A group of HST students have found an effective and innovative way to use their talents to battle the serious threats of the pandemic to healthcare workers on the frontlines.
The Covid-19 pandemic crisis has forced many people around the world into jobs and tasks they never imagined themselves doing. We, a group of PhD and MD students from the Harvard-MIT Program in Health Sciences and Technology (HST), found ourselves in the same position in late March. As Massachusetts and the greater Boston area joined the world in grappling with the impacts of Covid-19 on our healthcare infrastructure – due in part to the lack of a centralized response – we found ourselves feeling a sense of urgency to help in any way we could. Many of those on the frontlines of the crisis were our personal friends, teachers, and colleagues. We wanted to use our cross-disciplinary clinical and engineering perspectives to help them somehow.
The answer to our dilemma was to help in the formation of the Greater Boston Pandemic Fabrication Team (PanFab). PanFab, which has grown to include 150 volunteers, organized completely online in a matter of days as the terrifying effects of Covid-19 were spreading around the world. The catalyst for PanFab was Peter Sorger, Professor of Systems Biology at Harvard Medical School (HMS), and co-director of the Harvard Program in Therapeutic Sciences and the Harvard-MIT Center for Regulatory Sciences, and Dr. Nicole LeBoeuf, Assistant Professor in Dermatology at HMS. Our backgrounds are diverse, with affiliations spanning industry and academic centers across the country, and expertise ranging from radiation research to neurosurgery. However, we shared a common goal: to find a way to effectively respond to this pandemic and to leave behind openly available designs and work products that will aid in future crisis management.
Deborah Plana, one of PanFab’s coordinating leads, is an HST MD student who is also working on a PhD in the Harvard Systems Biology program and is advised by Sorger. She was the first HST student to join PanFab and has skillfully managed all of PanFab projects since their inception. Deborah also recruited the rest of us: Marc-Joseph (MJ) Antonini, Avilash Kalpathy Cramer, and Aditi Gupta are fifth year PhD students in HST’s Medical Engineering and Medical Physics (MEMP) program; and Malia McAvoy is a 2020 HST MD graduate who is starting her neurosurgery residency at the University of Washington. Also participating is Lyla Atta, an MIT alumna who is a second year MD-PhD student at Johns Hopkins University. Together, we focus on addressing shortages of personal protective equipment (PPE), identified by PanFab and its clinical partners. For Plana, PanFab embodies the ingenuity and passion of the HST program, and of the MIT Institute for Medical Engineering and Science (IMES), which is HST’s home at MIT.
She says that what started out as a local, grassroots volunteer effort has grown far beyond Boston into “a multi-institutional, multinational group and resulted in tangible work products.” These products include the creation and the delivery of over 3,000 face shields to front-line healthcare workers, the integration of a sterilization method for PPE reuse into the workflow of a major academic medical center, and the creation of an open-source Powered Air Purifying Respirator (PAPR) prototype.
None of us came into this project with expertise in pandemic response. We spent our “pre-pandemic” lives building skills and experience towards our own personal and professional goals, whether in 3D printing, materials, mechanical engineering, or otherwise. However, in the face of crisis, we realized we needed to find some way to use these skills in a completely different context. We all felt a need to answer this call for different reasons. For McAvoy, her motivation was to serve her fellow residents.
“I was a fourth year HST medical student finishing my last clinical rotation on the general surgery trauma service in March when I saw the healthcare system begin to change, and with it, the impact on medical residents,” McAvoy says. “I heard residents asking each other the same questions: how are we going to protect ourselves when we respond to codes? Are we all going to be reassigned?”
McAvoy said that due to the shortages of PPE, medical students were sent home. This was frustrating, she continues, because “I was mere months away from obtaining my medical license, so why couldn’t I start now? But I understood – the extra work required to train and on-board new doctors is not available during a crisis.”
McAvoy, who had worked in chemical engineering labs on drug-embedded coatings for medical devices before starting medical school, turned to her research lab roots to come up with a solution to defective N95 shields. “At that time, I was immersed in advancing my clinical skills and hadn’t entered a research lab in two years,” she says. Marshalling the skills she had learned doing lab research, she is pleased that she has been able to “use my experience in materials science to serve my co-residents on the front lines who were too busy treating patients to address critical PPE shortages endangering their own lives.”
McAvoy, now based in Seattle, leads a PanFab project to develop 3D-printed mask frames to replace defective N95 bands and improve N95 fit. She points out that while 3D printing wasn’t her area of expertise, she did have experience with CAD software and, and now had the time to devote to the project.
“Calling myself an engineer again has been a privilege,” McAvoy says. “The rapid development of prototypes to address a specific clinical need is exactly what the HST program trained us for and these skills will continue to benefit me as a surgeon.”
McAvoy is facilitating collaboration between PanFab and the University of Washington Center for Digital Fabrication, which has led to an effective exchange of insights, expertise, and solutions being developed by these respective groups, together and apart.
While Cramer, Antonini, and Gupta are not training to practice medicine, they work closely with those that are, and felt just as strong a desire to help protect them.
Cramer, whose background is in X-ray devices and radiation physics, was connected to PanFab when he was looking for tools to assess the efficacy of gamma irradiation for N95 respirator sterilization. The gamma sterilization was quickly found to be a non-viable technique. However, Cramer then joined a large team of scientists and clinicians, all brought together by PanFab, to develop the protocol for, and verify the safety of, an ionized hyrodegen peroxide system at the Dana-Farber Cancer Institute for respirator sterilization. These studies produced some of the first literature around these methods, and were used to inform clinical workflow, FDA emergency use authorization statements, and IAEA recommendations.
Cramer says that “many of my friends and colleagues – including my thesis advisor – are practicing healthcare providers, and I was concerned for their safety. Studying PPE sterilization was a clear and impactful way to use my training in physics and medicine to help protect my community.”
Face shields were the first critical PPE shortage PanFab sought to address through device design. Two local makers, Chris Van and Rich Oakley, initiated the project. They revised the Prusa face shield design based on feedback from Dr. Sherry Yu from Brigham and Women’s Hospital (BWH). Antonini and the rest of the PanFab team joined this effort – a project that was especially important to Antonini.
“At the beginning of the pandemic, I was growing frustrated that I didn’t know how to help despite being trained in medical engineering in the HST program,” Antonini says. “The face shield project allowed me to leverage my background in mechanical and industrial engineering and medicine to have a direct impact on the healthcare workers in local hospitals.”
The varying skills of the PanFab team blended expertise in material sciences, rapid prototyping, and medicine to address issues of biocompatibility, scalability and manufacturing for the PanFab face shield. In parallel, we partnered with the BWH Emergency Department to clinically validate our first prototype and iterate based on the feedback from a clinical study. The final design was also adapted to be compatible with larger scale manufacturing techniques, was made openly available on our website, and the findings were published as an open access preprint to maximize access and dissemination.
While completing various PanFab design and manufacturing projects, we encountered an unexpected challenge: difficulty in navigating the ever-evolving emergency regulations in medical device design. Several regulatory guidelines enable makers to contribute to addressing the PPE shortage. However, information regarding verification and validation of alternative PPE is scarce, resulting in the creation of products that may not meet user needs or safety and efficacy standards. Such ill-advised products can inhibit production and dissemination of effective PPE and greatly burden hospital procurement efforts. PanFab partnered with Ben Linville-Engler from MIT’s System Design and Management and member of the Massachusetts Emergency Response Team, and Shriya Srinivasan, a postdoctoral fellow in the Langer Lab and an HST MEMP PhD 2020 graduate, to develop a design framework for crisis situations to guide makers and hospital administrators in designing and evaluating medical supplies for short-term emergency use.
PanFab volunteers have worked in the past few months to help local healthcare workers gain access to PPE, whether through design and manufacturing of new PPE, or via research on PPE sterilization methods. Now, as Massachusetts moves past its peak in Covid-19 cases, we are looking to the future and how to further leverage our newfound knowledge, and to share it more broadly.
Gupta, who leads PanFab outreach efforts, cares deeply about equitable access to healthcare and technologies and is grateful that she has found a way to use her skills to help combat the pandemic.
Gupta is struck by the fact that even though we are privileged to live and work in Boston, where some of the world’s premier medical and engineering facilities intersect – the impact of this pandemic has still been devastating. She adds: “Having worked on engineering and clinical projects for resource limited settings in my academic career, I am very aware of inequities in healthcare access that exist, not just around the world, but in our own backyard. I wanted to ensure PanFab’s expertise and knowledge would benefit others with access to far fewer resources.”
To that end, PanFab has begun working with international groups to share knowledge and help create data-driven solutions around the world. Specifically, we are working closely with a group of volunteers in Brazil who are interested in manufacturing PPE to protect healthcare workers in Brazilian hospitals. We are also collaborating with Partners in Health sites in Haiti, Mexico, and Peru to assist them in leveraging local resources to start sterilizing their (often already limited) supply of PPE.
Though we will continue to do our small part to ensure that healthcare workers around the world are protected while they confront the Covid-19 crisis, our efforts are a stop-gap. In particular, our PPE designs and sterilization methods are not FDA approved, but rather are implementable under the FDA Emergency Use Authorization criteria, which in turn is contingent upon a declared state of emergency. What will happen to US healthcare workers dependent on alternative or sterilized PPE, if the federal government ends the declared public health emergency prematurely?
The Covid-19 pandemic has uncovered a clear need for better disaster preparedness infrastructure to ensure the protection of frontline workers and the resiliency of supply chains in future crises. While we are proud and honored to help our friends, teachers, and colleagues around the world during this crisis, we cannot help but reflect on why this need exists at all. We believe that certain measures could help mitigate such disruptions in future pandemics. A few examples of such measures include access to vetted, open-source designs for (ideally re-suable) PPE with associated sterilization procedures during crisis situations, and employment of hospital procurement officers with clinical and engineering expertise. PanFab aims to be an interim measure, not a long-term repeatable solution. Rather, we hope our learnings, which we will maintain as open-source and accessible to all, can inform systemic change to mitigate damage from future crises.
About the Authors
Aditi Gupta is a fifth year HST MEMP PhD candidate advised by Prof. Leia Stirling. She studies individualized variation in human walking strategy during exoskeleton operation. She previously earned a BS in Bioengineering at UC San Diego. She is very interested in issues of social justice and aims to use her skills to address disparities in healthcare, education, and technology access.
Deborah Plana is an MD‐PhD student. She is completing her MD in the HST program and currently pursuing her PhD in the Harvard Systems Biology program, jointly supervised by Peter Sorger and Adam Palmer from UNC School of Medicine. She previously earned her undergraduate degree in Biological Engineering at MIT, working under the supervision of Douglas Lauffenburger. Her research focuses on using data‐driven approaches to design combination treatments in oncology.
MJ Antonini is a fifth year HST MEMP PhD candidate. He has a master’s degree in mechanical and industrial engineering from Arts et Metiers ParisTech and a master’s degree in Neuroscience from Université Paris-Sud. At MIT he is focusing on the design and development of polymer fibers for neural recording and stimulation in the lab of Polina Anikeeva.
Avilash Cramer is a fifth year HST MEMP PhD candidate. He has a master’s degree in electrical engineering and computer science from MIT, and ScB in physics from Brown University. A former Fulbright scholar to India, his research in the lab of Dr. Rajiv Gupta is centered on the development of radiology tools for rural and low-income communities.
Malia McAvoy is a graduate of the HST MD program. Her research is on drug embedded electrodes for muscle stimulation with Prof. Daniel Anderson and Prof. Robert Langer. She previously earned BS/MS degrees in biochemistry at Brandeis University. She is entering a neurological surgery residency at the University of Washington under Dr. Richard Ellenbogen where she will study drug embedded coatings for endovascular coils.
Lyla Atta is a second year MD-PhD student at Johns Hopkins University. She is about to start her PhD in Biomedical Engineering and had previously earned her undergraduate degree in Biological Engineering at MIT. She is interested in systems and computational biology and how mathematical and statistical methods can be used to understand the biological networks driving disease.