BME100 f2017:Group7 W0800 L2

BME 100 Fall 2017	Home People Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3 Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6 Course Logistics For Instructors Photos Wiki Editing Help
OUR TEAM Name: Wesley Groves Name: Sayyed Ourmazd Mohseni Name: Michael Zou Name: Abdulomonem Aslhammari Name: Miguel Almanza Name: Your name LAB 2 WRITE-UP Device Image and Description Description The device will consist of two sensors. One EKG (ECG) nanosensor (and heartbeat monitoring system) being over the chest to monitor heart rate and variability, and another on the upper back to monitor respiratory information via a possible series of acoustic sensors. The idea is the combination of this cardiac and respiratory information that our device will provide will enable a collection of algorithms set as an app on other devices (such as phones/computers) to generate relevant data and allow preventive action to cardiac and respiratory attacks in patients (such as asthmatic episodes or severe allergic reactions). Technical and Clinical Feasibility Technical Feasibility a. What are the technologies needed? Acoustic sensors need to record the breathing pattern of the individual (similar to a stethoscope). Several versions of these sensors have been created or have been patented. These sensors include the RRa sensor created by Masimo which is connected to the throat area and monitors breathing patterns and a patent submitted by Valery G. Telford (US 9192351 B1) which is similar to the technology used in our device. The acoustic sensor needs to be connected to a heart monitoring sensor. These sensors are highly prevalent in various size and shapes such as those used in FitBits, Apple watches and etc. Both devices need to record the physiological data assigned and send them to a smart phone for further analysis; thus, there is a need for a network connection device which connects to wifi or other networks. The smart phone application will need to analyze the data provided by both sensors and identify the parent/other individuals of the health state of the person wearing the device. If the physiological state of the individual goes above a certain safety threshold, the application will notify trusted friends and emergency authorities of the health situation of the individual. The need for location identification imposes a need for a GPS or tracking device as well. If a network is not detected, the device will need to make a sound in order to identify individuals of the emergency state of the person wearing the device. b. What are the challenges? The size of the device is the most significant challenge. The device needs to use both an acoustic and a heartbeat sensor and have connectability to a network for data communication. It will also include a tracking device in order to provide information regarding the location of the individual in an emergency. 2-3 sensors need to be integrated into a device which should be wearable under regular clothes and not obvious to other viewers. Providing an appropriate connection platform is another challenge associated with the project. Wifi and LTE networks might not be available in all locations; thus, a more reliable network should be provided by providers. The application needs to be able to collect and analyze the data provided by both sensors. These application have been created in the past and have been proven to be successful; however, their creation would require a considerable level of programing skills. Finally, the device needs to stay in place on the human body. Finding the most efficient adhesive material or an appropriate design causes issues as well. c. What could go wrong? The most important issue with the device is network connectivity. As mentioned earlier, the device needs to have constant connection to network in order to convey information to smartphone for analysis. If a proper network is not available or if connection is lost, the device will not be able to work efficiently. In order to reduce this issue, the device will be able to send an alarm to individuals near the person wearing the device. Clinical Feasibility a. Given the technical feasibility will it work in the clinic? It is highly probable that this technology will work. The acoustic respiratory sensor can be programmed to sense specific sound patterns in the patient. To minimize risk of false alarms (incorrectly identifying acoustic signals) parameters can be set for the patient upon acquisition of the device. The device will be able to differentiate wheezing from, for example, talking or eating. The device will also be programmed to detect potential respiratory emergencies. There will be a programmed threshold that will send a push notification warning that the current activity is likely to cause a respiratory emergency. Physiological signals that would be indicative of this are dramatically increased heart-rate and respiratory rate for an extended period of time. The second threshold will detect current respiratory emergencies and send a push notification offering an option to ‘contact emergency medical services’ or ‘acknowledge’ which will give the parent/guardian an opportunity to treat the emergency with medication. Physiological signals that would indicate this form of emergency would be excessive breath sounds (wheezing, gurgling, coughing) combined with an increased heart-rate. The third and final threshold will recognize an unconscious/unresponsive victim and contact emergency medical services automatically. The physiological signals associated with this threshold would be lack of breath, cardiac dysrhythmia, or asystole. b. What are the clinical risks? There are not many immediate health risks that would come about from this device. There is a chance that the device can be parameterized incorrectly which will result in either false alarms or missing physiological distress signals in the user. A device that only has respiratory sensors has been shown to between 92-95.5% effective in detecting respiratory distress signals. Pairing a respiratory sensor with a cardiac activity sensor can help increase the device’s effectiveness. One of the clinical hurdles is the amount of personal data that would have to be collected from the subject in order to obtain accurate and precise information from developed algorithms. Protection for sensitive personal information is becoming more and more of an ethical issue. c. Have similar products been in a clinical trial? How long was the trial? Similar products such as MDPI respiratory sensor have gone through clinical trials demonstrating promising results. Masimo, a device that detects respiratory rates in pediatric patients, have been in a clinical trial from 2013 to present. So far they have demonstrated that 39/40 patients respond well to an acoustic sensor and demonstrate accurate results. Market Analysis Value Creation The device utilizes two sensors in order to notify individuals of their health status and contact proper authorities in an emergency situation. While this technology might be more expensive than other similar devices, it can benefit customers in various ways. First, the usage of two sensors increases the accuracy of measurements; thus, providing valuable information to customers. Secondly, the device can be used for patients with asthma or cardiovascular diseases. Finally, both sensors will be closely connected to the heart and lungs which makes the device much more efficient than others in the market. Manufacturing Cost heart rate sensors $0.50, respiratory sensor 3$, power supply $3, sound $.30, LTE connection bored $0.01, app $0.01, bluetooth sensor 1$, design details/materials 3$, Motherboard 0.1$, Infrared CO2 sensor 0.01$, Nano coat 2$, Manufacture 4$, Packaging $1 which lead to a total of 17.93$. The prices were gathered from websites such as Alibaba which sell parts and technologies to companies for mass production. Other costs such as manufacturing and packaging were estimated based on the time needed to create each device and average worker salaries. Sales Price ~89.65$, the cost of making the device is $17.93, so the sales price should be about 5x the cost. The cost of a data plan or a smartphone is not considered in this calculation under the assumption that the average consumer will already have these. Market Size $89.65*.05*108.6 mil = $486.80 million/year (18.4 million adults + 6.2 million children + 84 million people with coronary heart disease) = 108.6 million people that COULD use our product. When the probable penetrance (5%) is taken into account the number of people that are likely to use this product turns out to be 5.43 million. Fundability Discussion Sources MyDr, Bronchial Asthma and Cardiac Asthma, http://www.mydr.com.au/asthma/bronchial-asthma-and-cardiac-asthma