RSNA Annual Meeting 2023

Bringing 3D printing and procedural planning technologies to the point of care can help providers personalize outcomes, increase efficiency and lower the cost of care. Additionally, on-site 3D printing can be leveraged to fill supply chain gaps, enabling the production of needed medical supplies on demand. However, many 3D print labs have yet to experience the full potential of what is possible.

Meet with our experts in Booth #8010 to learn how you can deliver anatomic models, surgical guides, patient-specific implants and more at your center.

Implementing Three Scenarios for Point-of-Care 3D Printing: Our Experience

Presented by Devarsh Vyas
Monday, November 27, 2023 at 11:00 am CT

Regulatory oversight of point-of-care (POC) 3D printing is a hot topic of discussion. Over the last 10 years, regulatory bodies have been collaborating with industry and hospital experts to define how to best regulate POC additive manufacturing (AM) of medical devices. In December 2021, the FDA published a discussion paper on the topic, defining three different scenarios for adopting POC AM:

• The POC uses a medical device production system (MDPS), which is a validated and approved turn-key solution that can be used at the POC to manufacture specific medical devices.
• The medical device manufacturer co-locates at the POC as one of its satellite sites to manufacture approved devices.
• The POC chooses to be a legal manufacturer itself by getting approval from the FDA to manufacture its own devices at the POC.

In this presentation, we will share our experience implementing the above-mentioned scenarios with hospitals and health systems of different sizes, needs and capabilities. We will share our learnings and factors to evaluate which is the right scenario for your health system, and we’ll discuss what the future might look like to maximize the value of 3D printing technology for healthcare providers and patients. Join us for the discussion and meet with us at booth #8010.