Strategic Focus Team Name: The Cardiac Unit

Strategic Focus Team Name: The Cardiac Unit Our team mission is to develop a product that aids emergency medical technicians in improving survival rates for victims of cardiac arrest by making simultaneous chest compressions and defibrillation safe and possible. There is significant evidence that uninterrupted chest compressions improve sudden cardiac arrest survival rates, as a new method of resuscitation was initiated in Tuscon, Arizona in 2008. This method involved a larger number of compressions than the standard CPR procedure, and eliminated the pause taken to apply mouth-to-mouth ventilation. By changing their treatment procedure, survival rates of out-of-hospital sudden cardiac arrests in the city increased from 9% to 39% (Ewy, 2012). In the new method of resuscitation, the time paused to apply a defibrillation charge decreased from 11.5 seconds to 3.9 seconds (Cunningham et. al, 2012). It has been suggested that reducing this pause time even more, or applying defibrillation simultaneously with chest compressions, could increase survival rate substantially. We hope to accomplish our mission in a way that is appealing to technicians, as they are the primary personnel that determine compliance to our new product. Through the help of teammate and current emergency medical technician Nick Follrath, we will be able to interact with possible users in order to gather valuable design suggestions. Fortunately, we have a rather strong team to accomplish this. Nick s expertise acquired from working in the field provides a unique viewpoint that an engineering student simply would not have. Having access to Dr. Cook s knowledge and experience will also prove valuable, as he has many medical device patents in his name. From Aimee s past experience, she is familiar with ASTM standards, and with the product ideation process. Meagan has a tenacity for research and gathering information, and is very good at pinpointing relevant studies and standards for our project. Among team weaknesses, are Aimee s lack of focus and tendency to take on too many projects. Aimee has interest in a multitude of activities, and tends to sign up for anything and everything she can. This could become a detriment to the project if time is not allotted properly. Meagan lacks experience, which can slow down her work. Another detriment that could affect the team, is the conflicting class schedules that the teammates have. Team meetings will have to be carefully planned and executed. These meetings will also have to be on topic to ensure the best use of group time. In order to accomplish our team mission, we have several acceptance criteria that need to be met: Frequently consult with EMS personnel for input Develop a product that is appealing to EMS users Develop a product that allows for safe, simultaneous defibrillation and chest compressions Perform a variety of electrical safety tests throughout the Spring semester to validate design safety

Needs Exploration In order to develop this idea, Nick Follrath described his findings on simultaneous chest compressions and defibrillation. Nick approached teammates Meagan and Aimee with a QUEST research grant to complete the project. On September 20th, 2016, the teammates met to discuss what drove Nick to develop a product of this type. Observed Needs: Small product that can easily be stored in an ambulance Protects EMT from defibrillation shock administered to patient Allows for simultaneous chest compressions and defibrillation Withstands multiple usages Allows EMT to maintain dexterity and hand function for chest compressions Allows EMT to feel safe using the product Helps EMT or bystander perform compressions at the correct rate and depth Disease State Fundamentals A normal healthy heart is made up of four chambers, which include the atria and the two ventricles. The septum separates the chambers and has valves that allow blood flow in one direction. The blood flows from the body to the heart, from the heart to the lungs, from the lungs to the heart, and from the heart to the body. These cycles run constantly so that oxygenated blood is circulated through the body oxygen. This in turn supplies the brain and other organs with oxygen support and other vital nutrients. Cardiac arrest occurs when there is an electrical malfunction in the heart. This causes the heart to beat irregularly which disrupts blood flow. Sudden cardiac arrest can occur in a multitude of ways. It can be a result of excessive fibrillation of the ventricles or the whole heart, which leads to fatigue and the heart stopping. It can also be caused by coronary heart disease, a myocardial infarction, and electrocution. Drowning or choking can also lead to sudden cardiac arrest (Baura, 2011). Additionally, cardiac arrest may also be caused by intense physical stresses and physical changes in the heart. Cardiac arrest can affect many different people other than what might be typically associated with cardiac arrest. These people can include older people, athletes, and children. Cardiac arrest can happen in a number of settings as well, from in a person's home to a in hospital. Once a person s heartbeat is interrupted, his or her breathing stops, and they only have a short amount of time to receive help before the brain cells die. Some people notice an irregular heartbeat and lightheadedness before cardiac arrest occurs. People may also notice pain in their chest, difficulty breathing, nausea, or vomiting. The first normal sign that a person has undergone a cardiac arrest is that they have lost consciousness, and a positive identifer is that there is no noticeable pulse. CPR should be started immediately and the use of an AED can be helpful as well. Emergency medical help is needed as soon as possible, without help a person will die within minutes of the onset of cardiac arrest. One of the main problems with sudden cardiac arrest is that it happens without warning. It is hard to identify until after it has already happened. There are a few other signs of cardiac arrest

onset, such as fatigue, chest pain and weakness ( Sudden cardiac arrest, 2015). Patients that have frequent chest palpitations and pain are suggested to consult with a doctor before their untreated disease leads to cardiac arrest. However there are several tests that can help determine if a person is at risk for cardiac arrest. An electrocardiogram, or EKG, can be used to check the heart s electrical activity. It examines the strength of electrical signals as well as the timing of the signals. This test also shows any irregularity in heartbeat and can be indicative of heart damage already sustained. Other tests include echocardiography, MUGA testing, cardiac MRIs, cardiac catheterization, electrophysiology study, and blood test. All of these tests show how the heart is working, from its electrical signals, to blood flow, to heart structure, and chemicals present. There are many factors that can increase a person's likelihood of experiencing cardiac arrest. A person s age, gender, and ethnicity are large factors. People who are older have an increased risk, men are more likely to experience cardiac arrest than women, and people of African descent are at higher risk as well. People who have a coronary heart disease are also more likely to have cardiac arrest. Risk increases if they have a history of arrhythmias, family history of coronary disease or cardiac arrest, drug abuse, alcohol abuse, or a personal history of heart attacks or failures. Additional risk factors include smoking, obesity, diabetes, alcoholism, high blood pressure or high blood cholesterol ( Sudden cardiac arrest, 2015). Heart disease is the leading cause of death in the United States. As of 2016, more than 350,000 incidents of cardiac arrest occurred outside of a hospital setting nationally. Of these 350,000 incidents, 46.1% received CPR from a bystander, but of these 350,000 incidents only 12% survived to be discharged from the hospital. On average, 25% of cardiac arrests that occur outside of a medical setting occur without warning. A large amount of cases of cardiac arrest, 50.4%, go unwitnessed and most cases occur where people live at 69.5% ( Cardiac arrest statistics, n.d.). A typical total cost of treatment after sudden cardiac arrest can range in price between $30,000 and $300,000. This includes the cost of emergency care and the patient s hospital stay. The price variation is primarily dependent on the cause of sudden cardiac arrest, as cheaper treatments involve medication, whereas expensive treatments can require extensive bypass surgery ( Cardiac arrest treatment cost, 2016). The average hospital stay for sudden cardiac arrest is approximately 5 days (Russo, Ho, & Elixhauser, 2007). Medications can range from a few dollars to a few hundred dollars a month. Testing after the fact may also cost thousands of dollars depending on the test performed. Survivors may also experience complications after their cardiac arrest which are expensive to treat. Due to technological advancements in overall care and medical procedures, the financial cost of cardiac arrest is likely to continue to rise. Existing Solutions As mentioned above, there are many tests that can be used after someone has experienced sudden cardiac arrest, one of the more popular tests being an EKG. While this test can help determine the patient's overall heart health, it can become an expensive procedure, costing

between $50 and $3,000 ( EKG cost, 2016). However, in order to survive sudden cardiac arrest and receive testing, an automated external defibrillator is used to save the patient. The automated external defibrillator is used to apply a current shock across the patient s chest in order to reset the nodes of the heart (Baura, 2011). The capacitors used to store and discharge this charge are capable of delivering 500 joules of energy, and are available in voltage ranges of 600 to 8,000 DC volts ( Defibrillator capacitors, 2010). The average AED costs between $1,500 and $2,000 ( AED programs Q & A, 2015). After a patient has survived cardiac arrest they may continuing treatment. Treatment can take the form of a wearable cardioverter defibrillator or an implantable cardioverter defibrillator. These devices are intended for people at risk for another case of cardiac arrest. The device serves to monitor and control heart rate. Surgery may also be required. Common surgeries include coronary angioplasty, coronary bypass surgery, and corrective heart surgery ( Sudden cardiac arrest treatment, 2016). As mentioned previously, compression speed and depth are important in ensuring patient survival. The CPRmeter is a device that measures CPR as it is being performed, in order to increase the quality of CPR being given. It has two sensors to measure force and speed. These sensors determine if chest compressions are deep enough, and if the chest is allowed to fully recoil. The device gives feedback that allows the user to change their technique to better match CPR guidelines. While the CPRmeter can help users adjust compression depth and speed, the output monitor can be slightly confusing, and takes time to learn. The price of this device is also on the higher end, costing $895 ( CPRmeter, n.d.). Finally, there is already a device on the market that meets some of the need criteria that we intend to meet. The LUCAS mechanical chest compression system allows for chest compressions to be delivered at the same time as automated defibrillation. This system performs the chest compressions so that the EMT does not have to be in contact with patient during defibrillation. However, the system takes a medium of 32.5 seconds to position around the patient. The system has displayed an average compression rate of 104 pumps/minute (Yost, Phillips et al., 2012). Although the compression rate is similar in value to the recommended CPR compression rate, the time taken to position the system can be a detriment to patient survival. Many EMS personnel feel uncomfortable using the LUCAS model, and like teammate Nick Follrath, they prefer using their hands to perform compressions. Additionally, the LUCAS model costs $15,000, which is costly for ambulatory companies to house in their vehicles ( Physio-Control LUCAS 2.1 SW chest compression system, 2016).

Stakeholder Analysis Among patient stakeholders are the Center for Disease Control s estimated 300,000 people in the United States that suffer sudden cardiac arrest outside of a hospital each year. Out of these 300,000 people, approximately 8% survive and are later discharged from the hospital (CDC, 2010). Stakeholders also include medical personnel, such as EMS workers and doctors that frequently resuscitate people that have experienced cardiac arrest. The companies that these people work for, such as the EMS companies and hospitals, will have a high stake in cardiac arrest devices. Insurance companies will also be interested, as advancements can reduce the overall costs that the company has to insure. Family members of sudden cardiac arrest victims are also stakeholders, as they have an emotional investment in the overall survival and treatment of these patients. There are not any major conflicts between stakeholders in this instance. Any device that helps this area of interest will cause alignments between the various stakeholders. Overall, it will potentially reduce the cost to the hospital by reducing the amount of time that the patient will spend in the hospital. This in turn will reduce the amount of treatments and therapy needed, which reduces the cost for insurance companies. Anything that allows medical personnel to react more easily allows them to help sooner, which helps the patient overall. There will not be any competition for resources because this device will be small and included in any AED kit. Overall the stakeholders will have goals that align to create the best possible outcome for the patient. As long as the device is small, affordable, safe and effective, EMS companies will not have conflicting viewpoints on the device from the family members of patients. The stakeholders that are the final decision makers are the ones who will be using the device, namely the medical workers. These are the people who will be using the device and ultimately deciding if it effective and safe. As the device will have to not transmit a current from the patient to the worker, the worker must trust that the device will not harm them. To a lesser extent, the patient is a decision maker as well because they are being directly affected. In terms of the care continuum, the patient is most likely to be treated and survive if a bystander is present that is able to perform CPR or able to apply an AED. EMS personnel are able to continue these defibrillation attempts upon arrival. If the patient is resuscitated before or during

transport to the hospital, the emergency room doctors are then able to apply treatments in order to stabilize the patient s heart rhythms ( Sudden cardiac arrest treatment, 2016). Market Analysis The overall cardiac medical device market is expected to grow in the next few years as the Center for Disease Control estimates that 2.7-6.1 million people were diagnosed with atrial fibrillation in 2015. Products in the cardiac medical device market include cardiac rhythm management devices, such as implantable cardiac defibrillators and other pacemakers. Additionally, cardiac assist devices such as the defibrillator and heart valve replacements also fall under this category Key vendors in this market are Boston Scientific, LivaNova, Medtronic, and St. Jude Medical ( Cardiac medical devices market in the US 2016-2020, 2016). Unfortunately, the biggest hinderance to advancements in the field are the high cost of medical device development and Food and Drug Administration approval activities ( Cardiac medical devices market in the US 2016-2020 - increase in M&A - research and markets, 2016).In terms of the care continuum, the patient is most likely to be treated and survive if a bystander is present that is able to perform CPR or able to apply an AED. EMS personnel are able to continue these defibrillation attempts upon arrival. If the patient is resuscitated before or during transport to the hospital, the emergency room doctors are then able to apply treatments in order to stabilize the patient s heart rhythms ( Sudden cardiac arrest treatment, 2016). A related market, Holter monitors, is also expected to grow in the next four years. Holter monitors are portable heart monitor devices that keep track of the electrical activity of the heart

for several days. These devices are used to monitor a patient s heart while in the hospital after experiencing sudden cardiac arrest, or other drastic cardiac event. The market for Holter monitors is expected to grow by 5.09% by 2020. Key companies participating in the Holter monitor market are GE Healthcare, Mortara Instrument, Philips Healthcare, Schiller, and Spacelabs Healthcare ( Global Holter Monitors market 2016-2020, 2016). The market for manual resuscitators is also expected to reach $642 million by 2024. This market includes Bag Valve Mask that are commonly used to provide oxygen to COPD patients and neonatal patients. This device is also used to provide artificial ventilation to cardiac arrest patients ( Manual resuscitators market analysis by type by end-use, and segment forecasts to 2024, 2016). Finally, the development of a device that allows for spontaneous chest compressions and defibrillation is affected by two more markets. The first market, for defibrillators, has been projected to grow to $15,610 million by 2022 ( Defibrillator market by 2022, 2016). Future Markets Insights suggest that the market of automated CPR devices, valued at $50.7 million in 2014, will reach a value of $159 million by 2025. 26% of this market is based in North America, and 36% of this market is based in Europe ( Automated CPR devices market, 2015). One of the largest reasons for the growth of the automated CPR device market, is that according to the American Heart Association estimates that 70% of Americans feel helpless when faced with a cardiac emergency. This is highly due to the fact that most bystanders do not know how to administer CPR. Major companies involved in the automated CPR industry are ZOLL Medical Corporation, Zhuhai Kindway Medical Science & Technology Co., and Medtronic (http://www.transparencymarketresearch.com/automated-cpr-devices-market.html). Although stakeholder needs are being met to an extent, and there are devices that treat each stage of cardiac disease, the survival rate of cardiac arrest is still very low. Device improvements that lead to better survival rates would be lucrative, and appeal to patients and emergency medical workers alike. The primary goal of emergency medical workers is to save the patient, and therefore they would push for emergency medical companies to support adoption of a new device. Key considerations for choosing a target market are cardiac disease trends and rate of incidence, as well as consumer interest. The rate of cardiac disease and sudden cardiac arrest occurrences are currently on the rise in the United States due to the aging population and obesity. This provides an opportunity for profit and justification for technological advancements. Works Cited AED programs Q & A. (2015, June 25). Retrieved October 24, 2016, from American Heart Association, http://www.heart.org/heartorg/general/aed-programs- QA_UCM_323111_Article.jsp#How%20much%20does%20an%20AED%20cost? Automated CPR devices market - global industry analysis, size and forecast, 2015 to 2025. (2015, August 05). Retrieved October 24, 2016, from Future Market Insights, http://www.futuremarketinsights.com/reports/automated-cpr-devices-market

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