Last month, MedCity News featured Materna Medical as a medical device company designing a product to prevent pelvic floor damage to a mother, while minimizing vaginal tearing, shortening labor and delivery and reducing stress on a baby as it’s being delivered. While many liked the story on Facebook, many women took to our comments section and the blogosphere to voice disdain and skepticism toward the medical device technology. It’s not the first time Materna CEO Mark Juravic has heard this sort of negative feedback from women who are advocates of natural birth. Their concerns prompted this follow-up with Juravic.
Concern No.1: Over-medicalization of a natural process: You want to shorten labor by how much?
Juravic said the group that is skeptical of the device “generally tends to feel childbirth should be as natural as possible.” Many skeptics of the device want birth to be as natural as possible and less medicalized, and Juravic agrees to some extent. The goal would be to decrease the amount of instruments used during labor, not just add one more, Juravic said, as well as lowering need for a C-section.
Though the device is inserted for an hour during the first stage of labor, it doesn’t affect the speed of the first phase. It stretches the tissue around the vaginal canal; it never touches the cervix.
“(The baby) stretches that tissue around the vaginal canal from about 2.6 cm to about 9 or 10 cm in the course of seconds or minutes, and that is the tissue that we’re intending to stretch for about an hour.”
The device can be inserted for an hour any time during that first stage after the cervix has dilated 5 or 6 cm and can be used at intervals. For instance, it could be inserted for 15 minutes, taken out and the mother could walk around, then be re-inserted for more stretching, Juravic said. The first stage of labor could go on for several hours after the use of the device is over.
Therefore, it only would speed up the second phase of labor–the actual delivery–because the baby’s head wouldn’t need to stretch that vaginal tissue on its way out. It’s this slow stretching that Juravic said could reduce pelvic floor damage, and its unfortunate effects, such as prolapse and incontinence. This kind of damage, which can’t be seen, is what Juravic said, sometimes is considered “the cost of childbirth and we don’t think this needs to keep happening.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Most skeptics don’t take that into account,” he added.
Currently, because they are in the process of collecting data, they’ve only tested the device on women who’ve been given epidurals as a control group. A few of the women actually fell asleep during the study. “The women had been laboring for some time and were quite relieved when the epidural kicked in, that is why they sometimes fell asleep. The point being that our device wasn’t uncomfortable and was acceptable for those patients,” Juravic said in an e-mail.
Yet in time, Juravic said, the epidural may not be necessary. “We don’t want to marry ourselves to epidural. There are ways we could use the device on women who don’t use epidurals.” This could include applying a local anesthetic, lowering the force or changing the timing of use, he said. But for right now, the company is just trying to prove clinical merit.
“Our initial trial was a pilot study to learn more about the design features required for our device, learn more about successful dilation protocols and learn more about the clinical acceptability of the device,” he said in an e-mail.
“Some view our device as a more effective means of perenial massage,” he said. (For more on the evidence that supports perenial massage, click here. Right now, there’s not a lot of clinical data.)
However, perenial massage doesn’t require an epidural or anesthetic.
Though a marketing plan may be far-off, Juravic said clinical data would do much of the marketing for the device, as well as help doctors talk to patients about the device.
Its use would need to be a conversation a mother has with a doctor or midwife as a part of her birthing plan, Juravic said. (Though homebirthing is growing in the U.S., homebirths still present less than one percent of all births in the country.)
Ultimately, the device isn’t for everyone. Yet, he said, early feedback shows many women are interested in the device.
Concern No.2: Where are the women in device development?
“It would be very foolish for us not to get the opinions of women,” Juravic said. While the two full-time employees are both men, co-founder Dr. Jessica Grossman, several of the inventors and the PI for the upcoming study at Baylor College of Medicine, Dr. Susan Ramin, point to the earnestness of that aim within the company.
