BME100 f2017:Group3 W0800 L2
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LAB 2 WRITE-UP
Device Image and Description
This device is more than the typical glucose meter. At the top of the device is a built-in, touch-sensitive test strip that turns the device on as soon as blood makes contact with the strip. Once the device has processed the blood and generated results, it flashes an alert on the screen that confirms it's ready to transfer the results wirelessly from the device to your smartphone. A corresponding app allows the patient to view their own glucose levels while simultaneously transferring the results to the patient's doctor.
Technical and Clinical Feasibility
a) What are the technologies needed?
A software is required for the app so that it links through Bluetooth with the diabetic monitoring device. The app will need to have the capability to connect with the patient's physician and transmit data.
b) What are the challenges?
The challenges include finding a streamlined way to get the information from the app to the physicians as there are so many different company, networks, and providers. Some patients have multiple physicians so making sure the right information gets to the right person is the top priority.
c) What could go wrong?
There may be some incompatibilities between our software and the software of the physicians. This is an area we plan to research further as we do not know all of the technical logistics of data transmission.
a) Given the technical feasibility, would it work in the clinic?
It would work in the clinic. The purpose of the device is to be an at-home diabetes testing kit that provides customers with the same value and service that they receive when they visit the doctor's office to complete an examination. If clinics would like they may also purchase the kit to use at their clinics as it does all of the major tests for diabetes.
b) What are the clinical risks?
The clinical risks would be at the home mainly as customers will be self-administering these tests. The risk involved is making sure that the customers are knowledgeable on how to properly use the different tests in the kit to complete the testing. We plan to include instructional videos on the app so that customers know exactly how to complete each test and make sure the information is sent to the provider.
c) Have similar products been in a clinical trial? How long was the trial?
There have been no similar products in a clinical trial that we were able to find.
Our testing kit provides customers with being able to perform full diabetes check-up tests in the convenience of their home. This full range testing kit allows customers to complete the testing and receive all of the information on their phone, where the information is transmitted to the physician of the customer's choosing.
The cost to create this design will include the costs of the following:
1)$8,000-Bluetooth fee to Bluetooth company for usage of start-up Bluetooth product
2)$79.99-Bluetooth glucose meter
3)$100-800-Portable urinalysis test
4)$100-Body weight scale
5)$99.50-Wireless blood pressure test
6)$450-600-Cost of steel per ton
7)$50-20,000-Software design development cost to either use existing software or to develop software from scratch for our device
The cost for labor seems to be elevated in the United States rather than in China. Therefore, the total cost will likely be between $50-60 million to create our device in China (Blodget, 2012).
Our estimated anticipated average sale price would be between $300 -500 depending on what kit we are offering. The reason it is at $300+ is that the kit will contain multiple sensors that will each cost around $80-100 for the Bluetooth variation compared to our competition. We would use similar products but at a cheaper price to try and generate more sales for our product, giving us a higher overall profit margin with a higher market up price within the US for our product being manufactured in Asia for a fairly cheap cost of around $60. Though our profit would be affected by costs such as transportation, cost of regulations, and other costs such as capital investment needed to pay for the creation of our product, and other unforeseen costs such as accidents occurring.
By using the initial market size analysis from Lab 1, the market size in dollars per year is estimated to be $300*0.05*200 million = $3 billion.
We will have some challenges in terms of the technical logistics of data transmission, but this will be overcome as we plan on spending more time doing research, to find a streamlined process to transmit the data.
The testing kit will come with instructional videos built into the app, making the process simple and straightforward for the customers. This way customers can use the at-home test kit with ease.
Funding should be provided for our device for one reason, more people need it than ever before. With a Market Size score of 3 on the fundability worksheet and an industry ten times larger than before, three billion people would be able to get their hands on a technology that is easily assembled because it falls perfectly within regulations and most of the technology already exists, giving us 3's on Regulatory Pathway and Technical Feasibility as well. It is just combining all of these technologies and adding multiple sensors into our simple kit that have already been FDA approved, fast-tracking our regulatory. Clinical Feasibility would also be a 3 because all existing tests for our device have already been proven. Reimbursement for customers would likely be a 3 for companies buying our product because not needing to use hospital-provided equipment as much allows us to sell out more at a higher profit margin and create cheaper kits, making us more competitive on the market with cheaper prices than leading competitors. IP Position would be a 2 because there are some patents currently in place for Bluetooth technologies regarding medical data purposes. Competition would also be a 2 because there are companies that already product Bluetooth medical-based equipment, but only to a certain extent with limited technologies for limited testing. Customer Validation would be a 1 because there was no customer feedback during the creation of this idea. Overall, we believe our product should be funded not only based on the numbers, but also based on the fact that the world is more rapidly getting older than it is younger, and older people with Diabetes have a harder time getting into their appointments at a physician's office. Our device could potentially help with this problem, allowing our customers to feel safe and cared for in the comfort of their own home.
Blodget, H. (2012, January 22). This Article Explains Why Apple Makes iPhones In China And Why The US Is Screwed. Retrieved September 20, 2017, from http://www.businessinsider.com/you-simply-must-read-this-article-that-explains-why-apple-makes-iphones-in-china-and-why-the-us-is-screwed-2012-1