Additive manufacturing in the healthcare sector has moved beyond the promise phase to face its real challenges: scalability, regulation, and clinical application. Events like the upcoming RAPID + TCT 2026 will be crucial for this debate. The focus is no longer on whether a 3D-printed orthosis can be made, but on how to produce thousands of them repetitively, safely, and in compliance with strict regulations, without sacrificing the personalization that defines its medical value.
Standardize the process, not the product: the key to scaling 🏭
Experts like Shrenik Jain from iOrthotics point out that the path to mass production does not involve standardizing the final design, which must be unique for each patient, but rather standardizing and rigorously validating the manufacturing process. This involves fixed protocols for scanning, software-assisted design, material selection, printing parameters, and post-processing. A robust process enables the creation of orthoses with gradual properties, such as variable stiffness in a single piece, that adapt biomechanically to the user better than traditional methods, while maintaining the quality and traceability of each unit produced.
Beyond technology: collaboration and regulation 🤝
As consultant Laura Gilmour highlights, technical innovation is only part of it. Successful clinical translation requires close collaboration between engineers, clinicians, manufacturers, and technology companies to navigate the complex regulatory framework. The true value of specialized forums lies in facilitating these human connections, which are the catalyst for turning technical advances into effective, approved, and safe medical devices for the patient.
How can the gap between the unique customization of 3D orthoses and the scalability and regulatory requirements for their mass implementation in the healthcare system be bridged?
(PS: 3D prostheses are so customized that they even have a fingerprint.)