Building protection against unintended pregnancy and HIV

Condoms offer contraception and protection against HIV in one inexpensive, simple-to-use package. But the most commonly used condoms worldwide are male condoms, which means women who want to use this method depend entirely on their partners’ cooperation.

A female condom equalizes control by a small but significant amount. Unfortunately, the currently available female condoms are more expensive than male condoms (they cost ten times as much!) and can be less comfortable and more difficult to use.

In 1996, two PATH employees who were working together on new reproductive health technologies came up with an exciting idea: What if PATH could refine the female condom, with the cooperation of women and their partners, and come up with a design that would be easy to use, affordable, and as or more comfortable than a male condom? The brainstorming sessions that followed brought PATH’s reproductive health and technology experts together on “Project Orchid”—the first incarnation of the Woman’s Condom project, dedicated to producing a female condom that would serve women better through a user-driven design.

Why a new condom?

Cost is not the only factor that restricts developing-world use of the female condoms that are already on the market. As we started to research the problem, we realized that women wanted a number of things that they weren’t getting. They wanted a female condom that was easier to insert, use, and remove; that was more stable, so they didn’t have to worry that it would be dislodged or move out of place during use; that was more comfortable for both partners (in particular, less noisy); that interfered less with sensation.

Going to the source

To achieve a truly user-driven product design meant establishing testing sites around the world with populations that varied widely in physical and cultural needs. We gathered input from couples in Khon Kaen, Thailand; Cuernavaca, Mexico; Durban, South Africa; and Seattle throughout the design process. Our researchers observed clinical fittings of prototype condoms and interviewed the couples to find out how they responded to each new design.

The birth of the final design came after more than four years of hard work—spent in assessment, research and development of new materials, and evaluation of hundreds of prototypes. By the end, we had developed and tested more than 50 design generations in more than 300 unique prototypes. It was a stark contrast to the energy of the original brainstorming session—where anything seemed possible. But the result was a female condom that is easy to insert and remove, is very stable during sex, and feels good for both partners.

What did we change?

The most widely available female condom is shaped like an oversized male condom, with a semiflexible ring at the open end that rests outside the woman’s body and a loose ring inside that helps with insertion and holds the condom in place.

We refined the material from which the condom is made until we had something much softer and thinner, which got high marks from female testers. The inner ring was painful for some women, so we replaced it with four small dots of soft, absorbent foam. These foam dots adhere gently to the interior of the vagina, holding the condom securely in place during use and releasing easily from the vaginal walls on removal. To make insertion easier, we added a rounded cap to the end of the condom, which gathers the condom pouch together until after insertion. Once the condom is inserted, the tip quickly dissolves (in less than a minute, for most women).

From the lab to the market

After extensive evaluation and testing, the Woman’s Condom is ready for a combined Phase 2/3 clinical trial, the last step before US Food and Drug Administration approval. But while approval is the last step in design, it’s only the first step in making the condom available to women in the developing world—which requires finding a manufacturer and making the condom affordable.

PATH has spent more than a year designing and building machines that can manufacture thousands of these condoms, in the process solving some critical technical problems in production. Our new pilot production line, already up and running, is a significant cost-saver for potential manufacturers—bringing us closer to making the final price of the condom affordable to families with little money and many competing needs.

Photo: Glenn Austin.