For my first project in BME 416: Regulation of Medical Devices, I got to choose a specific medical device that I wanted to improve, then research existing patents to see what steps I would need to take to create my own, reinvented version of that chosen product. I chose to focus on soccer shin guards because I love soccer and wanted to see what patents for soccer equipment were already existent. I also thought that I could potentially come up with a way to add a piece to shin guards that could help prevent ankle or knee injury, since both ankle and knee injuries are very common in soccer.

I started by looking up the current patents for shin guards, and I was shocked to find that there are tons! It was cool seeing how the patents differed from one another, and I realized that if I were to attempt to make an improved shin guard, I would need a lot of licenses from previous patent owners! I found a few of the most prominent shin guard patents to analyze, then I moved on to looking at various knee and ankle braces.

I realized that combining a knee brace with a shin guard would probably end up being illegal in a soccer game, so I focused more on the ankle brace. Combining an ankle brace and a shin guard definitely seems probable, but I don’t know if it would be a popular choice among soccer players. I know that I always choose the shin guards without the ankle protector attached, but I decided that if this new device presented significant evidence that it could prevent further injury, it could become an accepted option.

After researching different ankle braces, I realized just how hard it would be to grow a device from an idea to a marketable product. I definitely understand why there is a huge need for patent lawyers!! I am so glad that I am taking this regulatory class because it is a huge part of the medical device development process. There are so many elements that go into the regulatory process that could completely prevent a device from being publicly marketable, so I am glad that I’m learning this now rather than after I’ve already begun trying to develop a product.

I am also so happy and thankful that I attend a university like USC because they give us the opportunity to meet with patent lawyers at the Stevens Institute for Technology, should we have any questions about the regulatory path a potential device would need to take. I think that the information taught in this class will prove to be invaluable, but it never hurts to get an outside, professional opinion, and USC gives us students just that!

Lauren Pelo-2015

Lauren Pelo-2015

Biomedical Engineering, Class of 2015, Learn more on her profile here!