Mira, the women’s health startup that launched last month at TechCrunch disrupt and won a recent startup competition at Health 2.0, has moved fast.

The three-year old company has 36 employees, a device nearly on the market, and FDA and CE Mark clearances. And almost unheard of for a tech startup, it does its own manufacturing.

“We built 11,000 square feet of manufacturing facility ourselves, which is ISO certified,” CEO Sylvia Kang told MobiHealthNews on the sidelines of last month’s Health 2.0 conference. “We can control our quality and the cost, so that’s really good for our future potential. Now it’s still at a pre-launch. We’re shipping next month, but we’ve got thousands of people waiting for this. So a lot of traction; a lot of traction from consumer, from pharma, this whole industry.”

The $199 device itself is a small analyzer, about the size of a fist, and a disposable wand that the user pees on and then inserts. The device produces a reading in about a minute, displaying a simple reading of high, medium, or low fertility on the device itself and then sending more detailed data — which can be viewed as a trend graph — into a connected app.

“We not only try to make huge lab equipment so small, but we did a lot of work on the industrial design on this one,” Kang said. “So this one looks like an egg, obviously for a woman’s product, for ovulation. And I think it looks like a crystal ball actually, and that’s why we called it Mira. Mira in Spanish means view or insights. A woman takes the measurement so they’ll know what’s inside of them; [it's] a crystal ball that tells you how you are today.”

Users will have to buy new wands to track, but Kang says the company tries to keep that cost — and the hassle of testing — down.

"They need to use it about 10 times every month and 10 times is actually much less than some traditional ovulation prediction kits," she said. "The reason is because we have the algorithm behind this, so we calculate, we only ask them to do it when they have to do it, so they test more often when it’s closer to ovulation and much less when often when they’re far away so they don’t have to waste money."

While the analyzer has a lot of potential, including kidney function testing using urine and many additional tests using other bodily fluids, the company has pegged fertility testing as an initial use case. It’s because women’s options for fertility tracking right now are imprecise, Kang said.

“Apps might work well for someone who has a more regular cycle or a younger person, but based on our data we’ve found the majority of women, their ovulation patterns never look like textbook definitions,” she said. “Some people have really high baselines, some people have really low baselines, some people have different thresholds. You know the peak value is very different as well. If you’re just tracking your period you see the beginning and end, but what’s happening in the middle is a black box for you. You can only do your estimation, but everyone’s different. And if you just apply the population average, you tend to have false positives and false negatives.”

Mira is also unique in that its analyzer uses the same flourescent-based test that hospital analyzers use, scaled down. Many of the other urine testing mobile health applications hitting the market now use a color panel, usually combined with computer vision.

Consumers will only ever have to buy one Mira analyzer, Kang says. When the company rolls out new functionality, it will be via alternate testing wands. Plans include pregnancy testing next year, as well as one for menopausal women who want to know their ovarian reserve. After the women’s health suite is rounded out, the company will go after family health, which could include everything from thyroid testing to weight management.