Two startups bridging the innovation gap in women’s healthcare
Imagine that there was a simple medical device that nearly half the country’s population encountered on a regular basis—but most disliked or downright hated it.
Now imagine that the design of this device was largely unchanged since it was first introduced almost 150 years ago.
It might seem strange that something so universally disliked hasn’t been redesigned or significantly improved upon, but it’s true: the device is the speculum, used in thousands of gynecological examinations every day. Hold a modern-day speculum up next to an antique version from 100+ years ago, and the design is almost identical, save for updated materials and hardware.
Now imagine another device, which serves a critical role in supporting recovery from pelvic organ prolapse, which affects 50% of women over the age of 50. This device too has improved hardly at all since the modern version was introduced in 1934, and other than the materials used, present day devices look and work very much like early ones dating back to Ancient Egypt.
This is the pessary, used by millions, and plagued with design problems that make it difficult and often painful to insert and remove. Both the pessary and speculum are in dire need of an update, both are used widely, and both are exclusive to women’s health.
Now contrast this with the leaps and bounds by which other medical technologies have advanced. Robot-assisted surgery, nearly unheard of 30 years ago, is now common. Highly targeted and effective pharmaceuticals are invented at a dizzying pace. Genomic sequencing has transformed the way we treat everything from cancer to neurologic disease.
Bringing healthcare innovation to underserved groups has long been a focus at Smart. We’ve been developing products and services for more than two decades, but we specifically seek out projects that help to close the healthcare gap. Our work with the nonprofit Upstream USA, for example, helps give women more agency around birth control and pregnancy; for Belgian pharma group UCB, we redesigned the medical syringe to make self-injection easier for rheumatoid arthritis sufferers. We’ve also convened three high-profile salons to shed light on unmet challenges in healthcare.
Recently, our attention has been drawn specifically to the speculum and the pessary, because they’re finally getting the design attention they deserve. Ceek and Reia are both small, woman-led start-ups, founded with the express purpose of bringing innovation to the women’s healthcare space—starting with these two neglected devices.
With the Nella, Ceek has created a redesigned speculum that’s more human-centered, accommodating the needs of both patients and the medical professionals who perform examinations. Reia, co-founded by a former Smart engineer, has designed a new kind of pessary that’s proven itself in trials to be easier to insert, more comfortable to wear, and easier to remove than anything currently on the market, without losing effectiveness.
Given the unique challenges and opportunities of design in the women’s healthcare space, Smart recently sat down with both companies to get a closer look.
Meet Ceek Women’s Health
Fahti Khosrowshahi started Ceek Women’s Health in 2018 after going through several rounds of IVF and fertility treatments, which require frequent exams that often involve a speculum. A 15-year veteran of the healthcare and pharmaceutical industries, Khosrowshahi was struck by the device’s shortcomings, especially considering how widely it’s used.
“I think a lot of clinicians feel it’s less about the product, and more about the care they provide,” she explains, “and the speculum is such a small portion of the exam that ‘women can deal with it’…you go for your exam once a year.” Her own experience with IVF showed how wrong that view was for many women, and upon further research, she discovered wide-ranging discontent with its design, both among patients and examiners.
“Every year we do a blind survey of 1000 to 5000 women to get feedback…and I was blown away when I saw the data the first time. More than 90% of women know what a speculum is, and over 80% of them don’t like it,” she says.
The century-old design had much to do with it: its made from cold, uncomfortable stainless steel, poor lighting makes examination awkward, and the mechanical clicking sound it makes during adjustment causes anxiety for patients. Updated designs, made from acrylic or with integrated lighting, each had shortfalls that limited adoption. The traditional speculum shape is also poorly optimized, requiring examiners to keep a range of sizes on hand, and often causing lasting pain for patients.
All of these observations defined a clear set of requirements for the Ceek design team. It had to be as narrow as possible, it had to be non-metal, and it had to be quiet. It should also include integrated lighting, and be easy to sterilize—another issue with existing models, which must be unscrewed and then reassembled each use.
The design team got plenty of latitude within those constraints though, leading to multiple rounds of exploration and prototyping. Different shapes and materials were tried out and tested. Inflatable versions, for example, were flexible and comfortable but noisy and difficult to use.
Fortunately, they had plenty of expert guidance. “I had a really passionate group of clinicians working with us…and they were fantastic in sharing feedback, and that’s how the portfolio was developed,” explains Khosrowshahi. “They were very critical, about everything from understanding how the speculum should fit both men’s and women’s hands, the angle of the speculum, everything! There were some heated conversations and I cannot tell you how many prototypes we did.”
Because they were redesigning an existing device, the Ceek team products are Class 2 510(k) exempt, so no FDA approval was required. So the Nella, along with the VuLight lighting attachment, are both currently in use by real-world practitioners, and response has been enthusiastic: “We’ve had a few patients reach out and say they wanted to be spokespersons for the brand,” says Khosrowshahi, “and feedback from the clinicians has been really positive.”
Despite this, the NuSpec faces several hurdles to widespread adoption. The existing speculum, as unpopular as it is, has become a fixture in American gynecology, and with most women encountering once a year or less, there’s little explicit demand to replace it. It’s also somewhat more expensive than a traditional speculum. The result is a situation that many agree needs improving, but few are motivated to change.
While the NuSpec was sparked by the personal experiences of one founder, Reia started life as a school project. Meegan Daigler, Kaitlin Maier, and Ariana Sopher met as engineering students at Dartmouth, and initially picked the pessary as a relatively simple but widely used product that could benefit from redesign. Delving into its history and talking with users, they realized how outdated its design was, and how poorly it served many women.
At its most basic, a pessary simply occupies space inside the vagina to provide support for the organs in the pelvic region. It plays an important role in treating incontinence and pelvic organ prolapse, a common but little-discussed condition in which organs shift internally, and place pressure on the vagina. Because of this, there’ve been versions of the pessary in use for over 2000 years, in materials ranging from cork and wool to brass and steel (the first known pessary was actually a pomegranate).
But like the speculum, modern pessaries are largely unchanged since the early 20th century, other than the material being upgraded to medical silicone. And the two most common options—the ring pessary and the Gellhorn—are notoriously difficult to insert and remove, leaving women unable to take them out without a clinician’s help.
“People lose control of this aspect of their life when they have to use a pessary,” says Daigler, “And in addition, it’s pretty uncomfortable to insert and remove. Another consequence is when people wear them for long periods of time without breaks—which is what happens if you can’t take it out yourself—that can cause tissue erosion. Those are the interrelated problems that we were trying to solve.”
Daigler, Maier and Sopher took on the pessary redesign as an independent study project. After graduating in 2015, the trio co-founded Reia Health along with Paul Hanissian, a urogynecologist at Dartmouth, with the goal of bringing to market the first truly improved pessary in decades; in 2019, the startup earned its first round of grant funding. Daigler, meanwhile, took a position as a Design Engineer at Smart, where she worked for five years before leaving to join Reia full time, bringing with her an abundance of experience applying user-centered design approaches to real world problems.
For a one-piece silicone object, getting the Reia pessary’s shape and material right took an enormous amount of trial, error, and analysis. The design the team finally arrived at, and patented, is marvelous in its elegance and deceptive simplicity. A rounded “double umbrella” shape allows the Reia pessary to collapse for insertion, then expand once beyond the pelvic floor muscles. Pulling on the underside makes it possible to re-collapse for removal, while still maintaining enough stiffness while open to support descending organs.
The right balance of stiffness and removability means the Reia design could potentially take the place of both the ring and the Gellhorn pessary. It also fulfills another key requirement: price. Insurance companies have set limits on how much they’re willing to cover for different medical devices, and pessaries are generally set at $55—so this constraint was built into the design process from the outset.
To make it as accessible as possible, the Reia team also designed an optional applicator for their pessary, for patients with reduced physical strength or dexterity. As Maier explains, “We found that practitioners might not necessarily prefer the applicator, because they have a different vantage point during insertion. So we wanted to design something that could be used easily by both patients and practitioners…the applicator is definitely an improvement, because it’s now possible to use it both ways.”
Currently in Premarket Approval (PMA) status, the Reia pessary and applicator face a long and rigorous FDA process to reach full approval, and numerous rounds of clinical trials.
Bridging the innovation gap
As startups focused on women’s healthcare devices, Ceek and Reia faced several challenges in common, beginning with attracting initial investment. In almost any category, investors tend to favor high-profile products with the potential for massive revenue and rapid scaling. And while the speculum and pessary are used by hundreds of millions of people, they lack the widespread recognition and large margins of surgical procedures or pharmaceuticals. This points to a structural issue that limits healthcare innovation in the US for “everyday” devices.
But healthcare innovation that’s specific to women faces an additional challenge, in a decades-long gap in research and insight. For much of the 20th century, medical research and trials often skewed male, leaving practitioners with an incomplete picture of how many conditions affected women.
Even today, anything pertaining to women’s reproductive or sexual health tends to attract less attention than “safer” topics. Breast cancer, for example, is now a high-profile concern thanks to years of public outreach, but menstruation, menopause, sexual health and vaginal prolapse still lag in awareness and investigation. These are topics that for most of modern history could only be discussed in the abstract, shrouded in euphemisms like “time of the month”, “life change” or “marital relations”—if they were discussed at all. While cultural attitudes gradually adjust in much of the world, the effects will linger for decades.
This creates an imperative, and an opportunity, to focus innovation and research efforts on women’s healthcare right now. Ceek and Reia have made tremendous improvements in products that could eventually improve quality of life for hundreds of millions of women, by simply applying good design principles. Conducting user research and looking at an experience from the user’s point of view often makes challenges and design flaws obvious, and can imply potential solutions. In the case of medical devices, making the experience better for practitioners is a critical part of the solution too.
The pessary and speculum impact just a tiny fraction of the women’s healthcare experience, leaving numerous opportunities for improvement. This is why Smart is committed to stepping up our efforts in this category: not only can we help close the innovation gap, we can also demonstrate first-hand how close attention to user experience can transform the lives of millions for the better.
It’s critical to tell and share the stories of companies like Ceek and Reia. The work they’re doing is difficult and full of obstacles, but it’s necessary and long overdue.
About Rose Bloomberg, Senior Program Manager
Rose Bloomberg is a senior program manager who believes design can improve everyday experiences. She brings expertise in project and client management and has worked across the housewares, beauty, consumer goods, and healthcare sectors. Her notable clients include OXO, L’Oreal, and SC Johnson. She holds a BFA from the University of Georgia. In her free time, you can find her experimenting with new recipes to cook in her tiny Brooklyn kitchen.
About Vasily Romanov, Senior Design Engineer
Vasily Romanov is a senior design engineer who strives to make the world a better place through good design and engineering. He brings expertise in product development and design for manufacturing to his clients and has applied his skills across the medical device, pharma, manufacturing, and consumer product industries. His notable clients include DJO Surgical, Stryker, and Beckton Dickinson, and has lectured as a part-time adjunct at the New Jersey Institute of Technology. He holds a master’s degree from Temple University. In his free time, he enjoys hanging out with his son, woodworking, and doing his own car and motorcycle maintenance.