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Additive manufacturing and 3D printing gained adoption last year as companies broadened their approaches to create prototypes, emergency use and point-of-care products in a COVID environment. While it’s inspiring to see technology innovation, it’s critical to patient safety and product effectiveness that quality assurance guidelines evolve.
In a recent session, Factory of the Future: 3D Printing, Mobile Manufacturing and Beyond at MedCon 2021, FDA additive manufacturing experts shared new products they’re seeing and preliminary thoughts on creating a framework for future regulation.
New 3D Printing Technologies
In response to COVID-19, manufacturers 3D-printed face masks, face shields and nasal swabs. However, the pandemic also led industry to realize the technology’s limitations.
“COVID-19 showed us the need for and utility of and challenges with 3D printing,” said Cmrd. James Coburn from FDA’s Office of Computational Science and Office of Counterterrorism and Emerging Threats.
While mobile and deployable manufacturing can help fill gaps when large suppliers are offline and provide products on-location where needed, the lack of assurance around product quality and safety became apparent and concerning, Coburn said.
These concerns led FDA to partner with the National Institutes of Health and Department of Veterans Affairs along with nonprofit America Makes – driven by the National Center for Defense Manufacturing and Machining – to help relieve shortages and bring order.
“We wanted to set up a way to give people confidence in what they were 3D printing backed by science,” Coburn said. “This is important as we move from nasal swabs to bigger things, say, someone’s jaw.”
FDA and its partners continue to bring quality assurance into additive and 3D printing as new processes and technologies emerge. Most new technologies center around intensifying manufacturing processes to bring them into small containers. In his presentation, Coburn shared several examples he’s seen:
Pharmaceuticals: The Massachusetts Institute of Technology is looking at making pharmaceuticals in a refrigerator-sized box. The system uses raw materials to rapidly produce different medications, including controlling and monitoring manufacturing and purification of pharmaceutical-grade compounds.
Biologics: The University of Maryland Baltimore County has found a way to manufacture large-molecule biologics in a briefcase-sized lab. The technology could make biologics on-demand in a portable and inexpensive fashion.
Tissue engineering: A public/private partnership between the Advanced Regenerative Manufacturing Institute and Biofab USA explores tissue engineering using frozen cell vials in an automated process, through which they become a completely expanded tissue culture that can be used to create a tendon or other thin membrane tissue without intervention.
Other emerging processes Coburn sees in addition to 3D printing include:
In situ monitoring for additive manufacturing, “allowing monitoring specifications and taking action during manufacturing.”
Continuous manufacturing, from raw material to a finished product in other areas like drugs. “Working on each piece as a unit may provide better resolution when things go wrong.”
Artificial intelligence and machine learning, especially with software as a medical device. “These can be decision aids for diagnosis, maybe recommending specialist review or a second opinion.”
Adaptive controls. “The COVID-19 vaccine development is one example. Based on a known standard, you can incorporate algorithms to look at the process to find opportunity to modify and improve quality.”
Coburn said that FDA is taking steps from the quality management system process to build quality controls appropriate for mobile manufacturing units.
“We’re thinking about what is most necessary and what can be taken to the laboratory and put into a box,” he said.
Point of Care Printing
Matthew Di Prima, Ph.D., of FDA’s Office of Science and Engineering Laboratories, picked up the discussion looking at industry from an operational perspective. Printing at the point of care is ongoing for a variety of applications such as prototypes, surgical instruments and dental applications. While the concept remains controversial for implants amongst players in orthopedics, FDA is creating a framework for the use of the technology in the hospital setting.
Dr. Di Prima shared a conceptual framework for 3D printing at the point of care for discussion purposes, including considerations such as:
- Availability of innovative products
- Safety and effectiveness regardless of manufacturing process
- Proper quality control to meet product specifications and minimize patient risk
- Equipping personnel and organizations with necessary knowledge and expertise
- Clearly identifying responsible parties for activities during the medical device total product life cycle
FDA seeks to take a risk-based approach to the framework to ensure that device specifications are identified and maintained, regardless of manufacturing location. According to Dr. Di Prima, the department thinks that there are capabilities available at the point of care to help mitigate production risks and ensure all entities are clear about their responsibilities. Many hospitals and other points of care have existing controls, which FDA hopes to leverage in its regulations.
“We understand that 3D printing is happening at point of care and it’s a great application of the mobile industry,” Dr. Di Prima said. “We don’t want to inhibit this innovation, but we need to ensure patient safety and effectiveness is maintained.”
Kathie Taylor is a BONEZONE Contributor.
