Need 1: A noninvasive way to help control and correct heart rhythms for everyday use to prevent arrhythmias. Disease State FundamentalsCardiac arrhythmia is described as an abnormal heart rate or rhythm, this is still not well explained physiologically. Recently, it is noticeable that there are important advances in understanding electrophysiologic mechanisms that causes the development of different cardiac arrhythmia. In general, there are two considerable categories of the mechanisms responsible for cardiac arrhythmias as shown in the figure below. First of all, enhanced impulse formation (focal activity). Secondly, conduction disturbances (reentry). The property that lets cardiac cell produce spontaneous action potential is called Automaticity. Spontaneous activity is the result of diastolic depolarization caused by a net inward current during phase 4 of the action potential, which progressively brings the membrane potential to threshold. In normal situations, highest intrinsic rate displayed by the sinoatrial (SA) node. when the SA node is can’t generate impulses or when these impulses unable to propagate, other pacemaker take over the function of starting excitation of the heart. Abnormal automaticity consists of both increased automaticity, which causes tachycardia, reduced automaticity which causes bradycardia. Abnormal automaticity caused Arrhythmias which can result from diverse mechanisms such as enhanced automaticity, secondary SA node dysfunction and delayed afterdepolarization-Induced triggered activity 1.The current tests and procedures to diagnose arrhythmia include, EKG (Electrocardiogram) , Holter and Event Monitors, blood test to determine the level of potassium and thyroid hormone. X-rays to determine whether the heart is enlarged, Electrophysiology study (EPS), Coronary angiography which uses dye and special x rays to show the inside of the coronary arteries. Catheter ablation, a procedure used to treat some arrhythmias, may be done during an EPS 2.Current State of the Art Technology There is much recent research regarding noninvasive methods of detecting cardiac arrhythmias. One current technology involves a housing containing many electrodes attached directly to the user 3. However, in this technology, the electrodes must be attached to form a watertight perimeter, thus involving a long time to put the device on. This device also only acquires cardiac data, and does nothing to correct abnormal heart beats. A second device, the Zio Patch, also only monitors heart rhythms 4. However, the Zio patch is much easier to wear, thus demonstrating the ability to have a wearable patch as a cardiac measuring device. When it comes to correcting abnormal heart rhythms, an advanced technology shows that radiation can be directed towards certain parts of the heart 5. However, this device is not a wearable device, but does show the ability to use other methods to correct arrhythmias besides electrical shocks. In conclusion, from recent research on detecting and correcting arrhythmias, state of the art technology shows that wearable devices are possible yet far from developed, and that there are other methods that can be employed in wearable devices that can correct abnormal heart rhythms.Stakeholder analysisFig. 1 – Cycle of care 2. Fig. 2 – Flow of moneyMarket Analysis Arrhythmia diagnosis and treatment devices can have many different segmentations. First, arrhythmias can be segmented into three different categories: supraventricular tachycardias, ventricular arrhythmias, and bradyarrhythmias 6. Secondly, the market that serves to detect arrhythmias can also be segmented, with most devices operating with either electrocardiogram technology or Holter monitors. Detection sites can also be segmented, with the majority of the market focusing on atrial bradycardia, premature atrial contractions, atrial flutter, and atrial fibrillation. Regarding geographical location, the arrhythmia market can be segmented into the North American region, the European region, and the Asia-Pacific region. The Asia-Pacific region has an increasing number of patients experiencing arrhythmias, demonstrating an increasing demand in diagnosis and treatment technology. In the United States, major companies in the field include Medtronic, Boston Scientific, and St. Jude Medical.Need 2: A way to consistently monitor and store blood pressure data for people with hypertension that is comfortable and convenient to wear in order to help mitigate future strainDisease state fundamentalsHypertension, or high blood pressure, is a condition characterized by a systolic blood pressure greater than 130 mmHg and a diastolic blood pressure of greater than 80 mmHg. In 2011, 29.1% of American adults over the age of 18 had hypertension 7. 65% of adults over the age of 60 and 42% of African Americans over the age of 18 had hypertension. Stage 1 hypertension involves systolic blood pressures between 130 and 139 mmHg and diastolic blood pressure between 80 and 89 mmHg 8. Stage 2 hypertension is classified as a systolic blood pressure greater than 140 mmHg and a diastolic blood pressure greater than 90 mmHg. Blood pressure is determined by the resistance of the cardiac arteries to blood flow from the heart. Blood pressure increases when resistance is high due to narrow arteries. Long term high blood pressure can lead to heart disease, heart attacks, and strokes among other serious health conditions. Patients with hypertension are often asymptomatic, but symptoms of late term hypertension can include headaches, shortness of breath, and nosebleeds. Hypertension often presents in two cases. Primary, or essential, hypertension is the most common and has no known cause. Secondary hypertension is more sudden and severe and often occurs as a result of sleep apnea, kidney problems, thyroid issues, adrenal gland tumors, medications, illicit drugs, and chronic alcohol abuse. The common risk factors for hypertension include age greater than 45 for men or 65 for women, African American descent, family history, obesity, tobacco use, excessive sodium in one’s diet, lack of consistent exercise, poor nutrition, stress, chronic disease, and alcohol abuse. Current State of the Art TechnologyHypertension is typically diagnosed using an inflatable arm blood pressure cuff 9. A medical professional places the cuff around the bicep of the left arm of the patient and inflates the cuff until blood flow through the brachial artery ceases. Air is then slowly let out of the cuff, while the medical professional uses a stethoscope placed on the brachial artery at the crook of the elbow. The systolic blood pressure is the pressure when the blood begins to flow through the brachial artery and is determined when the pounding sound of the blood can be distinguished through the stethoscope. The diastolic blood pressure is determined when the medical professional can no longer hear the blood rushing through the artery. Digital blood pressure monitors are now commercially available for the wrist and bicep, where the user simply presses a button and the machine inflates and deflates the cuff and determines blood pressure through the varying artery blood volumes. Current treatments of hypertension are largely lifestyle changes and pharmaceutical interventions. 77.9% of Americans with hypertension take medications to mitigate further risks 10. 54.7% of Americans were able to control their blood pressure with medication. The common medications include thiazide diuretics to eliminate sodium and water from the kidneys and reduce blood volume and beta blockers to reduce heart workload by making the heart pump slower 8. In order to prevent the narrowing of blood vessels, Angiotensin-converting enzyme (ACE) inhibitors or Angiotensin II receptor blockers (ARBs) are prescribed to prevent the formation and action of the chemical that causes the narrowing of blood vessels. Calcium channel blockers may also be prescribed to relax the blood vessels in the heart. Patients are also encouraged to eat a healthy, low sodium diet, refrain from smoking, exercise regularly, maintain a healthy weight, and limit alcohol use.Stakeholder AnalysisFig. 3 – Cycle of care 11. Fig. 4 – Flow of moneyMarket AnalysisKey factors that divide potential customers into market segments include age range and stage/severity of hypertension. Between ages 20 to 34, 11.1% of men and 6.8% of women in the U.S. are diagnosed with hypertension. This rises with age and by age 75+, 66.7% of men and 78.5% of women have hypertension. Only half of adults with hypertension have it under control and one third of Americans have it 12. We seem to be far from a solution, and there is a definite gap in monitoring. Monitoring is important because it can help facilitate treatment plans to reduce risk for heart attacks, stroke, heart failure, and kidney disease. Each market segment would face competition from major companies including Philips Healthcare, Welch Allyn, GE Healthcare, Drägerwerk AG & Co. KGaA, and Medtronic. Most of these products, however, are not in the category of wearable, everyday blood pressure monitoring 12. A quick internet search along with further journal research indicates that there are many useful at-home monitoring devices available, but are not exemplary of convenient, quick, or comfortable 13. The younger hypertension patients may be more intrinsically receptive to new technologies while the older population may be more skeptical, but in need of more options. Additionally, patients with later stages of hypertension may be more motivated to monitor their blood pressure independently than those in earlier stages. Wearable monitoring devices should be in the price range of a typical fitness tracker and so will likely be at a price point that is accessible to most of the population. Current models typically run at similar prices of $50-100.