Every now and then a product comes out where the sheer thrill of its existence is quickly replaced by a sense of horror that it took so long for something like it to come about in the first place.

Such was the case with FLEX, a new kind of tampon that is hypoallergenic, latex-free and safe to wear during sex. I'll spare you the gory stories that make a case for something like FLEX—think sex stories with more blood than a Quentin Tarantino film—but let's just say, innovation in the feminine hygiene industry was long overdue.

"FLEX was born out of a personal problem," says Lauren Schulte, CEO and Founder of The FLEX Company. "I hate tampons—they leak, they smell, they're uncomfortable and what's worse, they gave me terrible yeast infections after every period." Schulte explored other alternatives—such as menstrual cups—to no avail, eventually leading her to pursue a research and discovery phase in hopes that it would lead her to a more promising alternative. 

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"I dug into the feminine hygiene market and different inventions. I was particularly focused on determining what made them succeed (or fail)," Schulte says. "When I learned that the modern tampon and menstrual cup were invented in the 1930's with little innovation to date, I vowed to dedicate my life to making something better for women."

Schulte's research began with listing out every single question she had about the space and then ticking them off one by one. "This took me about a year," she explains. Starting with the market in the U.S. and then looking at the offerings on a global scale, Schulte read up on the history of different products and patents to understand how the supply chain, manufacturing process and marketing strategies worked together to create menstrual products. "I paid extra close attention to products that had failed. Why did they fail? What could be learned?"

Schulte found that most people ran out of money during proof of concept or proof of design. "For those who made it through those initial phases, some failed because, first of all, their product couldn't be manufactured at scale and at a price point consumers would be willing to pay and, additionally, in a manner that the product itself would not fail during use," she says. "Then there's the group of products that made it through design and manufacturing successfully, but haven't been able to achieve product-market fit at scale. I put menstrual cups in this category because they're very easy to design and manufacture as a single-shot injection mold, but even though the market has a high awareness of menstrual cups, there's a relatively low adoption rate among users." One example, DivaCup (pictured below), the category leader, saw sales of under $1M in U.S. retailers last year—this number indicated to Schulte that menstrual cups are still very niche.

"I also studied the regulatory framework through which American Class II medical devices—a product category that also includes condoms, for example—must operate under," Schulte says. The FDA has specific requirements for all Class II medical devices to ensure safety and effectiveness, which Schulte dug into extensively.

From there, Schulte moved into a series of interviews with 53 various industry experts and manufacturers. "I talked to the FDA, and three independent consultants who specialize in taking Class II medical devices through the FDA approval process," Schulte says. "I talked to entrepreneurs in four countries who had tried making a menstrual product but had failed, and really dug into figuring out why that happened. I spoke to a handful of entrepreneurs who had made completely different medical devices (and had succeeded) to figure out how they managed through some of the problems that I wasn't sure how to overcome. Around the same time I also started interviewing product designers who could help me design my product."

Schulte quit her lucrative marketing job and started working full-time on FLEX in 2015—right after she started getting calls from out-of-state strangers who had heard murmurings about her idea and wanted to know where they could buy the product.

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"I ordered every type of menstrual product I could find from the last 20 years," Schulte says. "I tried them all. I gave them to friends to try. I started collecting informal feedback. I hosted focus groups. I talked to strangers. I continued gathering feedback on what features and functions women really wanted in a product." All that user research and product testing informed Schulte's approach to product design as well as helped her develop a customer adoption plan, business model and marketing strategy. "The design is important, but without considering education, the economics of how the product would be sold and a marketing strategy, I knew I'd face the same fate of some of the women who had come before me and failed," Schulte says.

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Similar to menstrual cups, FLEX collects rather than absorbs menses, a.k.a. all that delightful blood and other matter expelled from the uterus during menstruation. Unlike menstrual cups, however, FLEX is a disc that is worn at the base of the cervix instead of in the vaginal canal. This allows for air to flow freely, which helps reduce cramping while also allowing users to have intercourse during wear. Also unlike many menstrual cups, FLEX is disposable—meaning there's no need to rinse and reuse, a feature that, while practical and eco-friendly, was a sanitary hangup for many of Schulte's friends who used the product. In a field that hasn't seen much innovation in decades, FLEX creates an entirely new product category: menstrual discs.

Due to Schulte's own experience with yeast infections, material choice was of the utmost importance with FLEX and she opted to use medical grade polymers for the menstrual disc. "These materials were chosen because they do not disrupt the pH of the vagina and have antimicrobial properties," Schulte says. "They are tested for safety inside the human body and are used in all types of surgical tools. All tampons (even organic ones) disrupt the vagina's pH, which is what can lead to yeast or bacterial infections." FLEX can be worn for up to 12 hours and holds about 5 tampons worth of fluid, so it only has to be changed once or twice a day. This is a stark contrast to the frequency of change required with tampons—closer to every 4 hours—which when not followed can result in a range of medical concerns including Toxic Shock Syndrome (TSS).

FLEX, on the other hand, has not been linked to TSS. "The critical difference between FLEX and tampons is that FLEX is made out of inorganic materials (medical-grade polymer) while tampons are made out of organic material (cotton), which is a bacteria magnet," Schulte says. (She writes about the science behind TSS here.)

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The final form and shape was the result of rigorous user testing, which found the disc to be the easiest form for women to insert and remove. "Women love the fact that FLEX doesn't block the vaginal canal, which makes it immensely more comfortable than any other product on the market," Schulte says. The founder and her team pulled from years of data on the "average" size of the vaginal fornix (the space around the cervix where FLEX sits)—collected from the days when the area was measured to prescribe diaphragms—to find an average that would fit over 90% of women. "And to help it fit even better, we used materials that employ your body heat to get softer, allowing them to mold to individual contours for a custom fit," Schulte says. "This is very different than a menstrual cup, which is made out of materials that are stable and must be appropriately sized, like latex or silicone."

As one might imagine, designing and developing a Class II medical device comes with its own suite of challenges, and not least of all was the process of raising capital. "Investors want to see product-market fit before they'll give you money; but you need money to build a product and it typically takes $2-3 million and two-three years to bring a Class II medical device to market," Schulte notes. Same goes for manufacturing. "Manufacturers want to know that you have money before they'll talk to you; but investors want to know that you have a product and manufacturer before they'll give you money."

FLEX ended up raising about $1.12 million in seed funding and recently acquired competitor Softcup, so it now owns much of this small yet growing market. With  funding locked down and manufacturing secured, FLEX is now available for pre-order online. "We've been overwhelmed by the positive response from women all over the world," Schulte says. "It's clear we've struck a nerve—women are tired of how shitty our products are. There is no product as ubiquitous and as hated as the tampon. They leak, they smell, they cause bloating and infections. It's no wonder we feel gross during our periods; it's not because our periods are gross, it's because walking around with a wet piece of cotton between your legs all day (or with a diaper strapped to your panties) is an uncomfortable experience. If men had periods, we'd be on the Mach 10 of tampons."

All this brings me back to square one. Why did it take so long for something like this to come about? The answer is likely a combination of the lack of discourse around a (widely considered to be) taboo topic along with the general absence of women in roles that can shine a light on these types of problems. Hopefully FLEX is the sign of more to come in this field, ushering in a renaissance of products and services to address other overlooked realms.

"I genuinely believe that if you are determined to solve a problem, you can do it, even if you don't have experience," Schulte says. "You have to approach the problem with an open mind and surround yourself with people who believe in your vision and have the capabilities to help you execute."