Engineering a Future for Women: The Role of Medical Device Design in Gender and Health Equity

Written by: Ilka Rodríguez-Calero, Ph.D.

Edited by: Austin Shannon and Peijin Han

In my twenties, I was put on a hormonal intrauterine device (IUD) — a safe and effective medical device — as a form of birth control (1). Soon after, I developed pelvic pain, a known side effect of the IUD. The pain, combined with other issues, could be difficult to manage, but my healthcare providers couldn’t find an underlying cause. Consequently, pain management was limited to self-care through exercise, mindfulness, and over-the-counter medications. I assumed that living with pain was the price to pay for reliable birth control.

Years later, I developed a nagging pain that was more intense than usual, though familiar enough I dismissed it at first. After a few weeks, I decided to get my symptoms checked. At that point, my provider said, “I wish you had come earlier, but I’m glad you’re here and we’re going to take care of it.” I was confused. Had I not anxiously asked if my pain was normal at every opportunity during the first year with the IUD?

Shortly after that visit, I decided I wanted to have the IUD removed. Hormonal IUDs can last 3 to 8 years, depending on the device. Because IUD removal per the manufacturer was not yet due – and despite what I had just experienced – my provider insisted there was no reason to remove the IUD, a recommendation consistent with available evidence. It took three separate and desperate requests for my provider to accept my choice to have the IUD removed early. At the time, I delved into the academic literature, which I knew how to do as a Ph.D. candidate with experience in medical device design. I was surprised to find an overwhelming absence of studies describing relationships between IUDs and patient-reported experiences like pelvic pain and irregular bleeding, particularly as these can vary so widely in intensity.

Medical devices encompass machines, implants, software, and other artifacts intended to be used for medical purposes, making them indispensable tools for advancing individual and population health (2). From a tongue depressor to a mechanical ventilator, medical devices are constantly and directly involved in patient experiences, and engineers are engaged at all stages of their lifecycle. However, when things go wrong, the limited evidence available for women like me can be leveraged to deny us agency as patients and to dismiss experiences or symptoms that are not thoroughly understood. This individual experience mirrors broader patterns about who is given a voice in medical device safety and decision-making: the input of patients holds less weight than input from researchers and manufacturers in regulatory decision-making (3), which drives much of medical device innovation. Therefore, many engineering solutions have failed women, putting us at higher risk of harm, contributing to marginalization, and exacerbating health inequities.

Medical device design falls short on meeting the needs of women

Engaging with stakeholders — patients, physicians, nurses, and others who impact and are impacted by design outcomes — is critical if a medical device is to be safely used. Engineering solutions benefit from stakeholder input if they are to define product requirements that correspond to user needs. Medical device manufacturers are expected to perform user needs analyses, human factors evaluations, and field trials consistent with regulatory guidance by the Food and Drug Administration (FDA). Even so, engineers have articulated barriers to engaging with stakeholders, which include: managing conflicting opinions among users, balancing product development and regulatory timelines, and navigating implicit norms regarding who within a company has access to these stakeholders (4). Further, the lack of systems and processes for integrating user input in design decisions can lead to technically sound products that inadequately address user needs (5).

One formal mechanism for user engagement in medical device design is clinical trials. However, trials are limited, as they are conducted after most design decisions have been made. Until recently, scientists avoided using female rodents in animal studies (6, 7) which often preclude studies with human subjects. And while progress has been made towards the inclusion of women in research, it has not been sufficient to address gender disparities in health outcomes (8). When examining the burden of disease – the quantified impact of a health issue – women are underrepresented in clinical trials in areas such as oncology, neurology, cardiology, and pediatrics (9). This same study also highlights types of clinical trials, including musculoskeletal disease and trauma, in which men are underrepresented relative to how these conditions collectively impact them. Therefore, collecting data separated by sex and gender in clinical trials may improve women’s health outcomes and address clinical needs across genders.

The range of women’s unmet clinical needs is difficult to define due to the gender data gap, although there are salient examples. Caroline Criado Perez, author of Invisible Women, defines the gender data gap as the absence of women and women’s roles throughout the biological and cultural evolution of humanity. One example of the gender data gap’s impact in medical device design is that women are more likely to suffer complications after receiving cardiac implantable electronic devices like pacemakers (10). Heart disease is the leading cause of death in both women and men (11), but some implantable devices used to treat heart disease differ in performance by sex (12). The gender data gap also extends to surgeons themselves. Surgical instruments are typically designed for male surgeons (13), which can result in workplace hazards to women. Adapting to bed heights designed for taller people by performing surgery standing on benches and body aches due to other mismatched device ergonomics are just two hazards women surgeons face (14). Due to historical and sociocultural factors, it would not be surprising to find the impact of the gender data gap in medical devices in other specialties too.

Engineering’s technology-centric ethos has social costs

Despite these gender gaps, engineering solutions have enormously benefited large portions of society. Global life expectancy has increased over the past 20 years (15). Appropriate medical devices certainly have an important role in promoting health by assisting in the diagnosis, monitoring, and treatment of illness. However, engineering design work is deeply intertwined with the state of scientific research (16), including the lack of prioritization of women’s needs and safety. Research funding from the National Institutes of Health (NIH) is awarded least often to early-career obstetrics and gynecological (OBGYN) researchers compared to other major specialties (17). Unsurprisingly, knowledge about conditions like endometriosis, fibroids, and polycystic ovarian syndrome is sparse, as are their interventions. Shockingly, one study found that the evidence used to approve high-risk OBGYN medical devices was
deficient even for the most strictly regulated devices, sometimes leading to recalls due to safety concerns (18). Beyond gynecological and reproductive health, basic research on diseases that disproportionately affect women tends to be underfunded, and diseases predominantly affecting men tend to be overfunded (19). Our inadequate understanding of how women are affected by health conditions may lead to more medical device failures in women. In fact, in 2019, failures of post-market devices — devices being used by patients — were found to disproportionately impact women, who made up 67% of over 300,000 examined injury and death reports submitted to the FDA (20).

Engineering fields have not traditionally focused on the social, political, and cultural contexts of engineering work. Interrogating problems like inequality is typically considered beyond the scope of engineering design practice. Further, some engineering codes of ethics state that engineers must remain impartial (21). Impartiality, which refers to equal treatment of all parties involved, assumes that all members of society have equal standing and enjoy the same benefits and privileges. This is verifiably untrue. By applying an impartiality lens to problems that disproportionately and negatively impact women, particularly women with multiple marginalized identities, engineers may be inadvertently contributing to a system structured to amplify inequities and experiences of marginalization.

More equitable solutions can emerge with an inclusive design lens

Individual solutions cannot and will not single-handedly address the systemic, deeply interconnected nature of problems underpinning the inequitable risks and benefits of medical device innovation. However, individual and collective action can certainly begin to make a difference.

Policy solutions: regulations and research funding changes

The FDA’s Centers for Devices and Radiological Health, which regulates medical devices, has put together a strategic plan outlining priorities to protect the health of all women (22). Meeting these goals will require a collective effort from scientists, clinicians, regulators, engineers, marketers, patients, and advocates. In addition, the FDA has established processes for public participation, including petitions and public comments on proposed rules. Their website (23) has instructions on how to provide input about the way the agency regulates medical devices. Comments and petitions may require extensive preparation with scientific and legal rationale, which creates a substantial barrier for non-technical audiences to participate. However, the public deserves to know how their government makes decisions and how they might participate in such processes, including processes to strengthen regulatory frameworks in matters of women’s safety.

There is no shortage of calls to action for increased research funding for health conditions that predominantly affect women, which surely will inform device design activities, and, importantly, help address the documented medical device performance differences by sex and gender. Government stakeholders recognize that health conditions which mostly impact women or manifest differently in women have been historically understudied, as evidenced by biennial reports published by the National Institutes of Health Office of Women’s Health Research (24) and a 2022 bill introduced in the U.S. Senate specifically seeking “to close persistent gaps in funding for sex- and gender-based biomedical research” (25). Some analyses suggest that increasing research funding in some areas of women’s health may result in slight health improvements that, in turn, have dramatic quality of life benefits for women and reduce disease-associated costs (26). Continued advocacy will be necessary until research funding is more equitably distributed across genders relative to the corresponding impact of different health conditions.

Industry efforts: devices designed for and by women

The market size for technology-enabled and consumer-centric women’s health products and solutions — FemTech — is between $500 million to $1 billion USD, according to some estimates. There has been increased entrepreneurial activity in FemTech over the last decade, with new startups and investment opportunities emerging every year (27). The increased interest could be an unprecedented opportunity to address historically neglected health needs of women. However, FemTech might not ultimately address the most pressing women’s health challenges because so many of these challenges are not simply technological (28). FemTech startups present substantial shifts in who gets to innovate. Women account for only 21% of executives in large medical device companies, although they make up 40% of the industry’s workforce (29). Further, the engineering workforce more generally — the people who design, build, and test devices —tends to favor people who already hold relative privilege in society due to gender, race, socioeconomic status, and disability (30). However, a report by McKinsey & Company highlights a promising demographic shift in the distribution of FemTech leadership: among the FemTech startups analyzed, 70% had a female leader, in contrast to a 20% female leadership norm for new startups more broadly (27). Highlighting these patterns is not meant to demonstrate a causal path or a solution. Instead, this is meant to illustrate a complex dynamic: the people who make decisions regarding whether engineering solutions can equitably fulfill benefits and mitigate risks are not always the ones closest to the problem.

Innovator decisions: recognizing sociotechnical aspects of problems

Medical devices are defined by their intended use, users, and use environments. These have largely reflected the preferences, priorities, and needs of people who historically held the power to make design, financial, and regulatory decisions. Within those bounds, it is critical that innovators engage in a reflective practice. When deciding on the intended use, users, and environments, innovators can adopt an inclusive design approach by asking, “Who is excluded?” Recognizing and making exclusion visible is the first step to mitigating it (31) — how can someone design for a problem that “doesn’t exist?” By determining who is excluded, innovators can engage typically excluded stakeholders in design decisions and outcomes along gender, racial, and socioeconomic lines.

Technology on its own will not provide incremental benefits to society, but interventions that recognize and address exclusion might help fulfill that promise. To build futures in which the health and well-being benefits of engineering solutions are equitably distributed across women with diverse intersectional identities, engineers must engage with both the technical and the social dimensions of problems, which are often overlooked. That needs to change. To this end, design frameworks that are people-, community-, and equity-centric can support engineers and innovators in considering people and their contexts when implementing engineering solutions.

Towards more equitable futures in medical device innovation

If we do this right, patients’ lived experiences will inform safe and effective medical devices in the future. We will be able to address, rectify, and repair the harms associated with the known absences of women in biomedical research and medical device design. If we do this right, women’s healthcare experiences will be better understood and appropriately addressed, as absence of evidence will be increasingly harder to use as evidence of absence. If we do this right, medical device design processes and the professional fields that support them will be equipped to respond to the needs of people whom these devices serve, as innovation will be driven by meaningful and equitable stakeholder engagement. Collective and individual efforts will make a difference in how devices are designed, developed, regulated, and distributed such that protecting the health and safety of women has rippling impacts on the overall population’s health. If we do this right, more equitable futures can be possible.

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