A grassroots uprising of makers, engineers and others are creating a backup plan for the backup plan for COVID-19. This is about the people and projects of Plan C from Maker Space.

In the face of COVID-19, shortages of medical equipment, such as ventilators for patients, and protective gear for personnel in hospitals are becoming a critical problem. Who will be able to address these shortages in time? The Maker Movement might provide a “Plan C” for America and the world.

Read more articles about Plan C: What makers are doing to combat Covid-19

Indeed, it’s starting to happen already. In Italy, shortages are contributing to a higher mortality rate for patients infected with COVID-19, even forcing difficult decisions about which patients are treated. Italy has shown that 3D printed parts can be made to repair ventilators and keep them in service, thus saving lives. But could makers do even more? The supply of ventilators in the US is not enough to meet the expected spread of infection, and many ventilators we have are already in use. Caregivers need more protective gear too.

“Plan A” is the federal government promptly using its emergency power to take over factories to produce needed equipment. President Trump could authorize the Defense Production Act to do so, but he has been slow to do it. “Plan B” is America’s private industry, stepping up to produce equipment and supplies in their factories. GM and Tesla each declared interest in doing so, but many of America’s largest companies don’t have factories nor the design and manufacturing talent. Of the five companies that sell ventilators, only the two smallest manufacture them in the US. An additional problem for manufacturing these devices is our dependence on a China-based supply chain that is unable to meet demand.

That leaves us with “Plan C”: groups of independent makers, entrepreneurs and innovators who are organizing online to provide alternative solutions. Many of them are excited by the prospect of creating open designs and rapidly producing ventilators in makerspaces. Individual examples of DIY solutions can be found online, such as a 10-year old design by Clarence Graansma. His project, as described on Instructables, was presciently called The Pandemic Ventilator, and was made of wood, using a ziplock bag as a bellows. Graansma years ago recognized the need for an improved design and began connecting with other makers.

Open Source Ventilators

Many groups have sprung up online, using Facebook and/or Slack, including:

They all share a common objective: to produce a viable design for a ventilator or other equipment that can be shared widely and replicated locally using 3D printers and other tools found in a makerspace. While the very idea of DIY ventilators frightens some medical professionals, they should take comfort in the idea of Plan C as a backup plan for the backup plan.

Critically ill COVID-19 patients need ventilators as their lungs fill with fluid and they have difficulty breathing on their own. While there has been much enthusiasm for an open source design, producing one has faced some challenges.

A typical ventilator is a complex machine, consisting of hardware and software performing at highly rigorous standards. As a medical device, it requires FDA approval. Representatives of the American Association of Respiratory Care have expressed understandable concerns about whether a quality open-source device for clinical use could be designed and manufactured in less than 18 months, given time for development, testing and approval.

But will America get to a moment when “good enough” is enough?

Open Collaboration

Plan C for COVID-19 is being organized by individuals who believe we may get to that moment. They are already communicating nationally and internationally and mobilizing locally. This may be a pioneering approach, but it is a strategy perfect for a global problem that is not happening in just one place, at a time when collaborative expertise can be accessed almost anywhere.

In addition to Graansma’s DIY Pandemic Ventilator, there are others. Another project from 2010 was Ambu-Bag, created in an MIT mechanical engineering students project developed as a portable “bag-valve mask (BVM)” ventilator for use in an ambulance. A patent was issued, but the project was abandoned. A bag-valve mask ventilator is a manually-operated air pump, requiring a person to compress and release the bag for hours on end. These assistive devices were used to treat patients during the flu epidemic of 1918. The Ambu-Bag modification replaces the person with a mechanical device that gently applies pressure on the bag and then releases it slowly, like a pair of human hands. While these ventilators may not be sufficient for the most critically ill, bag-valve masks can be used on less critical patients, freeing up more expensive, complex ventilators for use.

Ambu-Bag prototype

Robot builder Gui Cavalcanti, known for his Megabots project, is one of the lead organizers of the Open Source COVID-19 group. It started as a ventilator project, and like many others sought to design, prototype and fabricate a ventilator. After all, one might consider a ventilator just another robot. After reviewing the different needs, however, Cavalcanti decided that the group should pivot and not focus on the ventilator. “I interviewed a (medical) practitioner,” said Cavalcanti, “and I realized that there were even more problems beyond ventilators.” He added that he “found out that we were rapidly running out of all supplies needed to treat COVID19, and so I shifted the group’s focus to be about identifying all the equipment necessary.” The group is working on a website, said Calvancanti, “that will be a repository of vetted open source designs that fabricators around the world can make locally to provide to hospital systems in need.”

Colin Keogh, an engineering PhD candidate at Dublin University in Ireland, and two others created the Open Source Ventilator (OSV) Ireland. One of the projects, led by Trevor Smale, is the Open Lung BVM Ventilator, which is a 3D printed Bag-Valve-Mask device. The design has gone through seven revisions in a short period and the effort continues at OpenSourceVentilator.ie.

https://twitter.com/simplyacreative/status/1241765223981289472

Natalie Dickman, a bioengineering student at Rice University’s Oshman Engineering Design Kitchen (OEDK) and the “Take a Breather” team developed a design spec for a bag-valve mask. This was a 2019 capstone project designed for use in countries like Thailand. Dickman shared the spec in the Helpful Engineering Slack group. “Our overall goal is the creation of a hands-free, reliable, and long-lasting attachment to fit onto the standard bag valve mask,” she writes in the document.

Another project that referenced Ambu-bag is a specification for an Open-Source Mechanical Ventilator started by Julian Botta, a resident at Johns Hopkins University’s Emergency Medicine Department. Its specification is being edited by a group of 79 people.

A key challenge of all these groups is finding vetted specifications or standards for the devices they need to make. Makers — if they are to build ventilators — need quality design specifications.

Designs Depend On Design Specifications

An initiative to create quality design standards has already made an impact. In 2012, there was a call for proposals to address the Advanced Development of Medical Countermeasures for Pandemic Influenza by the Biomedical Advanced Research and Development Agency (BARDA, an agency modeled after DARPA). There’s a BARDA Industry Day presentation, “Respiratory Devices for Medical Countermeasures,” in which a slogan appears in the footer: “Resilient People. Healthy Communities. A Nation Prepared.” In December 2019, “Preparing for the Next Pandemic” was written by Robert Kadlec, the Assistant Secretary for Preparedness and Response (ASPR) of Health and Human Services, which oversees BARDA. He wrote that a portable ventilator had been developed by Phillips as part of the BARDA program and “was cleared by FDA earlier this year for use in institutional, home, and field settings by minimally trained operators and is now stockpiled in the Strategic National Stockpile for immediate distribution when needed.” Kadlec added:

“Containing a pandemic will require layered end-to-end solutions: better diagnostics, closer to the patient; improved therapeutics, especially for hospitalized patients; and, perhaps most importantly, better vaccines that are produced in the United States using more modern, fast and flexible technologies. We cannot continue to rely on technologies that are old and too slow to save lives. We must continue to evolve mitigation strategies and technologies.”

Hacking CPAP Machines

One story provides insight on how makers must balance between medical need and engineering efficiency. There are millions of CPAP machines in the world. With one that he uses for his own sleep apnea, Johnny Lee, a maker in the San Francisco Bay Area, thought about modifying these breathing machines to make a ventilator. (Lee contributed to the first issue of Make: magazine with his DIY Steadicam Project.) Working with the CPAP equipment at home, Lee created two different devices and published his designs on GitHub. One is a DIY BiPAP ventilator that he called “a last resort-only option” because of the risks of using it. The other was a low-cost Powered Air Purifying Respirator (PAPR), which provides filtered air inside a protective suit worn by those caring for COVID-19 patients. Johnny considers the PAPR device much less risky.

According to Lee, the big issue with a DIY ventilator is that a trained professional is still required to control it, using their awareness and judgement of the patient’s condition. The ventilator cannot be hooked up to a patient and just set to operate on its own. However, that means that training new operators properly is as much a problem as building the ventilators themselves.

“There are tradeoffs,” said Lee. He’s learned about those tradeoffs by speaking with pulmonologists whom he said are “very busy” and “took a little time to warm up to the idea.” Nonetheless, he felt the conversation was beneficial to both sides. Lee observed that a medical doctor tends to look at a machine as having certain features or not. Engineers, in contrast, see the opportunity in terms of how much control is needed; the machine can be modified to meet the needs.

Lee found it easy to control the CPAP’s motor using an Arduino. “It’s a brushless DC motor, just like you find in RC cars,” he said. “It took only a few lines of code to control it.” Some things are easy for makers and engineers that others might find hard. Lee’s design is still a work-in-progress, missing several feedback sensors that can help avoid doing damage to patients.

Lee is aware that a modified-CPAP machine becoming a BiPAP ventilator is potentially dangerous. “Community-driven engineering efforts like this run the risk of making it ‘too easy to be harmful,” a phrase that he picked up from the Open Source COVID-19 group. These projects require technical knowledge and expertise with tools, and should not be attempted by people without the proper background. For Lee, it’s a classic engineering problem of how to mitigate risks by improving design or by changing the way people might use a device.

Feedback on Lee’s GitHub page has been mostly positive, with only a few people concerned about his publishing the design. He’s heard from people in developing countries that they appreciated the project because they are happy to have the “last resort-only option.”

Protective Gear and Parts

There are other pressing needs that require attention.

Jose Gomez-Marquez of the Little Devices Lab at MIT, who grew up in Honduras and did graduate work there, had observed that medical technicians in developing countries often modify second-hand medical equipment that often comes from the United States. They have no choice; spare parts may not be available or equipment doesn’t work in the conditions of Latin America. In the Little Devices Lab, Gomez-Marquez prototypes medical devices that are intentionally designed to be modified, allowing innovation to be distributed in the field and adapted to local conditions. Gomez-Marquez also looked into reviving the Ambu-bag project but thought that there were easier projects to be done first, using some of the DIY design practices he’s developed in his lab. He emphasized the importance of DIY instructions and mentioned that the World Health Organization already publishes make-your-own instructions for certain products that might not be commercially available in some countries, such as Oral Rehydration Solutions (ORS).

Josef Prusa of Prusa Research, a 3D printing company in Prague, also decided that replicating untested designs for ventilators wasn’t the best place to start for 3D printing hobbyists. His company rapidly developed a printable design for a protective face shield for medical professionals that was reviewed by the Czech Health Ministry. Designs for face goggles are next in line.

Helpful Engineering has 3,000 registered volunteers, including engineers, doctors and scientists. “How to do the most good in the quickest time,” says its welcoming document for new volunteers. “Technology can’t solve every problem. But, idled by this crisis, vast amounts of engineering and manufacturing resources sit by with no use.”

Helpful Engineering is working through project proposals and submitting them to peer review by experts. The rapid review process looks at a project’s design and feasibility and makes recommendations about which projects the group should prioritize. A recent review recommended the “Hardware Personal Protective Equipment” project that has a short path to be realized.

Johnny Lee demonstrates that it is possible to push the limits of machines and make modifications rapidly. He emphasized that while the enthusiasm for a DIY ventilator remains high, more effort should be directed to creating solutions for protective gear — masks, gowns and other personal protective equipment.

This concern is echoed by Gui Cavalcanti. “Nurses in Seattle are already making face masks by duct taping plastic to rubber bands in conference rooms,” he said. “Nurses in Brigham & Women’s in Boston are asking for N95 donations from their community because the hospital can’t ask directly, and hospitals in San Francisco are having hand sanitizer and PPE stolen from hospitals.”

Getting Involved

To keep track of the many collaborative projects, check out COVIDbase, developed by DIYBio leaders, Eri Gentry and Tito Jankowski. There are many projects happening quickly, and it can be overwhelming to jump into the stream of a Facebook or Slack group.

It’s too soon to tell if these many Plan C efforts will be productive. Yet there are no assurances that Plans A and B will be enough. The German military strategist Helmuth von Moltke said famously that “no plan survives contact with the enemy.” Now that the pandemic is upon us, we’re in a mad scramble to find solutions when the context is constantly changing. Perhaps our governmental and business leaders can recognize the importance of Plan C by tapping into the latent base of engineering, design, and maker talent across America and the world. Perhaps they can even take a more active role to support, coordinate, and scale the efforts of Plan C.

A global problem requires massive innovation. It might be the right moment to unleash the decentralized, creative might of the Maker Movement to help solve the challenge.

Here are some the takeaways so far:

  1. Independent individuals and groups will develop and test open source designs, which they can share out to a larger community to begin replicating devices in local communities.
    1. If you are a maker with ideas and projects, join a group.
    2. All groups need to push for a quick consensus on the most appropriate project designs.
  2. More direct collaboration between the medical/scientific and the maker/engineering communities is needed to ensure that open source designs meet required specifications.
  3. Protective gear for medical personnel is a high priority with less stringent technical hurdles and offers an opportunity for innovative, localized even low-tech solutions.
  4. Some groups have started to look for funding to build prototypes, but given the urgency there isn’t time to do crowdfunding.
  5. There’s even more out maker activity going on there, and this article will be out of date by the time it is published.
  6. Time is everything.

This uprising of action in response to COVID-19 demonstrates the ingenuity and talent that flourishes at the grassroots, alongside the resources of government and the corporate sector. It also fills a powerful desire for people to get involved and bring whatever expertise they have to bear — technical, medical, social, political, legal.

This movement inspires hope for the future. Leveraging open, collaborative innovation by grassroots makers at international and local levels can help solve not just for the coronavirus, but teach us new ways to work together to solve other challenges too.

Look to Make: for ongoing updates on the people, projects and groups of the Plan C response.

If you’d like to share your projects or ideas, write Dale at [email protected]