Self-taught moldmaker develops first-of-its-kind medical device

Some people famously started a business in their garage—you've seen the commercial. For Jennifer Davagian Ensign, founder and CEO of Cristcot Inc. (Concord, MA), it all began in her kitchen, but her invention has nothing to do with cuisine. Au contraire. Using a Smooth-On silicone moldmaking kit, sundry parts from local hardware stores, and her oven, Ensign taught herself the fundamentals of molding and, this month, brought to market—trigger warning, this may cause some of you to wince—Sephure, a disposable suppository applicator. Her journey is a textbook example of developing a product for an unmet need that has the potential to achieve huge commercial success and improve peoples' lives. On the latter point, Ensign should know. She experienced it firsthand.

Ensign was diagnosed with inflammatory bowel disease more than 20 years ago. She was hospitalized about seven years ago and was prescribed rectal suppository medication. Taking the medication involved lying on the floor for 30 to 45 minutes twice a day, inserting the suppository while fighting the urge to expel it, and wearing protective undergarments to deal with the inevitable leakage. She did what most of us would do under the circumstances—she stopped the treatment—with predictable results, and landed in intensive care one year later. Leaving the hospital the second time, she vowed to take her medication as prescribed, but she also decided to find a better way to administer it. That's where the kitchen comes in.

A master seamstress by trade, "I have intuitive knowledge about how things are put together," Ensign told PlasticsToday. She set about designing a suppository applicator that would take the sting out of administering the medication and, in the process, improve patient compliance.

As would any budding inventor, she first went into the field to see if any existing products could be adapted, and seemingly there were. But the "problem with applicators for women," she explains, "is that they do not allow air to escape the body." Designing an applicator that applied Boyle's law of physics would be the solution.

"I taught myself silicone molding in the kitchen by watching YouTube videos. I bought Smooth-On and some supplies in the local hardware store, such as tubing used for freezer water lines, and started experimenting. As you may imagine, I don't have a vacuum hood in the kitchen to aid with the silicone molding process, but I found some creative ways to prevent air bubbles from forming," explains Ensign. "I heated molds in the kitchen oven to speed the curing process of the plastic, but this placed added stress on the molds. Eventually I struck a rhythm of creating new silicone molds and manufacturing parts for personal use. Sundays were manufacturing day, and for 2 1/2 years, every Sunday, I would mold applicators for my personal needs." Her invention enabled her to reduce administration time from 45 minutes to less than five seconds and eliminated the need for protective underwear. It was time to bring this device to the masses.

Ensign collaborated with an engineer to design a full prototype mold for manufacturing that could be used in an ISO 13485–certified facility. She settled on low-density polyethylene as the material for the device because of its long history of safe use in medical devices.

Today, several production molds later, Sephure is commercially available. In addition to engineering assistance in developing the mold and readying the device for manufacture, Ensign received assistance from the Massachusetts Life Sciences Center (MLSC), which awarded her an accelerator loan, and, perhaps surprisingly, FDA.

"The accelerator loan from MLSC was very helpful," says Ensign. "Getting a loan is a very competitive process, but they liked our design and the potential of the product to affect the lives of so many people." (Initiated in 2008 by Massachusetts Governor Deval Patrick, the Life Sciences Initiative, which is administered by the MLSC, is committed to spending $1 billion in tax dollars in 10 years to support the in-state life sciences industry and attract third-party investments. PlasticsToday reported on the program in an article devoted to Massachusetts' medtech hub.)

Ensign also has only kind words for FDA, which many in the medical device space see as more of a hindrance than enabler in getting innovative products to market. "This is a Class I device, but since it has no predicate—it's the first disposable rectal applicator approved by FDA—the application was challenging. The chief gastroenterologist at the agency was very helpful in drafting the application, and I found the whole experience to be very collaborative," says Ensign.

When it came time to scale up production of the device, Ensign had no trouble finding a manufacturing partner. "We are privileged to be in Massachusetts, which has such a tremendous healthcare focus, and we had no problem finding a qualified molder, IP expert, and so forth." Finding a qualified plastics supplier was another matter, however. "They tend to be reluctant in getting involved with a first-in-the-world device. But we navigated through that about three years ago, did the testing, put together the master drug file for the plastic, which we hold, and commenced full-scale manufacturing about four weeks ago."

Ensign believes strongly that her invention will achieve commercial success, simply because it responds to an unmet need that people are reluctant to talk about. "When I began to share my story," she recounts, "it was difficult talking about something so private in a public forum. The response I received was overwhelming. The fact of the matter is that it's an uncomfortable topic, and most patients are suffering in silence."

The potential patient pool is substantial. Suppositories are frequently prescribed in countries around the world—11 billion suppositories are sold worldwide each year, says Ensign. Even in the United States, where the use of suppositories is not as generalized, "one in three people will deal with hemorrhoids at some point in their lives, and suppositories are the first line of defense," she notes.

— Norbert Sparrow

Norbert Sparrow is Senior Editor at PlasticsToday. Follow him on twitter @norbertcsparrow and Google+.