Pop-Up Open Source Medical Hardware Projects Won’t Stop Coronavirus, but Might Be Useful Anyway. Here’s Why

Quick fixes that don’t scale probably won’t make much difference to this pandemic, but they might get the ball rolling for the next one

5 min read
Cristian Fracassi, founder of Isinnova, poses with one of the Venturi valves he produced using a 3D printer, in Brescia, Italy Tuesday, March 17, 2020.
Cristian Fracassi, founder of Isinnova, poses with one of the Venturi valves he produced using a 3D printer, in Brescia, Italy Tuesday, March 17, 2020. After hearing the nearby hospital of Chiari had run out of this valve, used in respirators, and that they were nowhere to be found, Fracassi decided to help printing them and donating them to the hospital.
Photo: Claudio Furlan/LaPresse/AP

Halfway to the moon and bleeding oxygen into space, the Apollo 13 spacecraft and its occupants seemed in dire straits. But the astronauts modified their CO2 scrubbers with a duct-tape-and-plastic-bag solution cooked up by NASA engineers and made famous in the 1995 movie. Now, in support of medical workers facing hardware shortages due to the coronavirus pandemic, several networks of volunteers are developing similarly MacGyver’d respiratory equipment using easy-to-find or printable parts.

Several such groups have taken on the open source mantle, and their stories illustrate some of the strengths and weaknesses of the wider open source movement.

One fast-moving team managed to use a 3D printer to produce 100 replacement valves for an Italian hospital’s intensive care unit, but was concerned that it might face legal threats from the original equipment manufacturer.

Another group is targeting a long list of supplies and devices, such as homemade hand sanitizer, 3D-printed face shields, nasal cannulas and ventilator machines. One company is prototyping an open-source oxygen concentrator. Some efforts are much lower-tech: One Indiana hospital asked volunteers to help sew facemasks following CDC guidelines.

The core idea is nothing new: anesthetist John Dingley and colleagues published free instructions for a low-cost emergency ventilator in 2010. But it may feel more urgent now that people are reading headlines about equipment shortages at hospitals in even the richest countries in the world.

One reason there often aren’t many manufacturers of a given medical device is the cost of getting the devices tested and approved for medical use. Even if the individual units don’t cost much, getting a medical device to market the usual way costs anywhere from $31 million to around $94 million, depending on the complexity and application, according to a 2010 estimate [PDF].

There are also issues with whether 3D-printed parts can be cleaned properly. Many ad hoc fixes won’t be as durable as products produced with an eye toward longer-term cost-effectiveness.

Still, moonshot-gone-wrong solutions may obtain expedited review from medical regulators for narrow uses, as is the case with the Open Source Ventilator Ireland group, which told Forbes it is getting a sped-up examination from Ireland’s regulator.

Michigan Technological University engineering professor Joshua M. Pearce, one of the editors of a forthcoming special issue of the journal HardwareX focusing on open source COVID-19 medical hardware, predicts that the U.S. Food and Drug Administration (FDA) will likely also waive some licensing requirements in the event of massive shortages.

“In the end I think it comes down to the Golden Rule: Do onto others as you would have them do onto you,” Pearce says. “I know I would be happy to have the option of even a partially tested open source ventilator if I had COVID19, needed it, and all the hospital systems were used.”

If volunteer medical device makers get past legal hurdles, they will also need to get in sync with patients and medical staff about what really works. 

The final users’ needs have often been “a minor part of the decision-making process” in commercial device development, wrote University of Pisa bioengineer Carmelo De Maria and colleagues in a chapter on open-source medical devices in the Clinical Engineering Handbook.

“Sometimes those people don’t have any competence in medical devices and they risk creating confusion,” De Maria says.

Already, some members of the Open Source COVID19 Medical Supplies group on Facebook have weighed in with that kind of criticism. One wrote: “None of the mask designs I’ve seen people printing here will do anything to stop the virus.” Another group member, a healthcare worker, pooh-poohed a thread devoted to an automatic bag valve, writing: “There is no real-life scenario an automated Ambubag would be useful. Everyone designing these can turn their skills elsewhere.”

That feedback, visible to any potential contributors, might help steer the group toward more viable solutions. One recent post, for example, suggested concentrating amateur efforts on lower-tech devices aimed at less critical patients, to free up first-line hardware for the most critical patients.

A different issue is coordinating all the digital Good Samaritans. One recently formed group, called Helpful Engineering, reported having over 3000 registered volunteers as of 19 March, and over 11,000 people on Slack, the messaging platform. (And you, newly remote worker, thought your office Slack was getting noisy.)

The speed with which people can talk about, and even design something online may be tantalizing, but it might not reflect how fast the output can spread in the real world. In the Clinical Engineering Handbook, De Maria and colleagues write that the growing ease with which people can make their own medical hardware makes it even more important to create accompanying rules and methods for validating do-it-yourself devices.

De Maria helped build Ubora, a platform where makers can document the work they have done to show their device’s efficacy.

“Open Source can create a reliable prototype but [when] you want to go to the next level you need another type of approach that has to take your brilliant idea, do an experiment together with experts before going to the patients,” De Maria says.

Generating widely affordable, easily buildable devices that withstand rigorous testing and are legal to distribute, even with the speed of open source and goodwill and skills of thousands of volunteers, may not happen as quickly as we need it to in order to suppress this pandemic.

That doesn’t make the effort a waste. Think of all the engineers who were inspired by the story of Apollo 13’s improvised scrubbers, and the institutional knowledge NASA gained for future missions. If the lessons of the hardware push in response to today’s COVID-19 outbreak stay in the open, they will be useful in the longer term.

With that in mind, De Maria and colleagues are challenging open source hardware makers with a competition calling for European-compliant medical designs that will be well-documented using Ubora. The first deadline is 30 April and awards won’t be presented until June.

“We created the competition looking for a solution, but in perspective,” De Maria says. Creating and validating systematic solutions will take months, not weeks.

While some smaller open source components have already received government approval for so-called “compassionate use” and spare parts such as those valves are welcome, it may be too late for them to make much of a difference in places still on the wrong side of the COVID-19 growth curve.

The real reward is saving lives in future pandemics.

Says Pearce: “I am operating under the assumption that… anything we do now will help for the next pandemic.”

IEEE Spectrum updated this story with quotes from De Maria.

Open/Close is a series of stories by Lucas Laursen for IEEE Spectrum that explores how openness and technology interact. The open source movement emerged from software, but has spread in many directions since, to hardware-focused Fab Labs and even voting booths. Openness offers plenty of tempting benefits: oversight by the crowd, preventing duplication of effort, and the ability to empower vulnerable people. But it also results in innumerable software forks, doesn’t always attract a critical mass of users, and can threaten privacy. This series will address how the tensions between open and closed technology are playing out in the engineering world.

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Restoring Hearing With Beams of Light

Gene therapy and optoelectronics could radically upgrade hearing for millions of people

13 min read
A computer graphic shows a gray structure that’s curled like a snail’s shell. A big purple line runs through it. Many clusters of smaller red lines are scattered throughout the curled structure.

Human hearing depends on the cochlea, a snail-shaped structure in the inner ear. A new kind of cochlear implant for people with disabling hearing loss would use beams of light to stimulate the cochlear nerve.

Lakshay Khurana and Daniel Keppeler
Blue

There’s a popular misconception that cochlear implants restore natural hearing. In fact, these marvels of engineering give people a new kind of “electric hearing” that they must learn how to use.

Natural hearing results from vibrations hitting tiny structures called hair cells within the cochlea in the inner ear. A cochlear implant bypasses the damaged or dysfunctional parts of the ear and uses electrodes to directly stimulate the cochlear nerve, which sends signals to the brain. When my hearing-impaired patients have their cochlear implants turned on for the first time, they often report that voices sound flat and robotic and that background noises blur together and drown out voices. Although users can have many sessions with technicians to “tune” and adjust their implants’ settings to make sounds more pleasant and helpful, there’s a limit to what can be achieved with today’s technology.


8 channels


64 channels

Since optogenetic therapies are just beginning to be tested in clinical trials, there’s still some uncertainty about how best to make the technique work in humans. We’re still thinking about how to get the viral vector to deliver the necessary genes to the correct neurons in the cochlea. The viral vector we’ve used in experiments thus far, an adeno-associated virus, is a harmless virus that has already been approved for use in several gene therapies, and we’re using some genetic tricks and local administration to target cochlear neurons specifically. We’ve already begun gathering data about the stability of the optogenetically altered cells and whether they’ll need repeated injections of the channelrhodopsin genes to stay responsive to light.

Our roadmap to clinical trials is very ambitious. We’re working now to finalize and freeze the design of the device, and we have ongoing preclinical studies in animals to check for phototoxicity and prove the efficacy of the basic idea. We aim to begin our first-in-human study in 2026, in which we’ll find the safest dose for the gene therapy. We hope to launch a large phase 3 clinical trial in 2028 to collect data that we’ll use in submitting the device for regulatory approval, which we could win in the early 2030s.

We foresee a future in which beams of light can bring rich soundscapes to people with profound hearing loss or deafness. We hope that the optical cochlear implant will enable them to pick out voices in a busy meeting, appreciate the subtleties of their favorite songs, and take in the full spectrum of sound—from trilling birdsongs to booming bass notes. We think this technology has the potential to illuminate their auditory worlds.

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