The Speculum Just Got a Major Redesign
IT WAS AFTERNOON in the San Francisco headquarters of Frog, the design firm best known for its hand in creating the iconic look of products like Apple's original Macintosh computers. Hailey Stewart, one of Frog's industrial designers, had scattered an array of prototypes on a table. On one end, you could see cylinders of foam that looked almost like skinny vibrators, with handles that stuck out at different angles and sketches of levers and screw mechanisms. And on the other, the common speculum—the device used in routine gynecological exams to inspect the cervix. Stewart picked one up and cranked it open. "You're literally in the stirrups with that sound"—the device made a loud, painful sounding click—"and and it's like, excuse my language, but what the fuck?" Most of the designers in the room had never seen a speculum before. Some (the men) had never considered the contents of a pelvic examination—stripping off your clothes, laying on an examination table, and strapping your feet into stirrups, while a doctor pries you open with a cold, metal gadget. But Stewart hadn't gathered her colleagues just to explain what happens to women at their annual exams. She had a greater goal in mind.
For the past several months, mostly during down time and on weekends, Stewart and interaction designer Sahana Kumar had been studying this device. They'd wrenched it open and closed, studied the curve of the bills, read endlessly about its history. And now, she told the rest of the designers at Frog, they had taken on what was turning into a particularly ambitious project: redesigning the speculum for the 21st century.
THE CURRENT DESIGN of the speculum, fashioned by American physician James Marion Sims, dates back to the 1840s. The device had two pewter blades to separate the vaginal walls, and hinged open and closed with a screw mechanism. Sims, sometimes called the "father of modern gynecology," used the speculum to pioneer treatments for fistula and other complications from childbirth. But his experiments were often conducted on slave women, without the use of anesthesia. So to say that the speculum was not designed with patient comfort in mind would be an egregious understatement. And yet, the speculum today looks almost identical to the one Sims used more than 150 years ago. The most noticeable difference between the original Sims device and the one you can find in gynecological offices today is that instead of pewter, modern specula are made of stainless steel or plastic.
That the speculum is old is not, on its face, a problem. It's that the design is neither optimal for patients nor physicians. Doctors have to stretch the speculum's bills wide in order to see as far back as the cervix, and even then, it's not always possible to get a good look inside. (Some specula come with built-in lights, but the problem has more to do with tissue falling in than the darkness of the vaginal canal.) All of that pressure causes discomfort; one review of the medical literature found that some women even avoid the gynecologist because of the dreaded device.
In 2014, the American College of Physicians went so far as to recommend against pelvic exams, citing the "harms, fear, anxiety, embarrassment, pain, and discomfort" associated with speculum examinations. Those side effects impact gynecologists, too. "The more comfortable a patient is, the faster they can do their job, the more patients they can see," says Stewart. "There's actual monetary value to [patient] comfort." It's not that nobody's tried to change things. In 2005, a San Francisco-based company patented the design for an inflatable speculum called FemSpec. The device was made out of polyurethane, the same material used to make condoms; a physician could insert it like a tampon and inflate it like a tiny balloon. It debuted to some fanfare, but ultimately flopped. As an article in The Chicago Times pointed out, most women never even got to experience the new speculum "because it is so new on the market that most doctors aren't using it." "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.
Next, they considered new materials. Instead of constructing the device out of plastic or metal, they decided to cover the whole thing in autoclavable silicone—a material that wouldn't feel cold, could be easily sterilized, and would make insertion more comfortable. "On the metal speculum, there are pokey bits," says Wang. "Those shouldn't go near your delicate body parts! Having all of that covered in silicon, it prevents tissue from getting damaged. And also when you look at it, it's nicer."
They experimented with using three prongs instead of two, opening the device into a triangle shape. They tried shrinking the device to the size of a tampon, or borrowing design language from the vibrator industry. They put the device's handle at different angles, ranging from 90 degrees to 120 degrees, to find most ergonomic position for physicians. And then they 3-D printed a few different prototypes and put them in the hands of OB/GYNs and medical providers.
"The one they were really excited about was the one that opened up using three bills, rather than just two," says Stewart. The triangle-shaped opening gave physicians the same field of view without having to open the bills as wide, making the process less "stretchy" for patients. OB/GYNs also liked the device's handle at 110 degrees, which enough extra space between the physician's hand and the patient's body to eliminate the "last scooch" down the examination table. The silicon covering was a big hit, too. A button unlocks or locks the speculum with one hand, freeing up the other hand; a push handle eliminates the need for screws. Even more comforting, the speculum was totally silent.
Conferring with OB/GYNs made one thing very clear, though: The project wouldn't succeed with redesigned hardware alone. Stewart wondered why she felt more comfortable getting a bikini wax than she did seeing the gynecologist once a year, and the answer boiled down to the environment. One felt cold, clinical, and scary; the other, relaxing and personal, even if it was more physically painful. If they wanted to redesign the speculum, they had to redesign the entire experience.
HALF A YEAR later, the project has turned into something of a coup d'état on the modern pelvic exam. There's the speculum itself, still in development with the insight from several OB/GYNs who have signed on to help. There's a list of guidelines for physicians, which include simple but meaningful tips like giving patients somewhere to hang their clothes and explaining the components of the exam. "It's never going to be perfect," says Kumar. "So how do we at least prepare people emotionally for how it's going to be, and make them feel like they got some value out of it at the end?" There's also a mock-up of an app, which would let patients fill out forms, ask questions, or follow a guided meditation before the exam. Kumar invented a gear kit—a stress ball, socks to cover your feet in the stirrups—to improve patient comfort, alongside the new speculum. The team also added Rachel Hobart, a visual designer at Frog, to help brand the experience. The result is called Yona. For now, the Yona project is still an early-stage design concept. Stewart and Wang are still hashing out new speculum prototypes, while Kumar and Hobart refine the app and experience. They're working with their board of physicians to fine-tune the idea, to negotiate what's feasible and what isn't. And collectively, they're searching for partners who may have similar goals, like the tech-savvy healthcare service One Medical, who can bring Yona from concept into reality.
The trickiest part, it seems, is developing something that physicians will actually adopt. It's not lost on the Frog designers that other prototypes have failed after physicians bristled at the idea of investing in something new, either financially (the cost of purchasing a new device) or mentally (the time it takes to learn how to use a new device). Gynecologists have been using the speculum for over a century, and so far, it's worked. Why change now? "You could create the most beautiful, most unique, most user-friendly device, but if a doctor doesn't want to learn how to use it, your patient's never going to see it," Stewart says.
But Wang says that's mostly a matter of getting the product out there, showing physicians how great it can be for them and for their patients. She knows the traditional speculum works fine for most gynecologists. "It passes, but it's not great," says Wang. "But we're working on making it better. When you give [physicians] the option to choose a better one or a worse one, then they're going to choose the better one. But they might not know that until they get that option."
Originally seen on Wired