Design History of the SILCS Diaphragm
The SILCS Diaphragm is a single-size contraceptive barrier designed to fit a broad range of women. Over ten years, PATH and its partners led a user-centered design process involving input from women, their partners, and health care providers from five countries. This feedback ensured that comfort, ease of handling, and acceptability were built into the device from the beginning.
Why a new diaphragm?
The SILCS user-centered development process began by identifying a need—women wanted access to contraceptive methods under their control that were nonhormonal, and had few side effects. Diaphragms seem to fit this description, but they have not been widely promoted in recent decades and are unavailable in developing-country family planning programs.
Therefore, PATH embarked on a design and development effort to redesign the diaphragm to better fit user needs. We set out to work with women’s groups, health care providers, and donor agencies to identify features and characteristics they wanted to see in an improved diaphragm. Women wanted a more comfortable device that was easier to handle, insert, and remove. Traditional diaphragms come in many sizes, and a trained health care provider is needed to conduct a pelvic exam to assess which size device best fits the woman. We found that donors and health care providers wanted a single-size device that would be easier to provide, stock, and supply to reduce barriers to access. This eventually could allow the product to be delivered outside the clinic setting. These performance objectives set the benchmark against which prototype SILCS designs were evaluated by users.
Iterative design process
In conjunction with our research partner CONRAD and with funding from USAID, PATH tested prototypes at multiple sites in the United States. Women and their partners evaluated prototypes through an iterative process. Our researchers observed clinical fittings of prototype diaphragms and interviewed the couples to find out how they respond to each new design. In the end, PATH and its partners developed approximately 200 prototype designs spanning six device generations.
Once users indicated that the features and materials had a strong likelihood of meeting their needs, PATH froze design development. The design was then verified in clinical studies by couples in the United States, the Dominican Republic, Thailand, and South Africa. Researchers in Zimbabwe subsequently evaluated SILCS and two other cervical barriers for acceptability and use among young women, and found that SILCS was preferable.
The final design
Through this user-centered design process, women and their partners were active agents developing a diaphragm that better speaks to their varied needs and desires. The result is a device with several features that allow it to be easy to insert, comfortable to wear, and easy to remove. The contoured shape allows this single-size device to fit a broad range of women.