219 Design: Helping the World Breathe Easier during COVID-19

by | Oct 5, 2020

219 Design has helped create a compact, inexpensive, and life-saving ventilator that can be easily stored and retrieved during an emergency. Having recently applied for Emergency Use Authorization (EUA) for this ventillator’s use during the COVID-19 pandemic, we interviewed the firm’s co-founder, Larry Miller, to compile suggestions from his team’s experience for other device designers wanting to help.


"On March 24, 2020, FDA issued an umbrella EUA in response to concerns about the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. This EUA authorizes the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance, and labeling..." - statement released by the FDA


1. Create a helpful product and the world will appreciate it


As the world has seen during the last few months, ventilators can save thousands—if not millions—of lives. Back in 2013, a decade after the SARS outbreak, 219 Design began working with OneBreath to design a low-cost ventilator. The project evolved to specifically target developing countries like India and China—areas that were either suffering from a shortage of ventilators or from having none at all. That project evolved into the OneBreath ventilator, which Stanford University dubbed “a biodesign success”.


In March, when the FDA released an EUA for ventilators, 219 Design again partnered with a Stanford BioEngineering lab, backed by Chan Zuckerberg Biohub to begin working on a new low-cost ventilator optimized to be inexpensive, immune to COVID-19’s supply chain challenges, and easily storable/retrievable in an emergency. The company that was formed to own this new product is named O2U.


The 219 Design team has always been dedicated to making products that help people. After this pandemic is over, they plan to work with O2U to get this ventilator approved for non-emergency usage too.


2. Be aware that the rarely-seen EUA can dramatically accelerate timelines


Every health-related object in a hospital—from tongue depressors to bed coverings — requires FDA approval. This process can take years for complex machines like ventilators. In the last couple decades, the FDA has issued only a few EUAs, which have the effect of drastically shortening the approval timeline. During the COVID-19 pandemic, hospitals currently need ventilators with great urgency, so the FDA is permitting designers to create and distribute them in a matter of months instead of years.


For a patient, an EUA-approved ventilator might sound concerning, but it does undergo a set of stringent requirements to determine that the EUA-approved ventilator is safe.


If you’re a medical device designer, EUA approval can be incredibly helpful. It allows you to get your product to market much faster and see how it works in vivo. Most importantly, it lets you help more people in need quickly. It is important to note that EUAs end once the emergency concludes, so planning to seek full FDA approval is highly recommended.


3. You can still use your optimized design process for an EUA


219 Design has an internal design process they use for all their devices. Their process for creating the ventilator for O2U followed these same standard steps, simply adjusted for COVID-19:


Stage One: Concept Exploration

Starting off with a blank slate, they figure out what kinds of design would solve their client’s problems. They ask questions like:

  • What is the product going to be?
  • How are we going to overcome any challenges?
  • What possibilities exist?


Stage Two: Concept Refinement

They take a broad range of possible designs and narrow that down to the final vision for the product through usability studies and technological feasibility studies using physical mockups.


Stage Three: Detailed Engineering

They develop a fully-functional prototype of the product, which may include mechanical designs, electronic designs, circuit boards, software, and firmware. In this engineering stage, they’re working out all the details of how the device will function and be manufactured.


Sometimes they hit a wall and have to rethink some of the assumptions they made at stage 2 (concept refinement), but eventually they arrive at a design that accomplishes what it needs to do.


Stage Four: Engineering Prototype

They ensure all the details exist correctly, ready to get out into the world. This process often involves a small production run of 10-20 devices for internal evaluations and user testing. When they’re done, they’ve refined a prototype to the precise design of how it will be made in production.


Stage Five: Production

They hand things off to a contract manufacturer so the necessary volumes of the product can be made smoothly.


Adjusting to COVID-19

For this ventilator, 219 Design still underwent all these stages, just in a compressed time frame. Given the importance of ventilators during this EUA, they wanted to get to stage 3 (detailed engineering) as quickly as possible.


Since COVID-19 prevented their team from working in proximity, the 219 Design team performed much of their communication through video calls at a distance. Stages 1 & 2 were a series of rapid meetings with clinical experts, therapists, and other ventilator experts.


Having started this project at the end of March, they now have the ventilator submitted to the FDA for EUA approval. As soon as approval is granted, O2U will engage the contract manufacturer for production.


Even during this EUA situation, 219 Design kept their design process intact, simply accelerating the timelines to fit the project.


4. Prioritize what matters for the emergency, and plan for contingencies


The ventilator couldn’t be designed from scratch within a few months while satisfying all the standard FDA requirements for a ventilator. The EUA provided a mechanism to relax some of the non-essential FDA requirements, so O2U and 219 Design developed a plan where they determined which requirements would be satisfied with the first version of the device and which would be satisfied with future versions. For any unmet requirements, they assessed the risk and documented the justifications for the decision.


During the design process, that mindfulness allowed them to cut development time down significantly, permitting 219 Design and O2U to choose alternatives to typical ventilator components that were unavailable (which happened very quickly after the FDA issued its COVID-19 EUA).Then, when they arrived at the testing stage, they narrowed down the set of tests that were performed to cover only the key requirements that the O2U ventilator meets. This narrow focus allowed them to provide the ventilator to the necessary hands much faster and with less cost than it otherwise would, while still performing the necessary functions of a ventilator for those in imminent need.


When O2U made the submission for EUA approval, they highlighted all of the requirements that the ventilator design met and didn’t meet, along with justifications for any non-compliance.


Conclusions


If you are currently involved in the medical device or treatment space and the FDA announces an EUA related to your area of expertise, it may be your time to help. You could get your product into the hands of patients much faster than you otherwise would, helping out with a necessary problem in real time.


Looking forward, O2U is awaiting feedback from the FDA and plans to engage a contract manufacturer to produce their new ventilator in high volume so that as many hospitals as possible can be prepared for the possibility of a sharp increase respiratory illness. 219 Design and O2U set out to make a low-cost ventilator that’s easily stockpiled, ready-to-deploy, and easy to manufacture. 219 Design is glad to be able to help during COVID-19 and when this pandemic is over, they’re looking forward to working with O2U to modify it for a 510k submission (FDA Premarket Notification) and thereby save even more lives.


Would you like help designing a medical device? Contact 219 Design.

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