This is a guest contribution by Egor Driagin, CMO at Top3DGroup
Usually, Formlabs sells 3D printers instead of printed products, but the company dedicated 250 3D printers to daily produce up to 100, 000 nasopharyngeal test swabs used for testing for Covid-19. The devices were produced at the company’s plant in Ohio and were previously used to produce dentistry test models that were used for selling.
The company delivered test swabs to the clinics that suffered from tools shortage. The list includes Northwell Health in New York and Tampa General Hospital in Florida.
David Lakatos, chief product officer at Formlabs in Somerville, Massachusetts, struggled to count how many healthcare facilities, clinics, and hospitals asked for help in the situation.
The pandemic overwhelmed the abilities of global supply chains for medical products, so several digital manufacturing companies decided to help.
During the times when clear and organized attempts at the federal level to increase the production capacities were lacking, a lot of production solutions were launched aiming to solve certain problems. Manufacturers, universities, healthcare institutions at both statewide and local levels are trying to find the companies that have the required abilities and experience. It’s done either by asking them directly or using networking to find such companies. Some commercial, research, and medical centers formed temporary coalitions to coordinate their actions.
Lowering critical shortages in supply chains could help stabilize the number of masks, test swabs, ventilators, and other products at a certain level in a short time. But 3D printing was mostly considered a temporary solution that is not perfect. The unorganized and non-focused approach that is common in the industry is far from perfect for manufacturing components and products that are important to keep the patients alive.
But in the end, the importance of 3D printing depended on how quickly the virus was spreading and how rapidly the manufacturers and suppliers would change their approaches and widen their abilities.
Vicky Holt, executive director at Protolabs, located in Maple Plain, Minnesota, mentioned that they didn’t have a lot of time to prepare. Protolabs specializes in making custom production using 3D printing and pressure molding. She added that the plan was to provide enough beds and intensive care units (ICU) before the pandemic peaks. The company gave the suppliers enough time to prepare.
A special research team that includes the specialists from South Florida University, Harvard, Stanford, and Beth Israel Deaconess Medical Center was actively working to standardize the production guideline for 3D printed test swabs. The group was consulting with the FDA and describing their experience on GitHub. In April 2020, they mentioned that several companies working on the project – including Formlabs, Carbon, Hewlett-Packard, and EnvisionTEC – were already preparing to release special swabs and would soon produce up to 4 million of them a week.
It was also mentioned that the clinics could ask emergency management agencies for required supplies.
Other efforts to use 3D printing to fight the pandemic include:
A company named Desktop Metal, located at Burlington, Massachusetts, launched a website for manufacturers where they could ask for metal components for medical devices in case of a limited supply.
Recently Redwood City based company Carbon collaborated with Verily to develop masks. This protective equipment can prevent infecting and spreading the virus among health care workers. During the beginning of the pandemic, several American clinics suffered from a shortage of such masks.
Prisma Health, a leading healthcare organization in South California, got their FDA approval to produce 3D printed VESper ventilator splitters that can be used to let 4 patients use one ventilator in case of serious breathing problems in case of shortage of ventilator supplies.
Formlabs also thought about producing ventilator splitters although the company considered it to be the last resort. American Society of Anesthesiologists and the American Association for Respiratory Care are against the idea of using one ventilator for several Covid-19 patients. They claim that it’s better to use a ventilator for one patient than failing to prevent the deaths of several people (or cause it).
According to Holt, Protolabs changed their business to solve medical product shortages in the US and Europe during the pandemic.
The company’s efforts included, among others, collaboration with the University of Minnesota in the development, testing, and setting of six parts for low-cost ventilators. They were authorized in April 2020. The open-source release happened in May 2020. Open design allows the clinics to manufacturing the product in case of shortage. The design includes the solution to regulate ambulatory ventilator bags. (MIT scientists also released a similar product)
Protolabs also makes components for large ventilator manufacturers but the name is kept a secret.
Regarding the safety of using 3D printed parts in medical devices which must be extremely reliable, Holt said that making fitting construction, testing and required actions are the responsibilities of their clients.
But manufacturing the products that interact with human bodies directly (such as test swabs) requires the companies to overcome normative barriers by themselves
Formlabs managed to quickly start producing test swabs in their plant in Ohio because their medical manufacturing efforts were FDA approved before. For example, dental products that were in direct contact with the human body: such as dental dams and crowns.
Formlabs work together with the USF Health and Northwell Health experts to accelerate the development and testing of test swabs. While they are relatively simple products, they must be thin, long, and flexible enough to go deep inside nasal cavities. If they don’t go deep enough, there’s a higher chance of false-negative Covid-19 test results. Lakatos mentions that this in turn will cause the patients to act normal that will spread the virus further.