It's hard to make a splash in condoms, despite it being a vital industry for public health that is projected, according to a May report by Global Industry Analysts, Inc., to comprise 48.5 billion units for a total market of $8 billion by 2022.

The humble rubber sheaths are federally regulated as medical devices by the Food and Drug Administration. That puts innovators in the cockamamie poppycock position of needing something in the ballpark of at least $5 million just to do human trials.

The problem is clear: There is a real need to make a next generation condom that is easier to use, stigma-free and more visually appealing, but the product is tightly controlled by government guidelines. And the cost of trying to rethink the product itself is like playing high stakes poker with a buy in that is out of reach for most people.  

That financial thorn is what poked holes in Mark McGlothin's condom dreams. McGlothin won $100,000 as part of a 2013 Gates Foundation Global Grand Challenges contest to usher in a "next-generation condom" to turn the tide on condom use (worldwide, only 5 percent of men use them). Three years later, McGlothin has about a dozen collagen-based prototypes but is legally bound not to let anyone use them — despite having sunk about $60,000 of his own money and 2,000 hours of sweat equity into it.

"It's completely unfair," he said. "I recently saw a speech by Peter Thiel that called this out: our progress in the world of bits and bytes, which is light-years ahead of where it was even a few years ago, versus our progress in the world of atoms, of actual objects — cars, drugs, condoms, buildings, whatever — which is stuck where it was decades ago because of all this regulation and oversight."

McGlothin was no random contestant. In the 1980s, buttressed by a $1.3 million National Institutes of Health grant and a matching sum from a family planning non-profit, he developed Avanti, a polyisoprene, non-latex condom now used by industry heavyweight Durex. He is condoms' Steve Jobs or Elon Musk, but is stuck living as the industry's Nikola Tesla, his San Diego office stocked with blocked ideas and contraband prototypes. 

But not all condom stories are so blue. In 2013, the same year McGlothin hit his brick wall, Tiffany Gaines, then a graduate student in design for social innovation at New York's School of Visual Arts, partnered with Claire Courtney, who was working with homeless teens in Los Angeles. The condom company they formed together, Lovability, has enjoyed wild creative success.

Unable to change much about the condoms themselves — although they source "fresh" latex that has a 12-week trunk-to-junk life —the entrepreneurs triggered major changes by tweaking largely presumed packaging traditions.

For one, their condoms open with buttercup wrappers — picture butter or grape jelly containers at a diner — that peel back without any of the tooth-and-nail approach seen in condoms' classic tearable pouches. And because the condoms lay flat in the container, they're always right-side up (no unrolling the condom a bit to see if you're doing it the right way).

"We've joked it's the hipster condom, the artisanal condom, the bespoke condom," Gaines said. "But no. It's not that. It's about taking the part we're kinda stuck with because of the FDA and changing the relationship since we can't change the technology. We're able to do these minor things that actually do a lot of heavy lifting in the anxiety battle. It transforms anxiety into power. It's like a training bra. It allows for a fuller, more comfortable conversation."

The packages are stored in small round tins, like breath mints. "It's unusual enough and discreet enough that someone can drop it out of her purse in an ice cream parlor full of kids and nobody is going to gasp," said Gaines. "That is huge. We took it out of that hyper-sexual, hyper-clinical pharmacy space where it's on an aisle with Band-Aids, cough syrup, and adult diapers. It needs to be more like lipstick, something that makes you feel sexier and braver and bolder when you use it."

Lovability is huge on feedback to avoid unnecessary or unhelpful designs that beleaguer products targeted to women, from the so-called "pink tax" to the inanity of, say, Bic's "for her" line of pens. Alternately, the Lelo Hex condom of tessellating hexagons is bro-y both in its aesthetic and its marketing.

These condom packaging wrappers by The Woork Co for Confortex purposefully look like candy wrappers.

Unafraid of targeting a younger audience, Debbie Martín, cofounder of design studio The Woork Co. in Madrid, flipped condoms' packaging by putting the instructions on the condom's wrapper and boxing it in a nondescript bright container for client Confortex. "We wanted it to look less like cough syrup and more like bubble gum," she said. "Now the condom looks — and feels — less like medicine and more like candy. You want it more."

Condom packaging using fruits and veggies to give sizing context, as dreamed up by Guan-Hao Pan.

Designers are also asking their users to weigh in on what's on the packaging. Take One Condoms. Sure, One's pouches are round instead of square and have one tear spot instead of a miniature picket fence of vulnerabilities. But what's key to One's strategy is what's on the wrappers. The word "One" is incidental to lavish, colorful illustrations commissioned by street artists, giving the condoms the allure and collectibility of Pokémon or pogs. It's not as gimmicky as it might sound. "A glow-in-the-dark condom may sound like a joke," said One Condoms senior director of brand strategy Jared Maraio, "But not if it allows a conversation about wearing a condom that might be too nerve-racking or offensive with a normal condom."

Every three months or so, One releases new designs, which have been voted on online. The result is not just their sneaker-style collectibility but that condoms become much cooler and more approachable. "It's self-expression," said Maraio. "It's emotion. It's power. It's art. And so it's designed to evolve with public attitudes and trends." The condom maker might partner with Tom of Finland or exhibit in Urban Outfitters. But they're very targeted. And whereas public health campaigns can creep slowly over years, One's approach allows for radical shifts in the somber I'm-the-rubber-you're-the-gloom scene of an STD clinic or middle school sex ed class almost immediately.

"We can do different designs for urban markets or gay markets or whatever,"  said Maraio. It's working. One now partners with 3,500 public health organizations and recently were acquired by Karex, a blue-chip condom manufacturer, with plans to expand the 55 condom sizes available in the United States to the full 66 sizes offered in Europe. 

Meanwhile, McGlothin, in his San Diego office, bemoans the small victories with which those in the condom industry must make do. "Ten million dollars would accomplish exactly what Bill Gates tried to do," he said. "But now I won't even listen to someone offering just another $1 million. It just wouldn't work. It's not an industry where million-dollar ideas have power anymore."