From Idea to the Shelves: Challenges Bringing a Medical Device to Market

So, you’ve got an idea to make health care better, potentially for millions of people. The question is, do you have the passion, determination, persistence and years of patience needed to bring a health care product to market? You’ll need all that and more.

The medical device, drug and biologic markets are highly regulated. Because of this, development and authorization to sell a product can be a lengthy, expensive process.

Health care products come to market in one of three ways: Engineers finding a better way to do something, physicians using side effects from one drug or device to treat a different illness, or a curious onlooker seeing an unmet need in the field. Enter two St. Thomas alumni.

Protégé Biomedical, a company founded and owned by a husband and wife team of Evening UST MBA graduates, started researching a blood-clotting product in 2010, as curious onlookers. Mike Wuollett stumbled into an article about treating wounded soldiers in the battlefield. He read it to his wife, Susie, and the couple began to brainstorm. They looked into the products being used, and had an “ah ha” moment, when they saw an opportunity to combine components of existing products to make a better one, available to the masses.

“Like a new business venture, we knew if we found a gap in the market or in the intellectual property, we could move forward with our own blood coagulant product,” said Mike. “With the additional research Susie and I did, we found a gap in both the market and IP for our new product idea. We had to see where it could go.”

The couple entered their business concept in the Fowler Business Concept Challenge in 2010, and won. With guidance from competition judges, (including testing their product on themselves at home), they saw serious potential to make a difference. That’s when the work really began.

“We spent a lot of 2011 further researching patents on our own, then working with patent attorneys,” said Mike. “Once we knew the product was okay to move forward, we tested, tested and tested some more. With feedback from users we redesigned, revamped and reengineered. Then, in September 2013, three years after Susie and I came up with the idea, we made our first sale.”

ClotIt, the product Protégé Biomedical sells, is a combination of two powdered minerals that when applied to a cut or laceration, rapidly stop bleeding. The company has secured three investments from the William C. Norris Institute at St. Thomas, which led to a $500,000 investment from an outside investor in January.

The couple is selling to veterinarians and pet owners, an industry that doesn’t take as long to get approval. They are working on authorization to sell the same product for human use, pending Food and Drug Administration clearance.

With a three-five year wait on medical device patents, ClotIt is patent-pending, with hopes for approval by 2016 or 2017. The couple has hopes of Protégé growing large enough to eventually sell to a larger medical manufacturer.

ClotIt is sold through select veterinary distributors and retail locations throughout the United States and online.