Healthcare staff provide lifesaving care to those in need. However, healthcare workers on the frontlines often put their own health at risk to treat patients with infectious diseases. Concerns over healthcare worker safety have mounted in response to the COVID-19 pandemic, as many healthcare workers are in close contact with patients who have the virus. To decrease exposure to COVID-19 (and other infectious diseases), workers need reliable medical equipment designed for this purpose.
Consider the case study of the Airway/Respiratory Containment (ARC) system developed by Texas Children’s Hospital ® in collaboration with Pacific Research Labs and Sawbones. This case study showcases why manufacturing medical equipment is absolutely vital and explains how the creators of the ARC system overcame multiple challenges to design a product that could help healthcare workers in a global emergency.
The ARC System: A Case Study
Texas Children’s Hospital® began developing the ARC system soon after the global COVID-19 pandemic began. Many Texas Children’s Hospital® staff members collaborated on the project together, including Medical Director of Emergency Management Brent Kaziny, respiratory therapist Richard Nguyen, and nurse practitioner Michael Pickett (who also designed and developed the RediStik line of products for healthcare workers).
Here’s how the ARC team designed, prototyped, and manufactured this new piece of equipment with help from Pacific Research Labs.
|The ARC design team had their work cut out for them from the very start. When they first began designing the ARC system, there was a great deal of uncertainty surrounding the virus and how it could potentially impact healthcare workers.
First of all, there was no way to tell with certainty whether patients had the virus unless they underwent testing. So, every patient visiting the emergency room in need of intubation would have to be treated as if they had COVID-19 to reduce risk to healthcare workers.
There was yet another problem, however. At the time, infectious disease experts strongly suspected that the virus was spread through respiratory aerosols. This included common exposure sources like sneezing, coughing, talking, or breathing, but it also included high risk medical procedures like respiratory intubation.
Respiratory intubation involves inserting a tube through the mouth and airways of a patient to enable them to breathe. It’s meant for patients who are unconscious, are going under anesthetic, or who are unable to breathe on their own. This includes patients who are diagnosed with COVID-19, as some patients experience severe difficulty breathing without assistance.
The problem with performing this procedure during the COVID-19 pandemic is that it’s an aerosol-generating procedure (AGP), meaning that it comes with an even higher risk of spreading infectious aerosols to healthcare workers.
In order for workers to perform this procedure safely, they needed a barrier between them and their patients to decrease their exposure to infectious aerosols. Healthcare workers also needed this solution fast, since many were already at risk of exposure while they waited for the equipment to be developed.
So, the ARC team got to work immediately on the first prototypes of an airway containment system for intubation.
|The ARC design team started off with a simple cardboard prototype to determine the rough dimensions of the system. In just one week, the team made four different cardboard prototypes like the one below.
The goal was to make a barrier that workers could quickly and easily put over a patient before they were intubated. Then, workers would place their gloved arms inside the barrier through protective openings to perform the intubation.
During this cardboard prototyping stage, respiratory therapist Richard Nguyen discovered a method for getting negative airflow to reduce exposure to infectious aerosols. By placing the system over the head and shoulders of the patient before the procedure began, there was less risk of direct aerosol exposure.
That weekend, using the cardboard models for reference, Nguyen then made a new prototype out of PVC and plastic.
He brought the prototype to the design team the following week and the team made adjustments to the prototype based on factors like:
The prototypes grew more complex as the project went on. For instance, the hospital facility donated plexiglass to use in prototypes so healthcare workers could test visibility. This was vital, as workers needed to see precisely what they were doing to insert the tube into the airway safely and with as little discomfort to the patient as possible.
After coming up with a working design and prototype, the ARC team then contacted Pacific Research Labs to help them refine the design and fabricate it. The hospital had worked with Pacific Research Labs before while designing the RediStik line of products, and they knew that the company was experienced with manufacturing medical equipment.
Pacific Research Labs collaborated closely with the team to improve the design for manufacturing. For example, during one of these collaborative sessions, the team determined that if they connected large tubing with a filter to the airway respiratory containment system, they could achieve an exceptional flow rate of 42 liters per second.
Texas Children’s Hospital ® is already using the latest physical model made by Sawbones in a pilot program across various departments in the facility.
|Pacific Research Labs fabricated and delivered the first ARC models to Texas Children’s Hospital ®, where they are being used by frontline workers and simulation teams in the emergency room. Staff are also in the process of performing systems testing and workflow management. Their goal is to finalize an ideal workflow for the ARC and share this information with other institutions, so they can use the system as well.
The next step will be to continue the implementation phase throughout the hospital and perform multiple studies to determine whether the ARC is confirmed to be effective.
The ARC is an open source project, meaning that anyone can download the fabrication plans from Sawbones and manufacture the medical equipment for their own facilities. The ARC design team and Pacific Research Labs strongly believed in keeping this project open to the public, as their primary goal was to decrease healthcare workers’ exposure to infections and help them feel more comfortable at work. They want as many facilities as possible to have access to this equipment if it’s proven effective.
Despite the short development timeline and complex nature of designing medical equipment, Texas Children’s Hospital ® and Pacific Research Labs have created a product that could have a lasting impact on the medical profession.
Tips for Manufacturing Medical Equipment with Global Impact
The number one tip product creators should remember when manufacturing medical equipment is to get feedback on the design as early and often as possible. ARC co-creator Michael Pickett explains that multiple experts were involved in every aspect of the design, prototyping, and fabrication process. Having actual healthcare workers on the team was important because they could provide invaluable feedback on the design, ergonomics, visibility, and ease of storage. These are details an engineer may not know to include due to lack of experience intubating patients.
Likewise, engineers at Pacific Research Labs were able to translate these design ideas into working prototypes and models that could be easily and quickly fabricated at a relatively low cost. With collaborative effort from both sets of teams, the ARC system was developed in just two and a half months, which was immensely important in response to the pandemic. If you want to get your product on the market as fast as possible, it’s best to work with an experienced contract manufacturer that has the capabilities necessary to produce short runs of quality products in a brief timeframe.
Looking to the future, ARC designers hope that this will be a long term solution that healthcare workers can use even in a post-pandemic world. This is a product that could potentially reduce exposure to other infectious diseases and it may even become part of a facility’s standard workflow. There will always be a need for safe medical equipment and innovations, and with help from skilled engineers, creators can design equipment that has a meaningful impact on workers’ lives.
Optimize Your Medical Device Product Development
If you want to start manufacturing medical equipment that makes a difference in the world, Pacific Research Laboratories and Sawbones can help. Whether you already have a product you want to fabricate or you need some help in refining your design, you can visit our contact page or call (206) 408-7603.