DURHAM – At the beginning of 2020, Dr. Alejandro Pino’s attention was focused on designing and patenting feeding tubes that can unclog themselves while also pursuing a pulmonology and critical care fellowship in the Duke University School of Medicine.
Just a few months later, a novel coronavirus turned the world upside down, and feeding tubes were no longer Pino’s most pressing project.
“All of our fellows who were working on research have been pulled in to help with the crisis,” said Pino, who now spends much more time on rotation, working on the front lines to care for COVID-19 patients at Duke University Hospital. “And none of us can see our family or our friends. I feel guilty just walking my dog because I’m working with COVID-19 patients on a daily basis and don’t want to endanger other people. It’s a lot to handle.”
But Pino hasn’t given up his inventive work entirely—instead, thanks to an innovative campus-wide partnership, he has pivoted to the hopeful work of designing solutions to help protect patients, himself and his fellow health workers.
“All of our fellows who were working on research have been pulled in to help with the crisis. And none of us can see our family or our friends. I feel guilty just walking my dog because I’m working with COVID-19 patients on a daily basis and don’t want to endanger other people. It’s a lot to handle.”
Pino was working on his feeding tube innovation as a fellow in the Duke Design Health Program, a university-wide initiative led by Duke Engineering that brings interdisciplinary teams of students into the clinical environment to actively identify, validate and solve previously unmet challenges. And while his focus has changed, Pino’s collaboration with engineering colleagues has grown even stronger over the past month, as he and other Design Health fellows serve as a direct link between engineers trying to rapidly solve emerging needs and the clinicians they’re trying to help.
It’s on the strong foundation already laid by cross-campus collaborations like Duke Design Health, Duke MEDx and Duke Engineering Entrepreneurship (EngEn) that faculty, staff and students have rapidly built Duke’s new COVID-19 Engineering Response Team.
Within four weeks of formation, the team has coalesced a fully operational pipeline that runs the engineering gauntlet from problem discovery, to rapid prototyping complete with field testing and documentation, to delivering final solutions to caregivers. They’ve already completed two products—3D-printed face shields that are being mass produced, and a 3D-printed part that helps turn an existing orthopedic surgical gown/helmet into a powered filtered-air positive pressure suit offering the highest level of protection caregivers can don.
And with more than seven teams working on a wide range of challenges, they’re only getting started.
SPINNING THREADS INTO A WEB
While the COVID-19 Engineering Response Team coalesced quickly, it began through an assortment of calls for help. Chip Bobbert, the senior engineer and fabrication architect at Duke’s Innovation Co-Lab, had been approached about using the Co-Lab’s many 3D printers to create face shields. Ken Gall, associate dean for entrepreneurship at Duke Engineering, had been approached with the idea of turning a surgical gown into a powered air purifying respirator (PAPR). Eric Richardson, associate professor of biomedical engineering and director of Duke Design Health, had been contacted by a Fortune 50 corporation about figuring out how to produce low-cost ventilators.
At another school, these and other budding projects might have continued down separate tracks. But because so many relationships and programs tie Duke Engineering together with the Duke School of Medicine and School of Nursing, the opportunity to pool resources did not go unnoticed.
“I was on a phone call with Ravi and Ken the weekend after everything started closing [for social distancing], and we realized we needed to formalize all of these projects into a cohesive effort,” said Richardson, speaking of Ravi Bellamkonda, the Vinik Dean of the Pratt School of Engineering. “By the end of the week we had coordinated teams to focus on specific projects.”
This step proved crucial. Rather than blindly barreling down a tunnel toward finished products, the COVID-19 Engineering Response Team led by Richardson, Gall and Paul Fearis took a week to step back, reach out through their existing networks in the health care system, and identified just what the priority needs really were.
“While the world was running around with its head in its hands dealing with tons of requests for PPE, ventilators and the like, we made the decision to take a breath, slow down and quickly talk to the hospital,” said Fearis, a senior lecturing fellow in biomedical engineering. “We’re in a unique position where all we have to do is walk across the road and ask, ‘Is this real? What will really help? And how good does it have to be?’ And we got engagement from the hospital back in spades, which is what really gave us traction rather than having us spinning our wheels.”
“The fact that our response has been so well organized is entirely enabled by having the engineering and medical schools so proximal to each other, both metaphorically and physically,” said Donna Crenshaw, executive director of Duke MEDx, a joint initiative between Duke’s engineering and medical schools to foster interdisciplinary collaboration. “There were already so many channels of communication existing between us. Without those, it would have taken months to organize what we’ve put together in weeks.”
After needs were assessed and working groups formed, the COVID-19 Engineering Response Team got to work. Less than three weeks after the team formed, completed projects were already heading out the door with new ones coming down the pike.
The first project to be realized was adapting existing plans for a 3D-printed face shield so that it could be mass-produced by a local company. After testing about 100 designs, a team led by Bobbert landed on its prototype of a 3D-printed headband that forms a face shield when attached to a laser-cut polycarbonate lens, which is a lightweight piece of plastic with high-impact resistance.
Along the way, with support from Ryan Shaw, associate professor and the Elizabeth C. Clipp Term Chair of Nursing, more than two dozen Duke nurses, graduate nursing students and medical professionals tested the 3D-printed face shields in a simulation lab and determined they met safety standards and could be sanitized for re-use. Similar efforts for testing and validation of other devices is also ongoing.
“What really struck a lot of people when our face shield came out was that we had done testing on it,” said Gall. “Lots of places already had pictures of face shields they’d produced online. It took slightly longer for us to get ours out, but the testing was differentiating compared to what others had done. And the testing matters. It made a big difference.”
The second project to see the light of day was a 3D-printed device that can mount filters onto a surgical helmet to turn it into a Powered Air Purifying Respirator or PAPR. PAPRs—which include reusable respirator hoods that completely cover health care workers’ faces and a battery-powered blower that pulls air through filters or cartridges to keep the suit ventilated, atmosphere breathable and visor clear—provide one of the highest levels of protection for health care workers. These are the preferred PPE for health care workers who are performing more invasive procedures like intubating patients. To date, more than 97 groups have accessed the license and 34 from the United States, Canada, Australia, Norway and United Kingdom have downloaded the design and instructions, which can be used without cost for a year.
The team developed the 3D-printed part for the PAPR under the leadership and guidance of Duke orthopedic spine surgeon Melissa Erickson, who originally approached them with the need and possible solution.
“We have these helmets that we wear during arthroplasty surgery and we started to wonder, ‘Can these be repurposed?’” said Erickson. “If there are national shortages on PPE and PAPRs, maybe we can use things that we have plenty of in the hospital and do modifications to be able to increase the amount of protective personal equipment we have for health care workers.”
ALL HANDS ON DECK
Taking all the help they can get, the COVID-19 Engineering Response Team is also relying on the talents of engineering undergraduate students.
Juniors in the Duke Biomedical Engineering Fellows program, which offers practical design experience through courses and internships, are playing an integral part in several projects. For example, Design Fellow Spencer Moavenzadeh used CAD stress/strain analyses to simulate the face shield frames and propose ways to stiffen them.
“I also have a team of juniors working on a low-resource ventilator design,” said program leader Dr. Mark Palmeri, associate professor of the practice of biomedical engineering. “There are many designs out there for open-source, AMBU-bag based ventilators, but many have missed the mark and not gained traction. This group is looking to learn from those efforts and propose something that is actually useful.”
Meanwhile, seniors Max Sondland and Dimitrios Bailas, who are completing their mechanical engineering capstone design course, have been tapped by their teacher to help create more safe spaces to treat patients. Besides their normal course load, the pair have been working with a team led by surgery resident Konstantinos Economopoulos prototyping and testing a negative-pressure patient isolation tent that expands treatment locations while reducing the risk to clinicians. In partnership with the School of Nursing’s Health Innovation Lab, the team is able to prototype their device across the street from Duke University Hospital. This provides easy access for working clinicians to give feedback.
“They have been extremely effective in developing the ventilation system, taking it from an idea to testing in less than a week,” said Neal Simmons, the Gendell Family Associate Professor of the Practice of Mechanical Engineering and Materials Science. “We could not have developed this idea as quickly or effectively without their intellect, skill and hard work.”
Yet other teams are working on 3D-printed “splitters” that make a single ventilator accessible to more than one patient and an intubation aerosol shield. Keeping up with all of these projects is Erika Segear, associate director of Duke’s Office of Regulatory Affairs and Quality, who is providing regulatory expertise and creating the documentation outlining specifications and testing information that will be provided with each device and shared with other teams nationwide.
And the ideas and devices keep coming.
“It’s fun working with extremely talented people and having an urgent and meaningful goal. I think we’re all exhausted, but we feel like we’re making an impact,” said Richardson.
Nursing Professor Margie Molloy tests the prototype in Duke University School of Nursings Health Innovation Lab led by Professor Ryan Shaw.
SHORT AND LONG-TERM INVESTMENTS
According to Gall, one of the key pieces that put this whole puzzle together is funding, thanks in large part to Allan Kirk, chair of the Department of Surgery in the Duke University School of Medicine.
“Allan and I are neighbors, so we see each other often,” said Gall. “We were talking from a safe distance and he told me about the urgent needs the hospital was facing. When we started building products and purchasing materials, I approached Allan and he stepped in immediately to help. Surgery’s generous financial support enabled us to turbo-charge the projects.” The Health System’s Perioperative enterprise also leaned in with immediate support.
Eric Richardson tries out the PAPR he helped design and produce with Dr. Melissa Erickson by his side.
Without the worry of funding looming over their heads, the COVID Engineering Response Team was able to, for example, purchase a high-temperature pizza oven to heat and bend the face shields to fit their 3D-printed headbands. Everyone in the group agrees that the support of every dean and department head in letting them focus their time on these projects has been crucial. They also agree that the original investments enabling this fast-moving, large-scale effort go back years.
MEDx was forged in 2015 by forward-thinking leaders in the Schools of Medicine and Pratt School of Engineering with support from Provost Sally Kornbluth. The initiative fuels collaboration and team science by providing seed funding for new joint research projects, educational opportunities, and events to spark new collaborations between people from both schools.
The Duke Innovation Co-Lab, a community makerspace with technology resources, programming and facilities to jumpstart successful ideas, was launched in 2016 with an entire wall of more than 80 3D printers. Duke has also been turning its attention toward design, recruiting faculty and offering courses in the freshman year through to a dedicated medical device design masters certificate in biomedical engineering. Even more recently, Duke Engineering launched Duke Engineering Entrepreneurship (EngEn for short), which features an experienced team of entrepreneurs working as instructors, mentors and leaders in an array of educational opportunities, programs and resources for faculty, students and staff.
“The seeds for all of our efforts over the past few weeks were laid well before this crisis, and have been nurtured and grown as new leadership has also realized their value,” said Gall, who co-leads EngEn and is the associate director of MEDx. “These programs are directly responsible for much of the COVID-19 Engineering Response Team even being here at Duke right now.”
“Our strategy of recruiting highly talented design engineers who have a deep interest in teaching, and then allowing them to ‘self-organize’ to do great things built the underlying intellectual capacity at Duke that has now been organized as Duke EngEn and the COVID-19 Engineering Response Team,” said Bellamkonda. “We had no way of anticipating COVID-19, but here we are, with their being front and center in Duke’s COVID response in support of our Duke Health colleagues. It’s a joy to see this ‘dream team’ in action, not just because they are smart, but because they care deeply about making the world better.”
ASTONISHING HUMAN BEINGS
Still, it is perhaps through current and former Duke Design Health Fellows that nimbleness of the COVID-19 Engineering Response Team can truly be understood.
The most recent class of fellows—most of them medical residents, nursing PhD students, and engineering graduate students—started back in August 2019 at the Design Health boot camp, where they were trained to do observational research in Duke Health clinical settings to identify unmet needs. Over the course of that summer and the subsequent semesters, the fellows learned design and business processes and championed teams of students from across the university to address the needs they had identified.
Then COVID-19 hit. The call from the hospital went out, and fellows like Pino, Economopoulos, and Muath Bishawi, a resident in cardiac surgery pursuing a PhD in biomedical engineering and advisor to the Design Health program, switched back into being clinicians. Fellow Jackie Vaughn, an experienced nurse in the midst of finalizing her PhD, began knocking down barriers and opening doors all over the hospital for Bishawi, Konstantinos, Alejandro and the rest of the task force team.
“Literally overnight they went from being our students to saving lives, while at the same time looking through the lens we had given them to identify real-time, real-world needs emerging in the hospital, bringing them back to the task force and embarking on solving them,” said Fearis. “Honestly they are astonishing human beings.”
Having been trained to understand the true need of a patient or clinician, regardless of what they say, and what can be tackled by their skillset, these “astonishing human beings” are the COVID-19 Engineering Response Team’s eyes and ears on the intensive care unit’s floor.
“As physicians, we learn a lot about the observation of patients and physical exams and how to draw conclusions from those,” said Pino. “What I’ve found most helpful from the Design Health Program is having learned how to observe from an engineering or innovator’s perspective, finding solutions for our patients and even questioning solutions that already exist.”
With few indications about how long the pandemic might last, nobody knows when their lives might return to some semblance of normal. But with each problem identified, each innovation tested, and each problem solved, everyone involved with the COVID-19 Engineering Response Team feels like they’re helping the world get just a little bit closer.
And the sooner the better. Nobody wants their friends and family to be in harm’s way.
“We deal with many ‘students’, but it really hits home when one realizes that the student you were joking with or critiquing last evening literally put their life in harm’s way this morning; because that’s what they do,” said Fearis. “I think they respect us as ‘professors’—but nowhere near as much as we respect them as human beings.”
(C) Duke University