25 Mar Gilero’s Response to COVID-19
In response to the current COVID-19 pandemic, we at Gilero feel compelled to help. As a company that designs, develops and manufactures medical devices, we have the opportunity to make an impact by relieving some of the shortages of essential medical equipment.
Gilero’s response to the situation is three-tiered. First, we are developing immediate designs for improvised face shields and simple facemasks. We will provide open source CAD and instructions for making a 3D printed face shield using readily available materials such as a two-liter soda bottle. We have also designed an improvised facemask using fabric from a cotton t-shirt. Although the CDC website states that “homemade masks are not considered PPE, since their capability to protect HCP [healthcare personnel] is unknown,” there is anecdotal evidence to suggest that handmade, cotton masks may offer some protection when medical grade alternatives are not available. If the supply of surgical and N95 masks runs out, wearing a cotton facemask with a face shield overtop can provide some protection to healthcare workers.
We recognize that improvised PPE is not a solution to long term shortages. Tier 2 of Gilero’s response is to develop and manufacture reusable respirators and goggles in partnership with our operation in China. We are using our mold building and injection molding capabilities for each of these designs. The respirator will consist of an injection molded mask with filtration equivalent to N95 requirements that can be easily replaced. Gilero will be able to supply filter media and recommend multiple sources for alternative filter media. The mask itself will be fitted to the face and can be disinfected using standard disinfectants. By developing a reusable alternative to the disposable N95 mask, we hope to help combat PPE shortages while offering HCPs the same or better levels of protection as a single-use respirator. This endeavor will take a few weeks, but we are working quickly while following an appropriate risk-based approach in light of urgent needs.
Our team plans to make all of this information easily accessible and downloadable from a number of online sources. We also plan to produce some of these improvised PPE solutions and make them available to our local healthcare communities as they face shortages of necessary PPE.
Answering the challenge from various solicitations around the globe, the third tier of our approach is to develop an emergency ventilator. This is a collaborative effort between Gilero engineers skilled in medical device design, Adam Steege, founder of Trio Labs, and Huade Tan, a life support systems engineer. We are in the process of developing a ventilator that can be powered by pressurized air sources found at most hospital beds or portable air compressors, as well as a standard wall power outlet. Our first concepts mirrored those of several other open source designs, producing a mechanical fixture that activates a traditional resuscitator/Ambu bag. We found the approach lacking as it relies on the bag resilience and longevity. We also struggled to achieve higher breath frequency (up to 40 breaths/min) and higher tidal volumes for large patients. Our ventilator powered by facility air sources or secondarily by air compressors does not have this limitation.
If we can reasonably demonstrate that this design is safe, effective, and meets all of the requirements by the various solicitations that have been put out there, such as UK’s National Health Service (NHS), we will make the design available for download and construction by anyone skilled to do so in an open source format.
Gilero is also offering additional ventilator manufacturing capacity in our newly renovated medical device manufacturing facility in Pittsboro, North Carolina. This facility is scheduled to come online in 2020 with several medical devices. However, in the interim, we have available manufacturing space (both cleanroom and white room), as well as the necessary Quality Systems and FDA registration. Should a ventilator supplier with capacity limitations need assistance, we are making our facility and employees available to help.
As these projects progress, we will be accepting contributions of filter media for respirators, TPE materials, disposable HMEs and a number of electronic and mechanical components. Access to additional 3D printers would also be valuable. While Gilero is funding tiers 1 and 2 of this plan, we will seek outside funding for tier 3, the emergency ventilator.
We are putting our smart teams and wide range of capabilities to work on finding real, immediate solutions in the wake of COVID-19. Gilero does not plan to patent, or profit from, any of these designs. Instead, we aim to make these designs and assembly instructions, backed by our medical device expertise, freely available to anyone.