"With a speculum, you just shove it in and expand it as wide as you want to get the visualization you want. With this, you have to put it in and gently move it around, kind of like a joystick." — Biomedical engineer Mercy Asiedu
Other do-overs have focused on more modest improvements. A prototype called the Lotus, created by a student at the Pratt Institute, kept the bill shape but curved it slightly for a more ergonomic insertion. The design also included a rotating handle to open the speculum bills vertically, and a hidden lever mechanism to prevent pinching. It seemed promising, but after appearing in a student showcase last year, it never turned into anything real.In Oregon, a group called Ceek Women's Health has begun clinical trials for a series of new devices—including a sleeve, a speculum with narrower bills, and a speculum that patients can self-insert. Their goal is to create a variety of specula to serve a variety of patients, rather than recreating another one-size-fits-all tool. "For women who have a lot of tissue, women who have had more than two vaginal births or a high BMI, for women with a history of trauma or rape, for post-menopausal women who have vaginal atrophy—there isn't any product to address their needs," says Fahti Khosrow, Ceek's co-founder and CEO. Give physicians a whole new toolkit, she says, and they can better serve their patients.
Perhaps the most promising new design comes from Duke University, where researchers are testing a device that could circumvent the speculum altogether. Mercy Asiedu, a doctoral candidate in biomedical engineering at Duke, designed a tampon-sized device with a 2 megapixel camera attached to the end. "The speculum was originally designed for a physician to view the cervix from outside the body," Asiedu says, "but with current technology, you can easily view the cervix from inside the body."Asiedu tested her prototype in a pilot study with 15 volunteers this year, the results of which were published in the journal PLOS One in May. Every single patient said the smaller device provided a better experience than the speculum.
The Duke study looked at patient satisfaction, and Asiedu acknowledges that physicians may offer more criticism of the device. The design emphasized comfort, modesty, and patient empowerment, not necessarily ease of use for physicians. "With a speculum, you just shove it in and expand it as wide as you want to get the visualization you want," Asiedu says. "With this, you have to put it in and gently move it around, kind of like a joystick."When Stewart and her team set off to redesign the speculum, they knew what they were up against. Plus, Stewart says, "I hadn't even seen a speculum."
So before they started researching or sketching ideas out, Stewart and Kumar listed the things that had bothered them in gynecological exams. There was the noise (like a can opener), the temperature (freezing cold), the feeling inside (as if someone was stretching your insides like a rubber band). When they acquired a set of specula, one plastic and one metal, they realized they needed to change the aesthetics too. These things looked like medieval torture devices.First, Stewart explored how to silence that ratcheting sound. She and Fran Wang, a mechanical engineer at Frog, investigated new types of opening mechanisms. No concept was too bizarre. What if, like a pufferfish, they used saline to inflate the device from the inside? Or what if they used air, blowing it up like an air mattress? They looked for inspiration in nature (cobra hoods), in machining (milling chucks), and in everyday objects (bicycle pumps); they studied how a tripod clamps open and shut, how ski bindings clip in and out, searching for ideas that might replace the old-fashioned screw mechanism.