OrthoDots CLEAR is a medical-grade silicone product that adheres to patients’ brackets to prevent irritation and sores. Courtesy OrVance
When Ron Schutt was getting braces several years ago, he had no way of knowing his orthodontist would one day become his business partner.
Schutt, former vice president of consumer health care marketing at Perrigo, was a patient of Dr. Eric Hannapel’s at his Caledonia practice.
Meanwhile, Hannapel was working on a side project with Michael Silver — a chemist and Hope College professor — developing a product to ease orthodontic pain.
Hannapel gave Schutt the chance to try out a prototype. Schutt saw it had potential and agreed to help the partners with business consulting on how to develop, scale, market and sell the product.
“I never had it on my list to be a CEO, but I came in to do the business planning, marketing and raising capital and so forth to commercialize it, and it just kind of morphed into heading up the company,” Schutt said.
OrVance was officially born in 2014 as a completely virtual business that is 90 percent owned by investor orthodontists, dentists and its six current managing partners. It has no office and runs on a workforce of contractors.
This month, the company sent the first shipments to vendors of its proprietary OrthoDots CLEAR product, a medical-grade silicone product that adheres to patients’ brackets to prevent irritation and sores.
The product recently was approved for sale in the U.S., Canada, the European Union, Australia and 24 other countries and comes with an instruction packet in 33 languages.
OrthoDots CLEAR is the third or fourth iteration of the product since 2015. It rolled out this latest CLEAR version last year in response to customer feedback that an invisible version of the dots would be more appealing.
An undisclosed Grand Rapids-based medical device maker that OrVance contracted manufactures the product.
“We never really wanted to duplicate something that already exists in West Michigan,” Schutt said, noting the medical device manufacturer OrVance uses is “world class” and is a member of The Right Place’s MiDevice consortium.
“We want to focus on the innovation itself, protecting intellectual property and the branding,” Schutt said.
Schutt said OrthoDots CLEAR is OrVance’s “flagship product” and the company is committing to establishing its success before rolling out other pain-prevention products it has in its pipeline.
The biggest hurdle OrVance had to overcome before going global was developing a product that would meet regulatory standards all over the world — no easy feat, Schutt said.
Once the company achieved that, it was able to secure two global distributors — American Orthodontics and G&H Orthodontics — as well as other suppliers in the U.S., Canada, Australia, New Zealand, the U.K. and Ireland.
Schutt said his background at Perrigo working on Rx to OTC switches will help the company eventually break into consumer sales as well as the vendor-to-provider sales it’s currently doing.
“Trying to develop majority market share in the professional channel will ultimately translate to the retail sector as well, which is where a lot of my experience is,” he said.
“There are only a little over 9,000 orthodontists in the country, so it’s a very reachable market, plus several of our investors are orthodontists and dentists.”
Current dental waxes orthodontists use are unhygienic, ineffective and noncompliant compared to OrthoDots, Schutt said, citing guidance the firm has received from global regulatory firms.
“When we sit down with medical device manufacturers, and you go talk to people in other health care sectors, and you show them this generic pack of wax with no labeling, no traceability, no disclosure of ingredients, and it’s not unit of use, kids are really just reaching in and tearing off a piece, which is very nonhygienic — the reaction of nurses, doctors, surgeons … (is) that’s kind of gross,” he said.
In order to build up a market for OrthoDots CLEAR, Silver has been conducting 40-minute lunch-and-learn education programs for orthodontists in residency programs on behalf of OrVance, followed by free product shipments.
“We expect to have all of the resident programs in the U.S. converted well within this year,” Schutt said.
Added Silver: “Omitting (quality and safety) standards for a health care product that is occasionally ingested leaves our patients and industry vulnerable. This is why we’re passionate to lead the industry in providing a product that meets these critical standards.”