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.
This week it's Part Two of our podcast with Sharon Rogone, a neonatal nurse turned inventor. Her experience caring for premature babies in Neonatal Intensive Care Units, or "NICU's," inspired her to create simple devices that improve the care of newborns.
If you like, tune into Part One, which was our last podcast. In Part One, Sharon discussed her first invention, the Bili-Bonnet. The Bili-Bonnet launched her career as an inventor and businesswoman. It's a device used to protect the eyes of premature babies when they're placed under the bright lights for phototherapy, a treatment for jaundice, which is common among newborns.
In the mid 1990's, Sharon Rogone started a company called "Small Beginnings" to sell her Bili-Bonnet. The Bili-Bonnet was a success and Rogone continued to invent. In this podcast, we'll hear about some of her other inventions, including the Bebeonkers, which is an oral suction device, and diapers specially designed for the special needs of preemies.
In addition to Sharon, we'll hear from Phil Rogone, her husband. He's worked as a respiratory therapist and physician's assistant, so, like Sharon, is experienced in the field. With his outgoing salesmanship and marketing skills, he helped Small Beginnings grow from its own small beginnings.
We'll also her from Ken Croteau, a business partner at Small Beginnings and a respiratory therapist who specializes in prenatal care. Sharon, Phil, and Ken were interviewed on January 17th and 18th, 2007, by Lemelson Center historian Maggie Dennis and Smithsonian Curator Judy Chelnick.
So let's begin today's podcast with Phil Rogone telling the story of how he met Sharon and how he got started with Small Beginnings in the mid 1990s:
Phil Rogone: She approached me because she was thinking about going to PA school. That was the first time I met her.
Maggie Dennis: And what's PA school?
Phil: Physician's Assistant.
Judy Chelnik: Ohhh.
Phil: Yeah, that's how we first met, and I was working with her daughter in the NICU. So I just met her quite by accident. Then she purchased a house and told me I should come by and see her house, because she had just gotten it and it was a good deal.
So I said, "OK, I'll come over and see the house, and we'll go out to dinner and grab a movie, maybe?" She said. "Oh, I don't date people I work with." and I went, "I don't work with you. You work the day shift; I work the night shift. We don't work together."
Well, I think it embarrassed her that she was being presumptuous, so she agreed to go out with me. That was kind of the first date, and we got married three months later. [laughs]
Phil: And we've been married for almost 12 years! It's a pretty neat love story. So that's how it started. I basically licked envelopes at the beginning. She did all of the billing, and then I would lick the envelopes and seal them and make sure everything was ready and then send it out. That's all our job was for the first four or five years, and I was with them doing that.
Sharon Rogone: We were married in '95, and Small Beginnings was underway at that point, already. When we decided to enlarge the company and go for more products and stuff, and it was time to do that first legal show, with the first catalog, with the positioning devices and everything.
The night before that show -- and Phil is a showman. He's been in the theater, he's very out there. I'm more the person behind the scenes, the quiet thinker, planner, organizer kind of person. This is how it is. The purse-strings, the one who says, "We have no money. We can't do this. This is what we can do; this is what we can't do" You know, the bottom line person.
So the night before the show, I was pretty much in tears. I was like, "I can't do this, I can't do this!" I just didn't know how I was going to get up there and be presenting my company here in Southern California. My peers are going to be there and they're going to laugh! "Here she comes with her beanbags! Who does she think she is?"
I did get that from some of the nurses. There's a professional jealousy thing that kind of happens like, "Who does she think she is? She doesn't have any big degrees." You know, I'm not a clinical nurse specialist. Where did her ideas come from? All that. So there was a little bit of that, not that bad, but a little bit. So I was very nervous and Phil just said, "Oh, I can do this for you, you don't even have to go out there tomorrow. I'll do this."
Phil: So we got to the show, and I didn't know how to behave at the show, so I just started acting like a barker at a circus. Step right up ladies, step right up, don't leave until you get a sample of what I have to offer. And I just started talking like that and the next thing, you know, we had 20 or 30 nurses around there.
We started showing them all the positioning devices and the different products that we had from the catalogue, and there was a ton of interest. It was so exciting. It had reached a fever pitch when I was throwing catalogues over about 10 nurses to get to the people in the back that had wanted them.
All the other booths were absolutely vacant. It was like we were the only booth in the whole thing that was getting action. And that was really exciting. It was really a rush. That's kind of how it started. That show catapulted us into the minds of the nurses around the country. They started to see us as a viable offering of the products that we had.
Maggie: So one thing that I notice about talking to all of you, before we get into individual products, is that your knowledge and your passion didn't come from your training as medical professionals.
Maggie: Nurses, and the rest of...
Phil: We know the plight of these babies.
Maggie: Right. Did you want to say a few words about that before I get to the second part of my question?
Phil: Well, you know, after watching these kids, Sharon's idea for a phototherapy mask was brilliant. It's when she developed the other products that she'd been working on like the Climate Cover and the Climate Cover 2... the nurses don't realize how important that product is.
It was such an important product because we knew what was happening to these babies when they're in that incubator. When you put them in a warmer, and you walk by their warmer, just the movement of your body going past their warmer, that cold air rushes across their body and you can watch them shake, you can watch them go into apnea, which is not breathing at all, or bradycardia. Just from stress of you walking by their bed.
So nurses in the past were taking Saran Wrap and literally wrapping the warmer with Saran Wrap to prevent the baby from getting exposed to... and they're still doing it today.
Paul: Ken Croteau, business partner at Small Beginnings.
Ken Croteau: We thought if we just did nothing more than make as permanent a developmental line as we could, people would at least practice developmental care in the NICU. That was the utmost importance to us.
We can always make money off other devices, like phototherapy masks or pacifiers or something and that's great because those are disposable and you're not going to reuse diapers and stuff like that in NICU. But it was important for us to have a developmental positioning strategy that people would use over and over and over and over so that they would always use it and get into practice of using it, because it's the best thing for the baby.
Maggie: So maybe you could, for the recording, say a few words about what you mean by developmental care.
Ken: It's an entire system of care for an infant that addresses its physiologic needs and its psychological needs. It addresses all the senses. You're basically concerned about how your baby's positioned so that the baby is comfortable and the airway is opened and the limbs are brought to center so that they're not splayed out.
You're also interested in sound, so babies aren't startled by sound. Light, so the babies don't get too much light, they get appropriate amounts of light at appropriate times. A lot of NICUs have certain times of the day that they turn the lights down and then they turn the lights back up after so much time - an hour, whatever - to help circadian rhythms to develop naturally for this child.
Also we're concerned about the environment, how the baby loses heat from conduction and convection and evaporation. So you do things in the NICU to kind of control all these things. We want to create a nurturing environment for the infant to get better.
Sharon: The need for a diaper that didn't leak, our Bebeonkers that suctions the mouth, that was another one that just kind of evolved. It's like, what can I do to suction out this baby's mouth without jabbing it to death with a cut-off catheter and make the baby's mouth bleed trying to get the oral secretions? When they have a tube down their throat, permanent taped in there, it causes more and more secretions and they can't get rid of it. Then it oozes, goes down the throat and gums up the works and everything and you try to keep their mouth cleared out. To get that out of there you're poking in there with a jagged edge that you've cut off of another catheter, and some of the contraptions that nurses have come up with to try to clear out the oral cavity is just unimaginable. So that was another one that came along that is one of our products.
Judy: Is that a miniaturization of another tube?
Sharon: There's an adult oral suction called a Yankower.
Sharon: It has a round bulb at the end of it so that you don't suck up tissue in there. For the babies they didn't really have anything like that and so they would take a suction catheter and just cut it off and use the little end of it to try and clear out the cavity. That was very inadequate so I started fooling around with different things and came up with this device and then Phil and Ken added their two cents and we came up with the Bebeonkers.
Phil: My claim to fame is, I said, "You really should have a universal adapter on the end so that regardless of the size of the tubing, you're going to be able to get it to fit." So she said, "OK, so then we'll both be on the patent."
I went, "OK, thank you very much."
What we did was, we created it by taking a temperature probe cover off of one device and then taking this off of a Meconium Aspirator, and just put the two together to create this device. The rounded tip was designed for one purpose only -- to prevent nurses from assuming that they can go down as far as they want to. If you go down too far in the baby's throat, you're going to cause mucosal tearing and you can hit the corina. If they hit the corina, we don't want them to damage the corina, so this rounded tip was preventing any damage when you went down there too far.
What we were trying to do is teach nurses that you don't have to do what you used to do -- poke and prod and squirt lavage in the baby's mouth to try and get out all the secretions. All you need to do is drop this until you hear it make sound [sound of sucking]. It's gone.
Sharon: When I started the business it was just to make a couple of little things that could help the babies. I was just going to make them out of my house and subsidize my income. It wasn't ever going to be a big business. But as I got into it more and more, the need for -- and found out how big business operates, and the fact that all of these developmental ideas were out there for so long and nobody is using them because the hospitals can't afford it. It's like, when are you going to do something about this? These babies need this. It just kind of evolved.
Phil: As our story progressed and we started to gain notoriety around the country as one of the other soft-goods companies, nurses came up to us and said, "Why don't you guys make a diaper?" We said, "Oh, my goodness, are you kidding me?" How are we going to make a diaper? You've already got Pampers, you've got Children's Medical Ventures and there was another company called Lunt that was making diapers for premature babies. I said, "What do you want in a diaper?"
Sharon had already made a list of what she thought should go into a diaper because she's way ahead of everybody. We started getting input from nurses around the country when we'd do these shows, and we'd say, "Well, what do you want in a diaper?" To see one of the babies in this diaper is just amazing, because it actually fits like a normal diaper. One of the big things that they don't talk about much in diapers is the psychological effect of a parent when they look at a baby in a diaper that is six sizes too large for them. And many of these diapers, when you put them on a micro-preemie baby, they fit almost up to the baby's neck.
Who would want to touch a baby that small? It looks like a little rat. It looks like a little tiny rat. You're frightened of it. But if you put a diaper, and I'll tell you, that in our catalog there's a picture of a baby, a 500 gram baby, wearing my diaper. If you didn't know better, you'd think it was a full-term baby. Because the diaper fits like a little tiny diaper is supposed to fit, right under the umbilicus. And the baby doesn't look scary at all. It just looks like a miniature version of a baby. And that, psychologically, is better for parents.
We believe that we're making a product that makes a difference in the baby in the unit. It makes a big difference. Abduction of the limbs can cost $82 an hour for a physical therapist to come in and work with a baby whose legs have been pushed out -- "abducted" is what we call it. When the legs are abducted like that, and the diaper can do that, two weeks in a diaper that's pushing their legs out will cause abduction of the limbs. And then it's $82 an hour, three days a week or four days a week for at least an hour a day for up to six months.
Well, the couple of pennies that they're saving on their diaper has gone into the toilet -- of all the other stuff that you have to do -- not to mention that if our job is to make life better for the baby, anything we do that causes a problem for the infant should not be done. And putting a diaper on a baby that spreads their legs out should be a no-no in every hospital.
Maggie: The other question for me about the diapers is are these something that's only used in the NICU or is this something that parents would be able to use at home after they bring the baby...
Phil: We just recently started selling the preemie size, the larger size, to preemie stores. And they can buy them through the preemie store. Or they can buy them by phone from us.
Maggie: Right. But the small, the ultra-preemie size you wouldn't have a baby that small at home...
Phil: No, but I think we sell the small size to the zoo. The San Diego Zoo buys them.
Judy: Oh, really?
Phil: For monkeys. Yeah. They've been buying them for years. They love our diapers. [laughter]
Judy: I love it.
Phil: It's kind of amazing, isn't it?
Sharon: Every time you go to the hospital, for me, every time I go I would work another shift or be in the unit again, and deal with whatever you're doing for the baby. There's always improvements you can see. You can look at things and say, this would sure work better if it was like this instead of like that. And that's why the guys don't like me to go to the hospital and work any more. Because, you know, I always come back with more ideas than we need to deal with. But there's always going to be improvements that can be made in all the products that are out there.
And for everything they come up with that is new whether it's taping something on their arm, or a new probe. It's like, well that would work better if it was attached this way. There's just always going to be something. It's never going to run out. It's never going to dry up.
Paul: Inventor Sharon Rogone with partners Phil Rogone and Ken Croteau. Sharon created Small Beginnings that brought comfort and hope to premature babies. They were interviewed by Lemelson Center historian Maggie Dennis and Smithsonian Curator Judy Chelnik.
You've been listening to prototype online from the Smithsonian's Lemellson Center for the Study of Invention and Innovation at the National Museum of American History. We're glad you had the opportunity to tune in. I'm Paul Rosenthal.
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