Novel Vaginal Speculum for Decreased Patient Pain and Enhanced Provider Functionality in Outpatient Reproductive Care

Abstract The vaginal speculum is an essential tool in gynecology that has a role in almost every procedure or exam in an outpatient setting. Traditional speculums have significant failings, such as patient pain and discomfort during use. Additionally, limitations for providers can cause procedures to be challenging and potentially more uncomfortable for the patient, especially patients with complicating factors such as obesity or existing conditions. Out of fear or anxiety of pain and discomfort, patients avoid seeking out care, especially those marginalized by prior history of trauma, sexuality, and race or ethnicity. Yona Care is developing a speculum that decreases patient pain and discomfort. For providers, the Yona speculum improves functionality with better field of view, greater tool access, and streamlined operation, all of which flatten the learning curve. Within the scope of work funded by an NIH SBIR grant, the Yona team will use a human-centered engineering process to develop and assess the speculum against user-driven emotional and performance objectives. During the engineering portions, the team will optimize the form and range of motion to minimize patient discomfort and maximize provider field of view, as well as develop lighting, locking, and material decisions. Prototypes will then be created to conduct bench testing to evaluate the engineering, including using pressure distribution as a proxy for pain. During the research portion, Yona’s clinical partner will invite patients and providers to handle and interact with the models in an interview setting to assess the impact that the Yona speculum would have on patient behavior and provider workflow. By developing a tool that improves the patient experience and augments the capabilities of the provider, the speculum can reduce the challenges and barriers to long term care outcomes, access, and adherence. In the US alone, roughly 69.4 million speculum exams are performed each year. At the individual level, an average patient may experience over 30 speculum exams or procedures in their lifetime, each of which has an unquantifiable emotional impact. For these patients, each interaction with a speculum could determine whether they actively seek out care in the future or if they allow fear, anxiety, and avoidance to shape their relationship to reproductive health. Patients who have fear and anxiety of the pain and discomfort of a speculum may avoid preventative care that could reveal treatable conditions, delay treatment when they are ill or experiencing abnormal symptoms, or make life-changing decisions about reproductive care based on pain-avoidance behavior rather than their actual needs. By improving the speculum, Yona Care can positively impact the health and experience of each individual who requires speculum-based care and can affect positive change at the public health level by reducing barriers, encouraging care adherence/seeking behavior, and mitigating the financial, resource, and wellness costs of delayed or avoided care.