Navigating Verification & Validation Activities of a Medical Device Manufactured at the PoC

3D printing at healthcare facilities has significantly risen over the past decade. This rise has led to discussions around quality control and how point-of-care 3D printing facilities can control the design and manufacturing of their products. Verification and validation (V&V) activities are used to evaluate and ensure that requirements can be met for the intended use of a product. Additionally, from a regulatory standpoint, these verification and validation activities allow the safety and effectiveness of a medical device to be evaluated. The 3D Medical Applications Center (3D MAC) has performed verification and validation activities for their highest risk medical device, a metal cranial implant intended to fill bony voids in a patient’s skull. These activities were used to support the substantial equivalence of 3D MAC’s metal cranial implant compared to other legally marketed metal cranial implants in the 3D MAC premarket notification (510(k)) submission to the Food and Drug Administration (FDA).

This presentation will briefly discuss the verification and validation requirements for the metal cranial implant and include an in-depth discussion about the testing activities that were needed to support substantial equivalence of the titanium cranial implant. Based on various FDA regulations and guidance documents, 3D MAC developed the testing plan using a risk-based approach, identified the worst-case device configuration based on the design and manufacturing envelopes, and executed the testing. Finally, 3D MAC performed an analysis of the results of testing the metal cranial implant compared to legally marketed devices on the market. The details of these activities will be presented to provide insight into 3D MAC’s testing development and execution process, as well as how these activities were used to support 3D MAC’s FDA 510(k) submission.