Wichita Woman Invents Lifesaving Childbirth Tool

I try to stay as up-to-date as possible when it comes to what’s going on in the world of birth, and I was pretty excited when I heard about the new startup, Prenatal Hope, whose flagship product is called VivO2 (formerly called Pedi-Cell). Imagine how excited I was when I realized that the inventor of VivO2 was a woman, who lives right here in Wichita!

Tammy Dorsey is a mom of five, and has a Bachelor’s degree in biomedical engineering. Married for 20 years, she has always had an interest in birth due to her own experiences birthing in hospital and at home. She is currently in a Master’s program for innovative design, which helped her bridge the gap between coming up with the idea of VivO2 and actually creating the product to put on the market.

WD: How did you come up with the idea to create VivO2?

TD: VivO2 actually started as Pedi-Cell, my senior design project. As a mom, I wanted to do something about the embarrassing fact that in the United States we are the costliest and most dangerous place in the developed world to give birth. I spent a lot of time talking with doctors, and interviewing OB-GYNs across the midwest and finding out what the biggest needs in obstetrical innovation were. Almost unanimously, they were saying, please help us find out if the baby is in distress during labor due to lack of oxygen, take away the guesswork.

WD: Explain in layman’s terms what VivO2 does and the benefits it offers.

TD: VivO2 is a vaginal wand allowing us to get an instant reading of ph levels, to find out if there is fetal distress. As long as the mom is in labor, a few centimeters dilated, with membranes ruptured, we can insert the wand into the vaginal canal. We can make direct contact with any part of the baby for a few seconds and get instant data output on how baby is doing. The wand can be used on the same patient as many times as the doctor or midwife thinks necessary, and then it’s totally disposable.

WD: What was the response like from OB-GYNs when you told them about VivO2?

TD: They were saying it was a game changer, they were acting like I handed them a bar of gold. They were saying “take my money!” Conservatively, they could see VivO2 being used in every hospital within five years. They are very excited about having reduced liability, a quantitative number to help them make decisions, reduced costs from interventions - it’s a win for everyone involved. I got a very warm response from midwives as well, which was so important to me because of how strongly the midwifery model of noninvasive care resonates with me.

WD: If this product is the first of its kind, then what is the current standard of care for determining fetal distress?

TD: The current standard of care is to test the baby’s umbilical cord ph levels after delivery. During labor, there is only the ability to form an educated guess by the use of monitors, and there’s a 49% margin of error. Right now, they test the umbilical cord after delivery so the doctor can confirm that their guess was right, for insurance purposes due to liability from a poor outcome. Mothers are not being heard. We’re addressing that, and taking the guesswork out of it so that we can increase positive outcomes.

WD: So where are you at in the process of FDA approval and widespread usage?

TD: There is a 2 1/2 year pathway to FDA approval, and we’re currently in the presubmission stage. We just met with the FDA about our status as a novel idea - there’s no other product like it on the market. We will be working closely with them in protocol development, risk mitigation, and setting up the product studies to make sure everything is completely safe, which is the most important thing when it comes to our babies. Of course, people can use the product prior to FDA approval - we just have to be careful about marketing and not make particular claims yet. Midwives could actually be the first early adapters to use the product. It’s not as expensive as you might think - a unit may go for $500 and we are looking at special pricing options for midwives, as they are paid directly by parents. We are also looking at charitable efforts to be able to help improve birth outcomes around the world.