Odon Device

Jorge Odón, Mario Merialdi, David Milestone, Claudia Weill, Chiara Atik, and Sonia Epstein on car mechanics, birthing technology, the Odón device, and BUMP

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi, translator Rosa Rivera, and David Milestone

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi, translator Rosa Rivera, and David Milestone

An amazing thing happened during the last weekend run of BUMP, the new comedy by Chiara Atik that was this year’s EST/Sloan Mainstage Production. The idea for the play began when Chiara discovered the story of Jorge Odón, an Argentine garage mechanic who saw a YouTube video about a cork getting removed from a wine bottle – and that video inspired him to invent a revolutionary new device to help in the late stages of childbirth delivery. A fictionalized version of Odón’s story became, in Chiara’s hands, one of three storylines in BUMP. Odón still lives in Argentina but on Thursday, May 31, three days before the play was due to close, the EST office got a call that Jorge Odón himself was flying in to attend the Saturday matinee performance . . . and yes, he would be happy to participate in a talkback after the performance. Odón arrived with his wife and with Mario Merialdi, the former World Health Organization executive who was critical in helping Odón turn his idea into a product that has gone on to be clinically tested in Iowa, South Africa, and Argentina and may start going into use in 2020.

Joining Odón and Merialdi for this remarkable talkback on June 2 were the playwright Chiara Atik, the director Claudia Weill, translator Rosa Rivera, and David Milestone, the Acting Director of the USAID’s Center for Accelerating Innovation and Impact, an organization that also played a key role in funding the development of the Odón device. Sonia Shechet Epstein, Executive Editor of Sloan Science and Film at the Museum of the Moving Image, moderated the discussion.

A lively comedy about childbirth, BUMP explores women’s evolving understanding of and control over the birthing process through three stories: a young first-time mother giving birth in colonial New England with the help of an experienced and peppery midwife; five women sharing quips, gripes and observations on an online message board; and a grandfather-to-be getting inspired to invent a device that could revolutionize how infants in difficulty get delivered (this is the storyline inspired by the experiences of Jorge Odón).

Some of the highlights of the June 2 discussion follow: (Recap by Rich Kelley)

Sonia Shechet Epstein: Chiara, in BUMP there are characters who give birth in a range of ways. Why was it important for you to present that range?

Chiara Atik: The play is not trying to say that there is a correct or incorrect way to give birth. My hope was that by offering an assortment of examples of what giving birth is like, that the audience could take what it wants from the different experiences. The play ends with the colonial girl looking at her future. That’s where I wanted the focus to be.

What Jorge Odón thought after seeing BUMP

Sonia: Jorge, what is your reaction to seeing your invention dramatized? 

Jorge (translated by Mario Merialdi): The play is great and he is still surprised about his invention and how it has been interpreted. . . . This invention actually took him around the world to meet many important people. He met Princess Caroline in Monaco. He met Pope Francis. The device got on the front page of The New York Times. Seeing this play was really a surprise for him.

When he was seeing the play he could see and feel very much of what had happened in reality. He was spending hours on this device. His wife Marcella, who is here with him today. She actually did sew parts of it . . . He congratulates Chiara the playwright and all the actors who interpreted his story.

Sonia: And what do you have there?

Jorge (translated by Mario): [shows prototype for Odón device] This is a simulator of the uterus that he uses for demonstrations of the Odón device. The first prototype of the device is what he is showing here. He’s a car mechanic. He’s not a doctor. He needed to learn how the baby exists inside the uterus. This part was used the first time to insert the device. It was difficult for the doctor to use it and to position the device correctly. This is the inserter. The gauge indicates when the device has been inserted properly.

From left: Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi

From left: Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi

It’s been fourteen years since he had the original idea. This is the bag we use now. Now he is going to fill it with air. This is not hard to do. The device immediately deflates once the baby is removed. You have now seen in just a few minutes the evolution of the device over fourteen years. Imagine what happened in between. Jorge was actually very afraid of seeing blood. Because of his passion, he was able to attend 48 deliveries. In these 48 deliveries he was able to deploy the device. Without the help of his family, his friends, and everyone who believed in him, he would not have been able to develop the device. Without them it would not have been possible for a big company like Becton Dickinson to pick up his idea and take it to the next level. It first was his family that supported him, then it was CEMIC, the Center for Medical Education and Clinical Research in Buenos Aires; then it was me [Mario Merialdi] who was shown this device and fifteen weeks later Jorge and I were together in a hospital in Des Moines, Iowa, a very specialized advanced center testing the device. . . . I didn’t mention that I’m actually his friend.

How the Odón device went from an idea to a product

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi

Sonia: Mario, you’ve been instrumental in the development of Jorge’s device. I’m curious about two things: first, what about the Odón device stood out for you when you first saw it and second, how aware were you of the need for innovation in obstetrics before the device?

Mario: Someone mentioned in the play that there had been no innovation in the instruments used for childbirth deliveries for centuries. There was definitely a gap there. I remember I was working at the time at the World Health Organization. I was leaving to go from Geneva to Buenos Aires for a meeting. I got a call in the evening from a colleague in Argentina telling me about a crazy doctor at a hospital working with an even crazier mechanic who had a new device for assisted vaginal delivery. I was very skeptical but at the same time I was intrigued because of the unmet need for new devices both in developed and developing countries. So I said I will be at this meeting and will be able to give him ten minutes. I met with Jorge who showed me the device. The moment I saw that this was something new in the field I was intrigued. The reason why it’s so appealing is that forceps and suction are all lifesaving procedures but they require professionals and they are not available everywhere in the world, especially in the area where most of the world lives. Seeing this device that is potentially easier to use and potentially safer was very, very promising and pushed me to invest and to develop a research plan.

How USAID innovates new medical solutions — and helped develop the Odón device

Sonia: Dave, I know that you and USAID also helped develop the device. What are some of the criteria you were using to decide which innovations to support?

From left: Jorge Odón, Mario Merialdi, Rosa Rivera, David Milestone

From left: Jorge Odón, Mario Merialdi, Rosa Rivera, David Milestone

David Milestone: I’m with the Global Health Bureau of the US Agency for International Development, the part of the State department that works on economic development and humanitarian assistance primarily in places with low resources. Think Sub-Saharan Africa, Southeast Asia. We’ve made a lot of progress in global health. For example, we cut child mortality in half in the last few decades. We still have a long way to go to reach what we call sustainable development goals that the United Nations targets around maternal newborn mortality. One of the things we recognize is that we need to start working and thinking in different ways if we’re going to have any chance of reaching those targets. Part of that is casting a wider net to different nontraditional problem solvers.

Over the last several years we’ve run programs called “Grand Challenges,” which are open innovation competitions around maternal and newborn health, like Saving Lives at Birth, and around the Ebola and Zika grand challenges to help us be better prepared for the next outbreak. [Note: The Odón device received funding in Round 5 of the Saving Lives at Birth challenge in 2015]. What we’ve found is that great ideas can come from anywhere, from Buenos Aires to just up the street at Columbia University where a group of students developed a type of colorized bleach to be used in decontamination settings during the Ebola outbreak in Liberia. It’s now being used in the current outbreak in the Democratic Republic of the Congo. What’s exciting about that is that was a group of students at Columbia. They now have a business, they’re making money and it’s sustainable. That was only three or four years ago, in 2014.

Traditionally, in global health it can take 30 to 40 years for a product to go from an idea in the garage to scale. This can really accelerate the progress. There’s a saying that vision without execution is hallucination. It takes a village to execute. Jorge delivered the vision. It took us as a government agency to take the risk and invest in this device and it took the World Health Organization to be supportive of it and to get it to scale. We look for products that are potentially game changers, that can leapfrog existing technology and address the leading killers of newborns and mothers.

Sonia: Were there any other innovations that you awarded that also address these needs?

David: Yes, over the course of the eight years that we have run the Saving Lives at Birth Grand Challenge we have awarded some 120 different awards to innovators. Some awards were as low as $250,000. Some as high as two million dollars in order to be catalytic. Yes, we’ve seen a whole host of ideas. About 15% of these will transition through development and get to scale. That doesn’t sound like a lot but when you’re looking for new approaches to reach what we call the last mile in real rural settings, it’s proven to be a pretty successful model. We’re going to be seeing more of it.

Claudia Weill on directing BUMP

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill

Sonia: Claudia, one of my favorite storylines in the play is during colonial times when you see and feel the terror of giving birth without the aid of technology or community. What was it like directing that scene?

Claudia Weill: We were very lucky. We found an amazing group of actors who really brought the play to life. The two actors in that scene (Lucy DeVito and Jenny O’Hara) were fantastic in making it come to life. When Chiara writes “1690” she writes it almost as a contemporary scene. It’s not like “Ye ole . . .” It’s very hip and edgy. That made it very easy to direct and easy to connect it with the other material.

Sonia: Claudia, can you tell us about the creation of the set and the development of the prototype for the device?  

Claudia: I wasn’t so much involved in developing the prototype. We had wonderful prop people who were.  In terms of the set, we worked with this wonderful woman Kristen Robinson. Early on, we realized we had to create the world of the Internet and to bring it onstage in some alternate space. She came up with this wonderful idea of this window. Everything that happens in the window is somehow connected with the Internet, whether it’s a YouTube video or a chat room or whatever. I thought that was a marvelous visual concept, a visual metaphor for what Chiara is doing in the play. One of the things Chiara is writing about is that we are more intimate with our devices and with what’s happening on the Internet than we are with the person next to us in bed. It’s as if that person in the device is in the room. It’s not a remote thing. The set brings that home.

Why outsiders may be key to medical innovation

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi

From left: Sonia Shechet Epstein, Chiara Atik, Claudia Weill, Jorge Odón, Mario Merialdi

Sonia: Jorge, another question. How do you think your experience as a car mechanic helped you to think about the problem that your device solved?

Jorge (through Mario): He has several patents related to automotive mechanics. When he was having issues with mechanics in his garage, he used to go to bed with the problem and woke up with the solution. This time when he had the idea his wife was not pregnant. He thanks God for giving him this idea. He wants to congratulate the actor who portrayed him on stage. He has only one complaint. In the program he is not described as an Argentine mechanic but simply as a grandfather inventing the device.

Sonia: I have a question for any of the panelists. Forceps were invented in the seventeenth century. I’m surprised there haven’t been more innovations in this area. Do any of you have ideas on why that is?

Mario: There have been many attempts to improve the forceps and the vacuum extractor. There are at least one thousand different kinds of forceps. Obstetricians have typically tried to improve on what’s already existing. Being a car mechanic, Jorge looked at the problem from a different perspective. Speaking as an obstetrician, I know we often refer to labor and delivery as a biological process, but mostly it’s a mechanical process. The baby has to go down the birth canal and navigate different diameters, taking different positions as it is being pushed by the mother. It has always struck me that Jorge has a better understanding of the dynamics of delivery than a physician. He always says he’s a car mechanic. He’s not a doctor, so he doesn’t have any kind of biological background. This always brings to mind for me the saying that sometimes imagination is more important than knowledge. What you need sometimes is someone who takes a totally different view who has a lot of creative imagination. It’s great that there are now platforms available for innovation. Innovation can come from totally different backgrounds. This is my view. This is why there has not been so much innovation. We had to wait for Jorge.

David: I’d add that it’s very expensive to develop new medical technologies. For a good reason. We want to make sure that they’re safe. So they often require these randomized controlled trials which are very expensive. If you’re a medical device company like Becton Dickinson, you want to make sure that the devices you’re developing and testing will allow you to make more of those and make a profit. Often In these low resource settings . . . in northern Nigeria, for example, women often will give birth by themselves by tradition. These are completely different markets with different user needs than are available in more developed places. There is not necessarily an incentive for innovation in these low resource stings. Fortunately, Becton Dickinson is very progressive in moving into these emerging markets – the fastest growing markets in the world – Africa and Southeast Asia – so we’ll likely see more of this innovation coming sooner than later.

How the testing process for a new medical device works

Question from audience: The play makes a point of the difficulty of moving from testing a device on dummies to clinical trials on people. How does that process work? How are the first human testers chosen?

Jorge (through Mario): There is a process you have to go through in order to get a device approved. There is an ethics committee that has to approve it. In this case, there actually was a first woman to test the device that had never been used before in the world. Jorge was involved in approaching the women. Jorge is really grateful to the first woman. We have to remember that the women in Argentina were going to have a normal delivery. They would not actually need the device. They needed to start with women who were going to deliver anyway. So the first women who agreed to participate were doing it for science. When you do research of this kind there is a very detailed form the women have to read and discuss with their family. Reading the two or three pages describing all the possible risks could have been very scary. Despite that, the women decided to participate. Another requirement of the ethics committee was that the first test had to be conducted with women who had advanced education, a university degree.  They wanted a population of women who could not be interpreted as being disadvantaged or who might consent without properly understanding what they were consenting to.

What inspired  BUMP

From left: Sonia Shechet Epstein and Chiara Atik

From left: Sonia Shechet Epstein and Chiara Atik

Question from the audience: Chiara, what was it about Jorge’s story that made you want to write a play about him?

Chiara: I read this article and I just loved the idea of a man, a mechanic, someone not in the medical field, someone just completely out of it in this very female experience and I thought this was a funny juxtaposition. The idea of someone with a plastic uterus in his garage just seemed lovely.

The 2018 EST/Sloan Mainstage Production, BUMP by Chiara Atik began previews at the Ensemble Studio Theatre on May 9 and completed its run on June 3, 2018.

Read more about BUMP

Interview with Chiara Atik about BUMP: Chiara Atik on new mom message boards, ALT lines, science stories, and BUMP

Background on the science behind BUMP: Childbirth’s “Grinding Pirouette,” a Colonial Midwife, the Odón Device: Some Background to BUMP

May 26 talkback panel on BUMP: Rebecca Tannenbaum, Debra Pascali-Bonaro, Chiara Atik and Robin Marantz Henig on Midwives, Doulas, Colonial Home Births, Birthing Positions, Medical Devices, and BUMP

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Rebecca Tannenbaum, Debra Pascali-Bonaro, Chiara Atik and Robin Marantz Henig on Midwives, Doulas, Colonial Home Births, Birthing Positions, Medical Devices, and BUMP

From left: Robin Marantz Henig, Debra Pascali-Bonaro, Rebecca Tannenbaum, Chiara Atik

From left: Robin Marantz Henig, Debra Pascali-Bonaro, Rebecca Tannenbaum, Chiara Atik

Following the May 26 matinee performance of BUMP, Chiara Atik's lively new comedy, EST/Sloan assembled a panel to discuss several of the compelling issues about childbirth the play addresses. Joining playwright Chiara Atik for this discussion were Rebecca Tannenbaum, Senior Lecturer in History from Yale University, and doula trainer Debra Pascali-Bonaro. Journalist Robin Marantz Henig moderated the talkback.

BUMP explores women’s evolving understanding of and control over the birthing process through three stories: a young first-time mother giving birth in colonial New England with the help of an experienced and peppery midwife; five women sharing quips, gripes and observations on an online message board; and a grandfather-to-be getting inspired to invent a device that could revolutionize how infants in difficulty get delivered (a storyline inspired by the experiences of Jorge Odón).

What follows are some of the highlights from the discussion. (Recap by Rich Kelley)

On the inspiration for the play

Robin Marantz Henig: What I love about this play is that you chose this emotional topic. It was very moving and very beautifully done.  What made you want to write about this?

Chiara Atik: Pregnancy and childbirth are things that a lot of my friends are going through right now. I'm at the age where people are starting to have kids or certainly starting to think about having kids, so it's a topic that comes up a lot. I was inspired by the article in The New York Times in 2013 about Jorge Odón, the real-life inspiration for Luis in the play. Odón invented this fabulous machine to assist mothers in deliveries. I thought that would make a great Sloan play — Sloan supports plays about science — then I incorporated the other stories.

Robin: What about the colonial story? Did you put that in there to give us a longer view of the history of childbirth?

Chiara Atik

Chiara Atik

Chiara: For me, it was an exercise in imagining what it would be like to be pregnant without Google, without a message board, without constant information at your fingertips, or even, in the case of our story, family support, which I think was rare even for the time ... In those days, most people likely had a lot of family, had big support systems; Mary doesn't. I wanted to show the opposite extreme. The Internet really influences the other two storylines and, thematically, just how much information you have: whether you have too much, whether you have too little, how it influences the experience.

Robin: So, Chiara, the message board: How did that come to you? Did you want all good feelings, or sort of a combination of old wives' tales and natural information?

Chiara: Yeah, definitely a combination. The message board, it's less about the specific kernels of information, which sometimes can be helpful and sometimes can be the least helpful thing in the world, and more about the feeling of community and feeling like you're not in this alone. You're a team: They're going through this experience at the exact same rate at the exact same time and I think that even pre-Internet groups like that were very helpful. I wanted a sort of a Greek chorus of the whole experience, or aspects of the experience. So, again, it's less about "Well, I got this information," and more about other people.

Robin: Sharing

Chiara: Sharing, yeah.

On the historical accuracy of the colonial storyline

Robin: Rebecca, is that how the birth would have gone in colonial times? The character had so little information: she thought she was going to have a pain and then have a baby. And she had no interaction with her midwife before she arrived that night... It was interesting that she was sitting in a chair when she was actually giving birth.

Rebecca Tannenbaum: Yeah, I thought that was actually quite accurate. We have this image of the woman today — many of us who have given birth did it this way ourselves — you lie on a table on your back, but that's not how women have given birth for a long time.  Certainly, in the colonial period, many midwives had birthing stools: special chairs with a hollowed-out seat and a lower seat for the midwife to sit on and catch the baby. Giving birth upright would've been the standard practice for that time and right up until the nineteenth century when physicians started performing a lot of births.

Rebecca Tannenbaum and Chiara Atik

Rebecca Tannenbaum and Chiara Atik

Another thing that struck me as very accurate was the walking because the walking was definitely something that midwives would encourage women to do: to keep moving; to not lie still because movement helps encourage the contractions as well. But one of the things about birthing in the colonial period, which came out in the play as well, was this idea that it was meant to be painful; that women were meant to suffer in birth. The biblical references that the midwife gave to Mary were very much the way birth was understood in the seventeenth and eighteenth centuries: that this is part of woman's lot for being a daughter of Eve and that the fear and pain was just something you had to accept as punishment for Original Sin.

Robin: Was it typical to bring a midwife in? Because the way she said, "We're paying you a lot for this; why are you going away?" almost seemed like it was a mark of being different from her neighbors.

Rebecca: Women certainly counted on having a midwife there: someone who was experienced; someone who could help them. So, it wouldn't have been unusual at all. What would've been unusual would've been having a male physician attend the birth. And as time passed, and as you got into the late eighteenth century and early nineteenth century, having a male physician actually became a status symbol. You start to see it first in urban areas among wealthy clientele. Part of it was just, like, "I have this doctor who was trained in Europe," and that's better news, but part of it also was that it was true that, beginning around the 1780s, 1790s, physicians could offer technology, like the forceps, that midwives could not. The fear the mother in the play showed was also pretty accurate for the colonial period, so having the reassurance that you had a practitioner who could offer this new technology that could pull a baby out without danger to the baby or the mother was something that people who could afford it really wanted.

Robin: Did this midwife pull out forceps?

Rebecca: Yes, I know noticed that she had forceps.

Chiara:  Yes.

Robin:   Why did she ... Was she really going to use it on the baby?

Chiara:  Yeah, they were there as a measure. And that was more of a dramatic choice than . . .

Robin:   But perhaps not historically accurate?

Rebecca: Yeah, not historically accurate. It would have been a formally-trained physician who used forceps.

Chiara:  Right.

Rebecca: It became kind of controversial, whether you would allow a man in the birthing room, seeing a woman in this intimate way, and one of the titles of one of the pamphlets that was actually advocating for midwife birth was "Hands of Flesh vs Hands of Iron."  "What do you want touching you: hands of flesh or hands of iron?"

Chiara:  Wow.

From left: Robin Marantz Henig, Debra Pascali-Bonaro, Rebecca Tannenbaum, Chiara Atik

From left: Robin Marantz Henig, Debra Pascali-Bonaro, Rebecca Tannenbaum, Chiara Atik

On the evolution of how babies are delivered

Adriana Sananes (who plays Maria in the play and who joined the audience for the talkback): Did I hear correctly that when physicians started doing the births, that's when women started lying down?

Rebecca: Yes, because it's easier for them to see what's happening ... easier for them to use their forceps ...

Adriana:  And that's more or less what time?

Rebecca: The late eighteenth, early nineteenth century, so between 1780 and 1820.

Debra Pascali-Bonaro:   Isn't that phenomenal to know? Whose comfort? The doctor’s? Not the person giving birth. How crazy is that? And that we have all the data to say it's actually harmful to lay down and push your baby out, and yet we're still doing it against the best science.

Adriana: That’s the reason for my question. I went through 27 hours of intense contractions in labor. And a lot of the time, I was laying down with all these things and the doctor kept telling me, "The baby's fine. The baby's fine." And it's like, "But I'm the one ..."  [laughter] So I was wondering when that whole aspect of the physician telling me ...

Rebecca: Well, the reason you had to be lying down is because you had all the monitors attached.

Adriana:  Exactly, exactly. I wasn't dilating, but still, it was incredible to just ... Your instinct is to walk. Breathe and walk and breathe and walk.

On home births, birth centers, and hospitals

Audience member: In the play the colonial mother has a home birth and Claudia wants to have a home birth. What is your feeling about having home births today?

Debra: I attend many home births in the New York/New Jersey area, and we have wonderful qualified licensed midwives for home birth. I think home birth is growing, and there is misinformation out there, but home birth for low-risk women is quite safe, and that's the midwife's role: to keep that safe and transfer, when needed, to a hospital. So as long as you're here in New York you're always thirty minutes from a hospital, but as long as you can transfer in time if you need extra care, home birth is very safe.

Robin:   And how about birthing centers? Is that a big midway thing?

Debra:  They are wonderful. The sad thing here in New York is we don't have many of them. Due to different regulations and licensing. But other states do have more birth centers, and birth centers are growing around the U.S. In the U.K. they have many birth centers. Good home birth rate, birth centers ... ultimately, that's what we need so people have the choice of where you feel safe, whether that's home, birth center, or hospital.

Audience member: What do you recommend women do in a hospital scenario?

Debra Pascali-Bonaro

Debra Pascali-Bonaro

Debra:  First, have a doula because a doula is really trained to navigate that, and doulas facilitate communication between the person giving birth and the team. We don't speak for anyone, but we amplify their voice. So we don't let anyone do anything that isn't really engaging them and ultimately, we need to bring home birth into the hospital. I teach at medical schools and midwifery schools, and I'm teaching bringing back the wisdom of our great grandmothers that knew how to do all these comfort measures. We've got to overhaul the system so that this is available. But in the short term where our system is still dysfunctional, bring a doula with you and get educated! A lot of people, like the message board, are passing some good information, but also some misinformation. And a lot of people that think they know a lot about birth that are pregnant actually don't always know what they think they know. I’m an advocate that, especially first-time mothers, get into a really good childbirth class ... not in most hospitals though, because hospital classes ... Sorry, I'm biased, but I think a lot of them are for patient compliance: They really teach you what they want you to do to be a good patient, and they don't really teach you your options. Then again, you're being led onto the assembly line of industrialized childbirth, and it's not about you. It's about getting you through the system.

On the difference between a doula and a midwife

Robin: Debra, you’re a doula, not a midwife. Can you explain what the difference is?

Debra:  Chiara, you mentioned "doula" in the play. I loved that. I lit up. So looking "herstorically," women had other women that were around them.  A doula really is reconnecting that circle of support of females. Sadly, we don't attend each other's births anymore. We would've known how to do that back then, but now we have to go to a workshop and relearn those skills. So a "doula" isn't really new; it's really rediscovering the role of women supporting women. Just like women's menstrual cycles come together when they live or work together, we're starting to learn that women have a physiology among each other. And the studies show that even the most wonderful, loving male, sorry to say, but he doesn't make labor any easier or less of an intervention.

When you bring another woman, who's trained in the natural comfort ways, labor actually is shorter and with less interventions. A doula is just offering that emotional, physical support. If there's religious or spiritual practices, they're integrating them, but doulas don't do any medical skills. And the midwife is really the keeper of that, making sure mother and baby are healthy and well. A doula is really like a sister, your best friend, being at the birth with you.

On the potential usefulness of the Odón Device  

Robin: Debra, can you talk a little bit about this device that sort of yanks the baby out?

Robin Marantz Henig and Debra Pascali-Bonaro

Robin Marantz Henig and Debra Pascali-Bonaro

Debra: I have this double-edged kind of look at it: On one side, I think that we've gone so far that we just keep making mothers lie down today to give birth. We have a fascination with getting the baby out in positions that don't work, so we are doing too much assisted birth. I'd hate to see us, now, create another technology that just again indulges our fascination with how we can get a baby out without physiology. But I am kind of interested in it because it sounds like it's gentler than the alternative, if we use it appropriately.

Audience member: Debra, I hear your reservations about the Odón device. But you've had so much experience in attending so many childbirths around the world ... Do you think something that's as low-tech as the Odón device could make a difference in low-resource environments?

Debra:  Oh, I do. And that's why I said it's double-edged: I think when you truly have a baby that's having trouble getting out you need to change positions a lot ...  A baby being born is — it may be a bad analogy but it may help explain — it’s like a lock and key. If you put the key in upside-down, it doesn't matter how long you push: you won't open the door. You'll eventually cut the door down. So all around the world, we always say "four to five pushes in a position" and if we're not making movement, we change again. In some places in the world, we're moving and moving and moving, because you move the mother, and it moves the baby. And we get all the babies out! So when we put people in a hospital and put them on their back, and then we're going to randomize a trial, you are going to have babies that are going to get stuck because we're not using gravity and we're not moving the mother, then I think we are just using more technology without really needing to. But if really just use it in the rare cases, then I think it's valuable.

Audience member: And you could envision a doula or a midwife doing this?

Debra:  Not a doula. Let’s remain historic. Doulas don't do any medical care.

Audience member: Not even that. Okay.

Debra: That’s the question. Around the world where if you're in really low-resource areas where we don't have access to doctors, will they then train the midwives in that? Although the midwives who use lots of positions will have a very, very, very low rate of babies that get stuck.

The panel taking questions from the audience (including members of the cast).

The panel taking questions from the audience (including members of the cast).

The 2018 EST/Sloan Mainstage Production, BUMP by Chiara Atik began previews at the Ensemble Studio Theatre on May 9 and completed its run on June 3, 2018.

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Inventor Jorge Odón, Global Health Experts Mario Merialdi and David Milestone, and Director Claudia Weill join Playwright Chiara Atik and Editor Sonia Epstein to discuss Birthing Technology and BUMP

Clockwise from top left: Jorge Odón. Mario Merialdi, David Milestone, Sonia Shechet Epstein, Chiara Atik, Claudia Weill

Clockwise from top left: Jorge Odón. Mario Merialdi, David Milestone, Sonia Shechet Epstein, Chiara Atik, Claudia Weill

On June 2, following the 2:00 pm matinee performance of BUMP, the lively new comedy by Chiara Atik, audience members are encouraged to stay for an extensive discussion of many of the issues the play addresses, especially current birthing technology, devices for instrumental vaginal delivery  (IVD), the Odón device, and how medical devices get approved for clinical use. Joining playwright Chiara Atik  and director Claudia Weill will be Jorge Odón, the inventor of the Odón device, Mario Merialdi, Senior Director of Global Health at Becton Dickinson, and David Milestone, Acting Director for the Center for Accelerating Innovation and Impact, USAID, for a conversation moderated by Sonia Shechet Epstein, Executive Editor of Sloan Science & Film at the Museum of the Moving Image.

BUMP is the exuberant exploration of the evolution of women's understanding about and control over the childbirth process through the  stories of three separate quests for knowledge: a young expectant mother in colonial New England getting coached through her first pregnancy by a peppery midwife (inspired by the diary of Martha Ballard); a contemporary message board where new pregnant moms swap gripes, quips, and observations; and a grandfather/mechanic's invention of a device that could revolutionize how babies in distress could be safely delivered (the last inspired by the story of Argentine mechanic and inventor Jorge Odón). 

The World Premiere of BUMP is this year’s mainstage production of the EST/Sloan Project, EST's partnership with the Alfred P. Sloan Foundation to develop new plays "exploring the worlds of science and technology," an initiative now in its twentieth year.

About the Panelists

Jorge Odón

Jorge Odón

Jorge Odón is the inventor of the Odón device. For more than thirty years, he operated the El Rayel S.A. automobile alignment and wheel balancing service center in Lanús, Argentina. During that time he patented several products relating to car parts. In 2005, he had an idea for facilitating childbirths after seeing a YouTube video about how to pull a cork from an empty wine bottle. After developing several device prototypes, Odón’s big breakthrough came in 2008 when he presented his device to Dr. Mario Merialdi, then director of Reproductive Health at the World Health Organization. That meeting led to both traveling that December to the birth simulation center at Des Moines University in Iowa for a successful series of tests. The WHO then agreed to conduct a series of hospital-based tests of the device in three phases in Argentina and South Africa. In 2013, Becton Dickinson and Company (BD) licensed the development rights of the Odón device and developed a new prototype based on their pre-clinical studies. In March 2018, BD and WHO announced the results of the latest round of tests. The report concludes: “Delivery using the Odón device is therefore considered to be feasible.” BD will next pursue a randomized pivotal clinical trial before potential introduction in clinical practice.

Odón has won recognition for his invention that includes finalist in the First WHO Forum on Medical Devices in Thailand (October 2009); winner of one of the 19 awards in the international contest Saving Lives at Birth: A Grand Challenge for Development, in Washington (July 2011); recognition at world congresses and athenaeums in gynecology and obstetrics; first prize from INNOVAR 2011, and the gold medal from IMPI as best inventor of 2012.

Dr. Mario Merialdi

Dr. Mario Merialdi

Mario Merialdi, MPH, MD, is Senior Director of Global Health at Becton Dickinson (BD), with a special interest in Maternal and Newborn Health. Prior to joining BD, Dr. Merialdi served as the coordinator of Human Reproduction and as a Medical Officer in the Maternal and Perinatal Health Research Unit at the World Health Organization in Geneva, Switzerland. He worked in the design, implementation and coordination of large multinational epidemiological studies involving research institutions in developed and developing countries. Dr. Merialdi’s research interests have been focused on issues related to the reduction of maternal and newborn mortality worldwide. He is a strong supporter of the need to foster international research collaborations between researchers from developing and developed countries.

David Milestone

David Milestone

David Milestone is Acting Director of USAID Bureau for Global Health's Center for Accelerating Innovation and Impact (CII). CII applies business-minded approaches to the development, introduction and scale-up of health innovations. Since 2011, USAID, CII, and its partners have cultivated a pipeline of over 150 innovations and supported them on their path to deliver health impact—from improved maternal and newborn health to enhanced outbreak response for diseases like Ebola and Zika to strengthened health supply chains. David has also held various strategic marketing roles at Stryker, an $11B medical device company, where he led innovation and strategy initiatives in India.

Claudia Weill

Claudia Weill

Claudia Weill is a film, television, and theatre director. After graduating Harvard in 1969, she made 30 short films for Sesame Street (still on the air) and directed documentaries, notably This is the Home of Mrs. Levant Graham (Kennedy Journalism Award) and The Other Half of the Sky: A China Memoir, with Shirley MacLaine, released theatrically in 1975 (Academy Award Nomination). She produced and directed her first feature, Girlfriends, in 1979, which she sold to Warner Brothers after winning multiple awards at Cannes, Filmex, and Sundance. Next she directed It’s My Turn for Columbia Pictures, winning the Donatello (European Oscar) for Best New Director.

She directed mostly new plays at Williamstown, The O’Neill, Sundance, ACT, Empty Space and in New York at MTC, the Public and Circle Rep among others. In 1984, she was nominated for the Drama Desk Best Director Award for the premiere of Donald Margulies’ Found a Peanut, produced by Joe Papp at the Public Theatre. Moving to Los Angeles in 1985, she began working in television, directing episodic, cable movies and pilots. She is most well-known for multiple episodes of Thirtysomething (Humanitas and Emmy Awards), My So-Called Life, Chicago Hope (Reynolds Award), Once and Again, and TV movies, including Johnny Bull and Face of a Stranger (Gena Rowlands, Emmy Best Actress). Returning to theatre in the last few years, she directed the West Coast Premiere of Pulitzer Prize winner, Doubt, at the Pasadena Playhouse; Tape, Memory House, and End Days at the Vineyard Playhouse, Archy and Mehitabel at the Yard; Huck and Holden at the Black Dahlia; La Bella Famiglia at ACT; Twelfth Night, Act a Lady and Sweet Mercy at Antaeus; Melancholy Play and The Shore at the Pasadena Playhouse.

Chiara Atik

Chiara Atik

Chiara Atik is a graduate of the Obie Award-winning EST/Youngblood program, and a portion of BUMP had its origins as a short play written for Youngblood's monthly Sunday Brunch series, specifically its annual crossover with the EST/Sloan Project, the Youngblood Science Brunch. Her plays include I Gained Five PoundsWomen (a mashup of Louisa May Alcott’s Little Women and HBO’s Girls) and Five Times in One Night, which was first produced at EST. She is the author of numerous articles for Cosmopolitan Magazine, Glamour Magazine, Refinery29, and New York, as well as the book, Modern Dating: A Field Guide. Her screenplay, Fairy Godmother, was on the 2016 Blacklist. Helen Estabrook (Whiplash) and Cassidy Lange will produce for MGM, which won the rights in a bidding war. Television: NBC’s Superstore.

About the Moderator

Sonia Shechet Epstein

Sonia Shechet Epstein

Sonia Shechet Epstein works at the intersection of science and culture. As Executive Editor of the Museum of the Moving Image’s website Sloan Science & Film, she produces all of its content. At the Museum, she also curates the ongoing series “Science on Screen” which pairs rarely screened films with discussions between scientists and filmmakers. Since 2014, she has been a mentor at NEW INC—the New Museum of Contemporary Art’s incubator for practitioners in art and technology.

BUMP began previews at the Ensemble Studio Theatre on May 9 and runs through June 3. You can purchase tickets here.

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Childbirth’s “Grinding Pirouette,” a Colonial Midwife, the Odon Device: Some Background to BUMP

In the spirit of the EST/Sloan Project’s commitment to “challenge and broaden the public’s understanding of science and technology and their impact in our lives,” we offer this essay on some of the scientific and historical background to BUMP by Chiara Atik, the current EST/Sloan mainstage production. BUMP begins previews on May 9 and runs through June 3. You can purchase tickets here.

Background essay by Rich Kelley

Apes and chimpanzees give birth in one to two hours. Human moms average ten to twenty. Why does our labor take so long?  

Blame our large brains. And our preference for walking upright. We are the only mammal to walk on two legs. That comes at some cost. In 1960, physical anthropologist Sherwood Washburn identified “the obstetrical dilemma.” Evolution, it seems, sometimes involves tradeoffs.  Some seven million years ago, walking upright offered our ancestors an advantage. Our arms could reach higher branches, our hands became free to carry food and to make tools. Walking on two legs uses less energy to cross long stretches of grassland. And we could run.

Diagram relates the size of the maternal pelvic inlet (outline) and the size of the neonatal head (dark circles) in selected primate species

Diagram relates the size of the maternal pelvic inlet (outline) and the size of the neonatal head (dark circles) in selected primate species

But to walk upright our pelvis needed to change its size, shape and positioning. And this changed how human females gave birth. Non-human primates have pelvises and birth canals that resemble a ring or a hoop.  The primate infant’s head is usually smaller than the birth canal, which is positioned forward on the body. This makes birthing simpler. Delivery can take one to two hours and the baby emerges face up, guided out by the hands of the mothers to immediately begin nursing. Primate mothers can manage this by themselves and usually give birth away from others, in seclusion.

Midwife's view of the birth canal in a chimpanzee ( P. troglodytes ),  A. afarensis  (A.L. 288–1, ‘Lucy’) and a modern human female. Note the necessary rotation of the head in the human female.

Midwife's view of the birth canal in a chimpanzee (P. troglodytes), A. afarensis (A.L. 288–1, ‘Lucy’) and a modern human female. Note the necessary rotation of the head in the human female.

Our human pelvis has to solve a tricky problem. For us to walk it needs to be narrow; but our brains are large and the female pelvis needs to be able to deliver the newborn’s head. As Tina Cassidy describes it in Birth: The Surprising History of How We Are Born:

“Today, the upper opening of the pelvis is wide from side to side . . . the lower pelvis, however, the baby’s exit, is widest from front to back. And therein lies the problem . . . human birth is, quite literally, a twisted process. In order to pass through the birth canal, the baby’s head—the largest part of its body—must rotate as it descends in a grinding pirouette. . . . Assuming the baby is not breech—being born feet or buttocks first—its head must enter the pelvis facing up toward the pubic bone, with the widest part of the head—ear to ear—lining up with the widest part of the pelvis—hip to hip. But that has to change quickly. The baby must begin to turn sideways, as much as forty-five to ninety degrees, in order to align its body with the widest pelvis outlet, its head emerging face down rather than face up.”

Sequential changes in the position of the child during labor.

Sequential changes in the position of the child during labor.

But why is labor so painful?  The chimpanzee brain is about one-third the size of the human brain. Because of the human infant’s large head, the cervix of the human female must dilate three times as much as other primates. Chimpanzee mothers dilate 3.3 centimeters before delivery. Human mothers must dilate 10 centimeters, which takes more time, and is significantly more painful. According to the Mayo Clinic, mothers describe the last three centimeters as being the most painful part of giving birth.

Because of the difficulties of human delivery—and the care the child needs during its second nine months—anthropologists Karen Rosenberg and Wenda Trevathan have argued that “assisted childbirth” is probably as old as bipedalism:

“Because the human fetus emerges from the birth canal facing in the opposite direction from its mother, it is difficult for the mother, whatever her position, to reach down, as non-human primate mothers often do, to clear a breathing passage for the infant or to remove the umbilical cord from around its neck. If a human mother tries to assist in delivery by guiding the infant from the birth canal, she risks pulling it against the body’s angle of flexion, possibly damaging the infant’s spinal cord, brachial nerves, and muscles.”   

In a survey of 296 cultural groups, Rosenerg and Trevathan found that “assisted birth comes close to being universal.”

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For most of human history, those assisting at births were exclusively women. Until about a hundred years ago, delivery occurred in the home, in the bedroom or around the hearth. In Europe and early America, these attendants were called “God’s siblings,” later shortened to “gossip,” their chatter the basis for the word’s current meaning. After a successful birth, the gossips would organize “a groaning party,” a feast for midwife, mother and the assembled women, its name recalling the sounds of labor. Men penetrated the birthing sanctum at their peril. In 1522, a German physician, Dr. Wert, eager to learn more directly about the birthing process, disguised himself as a woman to try to enter a delivery room. He was discovered and reportedly burnt at the stake.

A Midwife’s Tale: Martha Ballard

Martha Ballard, a midwife in colonial Maine, kept a detailed daily account of her activities from 1785 until a few months before her death in 1812. Over those twenty-seven years she delivered 814 babies. Her mortality rate (excluding stillbirths) was 2.5 per 100—very impressive for that time. Being a midwife then involved canoeing down rivers and trudging through snow, sometimes delivering two or more babies within twenty-four hours in houses miles apart. 

A page from Martha Ballard's diary, February 3 - 12, 1800.

A page from Martha Ballard's diary, February 3 - 12, 1800.

Laura Ulrich Thacher notes, in her Pulitzer Prize-winning biography of Ballard, “In Martha’s diary, it is doctors, not midwives, who seem marginal.”  One poignant entry records Ballard’s reaction when a new young doctor does not defer to her years of experience but rather “chooses” to participate himself in the birthing. From ancient times, male physicians were usually called in only for emergencies, when the life of the child or the mother was at risk, hence the adage, “When a man comes, one or both must necessarily die.” In those instances, the life of the mother was paramount. From the Hippocratic Writings we learn that the earliest medical tools related to childbirth were not tools to ease delivery but rather tools for the extraction of the dead fetus. Caesarian sections in ancient times were mostly performed so that the child and mother could be buried separately. The first record of a mother surviving a C-section was not until the 1580s in Switzerland (her husband, a professional pig gelder, performed the operation).

Forceps: A Family Secret

Peter Chamberlen the Third

Peter Chamberlen the Third

When obstetrical forceps first appeared in seventeenth-century Europe, only members of the all-male barber-surgeon guild could legally use them. The invention is credited to Peter Chamberlen the elder, a French inventor and surgeon. He and his surgeon brother gained fame for delivering babies in difficult cases because of their use of a secret instrument. For 150 years, through several generations of man-midwives, the Chamberlen family kept secret exactly how that instrument worked. Due to etiquette, man-midwives had to operate within severe constraints. A large sheet covered the expectant mother, one end wrapped around her, the other tied around the man’s neck. Without looking beneath the sheet, the man-midwife was expected to deliver the baby by feel.

The Chamberlen forceps

The Chamberlen forceps

The Chamberlens had a knack for theater. Two men would lug a large elegantly carved lined box into the delivery room.  They then cleared the room and blindfolded the mother before slipping their device under the sheet. During its use, they would clang bells, hammers, and chains to cause further misdirection. It wasn’t until 1813 when some of Peter Chamberlen’s tools were discovered in an attic of a house that the ingenuity of his invention became clear. His forceps used hinged blades that allowed each to be positioned independently around the head of the infant, something not possible with tweezers.

In the 1950s, Swedish professor Tage Malmstrom developed the ventouse, or Malmstrom extractor. In its current version this device involves placing a suction cup onto the head of the baby. The doctor uses a handheld pump to gently apply suction and the suction draws the skin from the scalp into the cup. Handles on the device enable the doctor to pull the baby out.   Over the last few decades, caesarean section and vacuum extractors have replaced forceps as the preferred means of delivery. Since 1985, the World Health Organization has maintained that the ideal rate of caesarean sections is between 10% and 15% of live births. Beyond 10% there is no added improvement in the maternal or newborn mortality rate. Yet from 1996 to 2014, the rate of caesarean sections of all births in the U.S. has risen 55%, from 21% in 1996 to 32.5% in 2014. A recent study by the British Medical Journal found that “C-section rates were lower among poorer women and increased with rising economic status.” High caesarean rates can result in negative outcomes: infection, hemorrhages, and surgical complications.

The Odon Device: Inspired by YouTube

In 2005, Jorge Odon, an Argentinian garage mechanic, bet a friend he could extract a cork from an empty wine bottle without breaking it. He won the bet thanks to a YouTube video he had seen that showed how to do this by inflating a plastic bag inside the bottle until it gripped the cork and then pulling both out. Odon then had the inspiration that this same technique could be used to deliver babies in distress. Having already patented several auto-related inventions, he set to work to realize his idea using a glass jar for the womb, one of his daughter’s dolls for the baby, and a fabric bag and sleeve sewn by his wife as the extraction device. Successful demonstrations to local obstetricians (always starting with the cork and bottle trick) led to consultations with doctors at CEMIC, the Center for Medical Education and Clinical Research in Buenos Aires. At first they thought he was pranking them, but eventually they responded positively and even recommended changes: doing away with the bag that surrounded the baby’s body and just having one bag to surround the baby’s head.

Jorge Odon demonstrating his device

Jorge Odon demonstrating his device

Odon’s big breakthrough came in 2008 when he was granted ten minutes at a conference in Argentina to present his device to Dr. Mario Merialdi, director of Reproductive Health at the World Health Organization. Merialdi deemed the device “fantastic.” Their ten minute meeting stretched to two hours and led to both traveling that December to the birth simulation center at Des Moines University in Iowa for a successful series of tests. The WHO then agreed to conduct a series of hospital-based tests of the device in three phases in Argentina and South Africa. In 2013, Becton Dickinson and Company (BD) licensed the development rights of the Odon device and developed a new prototype based on their pre-clinical studies. The Odon Device now consists of two main components: a plastic sleeve and an inserter. The sleeve contains an air chamber that is inflated around the fetal head by a manually operated bulb pump. Once the sleeve has surrounded the baby’s head, air is hand pumped into the inner surface of the sleeve until the sleeve has a secure grasp of head. The inserter is then removed and the baby is pulled out. The simplicity and low cost of the device make it potentially revolutionary in reducing mortality in instances of prolonged labor in low-resource settings. Caesarean sections, by contrast, require expensive surgical theaters.

The sequences of an Odon Device extraction

The sequences of an Odon Device extraction

In 2017, the WHO and BD conducted the third phase of testing. They prioritized three criteria: safe for mothers and babies, easy for different cadres of skilled birth attendants to use, cost-effective, and affordable in low resource settings. In March 2018, they announced the results of the latest round of tests. The Odon device was inserted successfully in 46 of 49 women (93%), and successful delivery with expulsion of the fetal head after one-time application of the Odon device was achieved in 35 women (71%). The report concludes: “Delivery using the Odon device is therefore considered to be feasible.” BD will next pursue a randomized pivotal clinical trial before potential introduction in clinical practice.

Gadding online

In her diary Martha Ballard identifies herself as a “gadder,” that is, someone who frequently visits neighbors to chat and exchange news, recipes, plant medicines, and stories. Today, what gadding goes on among mothers is more likely to happen online via message boards, forums, parenting networks, blogs, and Facebook, Yahoo, Google and Meetup groups. Many of these groups are centered around a physical community so that they can help a new mom find local resources, whether a Nanny, a doula, an OB/GYN or a great deal on strollers. The Bump, one of the largest and oldest (now ten years) online communities for new and expecting mothers, reports that 80% of working mothers use message boards or forums, with 75% naming them as one of the top two most valued resources for information, second only to talking to mothers face to face.    

You can read more about BUMP and the brilliant playwright who wrote it in our interview with Chiara Atik

The views expressed in this essay are solely those of the author. The Alfred P. Sloan Foundation funded BUMP in part because of the compelling nature of one of the stories that inspired it: Jorge Odon's invention of the Odon Device. Its support for the play should not be construed as endorsing the device or any of the products or services mentioned in the play or in this essay.