Additive manufacturing for medical technology: guidelines for safe implementation

The demand for patient-specific products such as prostheses or implants is constantly growing. Their complex geometries and individual requirements make additive manufacturing processes an ideal solution. However, the strict regulations in medical technology and the validation of such production processes pose major challenges for companies. Together with the Mass Personalization Performance Center, Fraunhofer IPA has developed a guideline entitled “Holistic Framework for the Implementation and Validation of PBF-LB/M with Risk Management for Individual Products through Predictive Process Stability”, which supports medical technology companies in the safe and efficient introduction of additive manufacturing processes.

Compared to conventional production methods, additive manufacturing offers the advantage of realizing complex geometries without additional effort. One example is abutments, which serve as connecting elements between dental implants and prostheses. These often have to have individual angles in order to meet both functional and aesthetic requirements. With processes such as Laser Powder Bed Fusion with Metals (PBF-LBM), several such abutments can be produced in a single printing process, which saves both costs and time.

In addition to the technical possibilities, patient safety is the top priority. The manufacture of medical devices is subject to strict standards, such as ISO 14971, which requires comprehensive risk management. Validation processes are particularly necessary for individual products, as the properties can change due to different geometries. This requires precise process controls and a methodical approach.

“The potential of additive manufacturing for individual products is huge. With a systematic approach, suitable products and technologies can be identified and their risks managed,” explains Hajo Groneberg, one of the authors of the guide.

The guidelines published by Fraunhofer IPA offer companies a structured method for implementing additive manufacturing processes safely and meeting regulatory requirements. The guide shows how suitable technologies and products can be identified and how their risks can be systematically managed. This enables companies to ensure both the quality and safety of their products while fully exploiting the benefits of additive manufacturing.