This post will review the development of a football helmet equipped to diagnose concussions in real time. The work is being done by Drs. Barclay Morrison and James Noble at Columbia University. Specific focus will be placed on the marketability of this project.

Diagnosis of a concussion first requires that symptoms are either noticed and reported by players themselves or others on sidelines. Because players are competitive and feel pressure to perform, they might chose to ignore or dismiss symptoms. As a result,  concussions can be difficult to diagnose when they occur and go unnoticed. Continuing to play after experiencing a concussion puts players at further risk of injury. The researchers at Columbia noticed this problem and posed a solution, a way of diagnosing concussions objectively and in real time by utilizing ECG technology imbedded into helmets.

The basic concept is that ECG electrodes and leads are outfitted into a helmet. The helmet sends a signal to a monitoring device that uses an algorithm that accounts for movement and is able to detect the unique signal produced by a concussion. This allows for clear and informed decision making.  Below, in figure 1 is a flow diagram depicting how the device would be used.

Figure 1. Diagram depicting how ECG technology and data would be used, collected, and analyzed. (NoMo Diagnostics)

Besides meeting the need of better diagnosing concussions, this product has potential to be profitable.  Therefore, it is interesting to examine its development and conception under the lens of patentability.

Helmet development is being funded by the Columbia-Coulter Translational Research Partnership which “provides funding and business support for translational projects that will improve patient care and address unmet healthcare needs”. This program is contributed to by Columbia Technology Ventures which  is analogous to the Office of Cooperative Research at Yale. Morrison and Noble cofounded a company called NoMo Diagnostics and its website reads, the “goal is to develop the first FDA approved, real-time, physiologically relevant concussion diagnostic to initiate early treatment thus avoiding life threatening and long term consequences associated with unrecognized brain trauma.” The source of funding for the project as well as the founding of this company indicate that  this product is marketable.

In order to be patentable an invention must be novel, useful, and non-obvious. The usefulness of a helmet that can diagnose concussions is already addressed above, which leaves the novelty and obviousness to discuss.

If the websites claim is true and this ends up being the first device of its kind, then it is unquestionably novel. The publications about this technology and product do not give many details and the reason for this could be that the company is trying to keep their idea novel in order to be able to patent it. If they were to give out more details, they might provide prior art which would make their patent claim void. An article published by Columbia however, explicitly states that the idea is not completely new  and that “researchers experimented with taping EEG electrodes to the scalps of college athletes” in the 1960’s.

In the case of this product I believe the novelty still remains because the team is taking an existing technology but using it in a new way. Additionally they are finding ways to improve that technology by miniaturizing it and developing new algorithms to analyze the data.

From a biomaterials perspective I’d be interested in knowing what the electrodes and leads are made out of because they would be in contact with human skin in order to pick up a signal. Therefore, their function would have to remain unaffected  by sweat.