BME100 s2017:Group4 W1030AM L2

BME 100 Spring 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: Lillie Robinson Name: Nick Holmes Name: Zoe Bargas Name: Brenna Hickey Name: Kyle Xue Name: Chase Wallace LAB 2 WRITE-UP Device Image and Description Prototype Description The proposed automatic chest compression device serves as a solution for EMS teams to provide accurate and consistent hands-free CPR to patients and is a safer, more versatile, and cheaper rendition of the devices currently out on the market. The innovative dimension of the proposed device primarily lies in the usage of a piezoelectric powered piston as the pump which delivers CPR. This allows it to have greater precision and adjustability so that it can function on children if needed, while also being safer than the most popular pneumatic pistons used by other ACCDs which can be seen as safety hazards due to the large amount of pure, compressed bottles of gas they consume. Finally, the proposed ACCD will be cheaper than most competitors by doing away with custom backboards and instead simply having restraints that work with the rigid surfaces already carried by EMS teams and ambulances such as backboards and stretchers. Technical and Clinical Feasibility Technical Feasibility Necessary Technology The proposed automatic chest compression device (ACCD) will use many technologies that are already well-established. These technologies include software engineering, harness restraints, medical grade straps, pistons, suction cups, plastic mold printing, and waterproof-coating. In addition to utilizing technology that has already been on the market for decades, the proposed ACCD will incorporate a piezoelectric actuator that is capable of at least a 2-inch displacement as well as a lithium iron phosphate based battery that can be fitted along with its charging component without the need for a large external battery pack. Challenges The only pieces of technology that are not fully optimized yet are the piezoelectric actuator and the compact but powerful lithium iron phosphate battery. As for the piezoelectric actuator, current technology of a purely piezoelectric actuator only demonstrates a displacement of a few millimeters. However, there are already larger versions of actuators that are a hybrid of piezoelectric actuators with hydraulics being produced by Kinetic Ceramics that more than meet the displacement requirement for adult cpr chest compression. These piezo-hydraulic actuators utilize a piezoelectric actuator in addition to hydraulics to greatly increase displacement at a small trade-off of precision. The implementation of piezo-hydraulic actuators in the proposed ACCD would likely involve a moderate amount of research and funding. In regards to the compact lithium iron phosphate, even if no research went into developing or finding more compact batteries, the body of the device could simply be enlarged to contain the battery unit. The main challenge with the battery arises if a battery life of 1 hour or or greater is sought. In general, this requires a larger battery than 30 minute or 45 minute runtime batteries that are used by our competitors. This would require a low to moderate amount of research and funding. Risks The possibilities of something going wrong with the proposed ACCD mainly center around two aspects, the structure/function and the internal electrical components. If the structure buckled under the force regularly exerted on it than the device would no longer be operable or if the actuator jammed or overheated then the device also would not be able to carry out its intended function. Battery or software failure could also cause the device to malfunction. The consequences of almost any type of failure with an automatic chest compression device are lethal. Technical Feasibility Fundability Score The proposed device receives a score of 2 for technical feasibility. Although there are a few hurdles involved in incorporating a piezo-hydraulic piston that is composed of a piezo-electric actuator and hydraulics fluid, the component is nothing but a piston on the base level. Furthermore, both the actuator and compact battery are not revolutionary devices that have hardly been researched. There are many companies such as Kinetic Ceramics investing in piezo-actuators and battery companies are always seeking ways to make their products more compact. The heavy part of research would fall upon industry whereas we would only have to experiment with the implementation of the device. Clinical Feasibility Clinical Application(will it work?) The clinical testing of an ACCD is slightly more challenging than other devices due to the nature of the problem it is meant to solve. Approval for clinical testing could be sought after animal testing or it is also possible to directly apply for a CIRC trial. In terms of effectiveness, the proposed ACCD should perform well because it allows for paramedics to more easily deal with hectic situations as well as giving patients more consistent and quality CPR. Clinical Risks The clinical risks are primarily derived from possible malfunctions of the proposed device or incorrect calibration. Incorrect calibrations could result in more frequent bruising, broken ribs, and vomiting for patients. System malfunctions would have a chance of lethal consequences as paramedics would have to spend seconds detaching the patient from the device in order to apply manual CPR. Similar Product(s) and their Clinical Trial The LUCAS Chest Compression System is an ACCD in the market that underwent necessary clinical trials. Their clinical trial involved both human and animal testing. The primary part of the clinical trial, the human testing appeared to span 4 years, from 2010-2013. Animal testing was done many years before human testing and was also referenced in their compilation of clinical testing data. The Zoll Autopulse is another ACCD in the market that had a clinical trial done. They do not seem to have done animal testing, but rather went straight to humans. The primary portion of their testing seems to have lasted 3 years with separate, individual studies being done a few years prior. Clinical Feasibility Fundability Score The proposed device receives a score of 2 for clinical feasibility. Although the benefit of ACCDs have sometimes experienced dubious results in certain studies, all of the major competitors in the market found success through clinical trials. There is a well documented history of ACCDs finding positive results in clinical trials. Although success is likely, clinical trials will require special expertise in the form of EMS technicians. Market Analysis Value Creation Our proposed device gives emergency crews a safe and versatile automated chest compressor while also greatly increasing accessibility of ACCDs by offering a cheaper but effective alternative on the market. With the usage of piezoelectric technology, EMS crews will not have to worry about the dangers posed by bottles of pure pressurized gas that other pneumatic based devices need in order to operate. Furthermore, while the pneumatic devices can only go in and out a set distance(they must complete full compressions). The piezoelectric linear actuator can stop at any point, with high precision, allowing for quick depth adjustments in case it ever needs to be used on children. Lastly, our device is not only cheaper but also more compact than most other ACCDs. This is because our device does not require cumbersome custom boards to function, which also take up space in an already crowded ambulance. Our device is meant to work with the restraints, backboards, and stretchers that are already part of the standard EMS kit. Our device simply requires the harnessing of straps that secure the device to the patient and then it is good to go. Unlike other small ACCDs, our device does not need to be attached to an external battery power source in order to function, which is not only burdensome to quickly moving teams but also adds to the expensives. By cutting out accessories, our device is able to be offered at a competitively low price which will help open up a market filled with devices that are never widely used. Manufacturing Cost Anticipated Average Sales Price The proposed device will be sold at a price of $5000 because it is still the cheapest ACCD in the market while selling at a markup of 173%. Market Size As of 2011, the Journal of Emergency Medical Services estimated the number of EMS certified vehicles to be 78,258. So by a conservative estimate our market size is $5000*78258 = $391,290,000. Putting the score at a 2. However, if we were to assume only 5% market penetration then this conservative estimate would only yield a market size of $19,564,500. Fundability Discussion Reasoning for Scores *as compiled from lab1 and lab2 Customer Validation There are many customers who are willing to use this product, however; it depends on the end cost if it would get widely adopted, and the size of the device. This product could be extremely valuable, especially considering the large increase in survivability of cardiovascular failure when similar devices are used. Competitors There is a healthy market for automatic chest compression devices, however; many are lacking certain features, and are far too expensive to be a viable option for the public. This means there could be a large opening in the market for cheaper devices. IP Position The IP position of this product would be about a two. There are various patents describing other chest compression devices, but none of them have some of the exact features our device will have. In addition, most of the very similar patents are pending. For example, we plan on attaching the device to a stretcher or board to reduce bulk. Market Size As of 2011, the Journal of Emergency Medical Services estimated the number of EMS certified vehicles to be 78,258. So by a conservative estimate our market size is $5000*78258 = $391,290,000. Putting the score at a 2. However, if we were to assume only 5% market penetration then this conservative estimate would only yield a market size of $19,564,500. Technical Feasibility The proposed device receives a score of 2 for technical feasibility. Although there are a few hurdles involved in incorporating a piezo-hydraulic piston that is composed of a piezo-electric actuator and hydraulics fluid, the component is nothing but a piston on the base level. Furthermore, both the actuator and compact battery are not revolutionary devices that have hardly been researched. There are many companies such as Kinetic Ceramics investing in piezo-actuators and battery companies are always seeking ways to make their products more compact. The heavy part of research would fall upon industry whereas we would only have to experiment with the implementation of the device. Clinical Feasibility The proposed device receives a score of 2 for clinical feasibility. Although the benefit of ACCDs have sometimes experienced dubious results in certain studies, all of the major competitors in the market found success through clinical trials. There is a well documented history of ACCDs finding positive results in clinical trials. Although success is likely, clinical trials will require special expertise in the form of EMS technicians. Overall Fundability Our device should at least have the potential to be funded based of the fundability chart scores. Of the six categories assessed, it scored decently with 2 for each one. Furthermore, our product may be able to revitalize the ACCD industry because of the services it offers at such a competitive price. In addition, it can be manufactured via 3D printing molds and easily manufactured. The ease of production in combination with the profit gained from sales also support the assessment that our device is fundable. The only circumstances under which this device would not be fundable are if we truly do get only 5% market penetration with the conservative estimate of the number of EMS vehicles 6 years ago.