Most medical implants are manufactured in quantity to cover large groups of people suffering from specific diseases. Those with rare conditions are often left out, but 3D printing, also known as additive manufacturing, now allows for the production of bespoke devices designed exclusively for individual patients. While 3D printing technology has advanced significantly over the past few decades, significant clinical and legal challenges exist that prevent its wider adoption in many spheres of medicine.
A diverse group of engineers, surgeons, and regulatory experts have been working together at the University Medical Center Utrecht, a major hospital in The Netherlands, to outfit two patients with rare spinal conditions with custom-made 3D printed metal implants. The team reports its experience in The Lancet, particularly focusing on issues of logistics and legal matters that they had to overcome to make this possible.
The implants, to treat one person with neurofibromatosis and another with vanishing bone disease, were designed based on patient CT scans and with the help of CAD software. They were then directly 3D printed using titanium.
To help pass the regulatory hurdles, the researchers worked with a department at Utrecht University that’s certified and experienced at handling legal matters involving new medical devices. Together, they created technical files, including risk analysis and the manufacturing process for the implants, and created a legal roadmap to allow for their eventual implantation. To go beyond the requirements, the team tested the implant prototypes in compression strength tests, performed finite-element analyses, and even tried them in cadavers.
Here’s a video abstract of the study in The Lancet:
Published study in The Lancet: Challenges in the design and regulatory approval of 3D-printed surgical implants: a two-case series
Via: UMC Utrecht
