“Thus, we stand on the shoulders of giants as we combat this disease. In the meantime, the remarkable spirit of innovation – a true trademark of physician anesthesia – carries on.” Jane Moon, MD, “History and COVID-19, Part II”
As recently as the 1980s in India, when CSA District 7 delegate Govind Rajan, MD, was a young physician, family members had to be recruited and trained to squeeze the manual resuscitation bags of intubated patients. Actual ventilators were in short supply. This was reminiscent of the Danish polio epidemic of 1952, when hand ventilation of patients was necessary because the hundreds of patients with respiratory muscle paralysis quickly exceeded the supply of ventilators of any kind. In 2008, in response to another threatened pandemic (H1N1), a team of Medical Device Design (class 2.75) students at the Massachusetts Institute of Technology (MIT), created a small prototypical device named the “Pandemic Ventilator” that used mechanized paddles to take the place of human hands to compress a resuscitation bag(1). This idea drew interest, and other prototypes were developed, but because the devices 1) were not ventilators, 2) were not sophisticated, 3) were not immediately needed and 4) had proprietary designs, they were not pursued.
Despite social distancing, physicians and scientists are actively collaborating and exchanging ideas. At MIT on March 12, 2020, a volunteer team (MIT E-Vent) of engineers, physicians, computer scientists, and others was formed in response to widespread fears of an inadequate supply of ventilators during the current pandemic. On March 13, 2020, in the attending physician lounge associated with the Main Operating Rooms at the University of California, Irvine (UCI) Medical Center, an impromptu conversation about the present pandemic took place between Dr. Rajan and Brian J. T. Wong, MD, PhD. Dr. Rajan, who specializes in difficult airway management, critical care, cardiac, and liver transplant cases, is also an inventor. He created the MADgic® Airway and other associated devices. Dr. Wong, an E.N.T. and facial plastics surgeon who specializes in the structure and function of the nose, is also a medical device developer.
The two also concluded that the availability of a mechanized resuscitation bag as a stop-gap measure would be valuable. This would allow for rationing the more sophisticated ventilators for the sickest patients, including COVID-19 patients. In collaboration with University of Texas biomedical engineer Thomas Milner, UCI respiratory therapist Trista Kallis, pulmonologist and Interim Director of UCI Beckman Laser Institute Matthew Brenner, MD, they began work on a design for a do-it-yourself (DIY) mechanized resuscitation bag, with support from UCI Director of Engineering Marc Madou. Thus, the Bridge Ventilator Consortium was born.
I encountered Dr. Rajan in his street clothes in the anesthesia library on the evening of March 23, 2020, when I was on an overnight O.R. call. He told me he was on vacation and was working on a project. He showed me the videos of the current MIT prototype and a succinct four-slide PowerPoint talk he had recorded with the aid of his daughter, Devika Rajan, an undergraduate student at the University of Washington.
Instead of keeping the work proprietary, the entire group chose to create and crowd-
source an open design of easily accessible parts, including a Toyota® windshield-wiper motor and an Ambu® manual resuscitation bag. According to their design, the resuscitation bag must be altered to include a long piece of corrugated tubing to allow care-givers access to the patient from a safe distance. The design also specifies pressure sensors and relief valves, and a simple means of calibrating the machine.
Inclusion of the practical theory behind the model and a list of the parts they used, allows other people to build an effective device out of the same or similar available parts (the parts for the 2008 prototype cost about $100.00 but the cost today would be closer to $500.00). They had sent out the design to engineers all over the world via Facebook earlier that day. Dr. Rajan stated “This is the purest and best version of crowd-sourcing I’ve ever seen. We posted a PowerPoint…Within hours Clive [Hawkins] (an engineer in Irvine, CA) contacted me to begin working on a solution…” The following morning, I received an email from Dr. Brian J. T. Wong, who, decades ago, was my resident in the surgical ICU, asking for help in obtaining mannequins to test the device. The request was passed to my colleague, Cameron Ricks, MD, who is deeply involved with simulation. (I have no part in this endeavor beyond that of interested observer and reporter.)
In subsequent days, Dr. Rajan shared with me a video of another mechanized resuscitation bag that was created by Clive Hawkins, which uses a KitchenAid® Artisan stand mixer as a motor. The Israeli Air Force, gaming computer manufacturers, engineers, and hackers all over the world have been devising similar devices from available parts.
In the U.S., Medtronic, which makes medical devices, has released its specifications for an older ventilator model. Ford and General Motors are committed to manufacturing more sophisticated ventilators. Tesla and Dyson are also diverting energy from normal operations to help fill the gap with innovative designs.
MIT engineers are still active in this effort, as are Rice University, University of Toronto, and open source groups Protofy.xyz in Spain and Open Source Ventilator in Ireland.
At the time of this publication, this list of participants worldwide has grown much larger.
Virgin Orbit (Richard Branson’s company within the Virgin Group which developed the midair-launched LauncherOne® rocket to provide launch services for small satellites) took on the task of building a mechanical resuscitation bag, which uses a motor to rotate a potato-shaped cam (a rotating or sliding piece in a mechanical linkage used to transform rotary motion into linear motion), pressing a patch of metal onto the bag with adjustable depth. Kevin Zagorski, who leads Virgin Orbit’s advanced manufacturing work, took direction and inspiration from the Bridge Ventilator Consortium. In the hands of Virgin Orbit, the design has improved after input from experts. The device is simple, practical, and robust, as well as easy to make. Virgin Orbit has submitted an application for Emergency Use Authorization and has presented the machine to Gavin Newsom, Governor of California and Dr. David Duncan, head of the Emergency Medical Services Authority.
The Virgin Orbit Bridge Ventilator does, in fact, exist, and is as sophisticated as the ventilators on the anesthesia machines I used for NICU babies and other patients early in my career. It is also portable and elegant. Dr. Rajan is presently working with UCI engineering students who are designing and building a toolbox-sized device that compresses a manual resuscitation bag pneumatically. He expresses regret that the practice of medicine is really quite removed from the work of engineers and designers of the equipment we use. He hopes that this gap can be “bridged.”
The Bridge Ventilator Consortium was recently involved in judging a pan-African contest on designing and building a bridge ventilator. A team of young engineers from Ghana won the competition. The Bridge Ventilator Consortium is also seeking other gaps that need bridging.
We are deeply in the trenches of a pandemic, exceeding our resources, experiencing a threat to countless human lives, the interruption of lifestyles and more critically, a disruption of our supply chain, with resulting medical and economic hardship. The new “giants” who may be emerging are clinicians and scientists, engineers and manufacturers, many of whom have expanded their area of expertise to contribute materially to this effort. In addition, scientists and physicians are expanding our knowledge and ability to fight this worldwide battle. There are also significant contributions from volunteers and entire companies making personal protective equipment. They are designing alternative ways to shield health care providers from contamination during care of infected patients, and considering ways to protect people as we re-open businesses and begin to travel again.
Whether or not people and companies presently moving out of their usual “swim lanes” are truly “giants” remains to be determined. They are, at the very least, “bridges,” helping to connect professional and clinical expertise within a discipline with designers and manufacturers who may have had no previous expertise in the field. Interdisciplinary teams are developing tools for diagnosis, contact tracing, and treatment. This bridging phenomenon and the present crisis will likely change some lives forever.
- Al Husseini, AM, HJ Lee, J Negrete, S Powelson, A Servi, A Slocum, J Saukkonen. Design and Prototyping of a Low-cost Portable Mechanical Ventilator. Proceedings of the 2010 Design of Medical Devices Conference DMD2010, April 13-15, 2010, Minneapolis, MN.