# BME100 f2016:Group12 W8AM L1

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# OUR TEAM

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

# LAB 1 WRITE-UP

## Health Care Issue

The health care issue we will be trying to alleviate is Cardiovascular Disease. Cardiovascular Disease is the cause of myocardial infarctions (Heart Attacks) which will lead to death unless promptly treated in a medical facility such as a hospital. Cardiovascular Disease takes place when atherosclerotic plaques are introduced into the bloodstream and lead to factors that promote blood clotting. When these clots build and impede blood flow too drastically or stop it completely, that is when the patient will suffer a myocardial infarction.

Citation: "Clinical and Pathological Aspects of Heart Disease." Murry Laboratory Regenerating the Heart. N.p., 2014-16. Web. 06 Sept. 2016. <http://www.pathology.washington.edu/research/labs/murry/index.php?a=research&p=info>.

## Our Device

The medical device will be roughly the size of a pacemaker. This device can both be used in preventative care and also long term care. It will have a ring like device attached to the primary device that is placed around an artery that it will monitor. The ring surrounding the artery will help to prevent damage from having a first or second Myocardial Infarction. The ring will perform this task by having a pressure sensor that will detect changes in blood flow through the artery. The ring surrounding the artery will 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, using the sensor, 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. 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.

## Competitors

Medtronic ENDEAVOR DRUG-ELUTING STENT SYSTEM

Opens the arteries after a collapsed artery.
Fixes the artery after damage has already taken place.
Coated in medication which prevents cell growth while the artery is healing.

Does not prevent clogged arteries in other locations within the arteries other than where the stent is placed.
Does not give preventative data to Providers/Patients.
Extensive list of risks associated with the stent.

Citation: M. (2016, May). ENDEAVOR DRUG-ELUTING STENT SYSTEM Coronary Artery Disease (CAD). Retrieved September 06, 2016, from http://www.medtronic.com/us-en/patients/treatments-therapies/heart-surgery-cad/balloon-angioplasty-stenting-endeavor.html

Metronic MICRA TRANSCATHETER PACING SYSTEM

This pacemaker is the worlds smallest pacemaker.
48% fewer complications than traditional pacemakers.
Patient is able to be safely scanned by specific types of MRI machines.

Specific patient requirements must be met prior to placing the implant.
Will not function if patient requires steroid use.
Pacemaker has the ability to encapsulate itself within the implant area.

Citation: M. (2016, August). Micra Transcatheter Pacing System - Leadless Pacemaker | Medtronic. Retrieved September 06, 2016, from http://www.medtronic.com/us-en/healthcare-professionals/products/cardiac-rhythm/pacemakers/micra-pacing-system.html

## Customer Validation

Patient
A patient would be interested in the device because once implanted, they would no longer have to take heart medication orally on a regular basis. In addition to this, the patient would be interested in the device because of its ability to monitor the health of that patient and warn the patient of impending heart complications.

Payer
A payer would be interested in the device because of the medical disease it provides care for. Cardiovascular Disease is the number one cause of death in America. This means it is also one of the biggest annual earners in the medical industry. Payers would be interested because it has the capability to compete in one of the largest markets in the world.

Physician
A physician would be interested in the device because it would allow them to get paid for the implantation of the device, and depending on how long the medication lasts, possible additional safe and easy operations of adding more medicine via injections.

Provider
A provider would be interested in the device because they are constantly looking for innovation in the medical industry. The sheer utility of the device would be enough to make a provider interested in the device. Providers would also be interested because of the massive amount of people the device could impact in a positive way.

Purchaser
A purchaser would be interested in the device because it is made for treating Cardiovascular Disease which is the number one cause of death in the United States of America. Purchasers would be gaining an extraordinary device that would allow them to solve two major problems within Cardiovascular disease; preventative care costs, and medication supply. The purchaser would be able to go to the market with an extremely versatile device.

## IP Position

Patent #: 9,333,297 Assignee: MiniPumps, LLC. Title: Drug Delivery Pump with Intelligent Control Summary: A closed loop feedback system with an algorithm to help lower the amount of times of under doses or overdoses to to get the right amount. Sensors that measure flow and adjust. File Date(s): Aug 18, 2010 May 8, 2009 May 8, 2008 Oct 30, 2008 Oct 30, 2008 Nov 3, 2008 Nov 3, 2008 Aug 18, 2009 Sep 24, 2012

Patent #: 8,273,063 Assignee: N/A Title: Implantable pump for drug delivery to treat erectile dysfunction. Summary: An implantable pump, for pumping drugs through patients body, has a drug delivery chamber. Configured for drug, and catheter, in communication to drug delivery site. File Date(s): May 30, 2006

## Fundability Worksheet Scores

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, overtime 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 2

IP Position

So the reason that the IP position got between a 2-3 was the fact that for the most part there wont 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 theres, or the way it works within the design to output the desired affect. For the most part being an original design, where really the only problems could be where some things look similar, and could be problem. 2-3