In her years working as a nurse practitioner providing women’s health services in Guilford County, NC, Gwynne Hite witnessed an alarming number of cases where women had deliberately modified or substituted their existing tampons to fit certain social situations—sexual intimacy, exercise, fashion and more. Mishaps involving alterations like removing the withdrawal strings, shortening the tampon or substituting alternative absorbent materials with non-hygienic materials led these women to Hite’s clinic to seek medical attention to remove these devices.
 
After seeing enough of these cases, Hite took matters into her own hands. In 2014,  she designed a horizontal tampon concept to provide women with a new alternative to traditional tampons. OutaSite Cervical Disc Tampon concept is a hybrid of a menstrual disc and standard tampon that combines the best of both designs. The circular flat bidirectional product concept is intended to be lodged high in the vaginal vault just anterior to the cervix like a disc and features an absorbent material to collect menstrual fluid like a tampon.
 
“Social media has provided insight into how younger women view existing menstrual care products,” Hite says. “The pros and cons of standard tampons and pads, along with newer discs, cups, and special undergarments, are openly discussed. Increasingly, women are making selections to match a particular product to a specific activity or outing that they are planning for the day or night, and typically use multiple products during one period.”
 
In company research, OutaSite found that respondents showed a high interest in the concept and a willingnesss to evaluate the product when it becomes available. Research subjects were profiled according to standard demographics, current menstrual product use and geographical location. The individuals were either able to hold an early concept prototype or watch a video that demonstrated the product and research questions addressed common situations during menstrual periods and whether the product concept described would be attractive during those times. 
 
“In our market research, we identified several issues women have with existing tampons on the market,” Hite says. “Women using standard tampons complained about vaginal dryness or irritation associated with the vaginal placement of vertical tampons. The location at which the OutaSite disc tampon is placed, the vaginal fornix, allows for elimination of vaginal wall irritation often caused by traditional tampons.”
 
Other concerns included embarrassing leaks caused by fluid passing around the edges of the tampon. The OutaSite concept minimizes leaks, with the absorbent material and elastic ring securely and snugly placed around the cervix similar to how a contraceptive diaphragm fits.
 
Figuring out how to combine the best qualities of a tampon and menstrual disc was not easy. It involved integrating multiple engineering and clinical concepts into a single design that has never been attempted before. Additionally, the product is a class-two medical device which also happens to be a textile consumer product. Finding available experts who understand both medical and textile products was a real challenge.
 
“My initial motivation was to design something simple and safe that would help these distressed women,” Hite says. “I soon began to realize that there is nothing simple about developing a personal care product, especially a novel concept, which integrates several engineering and clinical concepts. It has been the ride of my life to assemble a team of engineers and material science experts who can manifest a design concept of this caliber.”
 
This process was helped by the addition of Terry Young, a former researcher at Procter & Gamble and expert in absorbent technology, to the team as an engineering consultant in 2020 and as a full partner in 2023. Through his involvement, the company quickly added new IP to its design portfolio and has charted a course for future manufacturing. The company is now set to test out its assembly ideas and hopes to have a perfected design that can be clinically tested by mid-2024.

“Terry’s contribution has been invaluable in finding the right material for the tampon as well as understanding the methods to design and develop a finished product. Because of Terry’s dedication and input into the project, he was elevated to full partner at OutaSite in 2023,” Hite says. “ Along with finding Terry, it’s hard to express how difficult it was to identify and secure the required suppliers, engineers, consultants and clinicians, but I can assure you it wasn’t easy.”
 
Currently, the OutaSite team is simultaneously working out the assembly process while expanding its “form & function” absorbency bench testing. This includes engineering a special, absorbency testing device called a Syngina that is already being used to mimic a lot of the natural positions a user would go through during daily routines. Also underway is the testing of assembly methodology, specifically injection molding, which is currently under construction.
 
OutaSite was granted a utility patent in 2019 and subsequently received two additional patents. Additionally, the company has a separate patent pending, which was published in the public domain in October 2023. 

More information: Gwynne HIte or Terry Young