Implementation
Users
In the evolution of testing for Lyme disease, there have been many groups that have designed different methods that can be implemented into a testing device. We have designed our method of detection specifically to fit in a device that is very small, light, universal, and easy to use. Our dry lab and wet lab teams have been collaborating throughout the year to create a testing device that mimics the size and style of a pregnancy test that is reusable. Because our test targets the tick itself and not the species bitten, the test is universal between any species of animal as well as humans. Our testing device caters to this universal audience. Specifically, we have geared the test towards, farmers who may find ticks on their cattle, to quickly determine if their cattle need antibiotic treatment. Additionally, horseback riders can test ticks found on their horses' mid-ride as the test is fast, small, and light and can easily be carried with the person of interest. The test is also aimed at pet owners who may find ticks on their dogs as well as hikers who suffer from tick bites. In all cases, the test can be carried by the person and can be administered within minutes.
Availability
Due to the device's small size and low cost, it can be available commercially at pharmacies, outdoor stores, and other common consumer-level venues. From our market segmentation analysis, our team determined that the greatest demand for the product would be at the consumer level, chiefly outdoor enthusiasts and pet owners, closely followed by livestock owners and horseback riders. We determined that professional-level clients such as doctors and veterinarians would have less of a demand for the testing device and therefore, we have designed our test to meet the needs of the market segments that would have the highest demand for the test. Within our analysis, we also determined that our top market segments value cost, size, and speed. With these in mind, we focused our test on being portable and cheap by using a lateral flow assay, a tried-and-true method of low cost, and fast testing with relatively accurate results.
By using a 3D printing compatible device case, which is reusable, the cost of the device casing is reduced significantly and only costs about $40 to produce. The replaceable test portion of the device simply consists of a nitrocellulose strip with the dried reagents already in place as well as a small, sealed buffer reagents pellet.
Proposed End Users
Our device was intended for the use of many groups of people that may have a variety of needs. However, our team has researched and determined the top group of end-users for our device using a public survey and market segmentation analysis. Our research indicated that the most likely users are the outdoor enthusiasts and pet owners, which have a high amount of overlap in the aspects they value in a testing device. Other potential users were also considered, including horseback riders, cattle and livestock owners, veterinarians, doctors, and researchers.
Envisionment of Use
We predict that individuals will use our testing device to easily and quickly identify the presence of Lyme disease. This will allow them to better understand the potential risk that Lyme disease may impose on themselves or their animals. The goal of our test is to fill in the gap in current Lyme disease testing by eliminating unnecessary lab tests that are resource-intensive and time-consuming. By testing the ticks directly, individuals will be able to quickly identify if a tick possess a threat to them and if they should pursue further testing based on the results of the test.
Implementation
By utilizing our market segmentation analysis, our team determined how our device would be integrated into the market. After assessing various market segments, our team concluded that the segments most interested in our testing device were pet owners, outdoor enthusiasts. In addition, we believed that livestock owners and equestrians would also benefit from our product. To cater to the needs of our top market segments, our team envisioned having our device sold at venues accessible to them such as outdoor stores, pet stores, pharmacies, and more. We also ensured that the design of our device was easy to use, portable, and fast to meet the needs of our consumers.
Safety
The main safety aspect that we considered was the safe use of our device by consumers. To accomplish this, we intend to make the device user-friendly to ensure the use of the device poses as little risk of harm to the user as possible. Additionally, we also selected detergents and regents with the fewest possible risk factors including lysis detergents with a pH similar to that of human skin. Finally, we also will make it very apparent to our consumers that our test is not a definitive medical diagnosis for Lyme Disease rather an informative and rapid test that should be used as an indication as to whether further testing is required.
Challenges
The challenges we believe we will face with implementation are the mass production of the device’s components, especially the biochemical reagents. Our solution to the mass production of reagents is the creation of a bioreactor.