Creating a product from concept to manufacturing is a difficult and lengthy process. Creating a product that requires regulatory process narrows those chances even more. But these six mom entrepreneurs took their ideas all the way. They found that their inventions had clinical benefits and took their products to pioneer the medical device industry.
They are: An Air-free feeding system that mitigates infant GERD symptoms; acupressure bands to relief morning sickness; a portable pain-nerve blocker for needle procedures; a functional and reusable swab for safe bugger removal; a better way to measure cervical dilatation while laboring; and a keepsake book focused on the medical interventions that babies in distress require. Meet the founders and their stories below.
Priska Diaz, M.S. is the Founder and CEO of Bittylab, makers of Bare® Air-free feeding system. Priska realized that every time she bottle-fed her baby, she turned him into a bag of gas. In addition, it didn’t take long for her baby to prefer the bottle over breastfeeding. Like most parents, Priska was set to do whatever it took to help her baby out of painful gas symptoms and inconsolable crying. She learned that air inside the traditional bottles were causing the problem and designed an unprecedented feeding system without air-vents or plastic bags. Bare® Air-free feeding system is a healthier alternative to baby bottles. With patented technology, Bare® feeds baby AIR-FREE milk, in UPRIGHT position & lets baby CONTROL the FLOW/PACE of feeding. Together with our Perfe-latch nipple, Bare helps initiate, reinstate and extend breastfeeding while supplementing.
Bittylab launched Bare® Air-free in 2016. Thanks to the feedback of hundreds of moms, a pilot clinical study was conducted in 2017 and revealed that Bare® significantly reduced GERD symptoms in 75% of babies, in the first 2 weeks. Due to these clinical findings, Bittylab is seeking a regulatory approval and insurance reimbursement. Infant GERD is a serious condition that includes irritation to the esophagus, painful acid regurgitation and permanent damage of internal organs. GERD currently affects near 3 million infants, every year in the US alone! “I am so pleased to see that Bare® Air-free has already helped thousands of babies overcome this painful condition and will help our healthcare system save millions of dollars” says the mom-inventor.
Romy Taormina is CEO & Co-Founder of Psi Health Solutions, Inc., the maker of Psi Bands, a medical device for the relief of nausea due to morning sickness/pregnancy, chemotherapy, motion/travel sickness, and anesthesia. Romy suffered from debilitating morning sickness during both of her pregnancies and was sick for more than a year. She found nausea relief through acupressure wrist bands but was dissatisfied with existing products on the market so she set out to create a superior product to help those who suffer from nausea and vomiting. And Psi Bands were born.
Psi Bands are a FDA-cleared class 1 medical device in the USA. Psi Bands are acupressure wrists bands. Acupressure is a form of ancient Chinese medicine that has been around for more than 5,000 years. Acupressure is embraced by western society because it’s effective, affordable and drug free. Double blind randomized clinical studies support the use of acupressure for the relief of nausea and vomiting.
The company was founded in 2006. We are headquartered in Pacific Grove, CA.
Dr. Amy Baxter
Dr. Amy Baxter, pediatric emergency physician, pain researcher and mom-inventor of Buzzy. When my son had a bad injection experience, I figured there had to be a way to block pain from vaccines. I knew that when you put a burned finger under running water, pain would disappear. After some messy tries with running water cuffs, I invented a combination of cold and vibration to stimulate the same nerves that block burn pain.
Since the official product launch in 2009, Buzzy® has been used by over a quarter million patients. Buzzy is in over 5,000 hospitals and clinics, with 100,000 units sold, and 31 million needle procedures performed. With multiple patents and FDA 510 clearances for controlling pain from IVs, blood draws and cosmetic injections, muscle injury and myofascial trigger point pain, the company has broadened the product line to include VibraCool Sport Therapy and DistrACTION®products.
Oogiebear is the first booger removal tool that safely and gently removes both sticky and dried boogers from a child’s nose. Created by doctor and mom of three, oogiebear was developed with comfort in mind, offering two unique ends to effectively help children breathe easier and soothe them at a time of incredible discomfort. It has a loop-end perfect for sticky boogers and a scoop end for safely removing dried boogers. This revolutionary tool is made of soft rubber and firm plastic tips that is easy for a parent to hold and gentle enough for your baby. The bear-head design is both fun and safe — preventing the oogiebear from going too far into the baby’s nose. It works great for little ears too! With two patents- both utility and design, oogiebear is an FDA medical device.
Cervical dilation measurements guide decision-making during labor, from when to stay in the hospital to recommendations for interventions like pitocin augmentation or cesarean section. Unfortunately, the current measurement method is correct only about half the time, leading to confusion for both laboring mothers and provider teams. DilaCheck is a small, sterile, soft measuring tape that examiners wear on their fingertips to provide an objective measurement of cervical dilation. In a simulator trial with 50 Labor and Delivery clinicians, DilaCheck increased accuracy to 96%, doubling accuracy compared to our current methods. This simple device was designed specifically with mothers in mind- small and flexible, it adds no additional discomfort to examinations.
DilaCheck is categorized as a Class 1 medical device and FDA clearance is pending. It is currently undergoing a clinical trial with laboring moms at Thomas Jefferson University in Philadelphia. Our website is dilacheck.com.
Dreemie Preemie was started out of need. I was a new aunt to a niece that was born at 28 weeks and was barely over a pound. I felt the need to show my support, and I’m a gift giver. So, after looking and search all over I decided what I needed wasn’t available. My Sister in law was not a “scrapbooker”, nor did she have the time, space, or energy. I also had to be practical. Clothes, diapers baby equipment were months away of being useful or needed. There was also the overlooming question of will she survive, and would those “things” be a source of sadness? That’s when Dreemie Preemie was created. A fill in the blank style, unbound baby book that could be customized to tell the journey and life story of each individual baby that needed it. As it turns out 1 out of every 10 births is a baby that needs such a baby book as our NICU bundle, Medical pages, or Congenital Heart Defect Bundle. 9 out of every 10 babies born can use our full term bundles for those ready to go home right away. These pages are easy to fill out, and pre-loaded with all those new hospital treatments and procedures that parents never knew they would need to know until sitting beside their babies isolated in a NICU. Many times, these new parents want nothing more than to hold their precious baby but due to premature nervous systems, and or tubes and wires that is simply not possible. With www.DreemiePreemie.com products they can still bond with their child by telling their amazing journey of strength. Dreemie Preemie is a mom based business that provides hope, love, and way to document the story of the greatest moments in your child’s life.