BME100 f2016:Group15 W1030AM L2

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OUR TEAM

Name: Kelsey Boos
Name: Myong Chung
Name: Ashwin Limaye
Name: Nadiah Meor Azman
Name: Your name
Name: Your name

LAB 2 WRITE-UP

Device Image and Description

Our design is similar to that of the Fitbit, it could also be looked at as an upgrade to the very successful piece of technology. It has a plastic like material that could be any type of design to fit the customers' certain fashions and make it more appealing. Also the ends will include magnetic strips so that the bracelet clasps onto the wrist of the customer, making it easy for the customer to put on the bracelet without assistance. For its functions, not only will it track your physical activity throughout the day, but it will also monitor your heart rate with it's sensor. With its GPS it will contact the nearest hospital if the customer's heart beat is irregular: suddenly decreasing or increasing, or out of beat. When the message alerts the hospital they will call the customer for their location and ask for them to come in so they can make sure that everything is okay. And if the phone call is not answered they could call immediate family/ emergency contact listed in customer's emergency alert to make sure that the customer is okay. Ultimately the bracelet is more appealing and contains a sensor that will help to detect a heart attack before it happens and make sure to get the customer to the nearest hospital and avoid death or other complications.

Some other components that can be added to take further steps of trying to prevent cardiovascular disease. One of these is a sensor that uses ultrasonic waves to detect blood flow. This technology is currently being developed by Washington University in Missouri and is a good nonintrusive method of detecting a patient's blood flow, which will help clinics and physicians monitor and assist the patients with potentially abnormal body conditions. Their paper "Physical Review Letters" discusses this in further detail and explain that the ultrasonic waves create hot spots on the sensor and can create a photoacoustic image in real time. A second device that can be placed in is a device to measure the blood pressure. An article from the University of Leicester explains that scientists in Singapore have created a way to monitor blood pressure in the heart by using a sensor on the wrist like a watch. A combination of this data can help physicians determine if a patient is healthy or not and it will help the patient by detecting abnormalities automatically and notifying emergency centers when help is needed. The device will also need constant charging as it will need to continuously monitor the patient, since a patient would be at mortal risk if the device is not worn for an extended period of time. Solar panels on the watch itself could be an effective measure of solving this issue.

Bibliography


Kandha, VInod S. "GrabCAD - CAD Library." GrabCAD - CAD Library. GrabCAD-Corporation, 16 Apr. 2016. Web. 14 Sept. 2016.

Technical and Clinical Feasibility

Technical Feasibility

a. In a device such as this many advanced components are required. The interior components which comprise of the main processing chip will involve a mixture of detection chips as well as a well functioning communication chip. Both different types of chips will be placed so that the device can detect and transmit data from the client's heart to trusted contacts such as doctors, hospitals, friends,family etc. In addition to a reliable main processing unit, a durable strap preferably consisting of polyurethane compound is ideal. This is because polyurethane remains firm in harsh conditions and will not slip underwater. Furthermore a proper telemetrics system is required in order to make the service communications as smooth as possible. Furthermore, a specific patch is needed if the patient wants to have a more accurate heart reading. These are already available and companies such as sensium are mass producing them the only modificaation would be to integrate a communication chip with the wrist strap. By also adding two sensors that were only just or are currently still being developed, it adds an extra complication of attempting to compress the technology so that other sensors can be added and it is not too much of a strain on the patient. There is also a unique challenge posed by this type of device, since it cannot simply be charged overnight since an emergency may occur in that time. A patient could be in serious danger in that interval of time, so an effective method of charging or a method of the device charging while it is in use may need to be found (such as solar panels).


b. The challenges in finding such technologies are numerous. To begin with, a highly specialized compound must be developed which can make the strap durable this would require many hours of research and development to find a good strap material. Furthermore, some chip manufacturers have a monopoly on some processes. This means that we as a company must find a way to bring the price down and we need to do some calculations to figure out how many chips we should order. Also because this is a rechargeable device we must find an adequate charger (can probably be sourced from third party). The software will need to be tested also in hospitals in which the technology is not that great such as developing countries. Finding and compressing this technology will be difficult as some of the sensors weren't necessarily designed to be in watch form, or work in conjunction with other sensors. There is also the issue that some may not be fully developed.


c. Many things could go wrong such as communication cloudiness and product function failure. To begin with, the GPS chip which sits between the main unit and the band must be able to communicate with a satellite at all times. Furthermore, the telecommunications chip must be continuously connected to a main unit outside of the band otherwise an emergency situation will not get transmitted. Lastly, the band must be able to withstand many different movements otherwise, the heart pulse rating cannot be calculated properly.

Clinical Feasibility

a. The product will definitely work in a clinic as long as the proper technology is in place because this is a quite advanced system it is both a product and a service thus the two components must work together seamlessly. Furthermore, the product does not pose a significant risk to the life of the test subject.

b. Some clinical risks include allergy and reaction to electric fields. Some people cannot tolerate a certain level of weight and pressure on their arm this is an everyday device so it is imperative that this be cleared with people with allergies and diseases. c. Similar products have been in a clinical trial however they do not detect when a heart attack comes and do not send signals alerting friends and family. One example of a similar trial that has been tested clinically is a band by Simbec Research however, the trial was short lived and the company was eventually bought out by Google the trial lasted only for 1 and a half years. Our trial will be tested clinically but it will also involve technology outside of the device as well.

'Bibliography' - "Healthcare's First Medical Device Information System." SmartLinx Medical Device Information System. N.p., n.d. Web. 14 Sept. 2016.

"The Clinical Trial Process." Simbec. N.p., n.d. Web. 14 Sept. 2016.

"Clinical Laboratory Testing." Clinical Testing Laboratory. N.p., n.d. Web. 14 Sept. 2016.

"Sensium Healthcare." SensiumVitals® System. N.p., n.d. Web. 14 Sept. 2016.





Market Analysis

Value Creation

This technology would improve the current model for detecting heart rates and preventing heart attacks and other potential cardiovascular diseases. Since this gives the consumer a less intrusive option to the implanted chip, it adds value in that patients have an alternative to more dangerous and intrusive devices. There may be more sensors added around the watch to improve readings from the current model and detect other important measures of a person's physical health, such as the blood flow of the patient and what blood pressure they are at as well as detecting irregular heart rates for heart attack prevention. This invention also eliminates the need for the patient to be conscious to call the local medical center or doctor with automatic calling, but it would have to be highly accurate in detecting the heart attack, so the emergency centers are not called based off of a false alarm. It is also important to note that for many patients, the design and overall aesthetic appeal of the device as well as its convenience will be important factors in whether or not the patients will actually use the product that could potentially save their life. Our device will function similar to a regular watch, so it would stay relatively convenient and the design can easily change and could even be made to look like the traditional watch or bracelet, which may be an important factor in the actual use of these devices. There will also be a certain amount of value to physicians as well as the patient in adding sensors to detect blood flow and blood pressure, so there are multiple methods of identifying areas where cardiovascular health may be deteriorating and will need treatment

Manufacturing Cost

Components of the wristband: -Silicone wristband $0.75 -hard plastic enclosure $2.35 -biometrics monitoring chip (main PCB) $3.00 -bluetooth chip $1.00 -accelerometer $1.85 -vibrating motor $4.00 -battery $ 0.20 to $0.50 -charging cable $1.00 (third party source) -ultrasonic wave sensor/output $5.00 -blood pressure sensor $3.45 -solar panels(?)

This device would cost around $22.00-$24.00 to make it depends on supplier inventor and bulk discounts(How much will be ordered?).

"Advanced Packaging and Product Miniaturization Techniques." ON Semiconductor:. N.p., n.d. Web. 21 Sept. 2016.

"Medical." Semiconductors and ICs for Devices. N.p., n.d. Web. 21 Sept. 2016.'


Sales Price

Commonly, fitness watches and bands that monitor a person's heart rate, steps taken, and GPS location cost around $100-$200 with the top fitness watches costing $250. However, even the most advanced of these watches are not sold with the intended use of detecting heart rates and preventing heart attacks and other potential cardiovascular diseases. This would make our device a premium product that is more desirable and useful, and so it should be priced accordingly at around $400-$500. This is a standard average markup of electronics.

Market Size

At a very basic level, market level, or overall market volume is defined as number of target consumers by the penetration rate. Assuming that there will be a fairly low penetration rate (30%) due to its specialized focus on just cardiovascular health and the fact that the product won't be a necessity, we can then calculate the market volume can now be calculated. The number of target customers is also very unclear as people will not necessarily know if they will be struck by a heart attack, but by using the number of how many people get heart attacks every year (about 720000 people) we can now calculate the market volume, which ends up to be around 216,000 people. We can now apply this information and calculate the monetary size of the market, so assuming that each of the watches will cost around $400-$500, it could be anywhere from $86.4 million to $1.08 billion. Obese overseas countries are a good market because knowledge about heart attack is less and they have much higher BMI indexes. Outsourced production will also save cost with right transportation partners.

The Atlantic. Atlantic Media Company, n.d. Web. 21 Sept. 2016.





Fundability Discussion

Competitors: 2

There are quite a lot of competitors already designing this type of device. One of the common ones is SecuraFone app from Apple that is already being widely used. However, other competitors are in the process of improving this device. For instance, Fortify VR is a defibrillator implanted in this patient's chest, and it has alarm system that will warn people of possible heart attack hours before it happens. Yet it is still only used in patients with heart attack and they plan to improve it in order to offer the device also for people who are prone to the disease. Some of the improvements needed is to make it energy-efficient, to be low maintenance. Also, for the device to be able to sense irregularity in heart beat that would lead to heart attack long enough before it happens.

Customer Validation: 2-3

I believe that our product really speaks to the costumers wants and needs. It is a more desirable product compared to our competitors as it eliminates incision or a surgical procedure to receive similar results. Also it is easily worn around the wrist and can be designed to fit the costumer's specific fashion. It also provides the costumer comfort at it actually notifies the nearest hospital incase a sudden instant of alert happens in an area that is not of their hometown.

IP Position:1

There is a presence of patents out there trying to construct instruments that deal with both heart attacks and heart disease. None of these Patents include our design that adds a sense of style and increases the appeal of patients or costumers like our appliance. There are appliances with patents that avoid incision or surgical procedures, but the bracelet is easier to wear and includes a combination of features from the other devices with patents.



Technical Feasibility: 2

This is because our device is simply a better version of some of the already existed ones, yet still require more study to ensure its success. Since the components of this device are pretty advanced ones like the microchips, we would have to overcome some challenges in ensuring the device will run smoothly. A few trials would be needed, which meant addition to cost.



Clinical feasibility : 2

We believe this device would be successfully developed yet in order to do so, we need more research which could help to improve the specs. The material we discussed for now is to use plastic for the band, yet some people might be allergic to it. But the most important thing, we would want to make the product as comfortable as possible for people to wear it.


In a nutshell, based on how most of our fundability scores are around 2-3, we can say that our device is worth funding.