Powerful groups of mostly men are making major decisions about biology and bodies they know little about. Embryos in deep freeze that may never be used are just the latest example.
As a professor of biomedical design for the past 20 years, I have seen this trend increase in a seemingly exponential way since the Supreme Court’s Dobbs decision overturned Roe v. Wade, allowing states to ban abortion. And women continue to suffer from suboptimal medical care because of procedures and devices that were flawed from the start.
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When I was an engineering student in the 1990s, the prototypical human was a 154-pound man. We sat him in cars and analyzed how much impact he would feel in a crash. He was the model of a person who would sit on an operating table or be carried on a stretcher down a flight of stairs to an ambulance. Of course, this simplification was extreme, but justified, to get through undergraduate homework sets. But these kinds of oversimplifications can persist into professional design.
For example, emerging research supports the hypothesis that among people who wear durable left ventricular assist devices, which help the heart pump oxygen-rich blood to the body, worse outcomes in women are due to anatomical and physiological sex differences that weren’t considered in the original designs.
Biomedical design teams often lack the knowledge and diversity needed to adequately solve challenges in women’s health. This is, in part, a failure of training. Engineering design is typically taught as a standalone subject. There are protocols to determine product requirements and steps to follow to define design goals and metrics of success.
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Yet design is not a standalone subject. Designers bring themselves and their lived experience to the drawing board. And they can’t draw what they don’t know. Design is an iterative process of failures followed by incremental successes that lead to the final product, so siloed training and lack of diversity can dangerously limit engineers’ inquiries, data, and visions. This has been true for decades and, unfortunately, continues to be the case. Reproductive justice and autonomy won’t be possible without a revolution in biomedical design and engineering.
Design is an iterative process. And when it comes to women’s health, knowledge from past failures has not been used to inform future designs.
In the 1970s and 1980s, the Dalkon Shield — an intrauterine birth-control device invented and marketed by a two-man team and rushed to market with insufficient clinical data — harmed women for decades, causing pelvic infections, infertility, unintended pregnancies, and even deaths. After it was finally removed from the market, it took decades for other safe and effective IUDs to find widespread acceptance in the U.S. Failures like this of engineering design and of imagination continue to this day.
The Essure sterilization device was marketed as less invasive than tubal ligation. The initial device design came from an all-male team of mechanical engineers initially working on catheter design for assistive reproductive therapies.
It is not clear from the patent history whether any experts in female anatomy were consulted. After the original company filed for Chapter 11 bankruptcy, the device was marketed by a new startup and eventually acquired by Bayer. As the number of women implanted with the device grew, thousands reported side effects, including severe abdominal pain, bleeding, unintended pregnancy, and even potentially deadly ectopic pregnancies. Only after activists systematically collected these reports was Essure taken off the market in Europe in 2017, and in the U.S. in 2019. The manufacturer maintains this was a business decision, due to low sales rather than to inherent design problems.
A chart from a Johns Hopkins study routinely shows up on social media documenting that many popular sexual lubricants are hyperosmotic to vagin*l tissues, meaning they extract moisture rather than adding it. The study also documents vagin*l tissue damage at the cellular level. These products were designed for lubrication when applied, but their effects over the longer term may be the opposite. Did the designers consider the osmolality of vagin*l tissue? If they didn’t, it was a big omission.
Morcellators are surgical instruments used to remove tissue during laparoscopic surgery. When used to break up uterine fibroids (benign tumor tissue that can cause heavy menstrual bleeding and pain), these tools can spread cancer cells in some women whose fibroids concealed malignancies. Activists and the families of women who died from sudden stage 4 cancer — including Boston physician Amy Reed — lobbied the FDA to restrict morcellator use. Though the FDA put a black box warning on morcellators, these procedures continue today.
After years of studying these cases and teaching them over the past 10 years, I see certain commonalities.
First, knowledge of the female body is woefully incomplete. The very basics of many gynecological and obstetrical pathologies are still poorly understood. The causes of common conditions such as endometriosis and uterine fibroids aren’t known, and thus there are limited options to treat them. When the Dalkon Shield was invented, little was known about how big an IUD needed to be to be effective. Its centimeter-wide size and bizarre shape (like a crab with fins), and its defective removal string, suggests that the designers failed to consider cervical pain during insertion, the potential for uterine infection, and the mechanics of removal. In the small amount of premarket testing that was done, success was focused on prevention of pregnancy, while more holistic considerations, such as pain management and device removal procedures, were largely ignored.
In Hugh Davis’ 1971 book about his invention of the Dalkon Shield, he bemoans the lack of public and private funding for IUD research, stating that this “left the field largely in the hands of basem*nt inventors and a hardy band of unfunded investigators, and it is a testimonial to their ingenuity that improved IUD’s have nevertheless been contrived and tested.” Indeed.
Related:Momentum grows to subject medical devices to medicine’s gold standard — the placebo treatment
Second, designers routinely settle on suboptimal design because they assume that women, especially Black women, can endure higher levels of pain or risk than they actually can. The side effects of hormonal birth control are well known, but there has been little to no innovation to improve them. If designers prioritized reducing the sexual, lifestyle, and mood side effects of hormonal contraceptives and the short-term pain of IUD insertion, women would have better options that would find wider use.
Designers with no lived experience of gynecological pain, the anxieties of childbirth, or the stresses of avoiding pregnancy cannot properly assess the relative importance of these factors — especially when they do not even try. A painful solution might be better than no solution, but that doesn’t mean it’s good enough and designers can stop trying to improve it.
Third, regulatory and business incentives are not aligned with women’s health interests. The FDA’s 510(k) process allows medical devices originally used for something entirely different to be repurposed with little clinical testing. Morcellators are one example. Another is transvagin*l mesh, a plastic scaffold material used to correct pelvic organ prolapse. The mesh was first approved to correct abdominal hernias, and was later approved for use in gynecological surgery via the 501(k) process without significant additional testing. Women, and the medical establishment, learned the hard way that the mesh could cause urogenital complications, excessive scarring and pain, and, in some cases, could even poke out through the skin.
The term femtech has emerged as a buzzword in some circles meant to spotlight gaps in the women’s health market. Sadly, femtech is more likely to mean a period tracking app or an online pharmacy than innovative solutions in sexual and reproductive health. To make real progress, the design process must be reconceptualized, which begins by prioritizing diverse design teams.
The good news is that young women are already taking up the challenge. I talked with a startup founder Fran Wang, who is working on not just a new design for the vagin*l speculum — an instrument used in almost every pelvic exam that has undergone little change in 200 years — but a new design for the entire flow of a gynecological exam. Other groups are trying to democratize birth control and mifepristone access via telehealth, though both of these remain tenuous propositions in many places across the U.S.
A design team should include individuals from communities of intended users. Leaders need to look around the table and ask who’s not there and then actively get those voices — and bodies — into the room. One priority for achieving this goal is to increase the diversity of students being trained in engineering design. Until we get there, though, those of us at the table can make change happen now. In the earliest stages of concept building, we can ask, “Who is not here?” Is it a woman? Someone being treated for or living with cancer? Someone who has been pregnant or used birth control or needed an abortion? And then we can do a very simple thing, which is to pull out a chair.
Catherine M. Klapperich is a professor of biomedical engineering at Boston University.
