On 10 December, the US Food and Drug Administration’s (FDA) Centre for Devices and Radiological Health (CDRH) published a discussion paper and began seeking public input on 3D printing of medical devices at point-of-care (PoC) centres like hospitals. The paper goes into depth on the FDA’s perspective on the benefits, challenges and potential approaches for implementing policy development to prevent regulatory oversight. 3D printing medical devices at the PoC centres will allow for personalised care for patients and new innovations in this area. The discussion paper lists three possible scenarios in which 3D printing can be used for healthcare facility device manufacturing:
- A traditional manufacturer on or near the healthcare facility site that does not engage in any 3D printing activities. Instead, the healthcare facility develops a business relationship with the manufacturer, which will 3D print devices for the facility.
- 3D printing medical device production systems (MDPS) being used in PoC centres will have the MDPS manufacturer assume responsibilities for FDA regulatory requirements and manufacturing devices at the PoC centre using the MDPS.
- A PoC facility assumes all responsibilities and complies with FDA regulatory requirements applicable for device manufacturers.
Importantly, FDA regulations cover medical devices being made by 3D printers but not the 3D printers themselves. Because of this, the CDRH is developing a risk-based framework on how they will apply existing regulations and laws to cover the manufacturing of 3D-printed medical devices at healthcare facilities. The FDA is seeking public feedback to inform future policy development.
GlobalData projects that the global 3D printing market will be worth more than $60bn by 2030. According to GlobalData’s analysis, the main 3D printing market drivers are technology innovation, increased awareness from healthcare practitioners, and an ageing population with a consequent increase in demand for personalised treatment. Specifically, 3D printing will have the greatest impact on hospitals, medical devices manufacturers and education and research. Based on a case study done by GlobalData on two product lines (3D printed and traditional spinal interbody) from the same company in the US, the device sales of the 3D printed interbody recovered more quickly than traditional interbodies during Covid-19. The Covid-19 pandemic has expedited a trend in switching from traditional type devices as the cost of 3D printing decreases based on decreased material cost. As a result, as 3D printing continues to offer clinical efficacy and cost reductions, GlobalData expects the 3D printing market to continue to grow into the next year.