Judy started at Seton as a financial analyst. Then, she was the Perinatal Safety Project Manager responsible, in part, for earning Seton a Joint Commission Codman Award. In 2005, she shifted to perinatal teamwork simulation training. In 2007, she became the simulation manager at the Clinical Education Center. She is a certified Healthcare Simulation Educator, and a certified Healthcare Simulation Specialist, both by the Society for Simulation in Healthcare.
A Tale of Trial and Triumph: Inventing a Fetal Monitoring Simulation Device
Often, participants of the CEC Sim Labs would ask if Judy could acquire certain simulation training models. Many times they wanted things that didn’t even exist yet. When that happened, Judy would think to herself, “Maybe I can make one?” A couple of times she would piece together simple requests, and this early tinkering evolved into the rigorous design of a now-marketable, patented simulation training invention!
Clinicians needed a way to practice conducting sonograms on pregnant women. Consider this: a pregnant woman comes into a hospital or clinic with a fever, is feeling the baby move less and is worried “something happened.” A nurse would probably be asked to perform a fetal assessment and notify a physician if something were missing after these four points were covered:
- Fetal position (Where’s the head facing?)
- Fetal heart sound
- Amniotic fluid (Find all 4 pockets & amount of fluid in them)
- Basic fetal anatomy landmarks (Here are the feet, stomach, heart, etc.)
The problem is that nurses aren’t usually taught these basic imaging skills in nursing school.
So what could they do when the circumstance calls for them to perform basic imaging skills on a hospital unit or in a clinic? The nurse may also have to conduct an amnio fluid draw for further testing.
It is important for them to be able to practice! They need affordable, portable, flexible task trainers to do so. It would not be feasible to purchase another heavy (immobile) simulation mannequin that is optimized only for training on certain procedures with a $64,000 price tag. But no appropriate product existed to meet the training needs.
Sometimes, Judy would watch nurses lay on a simulation lab bed for long periods of time, pretending to be the pregnant patient for their peers to study. Another option for practicing sonography to detect defects in a fetus would be on an actual volunteer pregnant patient. The problem with this is finding a woman willing to sign up, especially one who already knows her baby has a defect or who is adamant against amnio fluid testing. Even if a woman were willing to volunteer her body in the name of medical education, only small amounts of amnio fluid can be pulled at a time safely, so training sessions would end quickly.
It became clear to Judy and her partner inventor Buffy Allen that they should be the first to create just the training model the clinicians needed to master fetal monitoring. So they set out to prototype a solution.
First, they tried doing an ultrasound on a baby doll underwater. That didn’t work. Judy realized she needed to research sono-compatible materials, which she learned are very hush hush. She explained how finding the right material was a very technical process that came down to understanding the speed of light, sound and reflection. To demonstrate the challenge of finding the perfect material to mimic human tissue, Judy showed Jim Bergamo from KXAN how trying an ultrasound on a regular mannequin wouldn’t work. Your average simulation mannequin is made of rubber and silicon that you can’t see through with ultrasound technology.
Fortunately, Seton inventors like Judy have access to medical equipment and expertise that are advantageous for prototype experimentation.
In a quest for space to test their simulated human tissue attempts, Dr. Celeste Sheppard came aboard. Not only was Dr. Sheppard’s office a great place to iterate and ideate with all the necessary equipment, adding her to the mix also meant gaining crucial expertise and new perspective. As a Maternal-Fetal Medicine Specialist, Dr. Sheppard was an ideal consultant, partner and co-inventor.
“Sometimes we’d come up with something and be so excited, sure it would work. Then ‘oops, you can’t see anything.'” – said Judy. The team retried the baby doll experiment countless times with different materials until they finally found the “secret sauce.”
Then they needed to add the baby’s heartbeat. The team sought help from Richard Drake, an expert from Seton’s biomedical engineering department at the time and the fourth member of the invention team. Richard said he had a German-made pump that he thought could work. It did, so Richard gave us our heartbeat.
A few more tweaks and lots of failures later, Judy and her team finally finished their working prototype. The time had come to seek help in filing a patent application. They were hesitant about the patent process and doubted themselves many times. To psych themselves out, Judy and the team would say “A patent is a big deal!” and “Surely someone has already invented that, right?!” But every time they started to falter, they were encouraged to push on. They presented their invention to Seton’s patent committee and some key physicians encouraged them to continue with their pursuit. Judy thought it felt funny to be walking around with a fake uterus and often being asked to explain it to people.
“It was exciting every time we showed someone and they said ‘Ooooh I get it!’ or ‘This is very cool!’ That made us want to keep on going.”
The Patent Process is a Long One
The United States Patent and Trademark Office has been working to speed up the patent application process because they realize all the waiting can really hurt innovation. But Judy had begun one other patent already so knew what she was in for. She saw the Seton’s legal support as a silver lining through the extensive reviews and waiting. Seton’s legal advisers hired artists and experts to refine the plans for the application. Medical experts had to validate and substantiate everything in the application. They assured her that even if there were other types of items similar to her invention, theirs could still be unique.
“Of course now there are more items like it on the market, just not the ones with a portable, flexible belly,” Judy pointed out.
From idea to patent issuance in July 2015, the entire process took 4 years. Remember, Judy and her team chose to pursue the endeavor outside of their regular work hours. Finding time and willpower to stick to the project in spite of their busy schedules as CEC Simulation Lab staff was a big challenge. Every Friday afternoon Judy, Buffy and Dr. Sheppard would spend time going over the latest iteration. They were confident in their product and were motivated to win the race to the patent office.
Ultimately the fusion of a multi-disciplinary team resulted in a successful, marketable product built with the power of grit and combined expertise.
We have a concept, a prototype and a patent. Now, we just need someone to make it nicer and more marketable.
The next step for the fetal monitoring invention will be commercialization.
Seton’s Innovation & Commercialization team with Seton legal has awarded a bonus and plaque to the members of Judy’s team for their successful patent. Now, I&C is working with Judy and setting up meetings to broker deals with potential licensees.
Judy’s Advice for Future Inventors
Anybody can invent.
I’m a better person than I was 4 years ago. This is totally different than where I thought I’d be when I worked in Perinatal Safety Project. I encourage everyone to do it! The patent process was also such a learning experience.
Go for it even if you think everyone else out there is doing it! Forget about whatever everybody else is doing and stay focused.
You need to be persistent and go in with your whole heart. I would be up at midnight searching online for ways to make things work. “If this ratio doesn’t work I’ll up this by 25%” and I think it’s a trial for me too because I get really frustrated.
You may think “Why is it taking so long?” Keep trying. It can get very discouraging. You won’t get an idea today that will work tomorrow. It’s a long journey but it will work. This process teaches patience and persistence… ” You have to be very brave to face your failure. It can be a good thing. We inventors learn about failure and teamwork and how to be open minded to accept feedback from one another.
Doing it by yourself is not very fun. Four people coming from different angles, however, is great. The “What if? What if?” comes out of it. It’s a wonderful opportunity to learn from each other.
Favorite Quote on Innovation
Confucius said, “Wherever you go, go with all your heart.”