My First Project in BME 416: Regulations of Medical Devices

Lauren Pelo-2015 Uncategorized 0 Comments

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!

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