product in the user, and the building of this product are simple and straight forward. There will be some challenges in the building of this product, by not enough to give it a score of 2.
Clinical Feasibility
The device will work in the clinic because there are 50 million people in the United States with nasal allergies. The product will first be tested on animals that have been known to get allergies (such as dogs) and these subjects will be examined to look for any complications and to see if the product worked. Once enough animal tests have been conducted, we will move onto human test subjects, where the device will be implanted in an individual who has seasonal allergies, and we will examine and see if the product works or if it causes any unforeseen complications. Some of the clinical risks that could be involved are that the device does not work to deliver the antihistamines to the proper site in the body, or that the body rejects the device. As far as we know, there are no similar products in the clinical trials that have results. However, there have been implants for other treatments, such as birth-control implants, which lasted in its clinical testing phase for 4 years.
Score: 1 - The product needs to be tested among users in clinical trials, and since this product has not been tested in the field before, the clinical successes are unclear. However, since products such as ours have been tested in the field (such as birth control implants) the success of our clinical trials may be likely, enough to give our product a score of 2 in this category.
Market Analysis
Value Creation
Our device saves time, has a low cost, provides a more direct dosage to the affected area, and customers don't have to remember to take it. Value is created by our product because it allows the user to experience a much more efficient and less time-consuming manner of drug delivery. Our product creates value because it saves time in the long run; it is a one time installation, lasting a 6-month period, which means that once the product has been installed, the user does not need to worry about it until it is time to refill the antihistamine cartridges, thus saving the time of buying and using the allergy pills. Our product has a relatively low cost compared to the current allergy pills on the market because the current medication for treating allergies cost anywhere from $100 to $200 in a 6 month time frame; however, our product, only costing the user a one-time price of $120, is more cost-effective. Our product creates is most value because of its more efficient drug delivery manner. Since the product will release the antihistamines directly into the bloodstream, it is a more effective method of drug delivery as it will require less dosage of antihistamines, and will work more efficiently and at a quicker rate than the allergy pill that goes through the digestive system.
Manufacturing Cost
The device itself is made out of ethylene vinyl acetate copolymer, which cost $5 per kilogram to make. The bluetooth used to transfer the data from the device to an electronic device costs $5 per chip; the CPU costs $18 per unit; the cost of the battery is $398, but since we will be need approximately 7.5 times less power, the average cost per battery will be $53; the medicine cartridges will cost approximately $8.10 per cartridge to make, with three cartridges per device. Considering all of these factors, the average price to manufacture the device will be $105.30.
Sales Price
The device will be sold for $120, that way a $14.70 profit can be made per device. This price is solely for the product, not the installation of the product. That pricing is up to the surgeon's discretion. $120 is the current ASP because it is a little less than the average price people affected by allergies pay for their allergy medication over a 6-month time frame, which is anywhere from $100 to $200.
Market Size
The market size is approximately a $3.5 billion.
Cost per device: $120
Total number of units expected to be sold: 25 million (50 million total affected by allergic rhinitis)
Customer Validation: 1 - Though we believe there will be many people interested in this product, we had to give ourselves a 1 since there is not enough customer feedback to date.
Market Size: 3 - We gave ourselves this score since our market size is almost $3.5 billion, potentially. There are over 50 million people in the united states alone that are affected by allergic rhinitis-- the problem our product aims to solve-- and if even half of those people buy our product, we will have a market size of $3.5 billion.
Competition: 2 - There is the current method of combating allergies, which is through allergy pills that need to be taken daily to be effective, but there can be improvements in the field. Our product is a completely new product that has not been introduced to the field, so it is considered a clinical improvement.
IP Position: 1 - Since the prototype has not been built yet, we had to give our product the IP Position score of 1. However, we believe that once the product had been tested and built, it could potentially have a score of 3 in this category, as there are no other patents for this specific product.
Technical Feasibility: 3 - The parts to build such a product are simple and straightforward. The design for the product, the implementation of the product in the user, and the building of this product are simple and straight forward. There will be some challenges in the building of this product, by not enough to give it a score of 2.
Regulatory Pathway: 1 - Our product received this score because there will need to be clinical data and testing done for this product before it is released for the users to use.
Clinical Feasibility: 1 - The product needs to be tested among users in clinical trials, and since this product has not been tested in the field before, the clinical successes are unclear. However, since products such as ours have been tested in the field (such as birth control implants) the success of our clinical trials may be likely, enough to give our product a score of 2 in this category.
Reimbursement: 3 - The product will be reimbursed by the insurance company as a prescribed medication, and many users will be able to pay in cash, since they can use the cash they save from not buying allergy pills.
Our prototype should be funded because it has a tremendous potential to completely revolutionize the field of treating allergies. It is a product that has not been introduced in the community before, and it incorporates already existing ideas of implants to a new medical problem, one that affects millions of people. This product has the potential to help millions of people, thus ensuring a very big market size. It is easy to create at a relatively low cost, and compared to the current allergy fighting medication, it is far more cost-effective.
BME 100 Fall 2016
