A conversation with Jules Sherman
Designing pediatric medical devices and the ethics of at-home care for medically complex children
Jules Sherman is currently the Director of the Biodesign Program at Children's National Hospital in Washington, DC. Her role is unusual in that she has an industrial design background (we get into the definition of that during the interview) instead of a bioengineering degree. This serves her well as she works directly with providers and families to design useful products that fall under medical device manufacturers’ radars (another topic we get into).
Jules wrote a striking STAT News First Opinion article in June of this year, detailing how parents are forced to DIY medical equipment for their medically complex children due to a combination of misaligned Medicaid reimbursement codes and inattention from device manufacturers. In this interview, we talk about potential remedies and the ethics of all of it.
This interview was condensed and edited for clarity.
Designing for pediatric patients
Olivia: First, what is industrial design? And how did you turn your industrial design background into medical design?
Jules: I’ve mostly focused on three-dimensional physical products — not digital products. “Industrial” means products made at scale or mass production of a product. I started my career in consumer product design, developing products that you might find at Restoration Hardware, Target or Costco.
I did that for 15 years, and then I had a very traumatic birth experience and decided that I needed to switch gears and focus on designing for maternal and neonatal healthcare. At the time I had been accepted to the Stanford graduate design program. I had a four-month-old and decided that I was going to craft all of my experience there around healthcare design.
Olivia: That's such an interesting way to process that experience.
Jules: Yeah, it was. It was cathartic.
Olivia: You’re currently embedded at Children’s National, designing products for pediatric patients. What does the process look like from ideation to product development?
Jules: One example that we’ve been working on for a few years is called Trach Sense. An ENT at our hospital told me about the need to better monitor mobile, independent tracheostomy patients. In plain language, he wanted to understand how we can keep an eye on kids who have a tracheostomy while they’re not connected to a ventilator, which sounds an alarm if there's a problem — specifically for kids between the ages of about 1 and 14, say, who are out and about moving around, crawling, walking, and playing basketball. Parents want to know if their child is breathing normally through their tracheostomy tube at all times, because many of these kids can't speak and alert someone if the tube falls out.
I started doing a lot of qualitative research with families first and then with other stakeholders in the space, like clinicians, Medicaid, and medical reimbursement experts, that resulted in a product called “Trach Sense,” which monitors CO₂ output.
Parents as (unintentional) industrial designers
Olivia: I'm assuming your STAT article came out of you hearing these needs from parents with medically complex children?
Jules: Well, over a few years, I co-wrote and published two peer-reviewed journal articles before I embarked on that STAT article. The first was “100 Things I Wish Someone Would've Told Me:” Everyday Challenges Parents Face While Caring for Their Children with a Tracheostomy, which was published in Qualitative Health Research. The second one was called Equitable Care for Children with a Tracheostomy: Addressing Challenges and Seeking Systemic Solutions, which was published in Health Expectations Journal.
I've also been part of a group called “Tracheostomy” on Facebook for a few years. They allowed me into their group to listen in on concerns and stories of parents who are caring for children with a tracheostomy. And so this Facebook group serves as a platform for parents to share DIY solutions caretakers have come up with themselves or needs that continue to be unsolved.
On Etsy, parents are creating like industrial designers. They’re making and selling non-FDA-cleared products to other parents that solve a major medical equipment problem. They use 3D printers and sewing machines and their ingenuity.
It's shocking, honestly, that companies haven't picked up on these homemade solutions and either improved their products themselves with accessories or directly reached out to these families who've invented these things and paid them to work on improvements.
Device manufacturers falling short
Olivia: Do you have any hypotheses about why device manufacturers aren't interested in doing that?
Jules: I do. I mean, as everybody knows in the pediatric device world, pediatrics is a small market.
One of the biggest reasons companies don’t make devices for kids is that the market is small. There just aren’t as many children needing these specialized devices compared to adults. That means companies don’t expect to make enough money to cover the high costs of development, testing, and approval. So from a business standpoint, it doesn’t seem worth it to them. We must remember that pediatric patients are not little adults; they have different needs based on their age, their maturity, and their bodies.
Also, testing new devices in kids can be a lot more complicated. Fortunately, there are strict ethical rules because children are a vulnerable population. Companies need internal review board (IRB) approval and permission from parents and sometimes kids themselves. Plus, kids are growing and changing, which sometimes makes the science trickier. All of that adds time, cost, and risk. So many companies shy away from it.
Most medical engineering and design work is focused on adults. So even when a device or medical tool is needed for a child, physicians may use a product made for adults “off-label,” simply because there is no other option.
Helping medically complex children thrive
Olivia: Is there anything else that you didn't get to cover in the STAT article that you’d like to include?
Jules: When children with medical complexity are in the hospital, they usually have high-level equipment working for them. But when these kids are discharged, meaning they’re well enough to go home, they're dependent on Medicaid and the durable medical equipment (DME) suppliers to provide appropriate medical equipment and supplies that serve their needs effectively. Unfortunately, most Medicaid programs still use payment rates for medical equipment that were set 10 to 20 years ago. Since then, a lot of new and better technologies have come out that can really improve health, but they usually cost more. The problem is, there aren’t any incentives for Medicaid, or even many private insurance plans, to pay more for these better options. So even when something works better for patients, it often doesn’t get covered.
The reality is that we have a disparity between the technological advances that save these children's lives in hospitals and the systemic neglect they face once discharged. If we give parents the option to use high-tech healthcare interventions that sustain the life of their child in a hospital setting, as a society, we have a responsibility to ensure that a similar level of technology is accessible for that family to use in their home.
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Book recommendations from Jules:
Research Design: Quantitative, Qualitative, Mixed Methods, Arts-Based, and Community-Based Participatory Research Approaches by Patricia Leavy
Medical Product Development: Meeting FDA's Human Factors Expectations by Michael Wiklund
Exposing the Magic of Design: A Practitioner's Guide to the Methods and Theory of Synthesis, by Jon Kolko
Humanizing Healthcare: Human Factors for Medical Device Design, by Russell J. Branaghan, Joseph S. O’Brian, Emily A. Hildebrand, and L. Bryant Foster
Meditation in Action by Chögyam Trungpa
The Electric Corset and Other Victorian Miracles: Medical Devices and Treatments from the Golden Age of Quackery, by Jeremy Agnew
For young children:
The Mindful Garden: Discover the magic of mindfulness, by Jules Sherman and Thapanee Chosagun