Military needs are the inspiration for our project, and as such we aim to become the emergency cricothyrotomy kit used by army medics. The CricSpikeTM was designed to be robust, mechanical, and light - aspects that are vital in the battlefield. The next step along the path of implementation would be the civilian market, consisting of Intensive Care Units (ICUs) and Emergency Departments (EDs). This market will be entered in addition to the military as we believe our device can have a significant impact domestically as well. Implementation in the military, however, remains our priority.

Several steps need to be taken in order to make implementation possible. First, it is necessary that our product be patent-protected. As of April 2016, Johns Hopkins Tech Ventures has agreed to file a provisional patent on the CricSpikeTM. We intend for the provisional patent to be filed prior to Design Day.  Second, the CricSpikeTM needs to be clinically validated through extensive testing.  In order to execute this, we need to create a step-by-step procedure for training users on the CricSpike™ using existing cricothyrotomy simulators, and recruit trained practitioners to perform the testing. These clinical trials, including cadaver testing, will allow us to show that CricSpikeTM is an improvement on the current military cricothyrotomy kit. Given a clinical trial that clearly shows a decrease in operation time and an increase in success rate, we will publish the data in order to validate our product and prove its legitimacy.

One of the important requirements for continuing our project will be acquiring funding. Because of this our third step will be applying for many different grants, including the 2016 Student Technology Prize for Primary Health Care, provided by the Ambulatory Practice for the Future and the Design By Biomedical Undergraduate Teams Challenge.  Along with this, we are able to apply for the Maryland Innovation Initiative because of our collaboration with Dr. Steven Tropello, MD.  In addition to these external sources of funding we will also have funding from the Johns Hopkins Center for Bioengineering and Design which will carry over from this year.

Once we have acquired the proper funding, the fourth step will be to explore FDA regulation. While the CricSpikeTM itself is a novel device, it has a number of established predecessors that can aid in our pursuit of FDA approval. This means that, even as a Class II device, the CricSpikeTM will be able to take a shortcut to premarket approval in the form of a 510k.  FDA approval means that the CricSpikeTM can be implemented in the civilian market environment, as mentioned above. It is important to note that FDA approval is not required for adoption into the military.  As a result, we will be marketing directly to the military along with our efforts to gain a 510k.

The CricSpikeTM’s novel and foolproof design, combined with a relatively low bar for validation and a smooth regulatory pathway, make it a device which can possibly reach the market quickly compared to other types of medical devices. With strong clinical data to support CricSpikeTM’s efficacy and the expertise of our very experienced committee, we anticipate being able to secure a spot inside the packs of combat medics and possibly emergency medicine practitioners around the world.