BME100 f2017:Group11 W0800 L2

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Name: Alexa Ng
Name: Connor Leiken
Name: Mauro Robles
Name: Braeden Malotky
Name: Your name
Name: Your name


Device Image and Description

Inflatable splint mark 1: Mark1.png Inflatable splint mark 2: Mark3.png

Our device will be inflatable, made of a vinyl substance. When deflated, the product will be able to fold into a compact, portable size that can be easily transported. Each of the individual air pockets will inflate, creating a strong cast-like pressure on the fractured bone. The device will be able to inflate to different amounts in order to accommodate varying bones and sizes.

Technical and Clinical Feasibility

Technical Feasibility
In order to create our product, we must use existing technologies that will allow us to design an expandable yet capable of hardening splint. Our main challenge will be finding the right material for our splint. Also, we must figure out to inflate our splint and have it pressurize correctly. We could use the technology employed in life vests for the inflation, but from there we must figure out how to ensure that the device will inflate enough to be effective. Some problems we could have are we may not be able to inflate our device correctly depending on what materials we use, there could be potential rupture points along the splint, the device could be expensive since it will be more advanced than other splints.

Technical Feasibility Score: 3 Our product would be using known technologies that are currently used with self-inflating life vests, paired with known materials such as rubber. We will have to do further research, however, in our methodology used to seal the components together in order to prevent rupturing during general use. Furthermore, an adjustment valve and alternative means of inflation paired with a selectively-flexible splint side will be necessary to fulfill our ultimate goal of making a device that can immobilize any appendage.

Clinical Feasibility
In our clinical trials, we will have to simulate broken bones in dummies and see whether our splint correctly immobilizes and sets the bone. Some clinical risks we could have are the splint could not set the bone properly, the splint could cut off circulation in the limb, or the splint could not immobilize the limb correctly. Also, since we are working on dummies we will be unsure whether the splint is causing pain or not. We could later move onto human subjects, but they would have to come with a unset, broken bone because it would be unethical for us to break their bones.

Clinical Feasibility Score: 3 As commented on during lab 1, we found several similar clinically successful devices that target single appendages on the body that are currently being sold in online stores. Though these devices are only realistically single-use, a problem our group is trying to solve, they are currently available without prescription or any major labeling hurdles needed to get them into the healthcare system.

Market Analysis

Value Creation
Our design will have several key features that distinguish it from previous iterations that can be found online: multiple uses (decreased probability of failure during use), compactibility for storage in first aid kits, immobilization on any appendage of the body, and temporary immobilization on-demand. With these, we aim to create a device that will serve all these purposes and provide for a variety of scenarios, specifically catering to being a staple within first aid kits for hiking, sports, and with orthopedic doctors. Other designs currently are, according to reviews, only able to be used once or twice, initially stored tightly but cannot be repackaged, catered to only one region of the body, and are not sturdy enough to walk on for extended periods of time. Through careful use of a mix of materials instead of a single large chamber, we hope to improve patient outcomes through our design.

Manufacturing Cost
The manufacturing cost would most likely be a higher price because of the fact we are trying to make our splint better than those already in production. Our splint would be more efficient compared to those already in production. An inflatable splint that is currently available is $24.50 to fit a full arm. Our splint would ideally be able to fit around different body parts, so that would also increase the manufacturing cost. The ideal situation would be that we could produce a solution that is low in cost to produce so it could be widely distributed to those in need without having to worry about affordability.

Sales Price
Our sales price is currently unknown due to the fact we aren't sure what theoretical materials we would be able to use. An idea is to use a mix of vinyl and an unknown solid material to produce a product that will be solid when it inflates, but it could also be folded to a compact size when not in use.

Market Size
6,300,000 (number of possible customers) * sales price * penetrance = theoretical market size in dollars

Fundability Discussion

As seen in our fundability worksheet in the last lab, we fell below the score needed to be truly fundable. To fix this we will need to figure out how to improve our design and improve our score as to get funding. With further research and thought, we will be able to achieve this.