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3D Printing in a Pandemic: Turning CHOP Into a Next-Gen Hospital
limjr [at] chop.edu (By Jillian Rose Lim)title="Email Jillian Rose Lim"
What do rare diseases and a pandemic have in common? Both, according to Flaura Winston, MD, PhD, are unprecedented. Both often come with no evidence base, definitive guidebook, or large test trials. In both, it can be a challenge to obtain the unique tools or resources needed to provide care. But it’s here that Dr. Winston and Raymond Wang Sze, MD, attending radiologist at CHOP, saw an opportunity: How could the process of 3D printing at a patient’s place of care be perfected to meet the needs of both rare conditions and pandemics like COVID-19 safely, speedily, and effectively?
“There’s very little out there about the hospital as a manufacturing facility,” said Dr. Winston, leader of CHOP’s Innovation Ecosystem. “Nevertheless, it’s important in pediatrics because it’s not commercially viable to get something for a specific child that there’s a small market for, but it may be crucial to manufacture something for that child to meet their medical or surgical need. We are exploring how to come up with a successful process for point-of-care (POC) manufacturing that will save lives. How do we meet the needs of our patients while staying safe and meeting regulations?”
Seeing the COVID-19 pandemic as an opportunity to address this, Dr. Winston and Dr. Sze, who is head of CHOP’s Additive Manufacturing for Pediatrics (CHAMP) Lab, collaborated to create a project called CRISIS, or Connected Rapid Innovation System to Meet Identified Problems with Solutions. Through CRISIS, which received funding by a National Science Foundation Rapid Response Research grant, the team sought to design a system for deploying solutions to address critical supply shortages through POC manufacturing.
CRISIS 3D-printed a number of COVID-19 materials, including a novel transparent face mask, protective ventilator components, nasal swabs, and even an innovative “COVID hook” to reduce hand contact. They detailed their experience in the Annals of 3D Printed Medicine, the first paper in a series of four that describes the research process of refining POC manufacturing within hospitals. But while CRISIS was born out of the COVID-19 pandemic’s lack of critical supplies, its application extends to other urgent POC needs as well. In fact, POC manufacturing has become so pertinent a topic that in December of 2021, the U.S. Food and Drug Administration released a request for public input about the process, in order to draft regulatory guidance.
But to understand the value of 3D printing within a hospital setting, it helps to begin this story with the CHAMP Lab and its innovative engineers.
Meet the Champions in the CHAMP Lab
Prior to CRISIS, Dr. Sze and Elizabeth Silvestro, lead engineer of the CHAMP Lab and a key member of CRISIS, had already been 3D printing for some time. In 2015, Dr. Sze and Silvestro had been tasked with revitalizing a 3D printer CHOP had purchased a few years ago by offering it as a service for pediatrics.
“We focused initially on providing 3D printing as a service for clinical applications, seeing as it’s housed in radiology,” Silvestro said. “And then from there, we had the idea of reaching out wider and wider on what we could actually help with. Now, we have four buckets of service: surgical models, education models for patients and families, training models for any kind of education for staff members, and then finally this kind of new service line of devices, especially point-of-care devices.”
Not surprisingly, the CHAMP Lab’s list of accomplishments are impressive and innovative: In 2018, Dr. Sze and Silvestro helped radiologist Susan Back, MD, and urologist Thomas Kolon, MD, create a 3D model of a 5-year-old patient’s kidney that contained a cancerous tumor. Because the personalized model could be opened up to help visualize the tumor and its relationship to the patient’s arteries, veins, and other structures, it helped Dr. Kolon study the patient’s anatomy from a new perspective. And in a recent story that made TODAY Show headlines, Dr. Back, Dr. Sze, and Silvestro created a 3D-printed model of the livers of conjoined twin girls, allowing CHOP surgeon Holly Hedricks, MD, to see how the twins were interconnected and prepare for surgery.
Thus, in 2020 when COVID-19 hit and the need for supplies became critical, Drs. Sze and Winston decided to use the CHAMP Lab’s expertise and energy. Beyond simply 3D printing materials needed by the hospital, Dr. Winston, who was already one of Dr. Sze’s mentors, introduced the idea of documenting the ups and downs of the experience in a research project that would help CHOP and other hospitals prepare for future emergency situations.
“We used the chance of the pandemic as an opportunity to figure out this pathway of POC manufacturing within hospitals, whether it was for building something needed for a research project, something that’s needed clinically, or a prototype,” Dr. Winston said.
Process Research in a Pandemic
In the first paper, the researchers describe key lessons learned from the pandemic, drawing on collaborations with other CHOP groups like Supply Chain, Infection Prevention, and the Bioresponse team. The CRISIS team sought to learn from their COVID-19 experience to improve systems post-pandemic, addressing Dr. Winston’s well-known concept of crossing “the valley of death” to transform an idea into an applicable, sustainable, and effective innovation-in-action.
“I often think about not just what research question our work will answer, but how the research is actually going to have an impact,” Dr. Winston said. “We knew engineering-wise we could build [these things], but to go over that valley of death, you needed to meet the standards the hospital would set. And there are also things related to cost and safety. So, we had to have little mini protocols to do that research testing to validate that this was good enough for our patients. With these COVID materials, we checked all the boxes.”
Lessons addressed in the paper include how to establish a general workflow process, from clearly identifying needs, to determining who has the authority to approve a printed device, to defining the lab’s maximum capabilities using the COVID hook as an example. The paper also addressed the need for robust evaluation processes for safety and compliance even amid unprecedented times. When temporary policy modifications like the FDA’s Emergency Use Authorization eased the regulatory burden to support device manufacturing for example, the team gathered a network of experts to conduct safety reviews in times of emergency.
In the following papers, the team further addressed the topics of safety (using the face mask as a case study) as well as how to identify which projects make sense to do in a 3D printing setting and the standards hospitals need to know should they begin manufacturing materials at the point of care.
While the FDA has not yet released regulatory guidance on the subject, 3D printing in hospitals continues to grow in popularity, and Dr. Winston sees the research as a way to take a leadership perspective and transform CHOP into a “next-generation hospital.”
“The way we look at it, it isn’t just that it’s how to do this during a pandemic,” Dr. Winston said. “A lot of pediatrics has the same issues because we’re dealing with rare conditions. There isn’t an evidence base for what we’re doing; it’s all new. The conjoined twins, for example, we don’t have a randomized trial of hundreds of thousands of conjoined twins on which to do our surgery. We want to meet the needs of our individual patients who have these rare conditions and be that place that can do it.”