Bioengineering Blog: FDA Looks for Input on Medical 3D Printing

Bioengineering Blog: FDA Looks for Input on Medical 3D Printing

Point-of-care 3D printing in hospitals is growing, and a regulatory framework is developing.
One of the first applications of 3D printing in healthcare was the production of highly realistic 3D-printed models of anatomical body parts used as training tools for medical students. As the technology advanced, 3D-printed patient-specific models allowed surgeons to view and plan in detail what is needed during surgery.

The technology is constantly improving, but it was proven as far back as 2017 when Chinese researchers printed the entire internal structure and surface of a liver in less than four hours. Their method created the model, including malignant tumors, for $80 to $90, aiding surgeons in performing difficult hepatic surgeries.

Now, medical 3D printing has reached the point where many hospitals, at least in the U.S. and Canada, have set up their own printing centers. In 2019, 113 facilities in the U.S. and Canada provided centralized 3D-printing services. Europe had 48 facilities, according to Statista.

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Momentum is building for 3D-printed medical models, becoming the standard of care for surgical planning and patient consent. Risky surgeries, many that previously would not even be attempted, are now being done because of these detailed models.

In late 2021, Formlabs announced it received a contract from Vizient to offer its 3D printers, materials, and solutions for converting CT/MR imaging into patient-specific anatomical replicas for surgical planning and patient consent. Vizient is the largest healthcare group purchasing organization in the nation, and the action confirms the technology’s place and needs in medicine.

The move comes after two years of the COVID-19 pandemic, where 3D printing became a staple in producing personal protective equipment and some single-use devices that were affected by large-scale shortages. While the technology’s potential to revolutionize healthcare is now well-documented, it still presents some challenges in point-of-care use.

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Now, the U.S. Food and Drug Administration is seeking input on the issue through a recent discussion paper outlining opportunities and challenges for the technology in point-of-care use. The agency is charged with regulating the technology and is looking for advice in four areas:
  • Assuring devices printed at the point of care are safe and effective.
    • FDA regulation is designed to provide a reasonable assurance that devices are safe and effective, regardless of where and how a product is manufactured.
  • Assuring appropriate control of devices 3D printed at the point of care.
    • “These approaches are well defined for traditional manufacturing but are less defined for 3D printing at PoC,” the paper noted.
  • Clarifying the responsible entity.
    • Specific requirements apply depending on the activities of an entity conducted across a device’s lifecycle. There may be an uncertainty of responsibilities for activities related to 3D printing at the point of care, including device design, testing, FDA premarket submissions, manufacturing, quality control, complaint handling, adverse event reporting, and corrective actions.
  • PoC training and capabilities.
    • Many 3D printing technologies are available; each has strengths and weaknesses for different clinical applications. Under many circumstances, the PoC facility could be responsible for complex processes, such as patient-matching or post-processing activities, to generate a final finished device. Additionally, devices can vary in risk depending on their intended use and technological characteristics. Therefore, the entities responsible for 3D printing at the PoC should have the requisite knowledge and expertise to conduct these activities.

​In the discussion paper, FDA recognizes that 3D printing technology is rapidly developing, and solutions arrived at today may not be appropriate in the future. “A durable solution will be built on a foundation of strong science, sensible clinical guidelines, and an appropriate regulatory approach that balances innovation with regulatory oversight. Such a solution can be created through stakeholder engagement, discussion, and consensus-building.”

​ John Kosowatz is senior editor

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