Formlabs Guide to SLA Quality Control Management for Healthcare Innovators

From patient-specific anatomical models, to surgical guides, boluses, orthotic devices and more, the adoption of 3D printing in healthcare is on the rise. As the role of 3D printing in medicine rapidly expands, it is more important than ever that the quality of 3D printed parts meets the same quality standards as traditional manufacturing methods across applications. While it is the device manufacturer’s responsibility to validate the safety and efficacy of all products it produces, Formlabs aims to ease that process by providing guidance on quality control management for SLA parts, and confidence that technical expectations are being met. Here we discuss standard workflow checks, quality checks and preventative maintenance cadences, ensuring dimensional accuracy, what to do post-failure, and other best practices to help you meet regulatory requirements for end-use SLA parts.

When printing for medical applications, it is essential that the requirements and expectations for the printed part are clearly established between the requestor and the person or team doing the printing (Bastawrous et al., 2021). This information will help you to develop quality checks and standards for 3D printing. While each design will be unique, here are some considerations for establishing your own quality standards:

• What risk is associated with this part? Does it need to be dimensionally accurate or is it just a visual guide?
• What mechanical properties and regulatory clearances are needed for your application? Does the chosen material meet those requirements?
• What critical structures need to be captured? Is the printer technology and/or material capable of producing the necessary features of your design? This could include color, texture, biocompatibility, sterilization capabilities, dimensional accuracy, tolerances, specific geometric features of interest, etc.

The answers to these questions and overall expectations for the final printed part should be documented for later reference and can be used to create a checklist to guide the part review. Ideally, this conversation is ongoing between the requestors and printers as the STL is being iterated, a material is being decided upon, and the printer settings can be determined. If implemented inside a QMS, keeping records of these interactions and a final approval by the requestor before manufacturing is suggested. FORMLABS: Formlabs Guide to SLA Quality Control Management for Healthcare Innovators 4 Regardless of your manufacturing process, you will need to make some favorable design choices for the chosen technology. This is commonly called “Designing for Manufacturing.” The same holds true for 3D printing, where it is called “Design for Additive Manufacturing”. You will have the most success when you design your part for the 3D printing technology you’ve chosen.