SBIR Phase I: Novel Gynecological Speculum Instrument for Decreased Patient Pain and Enhanced Provider Functionality

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel design approach for the gynecological speculum, a common instrument used for diagnostic exams and treatment procedures. Each year in the US, over 69.4 million speculum exams and procedures are performed with 40% of first-time patients reporting pain and 60% reporting anxiety. Common issues include pain, discomfort, and other factors that can result in potential trauma and stress. These factors deter patients from seeking out and adhering to care. This project utilizes human factors and ergonomic science for a differentiated form factor that aims to improve diagnostic accuracy, improve care processes and outcomes, and reduce barriers leading to long term care adherence for an instrument with a $462 million annual market. This Small Business Innovation Research (SBIR) Phase I project seeks to develop a 3-leafed gynecological speculum offering a broader, unencumbered field of view for the provider while reducing pressure on sensitive tissues for the patient. The novel instrument design redistributes and reduces pressure against the walls to enable better provider visualization of internal cavity organs and improving the patient’s exam experience. This project includes advancing the design engineering and iterative prototyping which will then be validated using a combination of a benchtop anatomical model, instrumented prototypes, and user feedback with objective human factors endpoints. The specific aspects are to 1) evaluate and optimize the opening angle and shape of the upper leaves to maximize field of view and evenly distribute applied pressure to the tissue walls upon dilation, 2) conduct testing on the integration of lighting and locking elements, and 3) optimize material selection and design of the silicone sheathing. The objective of Phase I is an optimized opening angle and form factor that addresses patient pain and provider field of view, ergonomically qualified locking and lighting for provider efficacy, and selection of most suitable materials for a final prototype. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.