Most medical implants are manufactured to cover large groups of people with the same conditions. People suffering from specific diseases, with rare conditions are often left out. Now, with 3D printing, it is possible to produce implants designed exclusively for individual patients. However, 3D printing technology has advanced significantly, but significant clinical and legal challenges still exist. That prevents its wider adoption in many spheres of medicine.
In the recent study: “Challenges in the design and regulatory approval of 3D printed surgical implants: a two-case series”, a group of engineers, surgeons, and regulatory experts explore how 3D printed titanium implants can be a solution for patients with rare spinal conditions. The team reports its experience, particularly focusing on issues of logistics and legal matters that they had to overcome to make this possible.
Both patients exhibited ‘semi-urgent’ cases of spinal instability: one person with neurofibromatosis and another with vanishing bone disease. The cases were considered complex, and traditional techniques ineffective. The implants were designed based on patient CT scans and with the help of CAD software.
The 3D printed implants were made with direct metal printing and then tested for strength, as well as biocompatibility. The researchers point out that previously, surgeons had been concerned about using 3D printed titanium implants because of restrictive legislative regulations in the Netherlands, but throughout this study, the effectiveness of such patient-specific treatment with successful outcomes was emphasized.
Both surgeries went well and the patients had a great recovery process:
- The surgical procedure of the first patient took only 150 minutes, and there were no complications. The patient recovered well, went home in a week, and did well, despite a fatigue fracture that had to be repaired in one of the rods.
- The surgery of the second patient only took 120 minutes, and the patient did well afterward. After six months, the patient was walking normally again.
You can see the video abstract of the study in The Lancet:
“An exemption from the usual approval procedure for the use of personalized implants can be obtained in an emergency or exceptional-use situation when specific safety requirements are met. We believe that thorough and efficient interactions between medical engineers and physicians to establish well-designed frameworks to navigate the logistical and regulatory aspects of personalized implant development are necessary,” stated the researchers.
“These frameworks can be locally administered and managed to obtain legal clearance for personalized implants in an optimal manner; only then can the possibilities be effectively exploited and the expected increase in personalized solutions accommodated.”
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.
3D printed implants are a fascinating subject today, not only because there are so many different types, but because of the ability they have to change a patient’s quality of life.