Period care startup Sunny lands FDA clearance
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A period care startup that originated in central Indiana has landed a key approval for its menstrual cup with a reusable tampon-style applicator.
Earlier this month, Sunny received the U.S. Food and Drug Administration’s 510k clearance for its product, which the company began shipping last fall.
Sunny was created by co-founders Drew Jarvis and Cindy Belardo, who say the product creates an eco-friendly alternative to tampons.
Jarvis told Inside INdiana Business the process to gain the FDA clearance took about a year.
“Menstrual cups are a Class II medical device and have historically been exempt from the 510k process due to substantial equivalence as they call it,” Jarvis said. “But because we invented that very first menstrual cup applicator, we had to kind of reprove that substantial equivalence so, we had to go through the 510k process. [It’s] first time that a menstrual cup has had to do this in quite some time, which I think really speaks to the innovative nature of our device.”
The Sunny Cup + Applicator is made of medical-grade silicone and other reusable medical-grade materials. The company says it inserts like a tampon, holds 2-5 times the amount of tampons, can be used for up to 12 hours at a time, and is reusable for up to one year.
Jarvis said receiving the clearance allows the company to continue innovating in the menstrual cup space.
“We our own predicate device now. So, we have the opportunity to expand on our sizes and colors and continue to innovate with this applicator device without having to go through such a strenuous process. The 510k process is not something that a lot of medical devices at our class and our level have to do.”
Jarvis, a graduate of the Indiana University Kelley School of Business, first pitched the idea for the product in 2018 when she was a senior at Fishers High School. Then known as Lily Pod, Jarvis won the $25,000 grand prize at a pitch competition called “The Next Launch” at Launch Fishers.
The company went viral with a pair of videos on TikTok explaining the product in April 2022 and received more than 20,000 preorders ahead of the product’s launch in September 2023.
She said she and Belardo weren’t initially aware that the 510k clearance was something they needed to get.
“When I was in high school and Cindy met up with me when I was in college, we didn’t actually even know this was a medical device,” she said. “I knew nothing about the FDA, but of course, we very quickly brought on the experts; we brought on FDA consultants and regulatory consultants who advised us throughout the process. We weren’t even sure if we were going to need to do a 510k process, and it was a bit of a surprise when we were told that we did.”
Now based in Boston, Sunny was able to fulfill the first 5,000 of its preorders after the September launched. Jarvis said it’s been a slow process because the company was hyper-focused on the 510k clearance process and continuing to improve manufacturing.
“With creating a medical device, we have additional hoops that we have to jump through in the manufacturing process as well,” she said. “So here soon, we’re going to start shipping again and fulfilling the outstanding17,000 preorders.”
For the products that have shipped out, Jarvis said they’ve received rave reviews, in line with the reaction they got when the products were first made available for preorder.
Looking ahead, she said establishing a sustainable manufacturing process will be the next big goal for Sunny.
“We want to be able to keep up with the demand and the orders. The demand is great. I think that speaks to the innovation and our capability of marketing and branding, but the manufacturing needs to be able to keep up with all of the wants of our customers.”