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Ensuring your dental product innovations get to the market is a matter of finding the right sources and support to get started and keep going.
35 Newtons–dentists who have experience with dental implant restorations know that the term doesn’t refer to the number of cookies in a package, but rather it’s a measurement of how much torque must be applied to a screw when attaching a restoration to an implant.
It’s also the company namethat Alex Shor, DMD, and Jim Janakievski, DDS, chose for their company, the makers of FirstPlug, a screw channel barrier.
“We had many ideas for the company name,” Dr Janakievski says. “But we decided to go with 35Newtons because it’s the amount of torque which dentists use when securing an implant crown.”
“And we thought, it’s very catchy and easy to remember, because everybody knows this number,” Dr Shor adds. “So, you have to be creative when developing your brand.”
The doctors behind 35Newtons are not unique in their quest to develop and deliver the next great dental idea, and the road to bringing that idea to market is neither easy nor straightforward.
The Big Idea
It all starts with a great idea.
Dr Janakievski has a periodontics practice in Tacoma, Washington, and Dr Shor a prosthodontics practice in Seattle, Washington. Like so many inventions, FirstPlug has its roots in a need. In this case, there was no ideal material specifically created for use as a screw channel barrier.
“It’s the typical, same old story,” Dr Janakievski observes.
“We were working together, struggling with what we’ve had in the practice and thinking, ‘Well, why are we using these off-the-shelf materials?’” Dr Shor adds, “We initially used medical cotton, but it’s not an ideal material as it allows for pathogenic bacteria to grow. We also used silicone and gutta percha, but they were difficult to handle and did not provide a good seal. And then colleagues came up with the idea of going to the hardware store and purchasing plumber’s tape. But this is an industrial product that was never developed for human use.”
Ultimately, they developed a material and system that they called FirstPlug.
“It is a medical-grade Polytetrafluoroethylene (PTFE),” Dr Shor says. “You may have PTFE at home, because you probably have a GORE-TEX jacket which is a specialized version of PTFE.”
There is rarely a direct line between having that great idea and realizing it. It took about 5 years to bring FirstPlug to market.
“It took us a long time,” Dr Janakievski says. “We started the process of both sourcing the manufacturer and doing beta testing. This development process with the engineers and the manufacturers required more time than we anticipated.”
“Then we started a patent process,” Dr Shor adds. “Patenting takes a long time, so that further delayed our official launch.”
Getting a new product into the spotlight can be complicated, so seeking out a seasoned professional can offer peace of mind and ensure that every aspect of the process is included and completed efficiently. Lou Shuman, DMD, President and CEO of Cellerant Consulting Group, was integral to guiding 35Newtons through their new company’s growing pains.
Dr Shuman says. “Bringing a product to market is challenging. I was thrilled to see that these 2 visionaries were focused on the opportunities that were ahead of them and ready for the hard work ahead.”
Dr Shuman explains that the process of defining “proof of concept” is not always clear.
They started by defining their market and identifying their competition. He asked important questions before the journey began. “Can this idea actually be created into a realistic product? And it also is important to research the competition because if there is a similar product that’s created by a billion-dollar company, that may be too much competition.”
Like so many other inventors, dentists might find it hard carving out the time to realize their invention.
“Because we’re talking about dentists, and if they have a practice that is taking a lot of their time, I would say that licensing is the best pathway to bringing an invention to market,” Registered Patent Attorney John Rizvi says. Rizvi is also known as The Patent Professor. “The alternative would be to build a business around your product, but most dentists have full-time careers already that leave little time for this route and starting a new business can be life-consuming. Licensing lets someone else do all the heavy lifting, while you collect royalties.”
Rizvi shares a streamlined, best practices process for realizing an invention’s development.
“The way I see it, bringing a product to market boils down to 3 steps,” he advises. “First, you want to file a patent on the invention, because until you do, that idea is up for grabs. The United States Patent Office works on a first-to-file basis, not a first-to-invent. In a nutshell, that means anyone can take your idea to the Patent Office and file a patent application for it. The Patent Office doesn’t care who came up with the idea first. Essentially, it’s a race to get a patent filed. If one of your competitors gets wind of your concept, they could file the patent application first and shut you out of profiting from your own idea. So, step #1 is to file that patent application.
“Then, it becomes safe to move onto step #2, which is to tell other people about your invention,” he continues. “Target companies that are likely to be interested in manufacturing and selling your product. Once you find a party that wants to license your idea, you would negotiate with them on the terms of a licensing agreement. Typically, licensees take responsibility for everything involved in taking the product to market. They likely already have the infrastructure in place to manufacture, distribute, and market the invention. As compensation to the inventor, it’s common to receive a percentage of your product’s sales in royalties.”
Regrettably, not all inventive dentists know those steps. That was certainly the case for 35Newtons.
“It wasn’t an easy process,” Dr Janakievski says. “One piece of advice that we would offer dentists is go to a company that’s making similar products and ask them to partner with you or to try to help develop your idea or your product. You need to find the right people, and that’s the most difficult part. You need specific knowledge and expertise in manufacturing.”
They found the information that they needed by researching in manufacturing trade journals.
“You can explore trade journals or look at manufacturing conventions,” Dr Shor says. “The medical device manufacturers that advertise in trade journals would like to get involved with new ideas. Another part of this discussion is making sure that your idea is marketable and there will be a demand for it. Sometimes as an inventor, you are your own first customer. So, we were 2 customers who tested our own idea. We really made it for ourselves first.”
There are countless wrong ways, and only a few right ways, to bring a product to market. First, Rizvi says that it’s important to play one’s cards close to the vest.
“Revealing an idea before a patent has been filed is one of the biggest missteps any inventor can make but I think dentists are more susceptible to this,” he says. “My wife is a dentist and we’ve been married 22 years. During that time, I’ve accompanied her to a lot of dental conferences. Dentists are a close-knit community, and they often share openly at their conferences. Also, dentists that are solving problems for patients of theirs are often curious to try their prototype out and it is tempting to discuss it or even show their prototype to others.”
There are several right ways to bring a product to market. Due diligence and performing one’s research are critical.
“Before you look to go forward, you need to recognize that the execution aspect is crucial,” Dr Shuman says. “After validating that your product is not already in the marketplace, you need to clinically validate it. You must define your unique selling proposition. Do you have something that’s a real game-changer?” Shuman continues, “When I meet with a company for the first time, I always ask the same question – ‘What do you want to be when you grow up?’ At first, they laugh, then they realize how serious that question is. If I am going to be able to be an integral part of helping this company grow, what is their exit strategy:
Dr Shuman adds, “After we answer these introspective questions, we tailor our operating plan in working with our clients based on their answer.”
There are plenty of predatory competitors eager to take advantage of an unsavvy inventor.
“Another common misstep for inventors is filing an informal patent as a ‘placeholder’ while they fine tune their idea and work on the final patent,” Rizvi says. “This is a mistake because competitors that file a fully enabling patent application in the interim will have superior rights.”
Inventors must also consider patent rights outside of the United States.
“Patent rights are territorial and there is no such thing as a ‘world patent’,” Rizvi says. “However, there are important treaties in place that provide an inventor in one country rights in other countries. One such treaty is the Patent Cooperation Treaty. A patent filed under the Patent Cooperation Treaty (PCT) buys an inventor time in over a hundred member countries for 30 months while an inventor evaluates foreign markets.”
Do your Research (with Experienced Help)
How do entrepreneurial dentists ensure that their great idea hasn’t already been somebody else’s great idea with an existing product on the market?
“As more and more patent databases come online, it is tempting for dentists to do their own search for their idea,” Rizvi says. “The patent search is a complex endeavor, and it should be done by an expert to really be valuable. Dentists that rely on their own informal keyword searches for the state of the art of their idea might end up having an overly optimistic view of how unique their idea is.”
Dr Shuman concurs.
“There are companies that can do a patent search for you, and it may be best to leave that to the experts in the patent field,” he says. “But you can also do some digging into the market to see what’s out there. You can investigate the community by Googling. Most dentists have a sense of the products that are already out there. You can start to look at the major distributors like Henry Schein, Patterson, and Benco, and see if there’s anything like your invention.”
While it may be tempting to do it all oneself, it is wise to bring in experienced help.
“Dentists are not experienced in this pathway,” Dr Shuman says. “There are consultants and key opinion leaders that can help. There are dental funds, like Revere partners, totally dedicated to dentistry. We are incubators and accelerators, but there are different events that occur where you can present your idea for funding and support in dentistry.”
Patent attorneys are also a good source of help.
“The way to find out is to seek out a patent search from a reputable patent attorney,” Rizvi says. “A thorough search will be conducted of the database of the US Patent and Trademark Office to identify any patents or patent applications for inventions that might be similar to your idea. The patent search provides insight into the novelty of your idea -- in other words, how unique it is. At my law firm, The Patent Professor, will advise our patent search clients if we believe that their idea is novel enough to proceed with a patent application.
“At the Patent Office, every patent application is assigned to an examiner,” he continues. “The examiner is the individual who determines whether your idea will be given a patent. At The Patent Professor, we have several former patent examiners on our staff who assess our clients’ patent search results and issue recommendations. As former examiners, their insight into the patentability of your idea is priceless.”
Handle with Care
It should come as a shock to no one that inventions that have to be placed in the human body need FDA clearance. However, that is a challenge all its own.
“When the Patent Office grants a patent, they are not evaluating the legality of making the invention, and they will not evaluate any other regulatory requirements,” Rizvi says. “In fact, even inventions that are ‘illegal’ can still be patented. For example, if you file a patent on a home-based marijuana cultivating system, the U.S. Patent Office will evaluate whether the idea is novel and non-obvious, but it will not take legality into account. Whether a new dental product requires regulatory approval is something that the patent office leaves up to the manufacturer of the invented product to grapple with and the patent office limits its decision to whether the idea is novel and non-obvious.”
Dr Shuman adds that premarket notifications, such as a 510(k), that determines that the product is safe and effective, can also take time before a launch.
“Do you need regulatory?” he asks. “Do you need 510(k) in order to be able to launch your idea?” Dr Shuman asks. “That is a lengthy process. We can come up with a great idea. We can get excited. We can start producing the product, but if it needs 510(k) or other clearances, everything can come to a full stop until FDA provides that 510(k), and that can take 6 months or longer. That is why one of most important strategic partners we have has significant experience in working with the FDA”
Even knowing that special consideration didn’t prepare 35Newtons for what was to come.
“We knew, of course, that there is a difference between consumer and a medical or dental products,” Dr Shor says. “But we didn’t know the complexity of it. We learned with our own research and sought experts for our team.”
“If there was one thing that we didn’t anticipate was how complex it is to actually develop this quality management system that’s in compliance with the FDA, and follows medical device laws,” Dr Janakievski adds. “That was more difficult than it was for us to create and design the product. We were two clinicians that had a need for a specific product and created it. But all the other stuff that goes into creating this business was a larger commitment than we expected.”
The road to bringing an innovative product to market is not a straight line – neither is it fast. Inventors have to be prepared that the road to bringing an innovative product to market will not be straightforward or fast.
“There’s no such thing as a bullet train,” Dr Shuman counsels. “This is hard work that takes time because of the amount of detailed work that needs to be accomplished. Some entrepreneurs are focused on getting to their destination quickly. They want it done now. But it doesn’t work that way. We’re in a profession that has 100,000 products to choose from. We’ve learned over the years that for a startup it takes around 18 months to achieve true competitive brand awareness in the community, and that’s working with us at Cellerant as experts.”
Every day, dentist see better ways to do something. Those dentists who take the initiative to invent a product that helps them do their jobs better are just starting out on a journey. However, without a map that journey can be long and perilous.