BME100 f2017:Group10 W1030 L2

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OUR TEAM Adrienne Parkinson Patrick Mullane Leslie Olivares Eddie Aparicio Sarah Desmond LAB 2 WRITE-UP Device Image and Description In order to minimize discomfort and skin irritation caused by other methods of securing nasal cannulas to a patient's face such as tape or headbands, the Cannulometer instead wraps around a patient's ears. Composed of silicone-coated plastic with a small body temperature sensor embedded into the surface, this device will be both compact and comfortable. In addition, the behind-the-ear thermometer instantly reads temperature, allowing care-takers to conveniently track critical patient's temperature and potentially detect signs of infection earlier. The design for the thermometer will include a small sensor that sends bluetooth signals to nurses' pagers notifying them of critical temperatures. Technical and Clinical Feasibility Technical Feasibility 1. Technologies Needed: 2. Challenges: The prototype must simultaneously secure the nasal cannula out of the way of the patient’s face while wrapping around to the base of the ear where body temperature can accurately be read. In addition, the device must not be too bulky so as to put pressure on the ear and cause discomfort. Cost-effectiveness is also a challenge because the devices require compact power sources, thermometers, and Bluetooth capabilities. 3. Potential Errors: Because the device is c-shaped, it might not properly fit the patient’s ear causing instability. The temperature sensor may not line up to the position behind the ear with the most accuracy and precision on every single person. The sensor could be inaccurate, causing medical professionals to run tests for infection when the patient actually does not have an elevated temperature. The Bluetooth connection could fail to transmit data real time and thus fail to alert nurses and doctors of a dangerously high fever. Clinical Feasibility 1. Clinical-Setting Application: The Cannulometer’s design is extremely simple and based off of a straightforward model of an original, plastic cannula and a thermometer that takes a patient's temperature behind the ear. Its success rate within clinics across the United States will be high since our new technology is a hybrid of two already highly utilized tools within hospitals and clinics alike. 2. Clinical Risks: Through trial, the physical risks are rather slim. Being that the device is simply a hook that wraps around the ear, very little can go wrong. However, like all new up and coming devices, the risks should be mentioned. Certain situations that involve “pulling” or “yanking” of the nasal tubing may cause bruising or discomfort in the ears. 3. Similar Clinical Trials: The technology within the behind the ear thermometer has not yet been patented, since it is a low-risk device it merely needs FDA approval without clinical data. There are many clinical trials have utilized nasal cannulas when treating pulmonary and respiratory complications, but no trials have been completed testing the effectiveness of a regular nasal cannula across a wide range of patients. The Cannulometer must show that it is substantially equivalent to nasal cannula and body temperature sensors, which have already been approved by the FDA. Market Analysis Value Creation From a medical standpoint, the Cannulometer simply provides a more comfortable fit for the already necessary nasal cannula. Such a simple yet effective design could undoubtedly alleviate medical issues (associated with tape or friction) from the patient and shift all focus to the detrimental condition that has plagued the patient to be in the hospital in the first place. Manufacturing Cost Sales Price Market Size Fundability Discussion