Paul Rosenthal: From the Smithsonian's National Museum of American History, welcome to "Prototype Online: Inventive Voices," brought to you by the Lemelson Center for the Study of Invention and Innovation.
I'm Paul Rosenthal.
Late last month, a little baby girl named Amillia Taylor went home from a Miami Hospital and grabbed the headlines. Born on October 24, 2006, little Amillia is believed to be the youngest preemie ever to survive and go home from the
hospital. She weighed just 10 ounces at birth. Skilled doctors and sophisticated life-saving technology are widely credited for making Amillia's amazing survival and the survival of other young preemies possible. But the story of improving care and technology in the neonatal intensive care unit or NICU does not start and end with the doctors and medical engineers.
Nurses work at the ground level. They toil long hours and provide meticulous round-the-clock care for these tiny babies that have to adapt to special situations. Then they need to be resourceful when materials are lacking. Nurses are inventive by necessity. Many of the improvements seen in the NICUs over the years have been driven by the daily experience of the nurses working there.
Our podcast today is about one of these neonatal nurses turned inventor. Her name is Sharon Rogone. And while you probably haven't heard of her, her inventions have helped to improve the care of the youngest of newborns. Working in the 1980s in NICUs in San Bernardino, California; she saw the need for basic, well-designed devices to help care for premature babies. Her first invention was the Bili Bonnet., a simple device that shields the baby's eyes from the dangerously bright lights used in phototherapy.
Premature babies often undergo phototherapy as a treatment for jaundice which is common among newborns. To block the lights, nurses had been using improvised devices made from black construction paper, cotton balls and other materials found in the NICU.
Sharon Rogone's Bili Bonnet was a drastic improvement. It's a simple low-tech invention that performs a vital medical function. The Bili Bonnet launched Rogone's career as an inventor and a business woman. In the mid 1990s, she started Small Beginnings, a company that she ran at her home. Her products now include specialized diapers, pacifiers, positioning devices and oral suction tools all designed to improve the care of preemies in the NICU and to lessen or prevent the medical problems once these babies leave the hospital.
Small Beginnings is no longer run at her home. It's a small company with about a half-dozen employees with distributors and warehouses across the country. The company has been a success and has held its own against large medical companies that unsurprisingly want a piece of the action. Clearly, Small Beginnings has blossomed from its very own small beginnings.
In this podcast, we'll focus on the story of Sharon Rogone's first invention- the Bili Bonnet - and explore her motivation to create the device. In addition to Sharon, we'll hear from her husband and business partner Phil Rogone, who has worked as a respiratory therapist and physician's assistant and Ken Croteau, her other business partner and a respiratory therapist that specializes in prenatal care.
Sharon, Phil and Ken were interviewed on January 17th and 18th of 2007 by Lemelson Center historian Maggie Dennis and Smithsonian curator Judy Chelnik.
Sharon Rogone: The developmental care that my products address... that was when we first started with these little tiny, floppy babies. We took care of them. We were just so concerned about just keeping them alive. They would lay on these flat, firm surfaces with no muscle tones. So that they would be in a frog-like flopped open position if they were on their back or on their stomach rather than nestled in a fetal position like they would be if they were in the womb, which is the way they're supposed to be.
We didn't even think about that because we were so focused on just keeping them breathing and their heart beating. And then as more and more of these babies started to survive and they would go home, we would see the flat heads from being laid side to side. The physical and occupational therapy that they would have to go through to bring their little arms and legs back to the midline so that they could do the normal developmental things that babies do - like put their fingers in their mouth. When they begin to walk, they would walk spread-legged because their legs had been spread apart.
All these developmental issues now were brought in to focus and developmental care was introduced but not practiced. Because the hospitals could not to afford to practice it and the companies out there were not making products that could be reused and reused over and over on these babies. So that they were not...
I mean, nurses tried, but they didn't have the right equipment to do it. My products are trying to meet that needs so that they can use them to do more of these developmental care and get these babies back to that fetal position of comfort which relieves stress and help them go home sooner. There's a lot for them other than just the occupational and physical therapy that they don't have to have after they go home. It shortens their hospital stay because they are nurtured. They're not just cared for. They're nurtured like they were in the womb.
Paul: Ken Croteau, business partner at Small Beginnings.
Ken Croteau: We went from babies that we couldn't save - that were merely five pounds to today where we have babies that are one pound. And now the trick is how do you get a one-pound baby, save it and have it come neurologically intact? Part of the neurological problem isn't just blood flow that's causing the bleeds or hyperized molar solutions that we use today. It's also a matter of keeping the baby's blood pressure low. If the baby is stressed, then it's not going to have low blood pressure.
So developmental care helps you to create an atmosphere to de-stress that infant. It's really a very important part of the baby's recovery. The NICU is a hostile environment, and unless there's a reason for that baby to leave the uterus because it becomes hostile, that's the best place for the baby. When it can't be there, then we have to create a nurturing environment for it. Those are a lot of changes over 37 years.
Paul: Phil Rogone, Sharon's husband and business partner:
Phil Rogone: What we see is all these situations occurring in NICU, and nobody's doing anything about it, because we're only talking about a population of 400,000, maximum, across the country. Approximately 400,000 babies a year go into the NICU. For a big company like Pamper's, 400,000 is not even enough to think about. It's just not. It doesn't make any sense to make something.
So all these companies that were making things for the NICU in the early days in the '90s were taking large products and making them smaller, thinking, "OK, we'll go from large to small. That will work just fine." But it doesn't, because they're not the same. Babies are not the same.
That's why Sharon's products are amazing, because she looks at what the situation is with the infant and carefully deducts what's going to work without thinking about what's out there. She just takes a look at what the baby needs.
Sharon: The nurses, when you're working in the unit, you find that there's a shortage of everything that you ever wanted or needed for these babies, because it was such a new area of medicine. When I first started working in that area, we did things like cut black construction paper in the shape of a little mask and used cotton balls to cover their eyes. And stocking net to make a little beanie to hold the mask in place when they went under phototherapy. Or, you used a tongue blade and covered it with a four by four and used that for an armboard, or rolled the blankets to position your babies. Whatever you needed to do, you had to make up for yourself, because there weren't products out there.
Then, as time went on, things started showing up that were very inadequate because the big companies put together things, modified adult products to use for the babies, and they were very inadequate. That's how I came up with my mask. I started making them for myself to use in the unit, and nurses would say, "Could you make me one of those?"
Then I started trying to get some of the big companies to make my mask. I made myself some waivers and non-disclaimer forms and sent off to several of the bigger companies to see if they wouldn't like to produce a mask that would work, rather than the ones that were out there.
I got letters back from them that said, "Just turn over your idea to us. If we decide to use it, we'll let you know and then we'll talk about compensation." Or, "We'll pay you one quarter of one percent of the net-net profit." Different -- ridiculous, as far as I was concerned -- offers.
So I was just doing nothing with it, when a sales rep that I was talking to, who was demoing a product at the hospital, said, "Why don't you just do it yourself? Why don't you just have it made?" I was like, "I wouldn't know where to go."
He said, "I have a lot of connections in LA. Why don't we see if we can get it made?" So we shook hands and got it made. Then we started putting them in Ziploc bags -- not Ziploc, because they didn't even have Ziploc bags yet! Plastic bags, with a little flyer and a sample and how to contact us. I carried a beeper and an 800 number and they would call the 800 number and it would beep me. Then I would call them back and take an order and put it in at night and ship it off in the morning.
We slowly, slowly started growing the business with just the Bili-Bonnet. It went to three sizes, then I got a distributor up in the Northwest, then I got a distributor on the East Coast. Gradually, I got maybe five distributors and the Bili-Bonnet was selling pretty good. Then I decided to come out with some of my other ideas that I had.
But the Bili-Bonnet itself has gone through metamorphosis as time has gone on. It's changed from just a flat piece of material to a molded piece of material that takes the pressure off the ocular socket and puts the pressure around the browbone and the cheekbone. The bonnet part is basically the same; the velcro's changed. The shape of the velcro's changed to take any sharp corners off. Just little things that we've done to improve it over the years.
Judy Chelnick: Before we go on, if you could take just a few minutes to explain what the Bili-Bonnet is for? Maybe to explain bilirubin.
Sharon: OK. When babies are born, in the birthing process, they take on a lot of extra red blood cells a lot of times, through the umbilical cord or whatever. Because their livers are still immature, they cannot get rid of the waste product that comes from the breaking down of those red blood cells, because red blood cells die every three days. We make new red blood cells and red blood cells die off. So at about three days of life, the bilirubin level has reached a peak level. And the liver can't get rid of it. And if you get a high bilirubin level, it can cause brain damage-- kernicterus.
And by putting a baby under phototherapy lights, the phototherapy changes the chemical chain of the bilirubin just slightly, like you've seen sugar chains, and how they show you fructose and sugar and glucose and dextrose. Well, it changes the bilirubin chain just slightly so that the bilirubin can now be excreted through the bowel and through the kidney, and so that the baby can get rid of it in a different way, not just through the liver.
And when they go under these bright lights, they need protection for their eyes from this bright light. And that's what the Bili-Bonnet is. It's a mask that protects their eyes from the bright light while they're undergoing this therapy.
Paul: Once again, Ken Croteau.
Ken: You know, I've been in the NICU for a long time. And so, when Sharon sat down, she said, "Well, we have a problem. Here's what the problem is. The phototherapy masks that are out there, they don't fit. They go down. They occlude the nose. They don't work right. And I developed this mask. And this is what I did. And it's really helpful to my babies."
And I was just amazed that she came up with this great idea using burn nit material that we use in the emergency room for burns and other areas of the hospital. And she made a bonnet out of it. And she put it on the babies. I told her I think that's the coolest thing I've ever seen. I didn't see it at the hospital where I worked. And I brought samples there right after. You guy's have got to try this. And I just thought that her idea was great.
And that was the only product they had. They didn't have any other products at that time, just the Bili-Bonnet. And I thought it was a great idea. Being an advocate for babies in the NICU, I looked at that and thought I should have had a V8. Why does anyone else think about this?
Because some of the stuff we were using... I mean, the very earliest things we used was black paper that we cut and put--and everybody used them--cotton balls. And put those over the eyes and black paper. And then taped it, or did something with it, to secure it to the face. And that really wasn't very efficient we now know.
Sharon: Nobody has actually been able to pin it down to how much damage, but it's a phototherapy light. It's very bright. And even harsh lights of any kind are hard on a baby's eyes. So, there's a need for this protection for their eyes.
Maggie Dennis: I guess one question I always like to ask people is when they were kids, what kind of activities did you enjoy? What were your favorite classes? That sort of thing.
Sharon: I have always been an artsy, craftsy kind of person that did a lot of oil painting, charcoal painting, which I think plays into the inventing product because you have a creative mindset where you see things differently than other people see things that makes you say, "Hey, I could use that for something else than what it was intended." You look at something and you say, "That would work for this."
Another thing though, people think that an inventor is an unusual thing to be. But in actuality, everybody is an inventor. Every time that you think, when you're doing something like peeling a potato, or washing dishes, and you think, I wish I had something that would do this and this. If you pursue that, that's an invention.
But people just don't pursue those things. And the pursuit of it, and the perseverance to follow up on those ideas is what makes the difference. Not that you are an inventor, it's just that you push on to the next level, because everybody comes up with ideas. And then down the road, they think of something and down the road they say, "Oh, I thought of that a long time ago, but they didn't do anything with it."
So, ideas are like floating around in the air. And if you don't grab hold if it when you think of it, pursue it, then somebody else will. But ideas are out there just floating around. And what makes me follow up on it, I don't know. I've had that thing that I have written on my wall that says, "Perseverance is the only thing that gets you through. Just to keep at it, and keep at it, and keep at it."
Paul: I don't know whether you've ever thought of a hospital as a place of invention; but as we just heard from inventor Sharon Rogone, with her business partners Phil Rogone and Ken Croteau, it sure is.
Next time we'll hear more from the folks at Small Beginnings and about many of the other inventions they've developed to help keep premature babies alive and comfortable. Thanks for listening to "Prototype Online: Inventive Voices," brought to you from the Smithsonian's Lemelson Center for the study of Invention and Innovation at the National Museum of American History. I'm Paul Rosenthal.
We're anxious to hear your thoughts about this program or any others from the Lemelson Center. Send us an email. The address is email@example.com. And visit us on the web at invention.smithsonian.org where you can learn more about the great inventors and innovators of the 20th and 21st centuries.