04: How A Rugby Head Guard Was Developed As A Medical Device with Mark Ganly

On this show, we have the co-founder of N-Pro. He shares with us their story on how they have developed a unique new rugby head guard. Learn why he was inspired to create the head guard, the importance of end-user research, and the intricacies of classing a product as a medical device with CE mark approval.

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What you will learn in this episode:

• What is N-Pro and the idea
• The reason a new approach to helmet development was needed
• The innovative process that went into creating N-Pro
• The benefits of classing the product as a medical device and how the product was tested
• Some thoughts about the ethics of animal testing
• The challenges of working in a field of innovation
• Advice for people dealing with the press and media

What is N-Pro and the idea

N-Pro was founded by Mark and his wife, in part because of their backgrounds. Mark had a company that was developing sports helmets for the Irish sport called Hurling, and he was also involved in the development of safety standards for sports helmets. Meanwhile his wife, is involved in the medical device industry.

The reason a new approach to helmet development was needed

The area of head injuries in sport is a controversial and emotive topic. While there are developments in the diagnostic space, Mark and his wife were more interested in reducing the risk factors of the injury happening in the first place. There are two major risk factors for head injuries in rugby: linear impacts (90 degree blows to the head) and rotational impacts (glancing blows that make the head spin).

The innovative process that went into creating N-Pro

The co-founders could see a huge unmet clinical need in the sport. They applied it to the principles and processes that had traditionally been used in the medical environment.

The benefits of classing the product as a medical device and how the product was tested

There are a number of companies around the world looking at sports helmet development, but according to Mark, lots of companies are making unvalidated claims. When you’re looking at addressing a clinical issue, he believes all those products should be under medical device directives.

N-Pro has been through over 3 years of research and development. They started with the traditional way you would test sports head gear—bench testing and drop testing. The next step was a pre-clinical animal study.

Some thoughts about the ethics of animal testing

Although some people are against animal testing, it’s still used in the medical field. Pre-clinical studies are very common in the medical device industry. Most medical devices, apart from very low-grade risk products, would have used pre-clinical studies, which some people might not know. However, that’s what commonly happens. You have to test a number of factors in the product before you can move into human testing.

The challenges of working in a medical field which evolving

There is always more to learn in the field of concussion research in sports. Mark says the current N-Pro product is only the first version of the product. They have several other designs planned for it and will be constantly innovating the product as new research and development occurs.

Advice to people dealing with the press & media

Head injuries are a hot topic so there are stories all the time. In terms of giving advice, he suggests managing expectations with the press. They have said clearly that the product is designed to reduce risk factors. However, a lot of the time people like to turn it into a sensational headline, that this is going to solve this issue. Mark has remained consistent in his message in the fact of this sensationalism:

“We’ve always said it’s a multifactorial response that’s needed here to address this issue.”

Find out more at the website www.n-pro.com or on Twitter: @nprosports

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