BME100 f2016:Group12 W8AM L2

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Contents

OUR TEAM

Name: Sheigh Cox
Name: Sheigh Cox
Name: Joshua Frazier
Name: Joshua Frazier
Name: Yanely Valenzuela
Name: Yanely Valenzuela
Name: Kollin Buster
Name: Kollin Buster
Name: Chris Beall
Name: Chris Beall

LAB 2 WRITE-UP

Device Image and Description

Rear side view of main device Front side view of main device. Two holes. One hole connecting a tube to the exterior of the leg Arterial sleeve Arterial Sleeve. The hole connects the sleeve to the main device for information transmission


The medical device will be roughly the size of a pacemaker, it will have a ring like device attached to the primary unit that is placed around an artery for the purpose of monitoring. The ring surrounding the artery will help to prevent damage from having a first or second Myocardial Infarction by having a pressure sensor that will detect changes in blood flow through the artery. The ring surrounding the artery will also be able to record the patients BPM, cholesterol levels, and blood sugar levels. The primary device will have the capability of slowly dispensing medications used to treat Cardiovascular disease. The primary device will be able to dispense precise doses over long periods of time. The device will be able to regulate how much medication the patient requires based off of the results that it receives from the pressure sensor,blood sugar levels, BPM, and cholesterol levels. The device will also be connected to the patient's phone via Bluetooth and should be able to warn the patient or a nearby hospital of an impending heart attack if the device senses blood flow slowing down drastically or any other complication. Not only will the device serve as a primary source of monitoring the health of the patient and dispensing proper doses of medication when needed, but the device will also be able to save lives by notifying healthcare professionals and the patient of impending complications.




Technical and Clinical Feasibility

Technical Feasibility
Technologies needed for our device:

Bluetooth Capability
Small circular Pressure Sensor
Capability to measure BPM, cholesterol, erythrocyte thickness sensor
Concentrated medication dispenser


Challenges with our technologies:

Creating a device small enough to be non-intrusive
Effortless surgical placement
Consistent and precise medication disbursement
Creating a non-invasive form of medication refill to the device after initial placement
Material corroding with the human body
Life cycle of the battery or form of power to the device


Possible errors/ what could go wrong?:

Bluetooth connection to outside device failing or not connecting properly
Device container leaking concentrated medication (overdosing the patient)
Small pressure sensor ring shifting along the artery
Pressure sensor ring pinching the artery
False medical data readings from device
Power source to the device failing
Electricity or magnetic fields interfering with the device

Clinical Feasibility

Will our device work in a clinic?:

Most aspects of our device already exist in some form. Examples: medication is supplied in the form of pills, there is a stent designed for after a heart attack, and pacemakers already monitor the heart rate.

Our device will work in a clinic if designed properly. The device will need to meet all the patient's needs as well as the doctor's needs. The clinic would use our device because it provides preventative care for Cardiovascular Disease.

What are the clinical risks?:

Drugs not being dispersed in proper doses
The human body not adapting well with the device (rejection)
Improper placement of device within the human body
Surgery risks
Medication not dispersing long enough to outweigh the benefit of the device
Infection due to the surgery recovery process

Similar products and their clinical trials:

Programmable Implantable Insulin Pump for Type 1 Diabetes

This clinical trial tested a programmable insulin pump for diabetes. The trial concluded that their pump was safe and effective for up to around 1.7 years. https://clinicaltrials.gov/ct2/show/NCT01185470

September 18, 1991

Citation:
"Clinical Trial of Programmable Implantable Insulin Pump For Type I Diabetes | Diabetes Care." Clinical Trial of Programmable Implantable Insulin Pump For Type I Diabetes | Diabetes Care. American Diabetes Association, 1992. Web. 07 Sept. 2016.





Market Analysis

Value Creation
The value creation would be a two for, originality, as well the future this could hold for products like this, or giving ideas to other entrepreneurs, and is able to go much further in other ways than we can think of.

Manufacturing Cost
For manufacturing Cost it will receive a score of two, this is because there are a few designs sort of like this one out there, which means that they are already in production and could easily be brought into on the line for cheaper than normal start up. With a build, or materials sort of the like the pacemaker, or the internal drug pump that is next to the spine.

Sales Price
The sales price will also get a two, because of the fact on how the pacemaker sells, and its wide usage. So if this device were to get adopted into large usage, and has been made efficiently, it will be cheaper to make, and available to more people.

Market Size
At this moment, it is between a one and a two. This is because of the fact that we haven't really seen much of it, so if people don't know they wont know to buy the product, as well as the fact that it could be difficult to sell to those who are used to taking pills. However past that it would be pretty sizable since there are not many products like this to compete, as well as the amount of people who do not want to swallow pills everyday and just want the freedom of forgetting about it.




Fundability Discussion

Technical Feasibility: 3 The reason that the Technical Feasibility was given a "3" was because of the fact that through research we found a few devices and designs that exist with the same form or idea. For example we found:


Clinical Feasibility: We found that the most similar product out there is a chronic pain drug pump from Medtronic, consisting of a pump and catheter. The pump gets surgically inserted under the skin in the abdomen. This is then connected to the catheter which is inserted into the patient's spine to deliver the drugs.

www.ncbi.nlm.nih.gov/pubmed/14996232

Competitors
We gave our competitor score a 2-3, closer to a 2 really, because of the fact that the two competitors have their products nailed down, and are quite efficient. Such as the pacemaker, already being the smallest in the market and being very proficient at what they do. As well as the artery repair unit, that while keeping the artery open after damaged has occurred administering drugs, over time into the blood stream, that keeps cells from growing. So with a "mix" of these two competitors it would allow for an item that hasn't truly been made, to be able to monitor, like a pacemaker, and to help administer the right amount of drugs so that the need for constant pill taking, and make life easier. 2-3

Customer Validation
We gave the customer validation a 2 because of the ability to be able to forget about the needless amount of pill taking or drug taking, with an item that would only need to be refilled over a course of time, couple of weeks, to maybe a couple of months, would allow for the patient to live comfortably before the next doctor/specialist visit for a quick refill and be out of there for another. So for example, a patient with Alzheimer's 2

IP Position

So the reason that the IP position got between a 2-3 was the fact that for the most part there won't really be any patents on our idea and its ability to do things. However where we might run into problems is with the design aspect maybe with people believing that it is too similar to theirs, or the way it works within the design to output the desired effect. For the most part being an original design, where really the only problems could be where some things look similar, and could be a problem. 2-3


Value to Customers


It allows for those suffering from heart related medical complications and are forced take endless pills a day to have a more effortless scheduled drug intake without any risk of wrong dosage, timing, combination, and provides patients and caregivers with a constant monitored reading of the heart's condition.

Manufacturing Cost



Titanium Body: $0.60 per unit (September 2nd 2016)

Chip/Motherboard:$70 (September 2016)

Wires: $10 (September 2016)

Sensors: $50 (September 2016)

Pump: $20 (September 2016)

Lithium Battery: $20 (September 2016)

Average Sale Price


Based on our research on the drug pump and the pacemaker, this product, including the device, drugs and surgery, will cost an average of $80K over a span of 5 years.

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