Richmond Dental and Medical Collaborates with Medical Community: Soft BiteBlock^® Developed with Inventor CRNA and Her Sisters

Diana Roloff began her career as a certified registered nurse anesthetist in 1981. Even while in nurse anesthesia school in the late 1970s, she noticed a particularly menacing clinical phenomenon: as patients emerged from surgeries requiring a deep-sleep anesthesia, many had a harsh bite reflex, leaving multiple patients with broken teeth.

Through more than three decades of practice as a CRNA, Roloff observed anesthesia teams using DIY methods to address the problem. “My colleagues would often roll four 4”x 4” squares of gauze into a bite block, so that patients couldn’t bite down on their breathing tubes or place too much downward pressure on their own teeth,” she said.

Sisters Join Forces to Address a Clinical Challenge

Roloff began wondering why no one had come out with a commercially available product. She formed a company with her two sisters, Susan Condry and Nancy Reis, to explore various innovations, beginning with a bite block product to replace all of the DIY methods she’d seen through the years, including the use of tampons between the teeth.

“When Nancy, Susan, and I formed our company, SANADA Innovations, we were inspired by our father,” said Roloff. “He always encouraged us to think outside the box, so we took the skills we had developed from our various professions and put them to work for each other.”

After 15 years of false starts, the SANADA team came across a company, half the country away from their North Dakota home, Richmond Dental and Medical, based in Charlotte, North Carolina. “We persevered, looking at rolling machines, procuring 4” x 4” squares, as well as rolled gauze. Nothing suited our needs, so we looked at cotton companies.”

Richmond Dental and Medical Steps in to Help

That change of scope proved fortuitous, when in, 2013, Roloff called Richmond and found her call routed to the office of George Hargrove, Vice President of Sales and Marketing at the company. “He actually answered the phone, and I gave him our pitch right then and there,” she said. “His first response was funny—‘How did you get my number?’”

By the end of the call, she could already sense that with Hargrove and Richmond’s openness to external sources of product innovation, she may have finally found the ideal partner to develop a soft bite block. “George and his team were so nice, but more important, they were really excited and motivated to work with me,” Roloff remembered.

“We started slowly, explaining the product concept and what we wanted from it,” Roloff recalled. “We met with Chuck Allen, the head of product development. When he showed us their existing dental roll, we pointed out that it didn’t have the density needed to prevent this phenomenon we’d seen in the operating room. He immediately pivoted to experimenting with us to get what we had in mind. The entire team was great to work with—they made samples just for us, and they modified their existing equipment in order to make prototypes for us.”

A Great Product Is Born

Eventually, the teams from SANADA and Richmond settled on a design. “Chuck did the redesign and figured out the question that had really challenged us—how to wrap the cotton roll so that it wouldn’t unravel once you cut it to size,” Roloff explained. “We ended up co-developing a really great product that now has a utility patent pending with the US Patent and Trademark Office. With the new Soft BiteBlock^®, users place the product between the back molars so that the patient can’t bite down on the endotracheal tube or Laryngeal Mask Airway, as well as their own teeth or tongue. Molars can take pressure of 100 PSI, while the front teeth can only withstand 10 PSI before they break. The product effectively addressed the required PSI needed to prevent breakages.

For Allen, the experience showed that the company could work effectively with outside inventors. “When she came to us, the product sounded a lot like dental rolls we had been making for years, just with some new wrinkles to address a terrible problem for surgery patients,” he said. “While we routinely work with our customers on new product innovations, this was the first time we’d had an inventor come to us. Based on the success of this project, I’ve been open to working with more as they have ideas.”

Allen said the development of the Soft BiteBlock^® wasn’t without its challenges and a testament to the determination of the combined team. “We had to modify our machines to make larger rolls, and it took a lot of testing to determine the correct density to meet the PSI demands for this surgical application,” he explained. “Multiple iterations took more than two-and-a-half years to develop into a working prototype. We modified our braiding machines to make much tighter braids. Once we had a good braid set and target weight, we had something to work from to achieve the functionality and performance that SANADA Innovations had envisioned.”

 

 

The Soft BiteBlock^® Makes an Immediate Impact on Patient Care

In 2016, the company launched the Soft BiteBlock^® . While the product has experienced early success with great feedback from the field, there are still a lot of educational opportunities to be executed in order to achieve greater market penetration, according to account manager Fran Eskew. “As soon as health care professionals try the product, they want their purchasing departments on board to buy it,” she explained. “The product is so effective, that we’ve had no negative feedback or adverse events. Anesthesiologists, CRNAs, and anesthesiology technicians love the product—it doesn’t compress more than seven millimeters under the pressure of the molars when placed at the back of the mouth—it’s just a matter of getting financial approval from their institutions. At a price point of one dollar, the economics of this product makes sense, especially when you consider the cost of added insurance claims for repairing post-surgical teeth breakage.”

SANADA Innovations and the team at Richmond Dental and Medical think the product has a much higher market potential, since nearly 20 percent of all claims from hospital operating rooms and over 25 percent of claims from ambulatory surgery centers stem from teeth damage (source: Jan. 2018, Anesthesiology News).

Due to the wider scope of demand, the company will soon roll out two new sizes, individually wrapped, aimed at small children and adolescents to complement the original Soft BiteBlock^® for adult surgeries. “It’s a matter of continuing to educate, as Fran and I do in the marketplace, for this product to get the exposure and use it deserves—this product can really impact lots of patient lives, saving them from a nightmare experience,” explained Roloff. “There are still too many do-it-yourselfers rolling 4”x 4” sponges in non-sterile break rooms, and our hospital regulatory agency, the Joint Commission on Accreditation of Healthcare Organizations, will mandate that bite blocks be individually wrapped, as we will soon do with the Richmond product.”

The story of the development of Richmond’s Soft BiteBlock^® is a tribute to the innovation and determination of a large group of people collaborating with more than 1600 miles separating them much of the time. The teams from SANADA Innovations and Richmond Dental and Medical stayed the course, developing a breakthrough product line over three years, by always keeping patients and their well-being top of mind.